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Proclivity ID
18811001
Unpublish
Citation Name
OBG Manag
Specialty Focus
Obstetrics
Gynecology
Surgery
Negative Keywords
gaming
gambling
compulsive behaviors
ammunition
assault rifle
black jack
Boko Haram
bondage
child abuse
cocaine
Daech
drug paraphernalia
explosion
gun
human trafficking
ISIL
ISIS
Islamic caliphate
Islamic state
mixed martial arts
MMA
molestation
national rifle association
NRA
nsfw
pedophile
pedophilia
poker
porn
pornography
psychedelic drug
recreational drug
sex slave rings
slot machine
terrorism
terrorist
Texas hold 'em
UFC
substance abuse
abuseed
abuseer
abusees
abuseing
abusely
abuses
aeolus
aeolused
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aholeed
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aholees
aholeing
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alcohol
alcoholed
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alcoholes
alcoholing
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allmaned
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alted
altes
alting
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analer
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anilingused
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anus
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areola
areolaed
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aryaned
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aryaning
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asiaed
asiaer
asiaes
asiaing
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asias
ass
ass hole
ass lick
ass licked
ass licker
ass lickes
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assbangedes
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asshated
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azz
azzed
azzer
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azzing
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beardedclamed
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beardedclames
beardedclaming
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beastialityed
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beastialityes
beastialitying
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beatched
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beatered
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biatched
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biatching
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biatchs
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big titsed
big titser
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bisexualed
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bitched
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bitching
bitchly
bitchs
bitchy
bitchyed
bitchyer
bitchyes
bitchying
bitchyly
bitchys
bleached
bleacher
bleaches
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bleachly
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blow job
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blow jobes
blow jobing
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boink
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boinkes
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bollock
bollocked
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bollocks
bollocksed
bollockser
bollockses
bollocksing
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bollockss
bollok
bolloked
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boner
bonered
bonerer
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bonering
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bonerser
bonerses
bonersing
bonersly
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bong
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bonges
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boob
boobed
boober
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boobies
boobiesed
boobieser
boobieses
boobiesing
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boobiess
boobing
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boobser
boobses
boobsing
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boobyes
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boogered
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boogering
boogerly
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bookie
bookieed
bookieer
bookiees
bookieing
bookiely
bookies
bootee
booteeed
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booteees
booteeing
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bootieed
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bootieing
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bootyed
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bootyes
bootying
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boozeed
boozeer
boozees
boozeing
boozely
boozer
boozered
boozerer
boozeres
boozering
boozerly
boozers
boozes
boozy
boozyed
boozyer
boozyes
boozying
boozyly
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bosomed
bosomer
bosomes
bosoming
bosomly
bosoms
bosomy
bosomyed
bosomyer
bosomyes
bosomying
bosomyly
bosomys
bugger
buggered
buggerer
buggeres
buggering
buggerly
buggers
bukkake
bukkakeed
bukkakeer
bukkakees
bukkakeing
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bukkakes
bull shit
bull shited
bull shiter
bull shites
bull shiting
bull shitly
bull shits
bullshit
bullshited
bullshiter
bullshites
bullshiting
bullshitly
bullshits
bullshitsed
bullshitser
bullshitses
bullshitsing
bullshitsly
bullshitss
bullshitted
bullshitteded
bullshitteder
bullshittedes
bullshitteding
bullshittedly
bullshitteds
bullturds
bullturdsed
bullturdser
bullturdses
bullturdsing
bullturdsly
bullturdss
bung
bunged
bunger
bunges
bunging
bungly
bungs
busty
bustyed
bustyer
bustyes
bustying
bustyly
bustys
butt
butt fuck
butt fucked
butt fucker
butt fuckes
butt fucking
butt fuckly
butt fucks
butted
buttes
buttfuck
buttfucked
buttfucker
buttfuckered
buttfuckerer
buttfuckeres
buttfuckering
buttfuckerly
buttfuckers
buttfuckes
buttfucking
buttfuckly
buttfucks
butting
buttly
buttplug
buttpluged
buttpluger
buttpluges
buttpluging
buttplugly
buttplugs
butts
caca
cacaed
cacaer
cacaes
cacaing
cacaly
cacas
cahone
cahoneed
cahoneer
cahonees
cahoneing
cahonely
cahones
cameltoe
cameltoeed
cameltoeer
cameltoees
cameltoeing
cameltoely
cameltoes
carpetmuncher
carpetmunchered
carpetmuncherer
carpetmuncheres
carpetmunchering
carpetmuncherly
carpetmunchers
cawk
cawked
cawker
cawkes
cawking
cawkly
cawks
chinc
chinced
chincer
chinces
chincing
chincly
chincs
chincsed
chincser
chincses
chincsing
chincsly
chincss
chink
chinked
chinker
chinkes
chinking
chinkly
chinks
chode
chodeed
chodeer
chodees
chodeing
chodely
chodes
chodesed
chodeser
chodeses
chodesing
chodesly
chodess
clit
clited
cliter
clites
cliting
clitly
clitoris
clitorised
clitoriser
clitorises
clitorising
clitorisly
clitoriss
clitorus
clitorused
clitoruser
clitoruses
clitorusing
clitorusly
clitoruss
clits
clitsed
clitser
clitses
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clitsly
clitss
clitty
clittyed
clittyer
clittyes
clittying
clittyly
clittys
cocain
cocaine
cocained
cocaineed
cocaineer
cocainees
cocaineing
cocainely
cocainer
cocaines
cocaining
cocainly
cocains
cock
cock sucker
cock suckered
cock suckerer
cock suckeres
cock suckering
cock suckerly
cock suckers
cockblock
cockblocked
cockblocker
cockblockes
cockblocking
cockblockly
cockblocks
cocked
cocker
cockes
cockholster
cockholstered
cockholsterer
cockholsteres
cockholstering
cockholsterly
cockholsters
cocking
cockknocker
cockknockered
cockknockerer
cockknockeres
cockknockering
cockknockerly
cockknockers
cockly
cocks
cocksed
cockser
cockses
cocksing
cocksly
cocksmoker
cocksmokered
cocksmokerer
cocksmokeres
cocksmokering
cocksmokerly
cocksmokers
cockss
cocksucker
cocksuckered
cocksuckerer
cocksuckeres
cocksuckering
cocksuckerly
cocksuckers
coital
coitaled
coitaler
coitales
coitaling
coitally
coitals
commie
commieed
commieer
commiees
commieing
commiely
commies
condomed
condomer
condomes
condoming
condomly
condoms
coon
cooned
cooner
coones
cooning
coonly
coons
coonsed
coonser
coonses
coonsing
coonsly
coonss
corksucker
corksuckered
corksuckerer
corksuckeres
corksuckering
corksuckerly
corksuckers
cracked
crackwhore
crackwhoreed
crackwhoreer
crackwhorees
crackwhoreing
crackwhorely
crackwhores
crap
craped
craper
crapes
craping
craply
crappy
crappyed
crappyer
crappyes
crappying
crappyly
crappys
cum
cumed
cumer
cumes
cuming
cumly
cummin
cummined
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cummines
cumming
cumminged
cumminger
cumminges
cumminging
cummingly
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cumminly
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cums
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cumshoted
cumshoter
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cumshoting
cumshotly
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cumshotsed
cumshotser
cumshotses
cumshotsing
cumshotsly
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cumsluted
cumsluter
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cumsluting
cumslutly
cumsluts
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cumstained
cumstainer
cumstaines
cumstaining
cumstainly
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cunilingus
cunilingused
cunilinguser
cunilinguses
cunilingusing
cunilingusly
cunilinguss
cunnilingus
cunnilingused
cunnilinguser
cunnilinguses
cunnilingusing
cunnilingusly
cunnilinguss
cunny
cunnyed
cunnyer
cunnyes
cunnying
cunnyly
cunnys
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cunted
cunter
cuntes
cuntface
cuntfaceed
cuntfaceer
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cuntfaceing
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cuntfaces
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cunthuntered
cunthunterer
cunthunteres
cunthuntering
cunthunterly
cunthunters
cunting
cuntlick
cuntlicked
cuntlicker
cuntlickered
cuntlickerer
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cuntlickerly
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cuntlickes
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cuntly
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cuntser
cuntses
cuntsing
cuntsly
cuntss
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dagoed
dagoer
dagoes
dagoing
dagoly
dagos
dagosed
dagoser
dagoses
dagosing
dagosly
dagoss
dammit
dammited
dammiter
dammites
dammiting
dammitly
dammits
damn
damned
damneded
damneder
damnedes
damneding
damnedly
damneds
damner
damnes
damning
damnit
damnited
damniter
damnites
damniting
damnitly
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damnly
damns
dick
dickbag
dickbaged
dickbager
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dickbaging
dickbagly
dickbags
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dickdippered
dickdipperer
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dickdippering
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dicker
dickes
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dickfaceed
dickfaceer
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dickfaceing
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dickheaded
dickheader
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dickheading
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dickheadsing
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dickishly
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dickly
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dicksipper
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dickweed
dickweeded
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dickweedly
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dickwhipperer
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dickzipper
dickzippered
dickzipperer
dickzipperes
dickzippering
dickzipperly
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diddle
diddleed
diddleer
diddlees
diddleing
diddlely
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dikeing
dikely
dikes
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dildoed
dildoer
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dildoing
dildoly
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dildosing
dildosly
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diligafed
diligafer
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diligafing
diligafly
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dillweed
dillweeded
dillweeder
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dillweeding
dillweedly
dillweeds
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dimwited
dimwiter
dimwites
dimwiting
dimwitly
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dingle
dingleed
dingleer
dinglees
dingleing
dinglely
dingles
dipship
dipshiped
dipshiper
dipshipes
dipshiping
dipshiply
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dizzyed
dizzyer
dizzyes
dizzying
dizzyly
dizzys
doggiestyleed
doggiestyleer
doggiestylees
doggiestyleing
doggiestylely
doggiestyles
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doggystyleer
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doggystyleing
doggystylely
doggystyles
dong
donged
donger
donges
donging
dongly
dongs
doofus
doofused
doofuser
doofuses
doofusing
doofusly
doofuss
doosh
dooshed
doosher
dooshes
dooshing
dooshly
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dopeyed
dopeyer
dopeyes
dopeying
dopeyly
dopeys
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douchebaged
douchebager
douchebages
douchebaging
douchebagly
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douchebagsed
douchebagser
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douchebagsing
douchebagsly
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doucheer
douchees
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douchely
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doucheyes
doucheying
doucheyly
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drunked
drunker
drunkes
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drunkly
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dumassed
dumasser
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dumassly
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dumbass
dumbassed
dumbasser
dumbasses
dumbassesed
dumbasseser
dumbasseses
dumbassesing
dumbassesly
dumbassess
dumbassing
dumbassly
dumbasss
dummy
dummyed
dummyer
dummyes
dummying
dummyly
dummys
dyke
dykeed
dykeer
dykees
dykeing
dykely
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dykeser
dykeses
dykesing
dykesly
dykess
erotic
eroticed
eroticer
erotices
eroticing
eroticly
erotics
extacy
extacyed
extacyer
extacyes
extacying
extacyly
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extasyed
extasyer
extasyes
extasying
extasyly
extasys
fack
facked
facker
fackes
facking
fackly
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fag
faged
fager
fages
fagg
fagged
faggeded
faggeder
faggedes
faggeding
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faggeds
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fagges
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faggited
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faggites
faggiting
faggitly
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faggly
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faggoter
faggotes
faggoting
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faggs
faging
fagly
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fagoted
fagoter
fagotes
fagoting
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fagser
fagses
fagsing
fagsly
fagss
faig
faiged
faiger
faiges
faiging
faigly
faigs
faigt
faigted
faigter
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faigting
faigtly
faigts
fannybandit
fannybandited
fannybanditer
fannybandites
fannybanditing
fannybanditly
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farter
fartes
farting
fartknocker
fartknockered
fartknockerer
fartknockeres
fartknockering
fartknockerly
fartknockers
fartly
farts
felch
felched
felcher
felchered
felcherer
felcheres
felchering
felcherly
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felches
felching
felchinged
felchinger
felchinges
felchinging
felchingly
felchings
felchly
felchs
fellate
fellateed
fellateer
fellatees
fellateing
fellately
fellates
fellatio
fellatioed
fellatioer
fellatioes
fellatioing
fellatioly
fellatios
feltch
feltched
feltcher
feltchered
feltcherer
feltcheres
feltchering
feltcherly
feltchers
feltches
feltching
feltchly
feltchs
feom
feomed
feomer
feomes
feoming
feomly
feoms
fisted
fisteded
fisteder
fistedes
fisteding
fistedly
fisteds
fisting
fistinged
fistinger
fistinges
fistinging
fistingly
fistings
fisty
fistyed
fistyer
fistyes
fistying
fistyly
fistys
floozy
floozyed
floozyer
floozyes
floozying
floozyly
floozys
foad
foaded
foader
foades
foading
foadly
foads
fondleed
fondleer
fondlees
fondleing
fondlely
fondles
foobar
foobared
foobarer
foobares
foobaring
foobarly
foobars
freex
freexed
freexer
freexes
freexing
freexly
freexs
frigg
frigga
friggaed
friggaer
friggaes
friggaing
friggaly
friggas
frigged
frigger
frigges
frigging
friggly
friggs
fubar
fubared
fubarer
fubares
fubaring
fubarly
fubars
fuck
fuckass
fuckassed
fuckasser
fuckasses
fuckassing
fuckassly
fuckasss
fucked
fuckeded
fuckeder
fuckedes
fuckeding
fuckedly
fuckeds
fucker
fuckered
fuckerer
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Total abdominal hysterectomy the Mayo Clinic way

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Total abdominal hysterectomy the Mayo Clinic way

The abdominal approach to hysterectomy remains the most common route to hysterectomy in the United States. Its greatest advantage: It allows the uterus to be removed intact.1–3

The recent US Food and Drug Administration (FDA) warning against the use of power morcellation in women with known or suspected uterine malignancy has left many gynecologic surgeons wondering what might be the optimal approach to the removal of a large uterus.4

Although most hysterectomies are performed for benign conditions—namely, uterine fibroids—malignancy should be considered in the differential diagnosis. When hysterectomy is performed laparoscopically, a large uterus must be morcellated intraperitoneally. Since the FDA safety communication was issued, some hospitals have imposed a moratorium on the use of power morcellators for removal of uterine tissue until more definitive evidence is put forth regarding safety and best practices. This chain of events allows us an opportunity to review the basics of abdominal hysterectomy.

For the sake of this discussion, I will assume that the hysterectomy is being performed for a benign indication as I highlight the Mayo Clinic approach to total abdominal hysterectomy (TAH).5

Preoperative considerations
The patient should be medically able to undergo operative intervention. If she has preexisting medical conditions, preoperative clearance should be obtained from her primary care provider, and her medical conditions should be optimized prior to surgical intervention.

Baseline laboratory studies include a complete blood count, electrolyte panel, glucose assessment, and an electrocardiogram (EKG). Bowel prep typically is not required. Provisions should be made to prevent deep venous thrombosis (DVT), usually by utilizing sequential compression devices, based on the individual patient’s risk factors.6,7

A prophylactic antibiotic to prevent surgical site infection (often a first-generation cephalosporin) should be given as a single intravenous (IV) dose prior to the incision.8 If bacterial vaginosis is present, treatment prior to surgery can reduce the frequency of vaginal cuff infection.9

Again, for the sake of this discussion, I will assume that malignancy has been ruled out.

Positioning and preparation
After induction of anesthesia, position the patient either in a dorsal supine (traditional) or lithotomy (yellow-fin stirrups) position and reexamine her to confirm the findings of the pelvic exam. If the patient is positioned in the supine position, use ankle straps to prevent her from moving as the Trendelenburg position advances during the procedure.

Prep the abdominal skin with a bactericidal agent (most often a povidone-iodine solution). Also prep the vagina with a povidone-iodine solution because the vaginal cuff will be opened during the TAH. Place a transurethral catheter to drain urine throughout the case. Use of a three-way catheter allows the bladder to be easily backfilled during the procedure for identification of its borders or assessment of its integrity.

Last, incorporate a surgical pause prior to the incision to confirm that you have the right patient, know the procedure and incision planned, and are aware of any allergies. Also confirm that antibiotics have been given.

Operative technique
Intraoperative principles
A planned approach avoids wasteful time and motion, and an adequate incision allows for sufficient exposure, which is critical but often underappreciated by the novice surgeon. We prefer a midline incision because it allows the most flexibility to adapt to intraoperative findings, but a Pfannenstiel incision also is an option.

Fixed retraction is paramount to “set up” exposure for the remainder of the case. We prefer a Balfour fixed retractor but, with smaller uteri, a self-retaining Alexis retractor (Applied Medical, Rancho Santa Margarita, California) affords decent exposure and may cause less postoperative abdominal wall discomfort; it also avoids the possibility of retractor-related neuropathy.

Moistened abdominal packing allows the bowel to be packed into the upper abdomen for the remainder of the case, which facilitates consistent exposure of the operative field. Adequate lighting is essential, as is one or more knowledgeable assistants.

Use sharp dissection throughout the procedure. Clean, sharp dissection averts ­injury to adjacent structures, such as the ureter, bladder, and rectum, and promotes recognition of any injuries, permitting immediate repair.

The application of proper traction and counter-traction on tissues allows accurate definition of the correct tissue planes and facilitates identification of important anatomic structures. Vital structures should be identified and, if necessary, mobilized before any clamps are placed or pedicles transected. Adhesions should be sharply lysed to facilitate exposure.

Freeing the bladder anteriorly and the rectum posteriorly prevents their inadvertent inclusion in closure of the vagina and minimizes the risk of fistula formation. The bladder and rectum should be sharply mobilized at least 1 cm beyond the site of planned vaginal transection.

Last, excellent support of the vaginal wall can be provided by securing the uterosacral-cardinal ligaments to the corners of the vaginal vault.

Identify the ureter

FIGURE 1: Place straight Kocher clamps to facilitate traction during the operation.

FIGURE 2: Clamp and divide the right round ligament, opening the broad ligament.

FIGURE 3: Identify the right ureter along the medial leaf of the broad ligament.

Identifying the ureter
Once good exposure and adequate Trendelenburg position are achieved, place ­Kocher clamps across the cornual portion of the uterus (incorporating the round ligament, tube, and utero-ovarian pedicle) (­FIGURE 1). This facilitates continuous traction and prevents back bleeding throughout the case.

With traction applied to the left, identify the right round ligament, clamp it with a ­Kocher clamp, and transect it. Incise the peritoneum parallel to the uterus and gonadal vessels (FIGURE 2). This opens the broad ligament and allows identification of the critical underlying structures (ureter, external and internal iliac vessels). Following the medial leaf of the broad ligament downward, identify the ureter by both visualization and palpation (FIGURE 3).

Although I do not discuss salpingo-­oophorectomy in this article, be aware that the ureter is at risk when clamping the gonadal vessels near the pelvic brim.

Once the ureter is identified, create a window in the broad ligament above the ureter. In a medial to lateral fashion, place your index finger through that peritoneal window, making certain the ureter is below and out of the way. Place a Kocher clamp across the tube and utero-ovarian pedicle, and transect and suture-ligate the pedicle (preserving the tube and ovary). Repeat this procedure on the patient’s left side, using traction and counter-traction to facilitate exposure (FIGURE 4).

Mobilizing the bladder
With the assistant providing upward traction on the uterus, use Russian forceps to ele­vate the peritoneum overlying the bladder. Undermine and incise the peritoneum from the patient’s left to the right (FIGURE 5). Begin sharp dissection of the loose areolar tissue. By gently spreading the tissue using the tips of the scissors, and snipping the tissue in the midline, you allow the dissection to proceed down the lower uterine segment (FIGURE 6).

Any bleeding usually means you are too close to the bladder or have ventured too far laterally. If the patient has had a previous cesarean delivery, this area may be densely scarred. Often, it is easiest to dissect laterally around the scar on each side, where there is less dense scarring, and mobilize the tissue until the denser central scarring can be dissected. Note that the bladder attachment curves upward on each side and lateral to the cervix, over the lateral vagina and the uterine vessels.

 

 

FIGURE 4: Clamp the left round ligament in preparation for division.
Clamp the left round ligament

It is absolutely critical to dissect and expose 1 or 2 cm of the entire anterior vaginal wall below the level of the cervix to be certain that the bladder has been fully mobilized and to prevent later incorporation into the vaginal cuff closure. The ­exact ­location of the cervix is best detected by placing a finger behind the uterus and using the thumb to compress the area of the anterior portion of the cervix under the bladder.

Fibroids can cause distortion of the anatomic planes we utilize. Be aware of the distortion and adjust your dissection accordingly. The structures of the urinary tract are most often affected; sharp dissection is necessary to mobilize the ureter and bladder in these cases. (See the case discussions)

Mobilize the bladder

FIGURE 5: Upward traction on the peritoneum overlying the bladder facilitates development of the bladder flap off of the lower uterus.

FIGURE 6: Dissect the bladder off the lower uterus

CASE DISCUSSION: Broad-ligament myomas
Large intramural or pedunculated myomas can be difficult surgical challenges. Broad-ligament myomas, however, are unique. Significant anatomic distortion can occur. Always consider the possibility of some degree of ureteral obstruction and be on the lookout for unrecognized bladder injury.

Case 1
This very large myoma essentially filled the pelvis but seems to arise from the left side of the uterus, distorting the anatomy. Note the attenuation of the round ligaments and the normal appearance of the tubes and ovaries (the left tube has a distal paratubal cyst.) Note also the bladder, particularly how sharp dissection will be required to mobilize it off the underlying mass.

To manage removal, at case outset, we placed bilateral external ureteral stents and used a lucite vaginal dilator to aid in respective ureter and vaginal apex identification. The bladder was attenuated over this large mass and was rather easily dissected, given the defined mass around it. The ureters were well lateral and inferior and readily identified with stent palpation. The cervix was certainly elongated and, after the uterine vessels were removed, the hysterectomy was completed without incident.

Surgical pearl: To extract very large masses during total abdominal hysterectomy, sometimes you have more “room” if the fixed retractor is removed. You can then use a series of handheld retractors (Deavor, Harrington, etc) on the side you are operating until the mass has been mobilized enough to place a fixed retractor.

CASE 2

This large cervical myoma is creating urinary urgency, frequency, and moderate obstruction of the right ureter. Sharp dissection is critical to mobilize the bladder well free of the myoma. We placed bilateral ureteral stents to start the case to aid in identification of the ureter.

The first illustration at right (top left) shows the operative appearance before the bladder flap was taken down. The second photo (top right) reveals the extent of this large myoma after the bladder has been sharply dissected free of the mass. The third photo (bottom left) displays the specimen sent to pathology (be sure to minimize the amount of vaginal tissue taken with the specimen). Note the distortion of the endocervical canal and cervix. The last photo (bottom right) reveals the sectioned specimen.

Surgical pearl: Use a three-way catheter and backfill the bladder for identification during the procedure and at the conclusion of the case to rule out bladder injury. A few drops of methylene blue added to the solution makes recognition easier.

Ligation of the uterine arteries
Apply cephalad traction to the uterus and place a Harrington retractor anteriorly to retract the bladder away from the cervix on the upper portion of the vagina. With the uterus pulled first to the left, palpate the right ureter between the thumb and index finger at the level of the uterine artery (FIGURE 7). Once you have determined the course of the ureter, place a Kocher clamp well down on the right side of the lower cervix at about a 45° angle, sliding off the side of the cervix (FIGURE 8). The clamp should now include the superior portion of the cardinal ligament with the uterine vessels and paracolpium immediately above the lateral vaginal fornix.

Transect the cardinal pedicle. Repeat the procedure on the left side after adjusting the Harrington retractor slightly to the left and identifying the course of the ureter where the Kocher clamp will be placed. Thus, a single Kocher clamp is placed on each side to control the blood supply.

It is paramount that you know the location of the ureter prior to placement and transection of the uterine vessels to prevent inadvertent injury or obstruction of the ureters.

Divide the uterine vessel–cardinal ligament complex close to the cervix (medial to the Kocher clamp), slightly undercutting the tip (FIGURE 9). This creates a fascial window, the anterior edge of which is the pubocervical fascia. This is subsequently developed and managed as a separate layer during the vaginal vault closure.

Repeat this procedure on the left side.

Ligate the uterine artery
FIGURE 7: After mobilizing the bladder, palpate the right ureter prior to placement of a Kocher clamp on the cardinal vascular pedicle. FIGURE 8: Place a single Kocher clamp on the right uterine vessels. See the right ureter well lateral of the clamp.

FIGURE 9: The right uterine vessels have been clamped and transected. The clamp is slightly undercut to allow access to the vaginal fornix.

Preparing and opening the vaginal cuff
Develop the anterior pubocervical fascia by cutting with a scissors horizontally across the anterior vaginal wall at the level of the cervix (FIGURE 10). This layer of tissue will be utilized to close the vaginal cuff in a secondary layer later on. This technique will serve to close the pubocervical fascial ring at the vaginal vault and, with support of the uterosacral ligaments, provide support to the vaginal apex. At this point, the vagina has not yet been entered. The remaining tissue beneath the mobilized layer and the anterior cervix is the anterior vaginal wall.

Pull the uterus up and anterior toward the pubic symphysis to make the uterosacral ligaments prominent. Then transect the uterosacral ligaments close to the uterus (FIGURE 11). You may encounter minor bleeding, but there is no need to ligate the stumps at this point. Cut the tissue between the ligaments horizontally, similarly to the anterior dissection. With gentle finger dissection, as necessary, this should free the rectosigmoid colon from the posterior vaginal wall.

If this is a new technique for you, it may serve you well to place a stitch in each uterosacral ligament, below the spot where you will transect it, prior to cutting. When you have the uterus on tension, the ligaments are most recognizable, and these sutures can then be incorporated into the vaginal angles.

At this point there should be a circular area just beneath the cervix that is the vaginal wall at the apex of the vagina. Retract the uterus anteriorly and to the left, and enter the vagina posteriorly and laterally, just above the stump of the right uterosacral ligament (FIGURE 12). The uterus now can be removed by circumcising the vagina as close to the cervix as possible to avoid vaginal shortening. As the uterus is being removed, place four vulsellum tenacula successively at the 3, 12, 9, and 6 o’clock positions of the vaginal cuff as it is developed (FIGURE 13). Then swab povidone-iodine on the vaginal cuff and canal.

Prepare the vaginal cuff

FIGURE 10: After mobilizing the bladder and securing the vascular pedicles, develop the anterior endopelvic fascia. It will be used as a second layer to close the vaginal cuff.

FIGURE 11: A. Transect the uterosacral ligaments. B. Mobilize the rectum posteriorly.

FIGURE 12: Enter the right vaginal fornix and grasp it with a vulsellum tenaculum.

FIGURE 13: A. After entering the right vaginal fornix, extend the incision in a counter-clockwise fashion, preserving vaginal length. B. Placement of the tenaculum as the incision proceeds.

Cuff closure
Place a lap salt sponge over the Kocher clamps to prevent suture entanglement. Use a 36-inch continuous 0-polyglactin suture to close the vaginal vault and achieve hemostasis. Begin suturing with a right vaginal angle stitch, placed so that the small vessels are ligated and the lateral supporting tissues from the base of the cardinal ligament are attached to the right vaginal angle. This closes the “window” that was created with slight undercutting of the cardinal ligament earlier. Continue suturing toward the left, with each bite placed submucosally so that the epithelial edges are approximated and inverted into the vagina. The suture does not enter the vagina (FIGURE 14). As you reach the left vaginal angle, obtain a healthy purchase of the left uterosacral ligament and then pass the needle laterally to the vaginal fornix angle, through the lateral supporting tissues at the base of the cardinal ligament, as was done on the right vaginal angle. Then lock the suture and return across the vaginal vault. This will plicate together the anterior and posterior pubocervical fascia layers developed earlier, creating a second layer, before closing the fascial ring at the vaginal apex. Incorporate the right uterosacral ligament into the right vaginal angle and tie the suture (FIGURES 15 AND 16).

Close the cuff and verify hemostasis. Use the lap salt sponge covering the Kocher clamps on the cardinal ligament pedicles to wipe the surgical field clean. Then use light cautery along the cuff and the base and back of the bladder. If there is some bleeding at the very corners of the vagina, it can usually be managed during suturing of the cardinal ligament pedicles into the corners of the vault.

Elevate the Kocher clamp containing the cardinal ligament and uterine vessels toward the midline. Then palpate the ureter between your index finger and thumb as it courses through the cardinal ligament toward the bladder. This step provides a second check on the location of the ureter (the first was when the clamp was originally placed) before the cardinal ligament is tied to the corner of the vault (FIGURE 17). The needle should enter the peritoneum, right uterosacral ligament, and full thickness of the right angle of the vagina just lateral to the suture used to close the vaginal apex. Bring the pedicle over the corner of the vagina and tie it close to the lateral aspect of the Kocher clamp, leaving an adequate stump. Then free-tie the stump of the cardinal ligament to add a double ligation of this vascular pedicle. Repeat this procedure on the opposite side (FIGURE 18). Then verify hemostasis throughout the operative field.

Take the patient out of Trendelenburg position and place her flat, and copiously irrigate the pelvis. Once needle and sponge counts are completed, close the abdomen in a layered fashion. Place a wound dressing and a Foley catheter, leaving the latter in place overnight.

Close the cuff
FIGURE 14: A. Begin in the right vaginal corner, closing the area that was “undercut” (see FIGURE 10). B. Close the first layer in in a subcuticular manner. FIGURE 15: The second layer of cuff closure utilizes the anterior and posterior endopelvic fascia and imbricates the first layer.



FIGURE 16: Two-layer closure of the vaginal cuff.
FIGURE 17: Prior to suture ligation of the right uterine vessels, palpate the ureter again to identify its location.

FIGURE 18: Suture-ligate the uterine pedicles into the corners of the vaginal cuff.

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References

1. Wu JM, Wechter ME, Geller EJ, et al. Hysterectomy rates in the United States, 2003. Obstet Gynecol. 2007;110(5):1091–1095.
2. Falcone T, Walters MD. Hysterectomy for benign disease. Obstet Gynecol. 2008;111(3):753–767.
3. Unger JB, Paul R, Caldito G. Hysterectomy for the massive leiomyomatous uterus. Obstet Gynecol. 2002;100(6):1271–1275.
4. US Food and Drug Administration. Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576.htm. Published April 17, 2014. Accessed September 15, 2014.
5. Webb MJ. Mayo Clinic Manual of Pelvic Surgery. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2000:55–72.
6. Committee on Practice Bulletins–Gynecology, American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 84. Prevention of deep vein thrombosis and pulmonary embolism. Obstet Gynecol. 2007;110(2 pt 1):429–440.
7. Gould MK, Garcia DA, Wren SM, et al. Prevention of VTE in nonorthopedic surgical patients: antithrombotic therapy and prevention of thrombosis. 9th ed. American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 suppl):e227S–e277S.
8. Committee on Practice Bulletins, American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 74. Antibiotic prophylaxis for gynecologic procedures. Obstet Gynecol. 2006;108(1):225–234.
9. Larsson PG, Carlsson B. Does pre- and postoperative metronidazole treatment lower vaginal cuff infection rate after abdominal hysterectomy among women with bacterial vaginosis? Infect Dis Obstet Gynecol. 2002;10(3):133–140.

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Related Articles

The abdominal approach to hysterectomy remains the most common route to hysterectomy in the United States. Its greatest advantage: It allows the uterus to be removed intact.1–3

The recent US Food and Drug Administration (FDA) warning against the use of power morcellation in women with known or suspected uterine malignancy has left many gynecologic surgeons wondering what might be the optimal approach to the removal of a large uterus.4

Although most hysterectomies are performed for benign conditions—namely, uterine fibroids—malignancy should be considered in the differential diagnosis. When hysterectomy is performed laparoscopically, a large uterus must be morcellated intraperitoneally. Since the FDA safety communication was issued, some hospitals have imposed a moratorium on the use of power morcellators for removal of uterine tissue until more definitive evidence is put forth regarding safety and best practices. This chain of events allows us an opportunity to review the basics of abdominal hysterectomy.

For the sake of this discussion, I will assume that the hysterectomy is being performed for a benign indication as I highlight the Mayo Clinic approach to total abdominal hysterectomy (TAH).5

Preoperative considerations
The patient should be medically able to undergo operative intervention. If she has preexisting medical conditions, preoperative clearance should be obtained from her primary care provider, and her medical conditions should be optimized prior to surgical intervention.

Baseline laboratory studies include a complete blood count, electrolyte panel, glucose assessment, and an electrocardiogram (EKG). Bowel prep typically is not required. Provisions should be made to prevent deep venous thrombosis (DVT), usually by utilizing sequential compression devices, based on the individual patient’s risk factors.6,7

A prophylactic antibiotic to prevent surgical site infection (often a first-generation cephalosporin) should be given as a single intravenous (IV) dose prior to the incision.8 If bacterial vaginosis is present, treatment prior to surgery can reduce the frequency of vaginal cuff infection.9

Again, for the sake of this discussion, I will assume that malignancy has been ruled out.

Positioning and preparation
After induction of anesthesia, position the patient either in a dorsal supine (traditional) or lithotomy (yellow-fin stirrups) position and reexamine her to confirm the findings of the pelvic exam. If the patient is positioned in the supine position, use ankle straps to prevent her from moving as the Trendelenburg position advances during the procedure.

Prep the abdominal skin with a bactericidal agent (most often a povidone-iodine solution). Also prep the vagina with a povidone-iodine solution because the vaginal cuff will be opened during the TAH. Place a transurethral catheter to drain urine throughout the case. Use of a three-way catheter allows the bladder to be easily backfilled during the procedure for identification of its borders or assessment of its integrity.

Last, incorporate a surgical pause prior to the incision to confirm that you have the right patient, know the procedure and incision planned, and are aware of any allergies. Also confirm that antibiotics have been given.

Operative technique
Intraoperative principles
A planned approach avoids wasteful time and motion, and an adequate incision allows for sufficient exposure, which is critical but often underappreciated by the novice surgeon. We prefer a midline incision because it allows the most flexibility to adapt to intraoperative findings, but a Pfannenstiel incision also is an option.

Fixed retraction is paramount to “set up” exposure for the remainder of the case. We prefer a Balfour fixed retractor but, with smaller uteri, a self-retaining Alexis retractor (Applied Medical, Rancho Santa Margarita, California) affords decent exposure and may cause less postoperative abdominal wall discomfort; it also avoids the possibility of retractor-related neuropathy.

Moistened abdominal packing allows the bowel to be packed into the upper abdomen for the remainder of the case, which facilitates consistent exposure of the operative field. Adequate lighting is essential, as is one or more knowledgeable assistants.

Use sharp dissection throughout the procedure. Clean, sharp dissection averts ­injury to adjacent structures, such as the ureter, bladder, and rectum, and promotes recognition of any injuries, permitting immediate repair.

The application of proper traction and counter-traction on tissues allows accurate definition of the correct tissue planes and facilitates identification of important anatomic structures. Vital structures should be identified and, if necessary, mobilized before any clamps are placed or pedicles transected. Adhesions should be sharply lysed to facilitate exposure.

Freeing the bladder anteriorly and the rectum posteriorly prevents their inadvertent inclusion in closure of the vagina and minimizes the risk of fistula formation. The bladder and rectum should be sharply mobilized at least 1 cm beyond the site of planned vaginal transection.

Last, excellent support of the vaginal wall can be provided by securing the uterosacral-cardinal ligaments to the corners of the vaginal vault.

Identify the ureter

FIGURE 1: Place straight Kocher clamps to facilitate traction during the operation.

FIGURE 2: Clamp and divide the right round ligament, opening the broad ligament.

FIGURE 3: Identify the right ureter along the medial leaf of the broad ligament.

Identifying the ureter
Once good exposure and adequate Trendelenburg position are achieved, place ­Kocher clamps across the cornual portion of the uterus (incorporating the round ligament, tube, and utero-ovarian pedicle) (­FIGURE 1). This facilitates continuous traction and prevents back bleeding throughout the case.

With traction applied to the left, identify the right round ligament, clamp it with a ­Kocher clamp, and transect it. Incise the peritoneum parallel to the uterus and gonadal vessels (FIGURE 2). This opens the broad ligament and allows identification of the critical underlying structures (ureter, external and internal iliac vessels). Following the medial leaf of the broad ligament downward, identify the ureter by both visualization and palpation (FIGURE 3).

Although I do not discuss salpingo-­oophorectomy in this article, be aware that the ureter is at risk when clamping the gonadal vessels near the pelvic brim.

Once the ureter is identified, create a window in the broad ligament above the ureter. In a medial to lateral fashion, place your index finger through that peritoneal window, making certain the ureter is below and out of the way. Place a Kocher clamp across the tube and utero-ovarian pedicle, and transect and suture-ligate the pedicle (preserving the tube and ovary). Repeat this procedure on the patient’s left side, using traction and counter-traction to facilitate exposure (FIGURE 4).

Mobilizing the bladder
With the assistant providing upward traction on the uterus, use Russian forceps to ele­vate the peritoneum overlying the bladder. Undermine and incise the peritoneum from the patient’s left to the right (FIGURE 5). Begin sharp dissection of the loose areolar tissue. By gently spreading the tissue using the tips of the scissors, and snipping the tissue in the midline, you allow the dissection to proceed down the lower uterine segment (FIGURE 6).

Any bleeding usually means you are too close to the bladder or have ventured too far laterally. If the patient has had a previous cesarean delivery, this area may be densely scarred. Often, it is easiest to dissect laterally around the scar on each side, where there is less dense scarring, and mobilize the tissue until the denser central scarring can be dissected. Note that the bladder attachment curves upward on each side and lateral to the cervix, over the lateral vagina and the uterine vessels.

 

 

FIGURE 4: Clamp the left round ligament in preparation for division.
Clamp the left round ligament

It is absolutely critical to dissect and expose 1 or 2 cm of the entire anterior vaginal wall below the level of the cervix to be certain that the bladder has been fully mobilized and to prevent later incorporation into the vaginal cuff closure. The ­exact ­location of the cervix is best detected by placing a finger behind the uterus and using the thumb to compress the area of the anterior portion of the cervix under the bladder.

Fibroids can cause distortion of the anatomic planes we utilize. Be aware of the distortion and adjust your dissection accordingly. The structures of the urinary tract are most often affected; sharp dissection is necessary to mobilize the ureter and bladder in these cases. (See the case discussions)

Mobilize the bladder

FIGURE 5: Upward traction on the peritoneum overlying the bladder facilitates development of the bladder flap off of the lower uterus.

FIGURE 6: Dissect the bladder off the lower uterus

CASE DISCUSSION: Broad-ligament myomas
Large intramural or pedunculated myomas can be difficult surgical challenges. Broad-ligament myomas, however, are unique. Significant anatomic distortion can occur. Always consider the possibility of some degree of ureteral obstruction and be on the lookout for unrecognized bladder injury.

Case 1
This very large myoma essentially filled the pelvis but seems to arise from the left side of the uterus, distorting the anatomy. Note the attenuation of the round ligaments and the normal appearance of the tubes and ovaries (the left tube has a distal paratubal cyst.) Note also the bladder, particularly how sharp dissection will be required to mobilize it off the underlying mass.

To manage removal, at case outset, we placed bilateral external ureteral stents and used a lucite vaginal dilator to aid in respective ureter and vaginal apex identification. The bladder was attenuated over this large mass and was rather easily dissected, given the defined mass around it. The ureters were well lateral and inferior and readily identified with stent palpation. The cervix was certainly elongated and, after the uterine vessels were removed, the hysterectomy was completed without incident.

Surgical pearl: To extract very large masses during total abdominal hysterectomy, sometimes you have more “room” if the fixed retractor is removed. You can then use a series of handheld retractors (Deavor, Harrington, etc) on the side you are operating until the mass has been mobilized enough to place a fixed retractor.

CASE 2

This large cervical myoma is creating urinary urgency, frequency, and moderate obstruction of the right ureter. Sharp dissection is critical to mobilize the bladder well free of the myoma. We placed bilateral ureteral stents to start the case to aid in identification of the ureter.

The first illustration at right (top left) shows the operative appearance before the bladder flap was taken down. The second photo (top right) reveals the extent of this large myoma after the bladder has been sharply dissected free of the mass. The third photo (bottom left) displays the specimen sent to pathology (be sure to minimize the amount of vaginal tissue taken with the specimen). Note the distortion of the endocervical canal and cervix. The last photo (bottom right) reveals the sectioned specimen.

Surgical pearl: Use a three-way catheter and backfill the bladder for identification during the procedure and at the conclusion of the case to rule out bladder injury. A few drops of methylene blue added to the solution makes recognition easier.

Ligation of the uterine arteries
Apply cephalad traction to the uterus and place a Harrington retractor anteriorly to retract the bladder away from the cervix on the upper portion of the vagina. With the uterus pulled first to the left, palpate the right ureter between the thumb and index finger at the level of the uterine artery (FIGURE 7). Once you have determined the course of the ureter, place a Kocher clamp well down on the right side of the lower cervix at about a 45° angle, sliding off the side of the cervix (FIGURE 8). The clamp should now include the superior portion of the cardinal ligament with the uterine vessels and paracolpium immediately above the lateral vaginal fornix.

Transect the cardinal pedicle. Repeat the procedure on the left side after adjusting the Harrington retractor slightly to the left and identifying the course of the ureter where the Kocher clamp will be placed. Thus, a single Kocher clamp is placed on each side to control the blood supply.

It is paramount that you know the location of the ureter prior to placement and transection of the uterine vessels to prevent inadvertent injury or obstruction of the ureters.

Divide the uterine vessel–cardinal ligament complex close to the cervix (medial to the Kocher clamp), slightly undercutting the tip (FIGURE 9). This creates a fascial window, the anterior edge of which is the pubocervical fascia. This is subsequently developed and managed as a separate layer during the vaginal vault closure.

Repeat this procedure on the left side.

Ligate the uterine artery
FIGURE 7: After mobilizing the bladder, palpate the right ureter prior to placement of a Kocher clamp on the cardinal vascular pedicle. FIGURE 8: Place a single Kocher clamp on the right uterine vessels. See the right ureter well lateral of the clamp.

FIGURE 9: The right uterine vessels have been clamped and transected. The clamp is slightly undercut to allow access to the vaginal fornix.

Preparing and opening the vaginal cuff
Develop the anterior pubocervical fascia by cutting with a scissors horizontally across the anterior vaginal wall at the level of the cervix (FIGURE 10). This layer of tissue will be utilized to close the vaginal cuff in a secondary layer later on. This technique will serve to close the pubocervical fascial ring at the vaginal vault and, with support of the uterosacral ligaments, provide support to the vaginal apex. At this point, the vagina has not yet been entered. The remaining tissue beneath the mobilized layer and the anterior cervix is the anterior vaginal wall.

Pull the uterus up and anterior toward the pubic symphysis to make the uterosacral ligaments prominent. Then transect the uterosacral ligaments close to the uterus (FIGURE 11). You may encounter minor bleeding, but there is no need to ligate the stumps at this point. Cut the tissue between the ligaments horizontally, similarly to the anterior dissection. With gentle finger dissection, as necessary, this should free the rectosigmoid colon from the posterior vaginal wall.

If this is a new technique for you, it may serve you well to place a stitch in each uterosacral ligament, below the spot where you will transect it, prior to cutting. When you have the uterus on tension, the ligaments are most recognizable, and these sutures can then be incorporated into the vaginal angles.

At this point there should be a circular area just beneath the cervix that is the vaginal wall at the apex of the vagina. Retract the uterus anteriorly and to the left, and enter the vagina posteriorly and laterally, just above the stump of the right uterosacral ligament (FIGURE 12). The uterus now can be removed by circumcising the vagina as close to the cervix as possible to avoid vaginal shortening. As the uterus is being removed, place four vulsellum tenacula successively at the 3, 12, 9, and 6 o’clock positions of the vaginal cuff as it is developed (FIGURE 13). Then swab povidone-iodine on the vaginal cuff and canal.

Prepare the vaginal cuff

FIGURE 10: After mobilizing the bladder and securing the vascular pedicles, develop the anterior endopelvic fascia. It will be used as a second layer to close the vaginal cuff.

FIGURE 11: A. Transect the uterosacral ligaments. B. Mobilize the rectum posteriorly.

FIGURE 12: Enter the right vaginal fornix and grasp it with a vulsellum tenaculum.

FIGURE 13: A. After entering the right vaginal fornix, extend the incision in a counter-clockwise fashion, preserving vaginal length. B. Placement of the tenaculum as the incision proceeds.

Cuff closure
Place a lap salt sponge over the Kocher clamps to prevent suture entanglement. Use a 36-inch continuous 0-polyglactin suture to close the vaginal vault and achieve hemostasis. Begin suturing with a right vaginal angle stitch, placed so that the small vessels are ligated and the lateral supporting tissues from the base of the cardinal ligament are attached to the right vaginal angle. This closes the “window” that was created with slight undercutting of the cardinal ligament earlier. Continue suturing toward the left, with each bite placed submucosally so that the epithelial edges are approximated and inverted into the vagina. The suture does not enter the vagina (FIGURE 14). As you reach the left vaginal angle, obtain a healthy purchase of the left uterosacral ligament and then pass the needle laterally to the vaginal fornix angle, through the lateral supporting tissues at the base of the cardinal ligament, as was done on the right vaginal angle. Then lock the suture and return across the vaginal vault. This will plicate together the anterior and posterior pubocervical fascia layers developed earlier, creating a second layer, before closing the fascial ring at the vaginal apex. Incorporate the right uterosacral ligament into the right vaginal angle and tie the suture (FIGURES 15 AND 16).

Close the cuff and verify hemostasis. Use the lap salt sponge covering the Kocher clamps on the cardinal ligament pedicles to wipe the surgical field clean. Then use light cautery along the cuff and the base and back of the bladder. If there is some bleeding at the very corners of the vagina, it can usually be managed during suturing of the cardinal ligament pedicles into the corners of the vault.

Elevate the Kocher clamp containing the cardinal ligament and uterine vessels toward the midline. Then palpate the ureter between your index finger and thumb as it courses through the cardinal ligament toward the bladder. This step provides a second check on the location of the ureter (the first was when the clamp was originally placed) before the cardinal ligament is tied to the corner of the vault (FIGURE 17). The needle should enter the peritoneum, right uterosacral ligament, and full thickness of the right angle of the vagina just lateral to the suture used to close the vaginal apex. Bring the pedicle over the corner of the vagina and tie it close to the lateral aspect of the Kocher clamp, leaving an adequate stump. Then free-tie the stump of the cardinal ligament to add a double ligation of this vascular pedicle. Repeat this procedure on the opposite side (FIGURE 18). Then verify hemostasis throughout the operative field.

Take the patient out of Trendelenburg position and place her flat, and copiously irrigate the pelvis. Once needle and sponge counts are completed, close the abdomen in a layered fashion. Place a wound dressing and a Foley catheter, leaving the latter in place overnight.

Close the cuff
FIGURE 14: A. Begin in the right vaginal corner, closing the area that was “undercut” (see FIGURE 10). B. Close the first layer in in a subcuticular manner. FIGURE 15: The second layer of cuff closure utilizes the anterior and posterior endopelvic fascia and imbricates the first layer.



FIGURE 16: Two-layer closure of the vaginal cuff.
FIGURE 17: Prior to suture ligation of the right uterine vessels, palpate the ureter again to identify its location.

FIGURE 18: Suture-ligate the uterine pedicles into the corners of the vaginal cuff.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The abdominal approach to hysterectomy remains the most common route to hysterectomy in the United States. Its greatest advantage: It allows the uterus to be removed intact.1–3

The recent US Food and Drug Administration (FDA) warning against the use of power morcellation in women with known or suspected uterine malignancy has left many gynecologic surgeons wondering what might be the optimal approach to the removal of a large uterus.4

Although most hysterectomies are performed for benign conditions—namely, uterine fibroids—malignancy should be considered in the differential diagnosis. When hysterectomy is performed laparoscopically, a large uterus must be morcellated intraperitoneally. Since the FDA safety communication was issued, some hospitals have imposed a moratorium on the use of power morcellators for removal of uterine tissue until more definitive evidence is put forth regarding safety and best practices. This chain of events allows us an opportunity to review the basics of abdominal hysterectomy.

For the sake of this discussion, I will assume that the hysterectomy is being performed for a benign indication as I highlight the Mayo Clinic approach to total abdominal hysterectomy (TAH).5

Preoperative considerations
The patient should be medically able to undergo operative intervention. If she has preexisting medical conditions, preoperative clearance should be obtained from her primary care provider, and her medical conditions should be optimized prior to surgical intervention.

Baseline laboratory studies include a complete blood count, electrolyte panel, glucose assessment, and an electrocardiogram (EKG). Bowel prep typically is not required. Provisions should be made to prevent deep venous thrombosis (DVT), usually by utilizing sequential compression devices, based on the individual patient’s risk factors.6,7

A prophylactic antibiotic to prevent surgical site infection (often a first-generation cephalosporin) should be given as a single intravenous (IV) dose prior to the incision.8 If bacterial vaginosis is present, treatment prior to surgery can reduce the frequency of vaginal cuff infection.9

Again, for the sake of this discussion, I will assume that malignancy has been ruled out.

Positioning and preparation
After induction of anesthesia, position the patient either in a dorsal supine (traditional) or lithotomy (yellow-fin stirrups) position and reexamine her to confirm the findings of the pelvic exam. If the patient is positioned in the supine position, use ankle straps to prevent her from moving as the Trendelenburg position advances during the procedure.

Prep the abdominal skin with a bactericidal agent (most often a povidone-iodine solution). Also prep the vagina with a povidone-iodine solution because the vaginal cuff will be opened during the TAH. Place a transurethral catheter to drain urine throughout the case. Use of a three-way catheter allows the bladder to be easily backfilled during the procedure for identification of its borders or assessment of its integrity.

Last, incorporate a surgical pause prior to the incision to confirm that you have the right patient, know the procedure and incision planned, and are aware of any allergies. Also confirm that antibiotics have been given.

Operative technique
Intraoperative principles
A planned approach avoids wasteful time and motion, and an adequate incision allows for sufficient exposure, which is critical but often underappreciated by the novice surgeon. We prefer a midline incision because it allows the most flexibility to adapt to intraoperative findings, but a Pfannenstiel incision also is an option.

Fixed retraction is paramount to “set up” exposure for the remainder of the case. We prefer a Balfour fixed retractor but, with smaller uteri, a self-retaining Alexis retractor (Applied Medical, Rancho Santa Margarita, California) affords decent exposure and may cause less postoperative abdominal wall discomfort; it also avoids the possibility of retractor-related neuropathy.

Moistened abdominal packing allows the bowel to be packed into the upper abdomen for the remainder of the case, which facilitates consistent exposure of the operative field. Adequate lighting is essential, as is one or more knowledgeable assistants.

Use sharp dissection throughout the procedure. Clean, sharp dissection averts ­injury to adjacent structures, such as the ureter, bladder, and rectum, and promotes recognition of any injuries, permitting immediate repair.

The application of proper traction and counter-traction on tissues allows accurate definition of the correct tissue planes and facilitates identification of important anatomic structures. Vital structures should be identified and, if necessary, mobilized before any clamps are placed or pedicles transected. Adhesions should be sharply lysed to facilitate exposure.

Freeing the bladder anteriorly and the rectum posteriorly prevents their inadvertent inclusion in closure of the vagina and minimizes the risk of fistula formation. The bladder and rectum should be sharply mobilized at least 1 cm beyond the site of planned vaginal transection.

Last, excellent support of the vaginal wall can be provided by securing the uterosacral-cardinal ligaments to the corners of the vaginal vault.

Identify the ureter

FIGURE 1: Place straight Kocher clamps to facilitate traction during the operation.

FIGURE 2: Clamp and divide the right round ligament, opening the broad ligament.

FIGURE 3: Identify the right ureter along the medial leaf of the broad ligament.

Identifying the ureter
Once good exposure and adequate Trendelenburg position are achieved, place ­Kocher clamps across the cornual portion of the uterus (incorporating the round ligament, tube, and utero-ovarian pedicle) (­FIGURE 1). This facilitates continuous traction and prevents back bleeding throughout the case.

With traction applied to the left, identify the right round ligament, clamp it with a ­Kocher clamp, and transect it. Incise the peritoneum parallel to the uterus and gonadal vessels (FIGURE 2). This opens the broad ligament and allows identification of the critical underlying structures (ureter, external and internal iliac vessels). Following the medial leaf of the broad ligament downward, identify the ureter by both visualization and palpation (FIGURE 3).

Although I do not discuss salpingo-­oophorectomy in this article, be aware that the ureter is at risk when clamping the gonadal vessels near the pelvic brim.

Once the ureter is identified, create a window in the broad ligament above the ureter. In a medial to lateral fashion, place your index finger through that peritoneal window, making certain the ureter is below and out of the way. Place a Kocher clamp across the tube and utero-ovarian pedicle, and transect and suture-ligate the pedicle (preserving the tube and ovary). Repeat this procedure on the patient’s left side, using traction and counter-traction to facilitate exposure (FIGURE 4).

Mobilizing the bladder
With the assistant providing upward traction on the uterus, use Russian forceps to ele­vate the peritoneum overlying the bladder. Undermine and incise the peritoneum from the patient’s left to the right (FIGURE 5). Begin sharp dissection of the loose areolar tissue. By gently spreading the tissue using the tips of the scissors, and snipping the tissue in the midline, you allow the dissection to proceed down the lower uterine segment (FIGURE 6).

Any bleeding usually means you are too close to the bladder or have ventured too far laterally. If the patient has had a previous cesarean delivery, this area may be densely scarred. Often, it is easiest to dissect laterally around the scar on each side, where there is less dense scarring, and mobilize the tissue until the denser central scarring can be dissected. Note that the bladder attachment curves upward on each side and lateral to the cervix, over the lateral vagina and the uterine vessels.

 

 

FIGURE 4: Clamp the left round ligament in preparation for division.
Clamp the left round ligament

It is absolutely critical to dissect and expose 1 or 2 cm of the entire anterior vaginal wall below the level of the cervix to be certain that the bladder has been fully mobilized and to prevent later incorporation into the vaginal cuff closure. The ­exact ­location of the cervix is best detected by placing a finger behind the uterus and using the thumb to compress the area of the anterior portion of the cervix under the bladder.

Fibroids can cause distortion of the anatomic planes we utilize. Be aware of the distortion and adjust your dissection accordingly. The structures of the urinary tract are most often affected; sharp dissection is necessary to mobilize the ureter and bladder in these cases. (See the case discussions)

Mobilize the bladder

FIGURE 5: Upward traction on the peritoneum overlying the bladder facilitates development of the bladder flap off of the lower uterus.

FIGURE 6: Dissect the bladder off the lower uterus

CASE DISCUSSION: Broad-ligament myomas
Large intramural or pedunculated myomas can be difficult surgical challenges. Broad-ligament myomas, however, are unique. Significant anatomic distortion can occur. Always consider the possibility of some degree of ureteral obstruction and be on the lookout for unrecognized bladder injury.

Case 1
This very large myoma essentially filled the pelvis but seems to arise from the left side of the uterus, distorting the anatomy. Note the attenuation of the round ligaments and the normal appearance of the tubes and ovaries (the left tube has a distal paratubal cyst.) Note also the bladder, particularly how sharp dissection will be required to mobilize it off the underlying mass.

To manage removal, at case outset, we placed bilateral external ureteral stents and used a lucite vaginal dilator to aid in respective ureter and vaginal apex identification. The bladder was attenuated over this large mass and was rather easily dissected, given the defined mass around it. The ureters were well lateral and inferior and readily identified with stent palpation. The cervix was certainly elongated and, after the uterine vessels were removed, the hysterectomy was completed without incident.

Surgical pearl: To extract very large masses during total abdominal hysterectomy, sometimes you have more “room” if the fixed retractor is removed. You can then use a series of handheld retractors (Deavor, Harrington, etc) on the side you are operating until the mass has been mobilized enough to place a fixed retractor.

CASE 2

This large cervical myoma is creating urinary urgency, frequency, and moderate obstruction of the right ureter. Sharp dissection is critical to mobilize the bladder well free of the myoma. We placed bilateral ureteral stents to start the case to aid in identification of the ureter.

The first illustration at right (top left) shows the operative appearance before the bladder flap was taken down. The second photo (top right) reveals the extent of this large myoma after the bladder has been sharply dissected free of the mass. The third photo (bottom left) displays the specimen sent to pathology (be sure to minimize the amount of vaginal tissue taken with the specimen). Note the distortion of the endocervical canal and cervix. The last photo (bottom right) reveals the sectioned specimen.

Surgical pearl: Use a three-way catheter and backfill the bladder for identification during the procedure and at the conclusion of the case to rule out bladder injury. A few drops of methylene blue added to the solution makes recognition easier.

Ligation of the uterine arteries
Apply cephalad traction to the uterus and place a Harrington retractor anteriorly to retract the bladder away from the cervix on the upper portion of the vagina. With the uterus pulled first to the left, palpate the right ureter between the thumb and index finger at the level of the uterine artery (FIGURE 7). Once you have determined the course of the ureter, place a Kocher clamp well down on the right side of the lower cervix at about a 45° angle, sliding off the side of the cervix (FIGURE 8). The clamp should now include the superior portion of the cardinal ligament with the uterine vessels and paracolpium immediately above the lateral vaginal fornix.

Transect the cardinal pedicle. Repeat the procedure on the left side after adjusting the Harrington retractor slightly to the left and identifying the course of the ureter where the Kocher clamp will be placed. Thus, a single Kocher clamp is placed on each side to control the blood supply.

It is paramount that you know the location of the ureter prior to placement and transection of the uterine vessels to prevent inadvertent injury or obstruction of the ureters.

Divide the uterine vessel–cardinal ligament complex close to the cervix (medial to the Kocher clamp), slightly undercutting the tip (FIGURE 9). This creates a fascial window, the anterior edge of which is the pubocervical fascia. This is subsequently developed and managed as a separate layer during the vaginal vault closure.

Repeat this procedure on the left side.

Ligate the uterine artery
FIGURE 7: After mobilizing the bladder, palpate the right ureter prior to placement of a Kocher clamp on the cardinal vascular pedicle. FIGURE 8: Place a single Kocher clamp on the right uterine vessels. See the right ureter well lateral of the clamp.

FIGURE 9: The right uterine vessels have been clamped and transected. The clamp is slightly undercut to allow access to the vaginal fornix.

Preparing and opening the vaginal cuff
Develop the anterior pubocervical fascia by cutting with a scissors horizontally across the anterior vaginal wall at the level of the cervix (FIGURE 10). This layer of tissue will be utilized to close the vaginal cuff in a secondary layer later on. This technique will serve to close the pubocervical fascial ring at the vaginal vault and, with support of the uterosacral ligaments, provide support to the vaginal apex. At this point, the vagina has not yet been entered. The remaining tissue beneath the mobilized layer and the anterior cervix is the anterior vaginal wall.

Pull the uterus up and anterior toward the pubic symphysis to make the uterosacral ligaments prominent. Then transect the uterosacral ligaments close to the uterus (FIGURE 11). You may encounter minor bleeding, but there is no need to ligate the stumps at this point. Cut the tissue between the ligaments horizontally, similarly to the anterior dissection. With gentle finger dissection, as necessary, this should free the rectosigmoid colon from the posterior vaginal wall.

If this is a new technique for you, it may serve you well to place a stitch in each uterosacral ligament, below the spot where you will transect it, prior to cutting. When you have the uterus on tension, the ligaments are most recognizable, and these sutures can then be incorporated into the vaginal angles.

At this point there should be a circular area just beneath the cervix that is the vaginal wall at the apex of the vagina. Retract the uterus anteriorly and to the left, and enter the vagina posteriorly and laterally, just above the stump of the right uterosacral ligament (FIGURE 12). The uterus now can be removed by circumcising the vagina as close to the cervix as possible to avoid vaginal shortening. As the uterus is being removed, place four vulsellum tenacula successively at the 3, 12, 9, and 6 o’clock positions of the vaginal cuff as it is developed (FIGURE 13). Then swab povidone-iodine on the vaginal cuff and canal.

Prepare the vaginal cuff

FIGURE 10: After mobilizing the bladder and securing the vascular pedicles, develop the anterior endopelvic fascia. It will be used as a second layer to close the vaginal cuff.

FIGURE 11: A. Transect the uterosacral ligaments. B. Mobilize the rectum posteriorly.

FIGURE 12: Enter the right vaginal fornix and grasp it with a vulsellum tenaculum.

FIGURE 13: A. After entering the right vaginal fornix, extend the incision in a counter-clockwise fashion, preserving vaginal length. B. Placement of the tenaculum as the incision proceeds.

Cuff closure
Place a lap salt sponge over the Kocher clamps to prevent suture entanglement. Use a 36-inch continuous 0-polyglactin suture to close the vaginal vault and achieve hemostasis. Begin suturing with a right vaginal angle stitch, placed so that the small vessels are ligated and the lateral supporting tissues from the base of the cardinal ligament are attached to the right vaginal angle. This closes the “window” that was created with slight undercutting of the cardinal ligament earlier. Continue suturing toward the left, with each bite placed submucosally so that the epithelial edges are approximated and inverted into the vagina. The suture does not enter the vagina (FIGURE 14). As you reach the left vaginal angle, obtain a healthy purchase of the left uterosacral ligament and then pass the needle laterally to the vaginal fornix angle, through the lateral supporting tissues at the base of the cardinal ligament, as was done on the right vaginal angle. Then lock the suture and return across the vaginal vault. This will plicate together the anterior and posterior pubocervical fascia layers developed earlier, creating a second layer, before closing the fascial ring at the vaginal apex. Incorporate the right uterosacral ligament into the right vaginal angle and tie the suture (FIGURES 15 AND 16).

Close the cuff and verify hemostasis. Use the lap salt sponge covering the Kocher clamps on the cardinal ligament pedicles to wipe the surgical field clean. Then use light cautery along the cuff and the base and back of the bladder. If there is some bleeding at the very corners of the vagina, it can usually be managed during suturing of the cardinal ligament pedicles into the corners of the vault.

Elevate the Kocher clamp containing the cardinal ligament and uterine vessels toward the midline. Then palpate the ureter between your index finger and thumb as it courses through the cardinal ligament toward the bladder. This step provides a second check on the location of the ureter (the first was when the clamp was originally placed) before the cardinal ligament is tied to the corner of the vault (FIGURE 17). The needle should enter the peritoneum, right uterosacral ligament, and full thickness of the right angle of the vagina just lateral to the suture used to close the vaginal apex. Bring the pedicle over the corner of the vagina and tie it close to the lateral aspect of the Kocher clamp, leaving an adequate stump. Then free-tie the stump of the cardinal ligament to add a double ligation of this vascular pedicle. Repeat this procedure on the opposite side (FIGURE 18). Then verify hemostasis throughout the operative field.

Take the patient out of Trendelenburg position and place her flat, and copiously irrigate the pelvis. Once needle and sponge counts are completed, close the abdomen in a layered fashion. Place a wound dressing and a Foley catheter, leaving the latter in place overnight.

Close the cuff
FIGURE 14: A. Begin in the right vaginal corner, closing the area that was “undercut” (see FIGURE 10). B. Close the first layer in in a subcuticular manner. FIGURE 15: The second layer of cuff closure utilizes the anterior and posterior endopelvic fascia and imbricates the first layer.



FIGURE 16: Two-layer closure of the vaginal cuff.
FIGURE 17: Prior to suture ligation of the right uterine vessels, palpate the ureter again to identify its location.

FIGURE 18: Suture-ligate the uterine pedicles into the corners of the vaginal cuff.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

References

1. Wu JM, Wechter ME, Geller EJ, et al. Hysterectomy rates in the United States, 2003. Obstet Gynecol. 2007;110(5):1091–1095.
2. Falcone T, Walters MD. Hysterectomy for benign disease. Obstet Gynecol. 2008;111(3):753–767.
3. Unger JB, Paul R, Caldito G. Hysterectomy for the massive leiomyomatous uterus. Obstet Gynecol. 2002;100(6):1271–1275.
4. US Food and Drug Administration. Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576.htm. Published April 17, 2014. Accessed September 15, 2014.
5. Webb MJ. Mayo Clinic Manual of Pelvic Surgery. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2000:55–72.
6. Committee on Practice Bulletins–Gynecology, American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 84. Prevention of deep vein thrombosis and pulmonary embolism. Obstet Gynecol. 2007;110(2 pt 1):429–440.
7. Gould MK, Garcia DA, Wren SM, et al. Prevention of VTE in nonorthopedic surgical patients: antithrombotic therapy and prevention of thrombosis. 9th ed. American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 suppl):e227S–e277S.
8. Committee on Practice Bulletins, American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 74. Antibiotic prophylaxis for gynecologic procedures. Obstet Gynecol. 2006;108(1):225–234.
9. Larsson PG, Carlsson B. Does pre- and postoperative metronidazole treatment lower vaginal cuff infection rate after abdominal hysterectomy among women with bacterial vaginosis? Infect Dis Obstet Gynecol. 2002;10(3):133–140.

References

1. Wu JM, Wechter ME, Geller EJ, et al. Hysterectomy rates in the United States, 2003. Obstet Gynecol. 2007;110(5):1091–1095.
2. Falcone T, Walters MD. Hysterectomy for benign disease. Obstet Gynecol. 2008;111(3):753–767.
3. Unger JB, Paul R, Caldito G. Hysterectomy for the massive leiomyomatous uterus. Obstet Gynecol. 2002;100(6):1271–1275.
4. US Food and Drug Administration. Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576.htm. Published April 17, 2014. Accessed September 15, 2014.
5. Webb MJ. Mayo Clinic Manual of Pelvic Surgery. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2000:55–72.
6. Committee on Practice Bulletins–Gynecology, American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 84. Prevention of deep vein thrombosis and pulmonary embolism. Obstet Gynecol. 2007;110(2 pt 1):429–440.
7. Gould MK, Garcia DA, Wren SM, et al. Prevention of VTE in nonorthopedic surgical patients: antithrombotic therapy and prevention of thrombosis. 9th ed. American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 suppl):e227S–e277S.
8. Committee on Practice Bulletins, American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 74. Antibiotic prophylaxis for gynecologic procedures. Obstet Gynecol. 2006;108(1):225–234.
9. Larsson PG, Carlsson B. Does pre- and postoperative metronidazole treatment lower vaginal cuff infection rate after abdominal hysterectomy among women with bacterial vaginosis? Infect Dis Obstet Gynecol. 2002;10(3):133–140.

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ACOG issues guidelines for managing listeriosis during pregnancy

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The first medical management guidelines for treating the bacteria listeria during pregnancy were recently released by the American College of Obstetricians and Gynecologists (ACOG).1

The new guidelines were developed in response to recent reports of recalls of listeria-contaminated food and concern because data show the incidence of listeriosis among pregnant women is approximately 13 times higher than in the general population.1 Maternal listeriosis can cause significant fetal and perinatal complications, including miscarriage, preterm labor, stillbirth, as well as neonatal listeriosis and neonatal death.2

“It is essential for ObGyns not only to be aware of the best ways to manage the care of a pregnant patient who has been exposed to listeria bacteria, but, just as important, to counsel pregnant women regarding how to avoid potential exposure,” said Jeffrey L. Ecker, MD, chair of the ACOG Committee on Obstetric Practice.2

Symptoms of listeriosis are similar to a flu-like infection and can include fever, muscle pain, backache, headache, and gastrointestinal symptoms, including diarrhea.2

The Committee Opinion offers management recommendations for three scenarios1:

  • Asymptomatic women who have been exposed to listeria: No testing is necessary unless symptoms develop within 2 months of exposure. Listeriosis-related fetal surveillance is unnecessary.
  • No fever, with mild symptoms consistent with listeriosis: A pregnant woman who has been exposed to a listeria-containing food and is displaying mild symptoms, but does not have a fever, does not require culture testing (although it may be done). If her blood is tested, the laboratory should be informed about the listeriosis threat so that the bacteria is not confused with a contaminant.
  • Fever, with or without symptoms consistent with listeriosis: A pregnant woman who has been exposed and has a fever exceeding 100.6°F should undergo blood culture testing. Because results will not be available for several days, the Committee Opinion recommends simultaneous listeriosis treatment for the patient and surveillance of the fetus.

Preventive measures to avoid listeria exposure include not eating the following foods1:

  • hot dogs, lunch meats, cold cuts served cold or heated to less than 165°F
  • refrigerated pate and meat spreads
  • refrigerated smoked seafood
  • raw (unpasteurized) milk
  • unpasteurized soft cheese (feta, queso blanco, Brie, blue-veined cheeses)
  • unwashed raw produce (when eating raw fruits and vegetables, skin should be washed thoroughly in running tap water, even if it will be peeled or cut).

Share your thoughts on this news! Send your Letter to the Editor to [email protected]. Please include your name, and the city and state in which you practice.

References

  1. American College of Obstetricians and Gynecologists. Committee Opinion. Management of pregnant women with presumptive exposure to Listeria monocytogenes [published online ahead of print August 5, 2014]. http://www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Obstetric-Practice/Management-of-Pregnant-Women-With-Presumptive-Exposure-to-Listeria-monocytogenes. Accessed September 29, 2014.
  2. American College of Obstetricians and Gynecologists. Ob-Gyns address management of listeria during pregnancy [press release]. http://www.acog.org/About-ACOG/News-Room/News-Releases/2014/Ob-Gyns-Address-Management-of-Listeria-During-Pregnancy. Published August 6, 2014. Accessed September 29, 2014.
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The first medical management guidelines for treating the bacteria listeria during pregnancy were recently released by the American College of Obstetricians and Gynecologists (ACOG).1

The new guidelines were developed in response to recent reports of recalls of listeria-contaminated food and concern because data show the incidence of listeriosis among pregnant women is approximately 13 times higher than in the general population.1 Maternal listeriosis can cause significant fetal and perinatal complications, including miscarriage, preterm labor, stillbirth, as well as neonatal listeriosis and neonatal death.2

“It is essential for ObGyns not only to be aware of the best ways to manage the care of a pregnant patient who has been exposed to listeria bacteria, but, just as important, to counsel pregnant women regarding how to avoid potential exposure,” said Jeffrey L. Ecker, MD, chair of the ACOG Committee on Obstetric Practice.2

Symptoms of listeriosis are similar to a flu-like infection and can include fever, muscle pain, backache, headache, and gastrointestinal symptoms, including diarrhea.2

The Committee Opinion offers management recommendations for three scenarios1:

  • Asymptomatic women who have been exposed to listeria: No testing is necessary unless symptoms develop within 2 months of exposure. Listeriosis-related fetal surveillance is unnecessary.
  • No fever, with mild symptoms consistent with listeriosis: A pregnant woman who has been exposed to a listeria-containing food and is displaying mild symptoms, but does not have a fever, does not require culture testing (although it may be done). If her blood is tested, the laboratory should be informed about the listeriosis threat so that the bacteria is not confused with a contaminant.
  • Fever, with or without symptoms consistent with listeriosis: A pregnant woman who has been exposed and has a fever exceeding 100.6°F should undergo blood culture testing. Because results will not be available for several days, the Committee Opinion recommends simultaneous listeriosis treatment for the patient and surveillance of the fetus.

Preventive measures to avoid listeria exposure include not eating the following foods1:

  • hot dogs, lunch meats, cold cuts served cold or heated to less than 165°F
  • refrigerated pate and meat spreads
  • refrigerated smoked seafood
  • raw (unpasteurized) milk
  • unpasteurized soft cheese (feta, queso blanco, Brie, blue-veined cheeses)
  • unwashed raw produce (when eating raw fruits and vegetables, skin should be washed thoroughly in running tap water, even if it will be peeled or cut).

Share your thoughts on this news! Send your Letter to the Editor to [email protected]. Please include your name, and the city and state in which you practice.

The first medical management guidelines for treating the bacteria listeria during pregnancy were recently released by the American College of Obstetricians and Gynecologists (ACOG).1

The new guidelines were developed in response to recent reports of recalls of listeria-contaminated food and concern because data show the incidence of listeriosis among pregnant women is approximately 13 times higher than in the general population.1 Maternal listeriosis can cause significant fetal and perinatal complications, including miscarriage, preterm labor, stillbirth, as well as neonatal listeriosis and neonatal death.2

“It is essential for ObGyns not only to be aware of the best ways to manage the care of a pregnant patient who has been exposed to listeria bacteria, but, just as important, to counsel pregnant women regarding how to avoid potential exposure,” said Jeffrey L. Ecker, MD, chair of the ACOG Committee on Obstetric Practice.2

Symptoms of listeriosis are similar to a flu-like infection and can include fever, muscle pain, backache, headache, and gastrointestinal symptoms, including diarrhea.2

The Committee Opinion offers management recommendations for three scenarios1:

  • Asymptomatic women who have been exposed to listeria: No testing is necessary unless symptoms develop within 2 months of exposure. Listeriosis-related fetal surveillance is unnecessary.
  • No fever, with mild symptoms consistent with listeriosis: A pregnant woman who has been exposed to a listeria-containing food and is displaying mild symptoms, but does not have a fever, does not require culture testing (although it may be done). If her blood is tested, the laboratory should be informed about the listeriosis threat so that the bacteria is not confused with a contaminant.
  • Fever, with or without symptoms consistent with listeriosis: A pregnant woman who has been exposed and has a fever exceeding 100.6°F should undergo blood culture testing. Because results will not be available for several days, the Committee Opinion recommends simultaneous listeriosis treatment for the patient and surveillance of the fetus.

Preventive measures to avoid listeria exposure include not eating the following foods1:

  • hot dogs, lunch meats, cold cuts served cold or heated to less than 165°F
  • refrigerated pate and meat spreads
  • refrigerated smoked seafood
  • raw (unpasteurized) milk
  • unpasteurized soft cheese (feta, queso blanco, Brie, blue-veined cheeses)
  • unwashed raw produce (when eating raw fruits and vegetables, skin should be washed thoroughly in running tap water, even if it will be peeled or cut).

Share your thoughts on this news! Send your Letter to the Editor to [email protected]. Please include your name, and the city and state in which you practice.

References

  1. American College of Obstetricians and Gynecologists. Committee Opinion. Management of pregnant women with presumptive exposure to Listeria monocytogenes [published online ahead of print August 5, 2014]. http://www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Obstetric-Practice/Management-of-Pregnant-Women-With-Presumptive-Exposure-to-Listeria-monocytogenes. Accessed September 29, 2014.
  2. American College of Obstetricians and Gynecologists. Ob-Gyns address management of listeria during pregnancy [press release]. http://www.acog.org/About-ACOG/News-Room/News-Releases/2014/Ob-Gyns-Address-Management-of-Listeria-During-Pregnancy. Published August 6, 2014. Accessed September 29, 2014.
References

  1. American College of Obstetricians and Gynecologists. Committee Opinion. Management of pregnant women with presumptive exposure to Listeria monocytogenes [published online ahead of print August 5, 2014]. http://www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Obstetric-Practice/Management-of-Pregnant-Women-With-Presumptive-Exposure-to-Listeria-monocytogenes. Accessed September 29, 2014.
  2. American College of Obstetricians and Gynecologists. Ob-Gyns address management of listeria during pregnancy [press release]. http://www.acog.org/About-ACOG/News-Room/News-Releases/2014/Ob-Gyns-Address-Management-of-Listeria-During-Pregnancy. Published August 6, 2014. Accessed September 29, 2014.
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Uterine rupture, child stillborn: $3.8M net award

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Uterine rupture, child stillborn: $3.8M net award
At 35 weeks' gestation, a woman went to the emergency department (ED) with abdominal pain, fast heartbeat, and irregular contractions. Her history included three cesarean deliveries, including one with a vertical incision. She was admitted, and a cesarean delivery was planned for the next day. After 8 hours, during which the patient’s condition worsened, an emergency cesarean delivery was undertaken. A full rupture of the uterus was found; the baby’s body had extruded into the mother’s abdomen. The child was stillborn.

PARENTS’ CLAIM The stillbirth could have been avoided if the nurses had communicated the mother’s worsening condition to the physicians.

DEFENDANTS’ DEFENSE After the hospital and physicians settled prior to trial, the case continued against the nurse in charge of the mother’s care and the nurse-staffing group. Negligence was denied; all protocols were followed.

VERDICT A $2.9 million Illinois verdict was returned. With a $900,000 settlement from the hospital and physicians, the net award was $3.8 million.

_______________

Where did rare strep A infection come from?
A 36-year-old woman reported heavy vaginal bleeding to her ObGyn. She underwent endometrial ablation in her physician’s office.

The next day, the woman called the office to report abdominal pain. She was told to stop the medication she was taking, and if the pain continued to the next day, to go to an ED. The next day, the patient went to the ED and was found to be in septic shock. During emergency laparotomy, 50 mL of purulent fluid were drained and an emergency hysterectomy was performed. Three days later, the patient died from pulmonary arrest caused by toxic shock syndrome. An autopsy revealed that the patient’s sepsis was caused by group A streptococci (GAS) infection.

ESTATE’S CLAIM The patient was not a proper candidate for endometrial ablation because of her history of chronic cervical infection. The ObGyn perforated the cervix during the procedure and tried to conceal it. At autopsy, bone wax was found in the rectal lumen that had been used to cover up damage to the cervix. The ObGyn introduced GAS bacteria into the patient’s system. The ObGyn’s staff failed to ask the proper questions when she called the day after the procedure. She should have been told to go directly to the ED.

DEFENDANTS’ DEFENSE The ObGyn did not perforate the cervix or uterus during the procedure. GAS infection is so rare that it would have been difficult to foresee or diagnose. Potentially, the patient had a chronic
cervical infection before ablation.

VERDICT A Texas defense verdict was returned.

_______________

DURING INSERTION, IUD PERFORATES UTERINE WALL; LATER FOUND BELOW LIVER
On July 21, a 46-year-old woman went to an ObGyn for placement of an intrauterine device (IUD). Shortly after the ObGyn inserted the levonorgestrel-releasing intrauterine system (Mirena, Bayer HealthCare), the patient reported severe pelvic and abdominal pain. On July 26, the patient underwent surgical removal of the IUD.

She was discharged on July 29 but continued to report pain. She was readmitted to the hospital the next day and treated for pain. She was bed ridden for 3 weeks after IUD-removal surgery, and had a 3-month recovery before feeling pain free.

PATIENT’S CLAIM The ObGyn was negligent in perforating the patient’s uterine wall during IUD insertion, causing the device to ultimately migrate under the patient’s liver.

DEFENDANTS’ DEFENSE Uterine perforation is a known complication of IUD insertion. The IUD escaped from the patient’s uterus at a later time and not during the insertion procedure.

VERDICT A Florida verdict of $208,839 was returned; the amount was reduced to $161,058 because the medical expenses were written off by the health-care providers.

_______________

 

Was travel appropriate for this pregnant woman?
A woman with a history of two premature deliveries
and one miscarriage became pregnant again. She received prenatal care at an Army hospital. She traveled to Spain, where the baby was born at 31 weeks’ gestation. The baby required treatment in a neonatal intensive care unit (NICU) for 17 days. The child has cerebral palsy, with tetraplegia of all four extremities. She cannot walk without assistance and suffers severe cognitive and vision impairment.

PARENTS’ CLAIM The ObGyn at the Army hospital should not have approved the mother’s request for travel; he did so, despite knowing that the mother was at high risk for premature birth. The military medical hospital to which she was assigned in Spain could not manage a high-risk pregnancy, didn’t have a NICU, and didn’t have specialists to treat premature infants.

DEFENDANTS’ DEFENSE The ObGyn argued that he did not have access to the medical records showing the mother’s history. The patient countered that the ObGyn did indeed have the patient’s records, as he had discussed them with her.

 

 

VERDICT A $10,409,700 California verdict was returned against the ObGyn and the government facility.

_______________

Triple-negative BrCa not diagnosed until metastasized: $5.2M
After finding lumps in both breasts, a woman in her 30s saw a nurse practitioner (NP) at an Army hospital. A radiologist reported no mass in the right breast and multiple benign-appearing anechoic lesions in the left breast after bilateral mammography and ultrasonography (US) in July 2008. The Chief of Mammography Services recommended referral to a breast surgeon, but the patient never received the letter. It was placed in her mammography file, not in the treatment file.

In November 2008, the patient returned to the clinic. Bilateral diagnostic mammography and US were ordered, but for unknown reasons, cancelled. US of the left breast was interpreted as benign in January 2009.

After imaging in March 2010, followed by a needle biopsy of the right breast, a radiologist reported finding intermediate-grade infiltrating ductal carcinoma.

The patient sought care outside the military medical system at a large university hospital. In April 2010, stage 3 triple-negative invasive ductal carcinoma (IDC) was identified. The patient underwent chemotherapy, a double mastectomy, removal of 21 lymph nodes, and breast reconstruction. She was given a 60% chance of recurrence in 5–7 years.

PATIENT’S CLAIM It was negligent to not inform her of imaging results. Biopsy should have been performed in 2008, when the IDC was likely at stage 1; treatment would have been far less aggressive. Electronic medical records showed that the 2008 mammography and US results had been “signed off” by an NP at the clinic.

DEFENDANTS’ DEFENSE While unable to concede liability, the government agency did not contest the point.

VERDICT A $5.2 million Tennessee federal court bench verdict was returned, citing failures in communication, poor and improper record keeping and retention, failure to follow-up, and an unexplained cancellation of a medical order.

_______________

Woman dies from cervical cancer: $2.3M
In 2001, a 41-year-old woman had abnormal Pap smear results but her gynecologist did not order more testing. The patient was told to return in 3 months, but she did not return until 2007—reporting abnormal bleeding, vaginal discharge, and pain. Her Pap results were normal, however, and the gynecologist did not order further testing. In 2009, the patient was found to have advanced cervical cancer. She died 2 years later.

ESTATE’S CLAIM Further testing should have been ordered in 2001, which would have likely revealed dysplasia, which can lead to cancer. The laboratory incorrectly interpreted the 2007 Pap test; if the results had been properly reported, additional testing could have been ordered.

DEFENDANTS’ DEFENSE The laboratory and patient’s estate settled for a confidential amount before trial. The gynecologist denied negligence.

VERDICT A New Jersey jury found the gynecologist 40% at fault for his actions in 2007. The jury found the laboratory 50% at fault, and the patient 10% at fault. A gross verdict of $2.33 million was returned.

_______________
 

Bowel injury after cesarean delivery; mother dies of sepsis
At 40 4/7 weeks' gestation, a 37-year-old woman gave birth
to a healthy child by cesarean delivery. The next day, the patient had an elevated white blood cell (WBC) count with a left shift, her abdomen was tympanic but soft, and she was passing flatus and belching. The ObGyn ordered a Fleet enema; only flatus was released. A covering ObGyn ordered an abdominal radiograph, which the radiologist reported as showing postoperative ileus and mild constipation. The patient was given a second Fleet enema the next day, resulting in watery stool. She vomited 300 mL of dark green fluid.

After a rectal tube was placed 2 days later, one hard brown stool and several brown, pasty, loose, and liquid stools were returned. She vomited several times that day, and was found to have hypoactive bowel sounds with continued tympanic quality in the upper quadrants. Laboratory testing revealed continued elevated WBC count with left shift. The next day, she had hypoactive bowel sounds with brown liquid stools. Later that morning, she was able to tolerate clear liquids. The ObGyn decided to discharge her home with instructions to continue on a clear liquid diet for 2 more days before advancing her diet.

The day after discharge, she was found unresponsive at home. She was taken to the hospital, but resuscitation attempts failed. She died. An autopsy revealed that the cause of death was sepsis.

ESTATE’S CLAIM The ObGyn was negligent in failing to diagnose and treat a postoperative intra-abdominal infection caused by bowel perforation. A surgical consult should have been obtained. The woman was prematurely discharged. The radiologist failed to report the presence of free air on the abdominal x-ray.

 

 

DEFENDANTS’ DEFENSE The case was settled during trial.

VERDICT A $1 million Maryland settlement was reached. 

_______________

Right ureter injury detected and repaired
During laparoscopic-assisted vaginal hysterectomy, the ObGyn detected and repaired an injury to the right ureter. The patient’s recovery was delayed by the injury.

PATIENT’S CLAIM The ObGyn was negligent in using a Kleppinger bipolar cauterizing instrument to cauterize the vaginal cuff. Thermal overspray from the instrument or the instrument itself damaged the ureter. The ObGyn was also negligent in not performing diagnostic cystoscopy to confirm patency of the ureter after the repair was made.

PHYSICIAN’S DEFENSE Ureter injury is a known risk of the procedure. All procedures were performed according to protocol.

VERDICT A Florida defense verdict was returned.

_______________

Failure to detect inflammatory BrCa; woman dies
A 42-year-old woman underwent mammography in February 2002 after reporting pain, discoloration, inflammation, and swelling in her left breast. The radiologist who interpreted the mammography suggested a biopsy for a differential diagnosis of mastitis or inflammatory carcinoma. The biopsy results were negative.

The patient’s symptoms persisted, and she underwent US in late May 2002. Another radiologist interpreted the US, noting that the patient could not tolerate compression, which led to less than optimal evaluation. The radiologist suggested that mastitis was the likely cause of the patient’s symptoms.

The patient then consulted a surgeon, who ordered mammography and magnetic resonance imaging (MRI) followed by biopsy, which indicated cancer. The patient underwent a mastectomy but metastasis had already occurred. She died at age 50 prior to the trial.

ESTATE’S CLAIM If the cancer had been diagnosed earlier, the outcome would have been better. Both radiologists misinterpreted the mammographies.

DEFENDANTS’ DEFENSE The mammographies had been properly interpreted. Any missed diagnosis would not have impacted the outcome due to the type of cancer. The scans had been released to the patient, but were subsequently lost; an adverse interference instruction was given to the jury.

VERDICT A New York defense verdict was returned.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

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Uterine rupture, child stillborn: $3.8M net award
At 35 weeks' gestation, a woman went to the emergency department (ED) with abdominal pain, fast heartbeat, and irregular contractions. Her history included three cesarean deliveries, including one with a vertical incision. She was admitted, and a cesarean delivery was planned for the next day. After 8 hours, during which the patient’s condition worsened, an emergency cesarean delivery was undertaken. A full rupture of the uterus was found; the baby’s body had extruded into the mother’s abdomen. The child was stillborn.

PARENTS’ CLAIM The stillbirth could have been avoided if the nurses had communicated the mother’s worsening condition to the physicians.

DEFENDANTS’ DEFENSE After the hospital and physicians settled prior to trial, the case continued against the nurse in charge of the mother’s care and the nurse-staffing group. Negligence was denied; all protocols were followed.

VERDICT A $2.9 million Illinois verdict was returned. With a $900,000 settlement from the hospital and physicians, the net award was $3.8 million.

_______________

Where did rare strep A infection come from?
A 36-year-old woman reported heavy vaginal bleeding to her ObGyn. She underwent endometrial ablation in her physician’s office.

The next day, the woman called the office to report abdominal pain. She was told to stop the medication she was taking, and if the pain continued to the next day, to go to an ED. The next day, the patient went to the ED and was found to be in septic shock. During emergency laparotomy, 50 mL of purulent fluid were drained and an emergency hysterectomy was performed. Three days later, the patient died from pulmonary arrest caused by toxic shock syndrome. An autopsy revealed that the patient’s sepsis was caused by group A streptococci (GAS) infection.

ESTATE’S CLAIM The patient was not a proper candidate for endometrial ablation because of her history of chronic cervical infection. The ObGyn perforated the cervix during the procedure and tried to conceal it. At autopsy, bone wax was found in the rectal lumen that had been used to cover up damage to the cervix. The ObGyn introduced GAS bacteria into the patient’s system. The ObGyn’s staff failed to ask the proper questions when she called the day after the procedure. She should have been told to go directly to the ED.

DEFENDANTS’ DEFENSE The ObGyn did not perforate the cervix or uterus during the procedure. GAS infection is so rare that it would have been difficult to foresee or diagnose. Potentially, the patient had a chronic
cervical infection before ablation.

VERDICT A Texas defense verdict was returned.

_______________

DURING INSERTION, IUD PERFORATES UTERINE WALL; LATER FOUND BELOW LIVER
On July 21, a 46-year-old woman went to an ObGyn for placement of an intrauterine device (IUD). Shortly after the ObGyn inserted the levonorgestrel-releasing intrauterine system (Mirena, Bayer HealthCare), the patient reported severe pelvic and abdominal pain. On July 26, the patient underwent surgical removal of the IUD.

She was discharged on July 29 but continued to report pain. She was readmitted to the hospital the next day and treated for pain. She was bed ridden for 3 weeks after IUD-removal surgery, and had a 3-month recovery before feeling pain free.

PATIENT’S CLAIM The ObGyn was negligent in perforating the patient’s uterine wall during IUD insertion, causing the device to ultimately migrate under the patient’s liver.

DEFENDANTS’ DEFENSE Uterine perforation is a known complication of IUD insertion. The IUD escaped from the patient’s uterus at a later time and not during the insertion procedure.

VERDICT A Florida verdict of $208,839 was returned; the amount was reduced to $161,058 because the medical expenses were written off by the health-care providers.

_______________

 

Was travel appropriate for this pregnant woman?
A woman with a history of two premature deliveries
and one miscarriage became pregnant again. She received prenatal care at an Army hospital. She traveled to Spain, where the baby was born at 31 weeks’ gestation. The baby required treatment in a neonatal intensive care unit (NICU) for 17 days. The child has cerebral palsy, with tetraplegia of all four extremities. She cannot walk without assistance and suffers severe cognitive and vision impairment.

PARENTS’ CLAIM The ObGyn at the Army hospital should not have approved the mother’s request for travel; he did so, despite knowing that the mother was at high risk for premature birth. The military medical hospital to which she was assigned in Spain could not manage a high-risk pregnancy, didn’t have a NICU, and didn’t have specialists to treat premature infants.

DEFENDANTS’ DEFENSE The ObGyn argued that he did not have access to the medical records showing the mother’s history. The patient countered that the ObGyn did indeed have the patient’s records, as he had discussed them with her.

 

 

VERDICT A $10,409,700 California verdict was returned against the ObGyn and the government facility.

_______________

Triple-negative BrCa not diagnosed until metastasized: $5.2M
After finding lumps in both breasts, a woman in her 30s saw a nurse practitioner (NP) at an Army hospital. A radiologist reported no mass in the right breast and multiple benign-appearing anechoic lesions in the left breast after bilateral mammography and ultrasonography (US) in July 2008. The Chief of Mammography Services recommended referral to a breast surgeon, but the patient never received the letter. It was placed in her mammography file, not in the treatment file.

In November 2008, the patient returned to the clinic. Bilateral diagnostic mammography and US were ordered, but for unknown reasons, cancelled. US of the left breast was interpreted as benign in January 2009.

After imaging in March 2010, followed by a needle biopsy of the right breast, a radiologist reported finding intermediate-grade infiltrating ductal carcinoma.

The patient sought care outside the military medical system at a large university hospital. In April 2010, stage 3 triple-negative invasive ductal carcinoma (IDC) was identified. The patient underwent chemotherapy, a double mastectomy, removal of 21 lymph nodes, and breast reconstruction. She was given a 60% chance of recurrence in 5–7 years.

PATIENT’S CLAIM It was negligent to not inform her of imaging results. Biopsy should have been performed in 2008, when the IDC was likely at stage 1; treatment would have been far less aggressive. Electronic medical records showed that the 2008 mammography and US results had been “signed off” by an NP at the clinic.

DEFENDANTS’ DEFENSE While unable to concede liability, the government agency did not contest the point.

VERDICT A $5.2 million Tennessee federal court bench verdict was returned, citing failures in communication, poor and improper record keeping and retention, failure to follow-up, and an unexplained cancellation of a medical order.

_______________

Woman dies from cervical cancer: $2.3M
In 2001, a 41-year-old woman had abnormal Pap smear results but her gynecologist did not order more testing. The patient was told to return in 3 months, but she did not return until 2007—reporting abnormal bleeding, vaginal discharge, and pain. Her Pap results were normal, however, and the gynecologist did not order further testing. In 2009, the patient was found to have advanced cervical cancer. She died 2 years later.

ESTATE’S CLAIM Further testing should have been ordered in 2001, which would have likely revealed dysplasia, which can lead to cancer. The laboratory incorrectly interpreted the 2007 Pap test; if the results had been properly reported, additional testing could have been ordered.

DEFENDANTS’ DEFENSE The laboratory and patient’s estate settled for a confidential amount before trial. The gynecologist denied negligence.

VERDICT A New Jersey jury found the gynecologist 40% at fault for his actions in 2007. The jury found the laboratory 50% at fault, and the patient 10% at fault. A gross verdict of $2.33 million was returned.

_______________
 

Bowel injury after cesarean delivery; mother dies of sepsis
At 40 4/7 weeks' gestation, a 37-year-old woman gave birth
to a healthy child by cesarean delivery. The next day, the patient had an elevated white blood cell (WBC) count with a left shift, her abdomen was tympanic but soft, and she was passing flatus and belching. The ObGyn ordered a Fleet enema; only flatus was released. A covering ObGyn ordered an abdominal radiograph, which the radiologist reported as showing postoperative ileus and mild constipation. The patient was given a second Fleet enema the next day, resulting in watery stool. She vomited 300 mL of dark green fluid.

After a rectal tube was placed 2 days later, one hard brown stool and several brown, pasty, loose, and liquid stools were returned. She vomited several times that day, and was found to have hypoactive bowel sounds with continued tympanic quality in the upper quadrants. Laboratory testing revealed continued elevated WBC count with left shift. The next day, she had hypoactive bowel sounds with brown liquid stools. Later that morning, she was able to tolerate clear liquids. The ObGyn decided to discharge her home with instructions to continue on a clear liquid diet for 2 more days before advancing her diet.

The day after discharge, she was found unresponsive at home. She was taken to the hospital, but resuscitation attempts failed. She died. An autopsy revealed that the cause of death was sepsis.

ESTATE’S CLAIM The ObGyn was negligent in failing to diagnose and treat a postoperative intra-abdominal infection caused by bowel perforation. A surgical consult should have been obtained. The woman was prematurely discharged. The radiologist failed to report the presence of free air on the abdominal x-ray.

 

 

DEFENDANTS’ DEFENSE The case was settled during trial.

VERDICT A $1 million Maryland settlement was reached. 

_______________

Right ureter injury detected and repaired
During laparoscopic-assisted vaginal hysterectomy, the ObGyn detected and repaired an injury to the right ureter. The patient’s recovery was delayed by the injury.

PATIENT’S CLAIM The ObGyn was negligent in using a Kleppinger bipolar cauterizing instrument to cauterize the vaginal cuff. Thermal overspray from the instrument or the instrument itself damaged the ureter. The ObGyn was also negligent in not performing diagnostic cystoscopy to confirm patency of the ureter after the repair was made.

PHYSICIAN’S DEFENSE Ureter injury is a known risk of the procedure. All procedures were performed according to protocol.

VERDICT A Florida defense verdict was returned.

_______________

Failure to detect inflammatory BrCa; woman dies
A 42-year-old woman underwent mammography in February 2002 after reporting pain, discoloration, inflammation, and swelling in her left breast. The radiologist who interpreted the mammography suggested a biopsy for a differential diagnosis of mastitis or inflammatory carcinoma. The biopsy results were negative.

The patient’s symptoms persisted, and she underwent US in late May 2002. Another radiologist interpreted the US, noting that the patient could not tolerate compression, which led to less than optimal evaluation. The radiologist suggested that mastitis was the likely cause of the patient’s symptoms.

The patient then consulted a surgeon, who ordered mammography and magnetic resonance imaging (MRI) followed by biopsy, which indicated cancer. The patient underwent a mastectomy but metastasis had already occurred. She died at age 50 prior to the trial.

ESTATE’S CLAIM If the cancer had been diagnosed earlier, the outcome would have been better. Both radiologists misinterpreted the mammographies.

DEFENDANTS’ DEFENSE The mammographies had been properly interpreted. Any missed diagnosis would not have impacted the outcome due to the type of cancer. The scans had been released to the patient, but were subsequently lost; an adverse interference instruction was given to the jury.

VERDICT A New York defense verdict was returned.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Uterine rupture, child stillborn: $3.8M net award
At 35 weeks' gestation, a woman went to the emergency department (ED) with abdominal pain, fast heartbeat, and irregular contractions. Her history included three cesarean deliveries, including one with a vertical incision. She was admitted, and a cesarean delivery was planned for the next day. After 8 hours, during which the patient’s condition worsened, an emergency cesarean delivery was undertaken. A full rupture of the uterus was found; the baby’s body had extruded into the mother’s abdomen. The child was stillborn.

PARENTS’ CLAIM The stillbirth could have been avoided if the nurses had communicated the mother’s worsening condition to the physicians.

DEFENDANTS’ DEFENSE After the hospital and physicians settled prior to trial, the case continued against the nurse in charge of the mother’s care and the nurse-staffing group. Negligence was denied; all protocols were followed.

VERDICT A $2.9 million Illinois verdict was returned. With a $900,000 settlement from the hospital and physicians, the net award was $3.8 million.

_______________

Where did rare strep A infection come from?
A 36-year-old woman reported heavy vaginal bleeding to her ObGyn. She underwent endometrial ablation in her physician’s office.

The next day, the woman called the office to report abdominal pain. She was told to stop the medication she was taking, and if the pain continued to the next day, to go to an ED. The next day, the patient went to the ED and was found to be in septic shock. During emergency laparotomy, 50 mL of purulent fluid were drained and an emergency hysterectomy was performed. Three days later, the patient died from pulmonary arrest caused by toxic shock syndrome. An autopsy revealed that the patient’s sepsis was caused by group A streptococci (GAS) infection.

ESTATE’S CLAIM The patient was not a proper candidate for endometrial ablation because of her history of chronic cervical infection. The ObGyn perforated the cervix during the procedure and tried to conceal it. At autopsy, bone wax was found in the rectal lumen that had been used to cover up damage to the cervix. The ObGyn introduced GAS bacteria into the patient’s system. The ObGyn’s staff failed to ask the proper questions when she called the day after the procedure. She should have been told to go directly to the ED.

DEFENDANTS’ DEFENSE The ObGyn did not perforate the cervix or uterus during the procedure. GAS infection is so rare that it would have been difficult to foresee or diagnose. Potentially, the patient had a chronic
cervical infection before ablation.

VERDICT A Texas defense verdict was returned.

_______________

DURING INSERTION, IUD PERFORATES UTERINE WALL; LATER FOUND BELOW LIVER
On July 21, a 46-year-old woman went to an ObGyn for placement of an intrauterine device (IUD). Shortly after the ObGyn inserted the levonorgestrel-releasing intrauterine system (Mirena, Bayer HealthCare), the patient reported severe pelvic and abdominal pain. On July 26, the patient underwent surgical removal of the IUD.

She was discharged on July 29 but continued to report pain. She was readmitted to the hospital the next day and treated for pain. She was bed ridden for 3 weeks after IUD-removal surgery, and had a 3-month recovery before feeling pain free.

PATIENT’S CLAIM The ObGyn was negligent in perforating the patient’s uterine wall during IUD insertion, causing the device to ultimately migrate under the patient’s liver.

DEFENDANTS’ DEFENSE Uterine perforation is a known complication of IUD insertion. The IUD escaped from the patient’s uterus at a later time and not during the insertion procedure.

VERDICT A Florida verdict of $208,839 was returned; the amount was reduced to $161,058 because the medical expenses were written off by the health-care providers.

_______________

 

Was travel appropriate for this pregnant woman?
A woman with a history of two premature deliveries
and one miscarriage became pregnant again. She received prenatal care at an Army hospital. She traveled to Spain, where the baby was born at 31 weeks’ gestation. The baby required treatment in a neonatal intensive care unit (NICU) for 17 days. The child has cerebral palsy, with tetraplegia of all four extremities. She cannot walk without assistance and suffers severe cognitive and vision impairment.

PARENTS’ CLAIM The ObGyn at the Army hospital should not have approved the mother’s request for travel; he did so, despite knowing that the mother was at high risk for premature birth. The military medical hospital to which she was assigned in Spain could not manage a high-risk pregnancy, didn’t have a NICU, and didn’t have specialists to treat premature infants.

DEFENDANTS’ DEFENSE The ObGyn argued that he did not have access to the medical records showing the mother’s history. The patient countered that the ObGyn did indeed have the patient’s records, as he had discussed them with her.

 

 

VERDICT A $10,409,700 California verdict was returned against the ObGyn and the government facility.

_______________

Triple-negative BrCa not diagnosed until metastasized: $5.2M
After finding lumps in both breasts, a woman in her 30s saw a nurse practitioner (NP) at an Army hospital. A radiologist reported no mass in the right breast and multiple benign-appearing anechoic lesions in the left breast after bilateral mammography and ultrasonography (US) in July 2008. The Chief of Mammography Services recommended referral to a breast surgeon, but the patient never received the letter. It was placed in her mammography file, not in the treatment file.

In November 2008, the patient returned to the clinic. Bilateral diagnostic mammography and US were ordered, but for unknown reasons, cancelled. US of the left breast was interpreted as benign in January 2009.

After imaging in March 2010, followed by a needle biopsy of the right breast, a radiologist reported finding intermediate-grade infiltrating ductal carcinoma.

The patient sought care outside the military medical system at a large university hospital. In April 2010, stage 3 triple-negative invasive ductal carcinoma (IDC) was identified. The patient underwent chemotherapy, a double mastectomy, removal of 21 lymph nodes, and breast reconstruction. She was given a 60% chance of recurrence in 5–7 years.

PATIENT’S CLAIM It was negligent to not inform her of imaging results. Biopsy should have been performed in 2008, when the IDC was likely at stage 1; treatment would have been far less aggressive. Electronic medical records showed that the 2008 mammography and US results had been “signed off” by an NP at the clinic.

DEFENDANTS’ DEFENSE While unable to concede liability, the government agency did not contest the point.

VERDICT A $5.2 million Tennessee federal court bench verdict was returned, citing failures in communication, poor and improper record keeping and retention, failure to follow-up, and an unexplained cancellation of a medical order.

_______________

Woman dies from cervical cancer: $2.3M
In 2001, a 41-year-old woman had abnormal Pap smear results but her gynecologist did not order more testing. The patient was told to return in 3 months, but she did not return until 2007—reporting abnormal bleeding, vaginal discharge, and pain. Her Pap results were normal, however, and the gynecologist did not order further testing. In 2009, the patient was found to have advanced cervical cancer. She died 2 years later.

ESTATE’S CLAIM Further testing should have been ordered in 2001, which would have likely revealed dysplasia, which can lead to cancer. The laboratory incorrectly interpreted the 2007 Pap test; if the results had been properly reported, additional testing could have been ordered.

DEFENDANTS’ DEFENSE The laboratory and patient’s estate settled for a confidential amount before trial. The gynecologist denied negligence.

VERDICT A New Jersey jury found the gynecologist 40% at fault for his actions in 2007. The jury found the laboratory 50% at fault, and the patient 10% at fault. A gross verdict of $2.33 million was returned.

_______________
 

Bowel injury after cesarean delivery; mother dies of sepsis
At 40 4/7 weeks' gestation, a 37-year-old woman gave birth
to a healthy child by cesarean delivery. The next day, the patient had an elevated white blood cell (WBC) count with a left shift, her abdomen was tympanic but soft, and she was passing flatus and belching. The ObGyn ordered a Fleet enema; only flatus was released. A covering ObGyn ordered an abdominal radiograph, which the radiologist reported as showing postoperative ileus and mild constipation. The patient was given a second Fleet enema the next day, resulting in watery stool. She vomited 300 mL of dark green fluid.

After a rectal tube was placed 2 days later, one hard brown stool and several brown, pasty, loose, and liquid stools were returned. She vomited several times that day, and was found to have hypoactive bowel sounds with continued tympanic quality in the upper quadrants. Laboratory testing revealed continued elevated WBC count with left shift. The next day, she had hypoactive bowel sounds with brown liquid stools. Later that morning, she was able to tolerate clear liquids. The ObGyn decided to discharge her home with instructions to continue on a clear liquid diet for 2 more days before advancing her diet.

The day after discharge, she was found unresponsive at home. She was taken to the hospital, but resuscitation attempts failed. She died. An autopsy revealed that the cause of death was sepsis.

ESTATE’S CLAIM The ObGyn was negligent in failing to diagnose and treat a postoperative intra-abdominal infection caused by bowel perforation. A surgical consult should have been obtained. The woman was prematurely discharged. The radiologist failed to report the presence of free air on the abdominal x-ray.

 

 

DEFENDANTS’ DEFENSE The case was settled during trial.

VERDICT A $1 million Maryland settlement was reached. 

_______________

Right ureter injury detected and repaired
During laparoscopic-assisted vaginal hysterectomy, the ObGyn detected and repaired an injury to the right ureter. The patient’s recovery was delayed by the injury.

PATIENT’S CLAIM The ObGyn was negligent in using a Kleppinger bipolar cauterizing instrument to cauterize the vaginal cuff. Thermal overspray from the instrument or the instrument itself damaged the ureter. The ObGyn was also negligent in not performing diagnostic cystoscopy to confirm patency of the ureter after the repair was made.

PHYSICIAN’S DEFENSE Ureter injury is a known risk of the procedure. All procedures were performed according to protocol.

VERDICT A Florida defense verdict was returned.

_______________

Failure to detect inflammatory BrCa; woman dies
A 42-year-old woman underwent mammography in February 2002 after reporting pain, discoloration, inflammation, and swelling in her left breast. The radiologist who interpreted the mammography suggested a biopsy for a differential diagnosis of mastitis or inflammatory carcinoma. The biopsy results were negative.

The patient’s symptoms persisted, and she underwent US in late May 2002. Another radiologist interpreted the US, noting that the patient could not tolerate compression, which led to less than optimal evaluation. The radiologist suggested that mastitis was the likely cause of the patient’s symptoms.

The patient then consulted a surgeon, who ordered mammography and magnetic resonance imaging (MRI) followed by biopsy, which indicated cancer. The patient underwent a mastectomy but metastasis had already occurred. She died at age 50 prior to the trial.

ESTATE’S CLAIM If the cancer had been diagnosed earlier, the outcome would have been better. Both radiologists misinterpreted the mammographies.

DEFENDANTS’ DEFENSE The mammographies had been properly interpreted. Any missed diagnosis would not have impacted the outcome due to the type of cancer. The scans had been released to the patient, but were subsequently lost; an adverse interference instruction was given to the jury.

VERDICT A New York defense verdict was returned.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

References

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Uterine rupture, child stillborn: $3.8M net award
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Uterine rupture, child stillborn: $3.8M net award
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  • Where did rare strep A infection come from?
  • During insertion, IUD perforates uterine wall; Later found below liver
  • Was travel appropriate for this pregnant woman?
  • Triple-negative BrCa not diagnosed until metastasized: $5.2M
  • Woman dies from cervical cancer: $2.3M
  • Bowel injury after cesarean delivery; mother dies of sepsis
  • Right ureter injury detected and repaired
  • Failure to detect inflammatory BrCa; woman dies
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The Affordable Care Act: What’s the latest?

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The Affordable Care Act: What’s the latest?

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When I last wrote about the Affordable Care Act (ACA), in May 2014, I focused on the contraception issue. Since then, the US Supreme Court ruled, in Burwell v. Hobby Lobby, that closely held, for-profit companies with religious objections to covering birth control can opt out of the requirement to provide contraceptive coverage to their employees.

In this article, I explore that decision and what it means for women’s health. I also present data on the uninsured rate in the United States, which has dropped significantly since enactment of the ACA, and I discuss one increasingly common barrier to access to care—the use of narrow networks by insurers.

A corporation now can hold a religious belief
The Supreme Court’s majority 5-4 ruling recognized, for the first time, that a for-profit corporation can hold a religious belief, but the Court limited this claim to closely held corporations. The Court also decided that the ACA placed a substantial burden on the corporations’ religious beliefs and concluded that there are less burdensome ways to accomplish the law’s intent, rendering the contraceptive coverage provision in the ACA in violation of the Religious Freedom Restoration Act (RFRA). The Court limited its ruling to the contraceptive coverage requirement, essentially turning the requirement into an option for many employers.



Are contraceptives abortifacients?

The religious belief at the center of Burwell v. Hobby Lobby was that life begins at conception, which the Green family—the owners of Hobby Lobby—equate to fertilization. Hobby Lobby’s attorneys also asserted that four contraceptives approved by the US Food and Drug Administration and included in the ACA mandate may prevent implantation of a fertilized egg, thereby constituting abortion.

Although there is no scientific answer as to when life begins, ACOG and the medical community agree that pregnancy begins at implantation. In its amicus brief to the US Supreme Court, ACOG asserted the medical community’s consensus that the four contraceptives prevent pregnancy rather than end it, and are not abortifacients:

  • emergency contraceptive pills: levonorgestrel (Plan B) and its generic equivalents and ulipristal acetate (ella)
  • the copper IUD (ParaGard)
  • levonorgestrel-releasing intrauterine systems (Mirena, Skyla).

What is a closely held corporation?
In general, according to the Pew Research Center, a closely held corporation is a private company (not publicly traded) with a limited number of shareholders. The Internal Revenue Service (IRS), an important source, defines a closely held corporation as one in which more than half of the stock is owned (directly or indirectly) by five or fewer individuals at any time in the second half of the year.

“S” corporations are also considered closely held. These are corporations with 100 or fewer shareholders, with all members of the same family counted as one shareholder. “S” corporations don’t pay income tax; their shareholders pay tax on their personal returns, based on the corporations’ profits and losses.

Hobby Lobby is organized as an “S” corporation. According to the IRS, in 2011, there were 4,158,572 “S” corporations, 99.4% of them with 10 or fewer shareholders.1

The US Census Bureau estimates that, in 2012, about 2.9 million “S” corporations employed more than 29 million people. Many closely held corporations are quite large.2 According to the Pew Research Center, family-owned Cargill employs 140,000 people and had $136.7 billion in revenue in fiscal 2013. Hobby Lobby has estimated revenues of $3.3 billion and 23,000 employees.2

What’s next?
ACOG helped secure coverage of contraceptives in the ACA and is working with the US Congress and our women’s health partners to restore this important care. Days after the Supreme Court decision, Senator Patty Murray (D-WA) introduced the Protect Women’s Health from Corporate Interference Act, S. 2578, with 46 cosponsors as of this writing. ACOG fully supports this bill, also known as the “Not My Boss’ Business Bill,” which would reestablish the contraceptive coverage mandate as well as other care required by federal law. This bill still maintains the exemption from contraceptive coverage for houses of worship and the accommodation for religious nonprofits.

In introducing her bill, Senator Murray pointed out that “the contraceptive coverage requirement has already made a tremendous difference in women’s lives—24 million more prescriptions for oral contraceptives were filled with no copay in 2013 than in 2012, and women have saved $483 million in out-of-pocket costs for oral contraceptives.”3

Uninsured rate is declining
The Commonwealth Fund shows that, from July–September 2013 to April–June 2014, the nation’s uninsured rate fell from 20% to 15%, resulting in 9.5 million fewer uninsured adults.4 The biggest drop occurred among young adults, with the uninsured rate falling from 28% to 18%, and in states that adopted the Medicaid expansion, where uninsured rates fell from 28% to 17%.4

 

 

States that didn’t expand their Medicaid program didn’t show any noticeable change, with the uninsured rate declining only two points, from 38% to 36%.4

Coverage resulted in access to care for the majority of the newly covered. Sixty percent of people with new coverage visited a provider or hospital or paid for a prescription. Sixty-two percent of these individuals said they wouldn’t have been able to access this care before getting this coverage. Eighty-one percent of people with new coverage said they were better off now than before.4

ACA works better in some states than others
The Kaiser Family Foundation looked at four successful states—Colorado, Connecticut, Kentucky, and Washington state—to see what lessons can be learned. Important commonalities include the fact that the states run their own marketplace, adopted the Medi-caid expansion, and conducted extensive outreach and public education, including engaging providers in patient outreach and enrollment.5

Other tools of success were developing good marketing and branding, providing consumer-friendly assistance, and attention to systems and operations.5

How the Hobby Lobby decision affects individual states

Because the Supreme Court’s decision concerned interpretation of a federal law—the Religious Freedom Restoration Act (RFRA)—it does not supersede state laws that mandate coverage of contraceptives.

Twenty-eight states have laws or rulings requiring insurers to cover contraceptives, most of them dating from the 1990s and providing some exemption for religious insurers or plans. Only Illinois allows an exemption for secular bodies.

Although these state laws remain in effect, state officials may opt to stop enforcing them with regard to certain companies. For example, after the Hobby Lobby decision, Wisconsin officials announced that they no longer will enforce contraceptive coverage when a company has a religious objection.

For companies that self-fund or self-insure worker health coverage, the state coverage laws don’t apply—only federal law does. These companies do not have to adhere to state insurance mandates.

Some states have their own version of the RFRA. See the chart at right for details on a state-by-state basis.

The Supreme Court ruling also has no effect on state laws that guarantee access to emergency contraception in hospital emergency departments and that require pharmacists to dispense contraceptives.

StateContraceptive
equity law?
Employer/insurer exemption to equity law?Religious freedom law?
Alabama
Alaska
Arizona
Arkansas
California
Colorado
Connecticut
Delaware
Florida
Georgia
Hawaii
Idaho
Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
Maine
Maryland
Massachusetts
Michigan
Minnesota
Mississippi
Missouri
Montana
Nebraska
Nevada
New Hampshire
New Jersey
New Mexico
New York
North Carolina
North Dakota
Ohio
Oklahoma
Oregon
Pennsylvania
Rhode Island
South Carolina
South Dakota
Tennessee
Texas
Utah
Vermont
Virginia
Washington
West Virginia
Wisconsin
Wyoming
TOTAL
28
20
18

Narrow networks limit access to care
Huge concerns abound regarding implementation and real-life experiences related to the ACA. A number of them—high deductibles, low payment rates, limited access to physicians, long drive and wait times—can be related to “narrow networks.” Insurers exclude certain providers and offer all providers lower payment rates (which leads some physicians to drop out of the plan); they also create tiers (charging consumers lower copays and deductibles for using inner-tier preferred providers and high out-of-pocket costs for using other providers, even though they may be in the network).

Narrow networks work for insurers as an effective tool for lowering provider payment rates to keep premiums low and gain market share. The narrower the network, the lower are physician payments and premiums.

The ACA promises expanded access to high-quality, affordable health care for millions of Americans—a promise being compromised in many areas of the country through narrow networks. In these instances, insurers offering new plans in a health-care marketplace limit patient access to the numbers, types, and locations of physicians and hospitals covered under certain plans. Insurers typically offer patients low premiums, offer selected providers a high volume of patients at low payment levels, and exclude other providers whom the insurer deems to be high-cost.

Narrow networks aren’t new
As with so many elements of the ACA, narrow networks aren’t a new phenomenon. Many of us remember the public relations price that HMOs paid in the 1980s and 1990s for exceedingly limiting patients’ access to care while charging low premiums. The consumer outcry led the National Association of Insurance Commissioners to urge states to require managed-care plans to maintain adequate networks, the approach adopted by the federal government in the ACA.6

 

 

The pendulum swung in the next decade to broader networks in which consumers had much greater access, but premiums increased by an average of 11% per year.6 Employers then pushed insurers to reduce premium costs, leading back to narrow ­networks in the years just before the ACA. Narrow network plans accounted for 23% of all employer-sponsored plans in 2012, up from 15% in 2007.6

Increasing consolidation contributes to narrow networks
The trend toward narrower networks is also linked to increasing consolidation in health care. As health systems grow and individual or small group practices disappear, insurers rely on being able to credibly threaten to exclude systems and big groups from their networks as leverage in payment negotiations. By restricting the choice of providers in a plan, the insurer can promise more customers for the doctors and hospitals that are included, and negotiate lower payments to those providers.

The downside for physicians is clear:

  • low payment rates
  • exclusion from networks and coverage
  • inability to refer patients to providers the physician determines to be best for that patient’s needs.
  • The downside for patients:
  • If they have to go out of network to get needed care, they may end up paying high out-of-pocket costs
  • If they delay or forego care, their health may suffer significantly.

The insurance industry’s position is that patients have choices. Plans with access to more hospitals and specialists are available but usually at a higher price.

Narrow networks are one way to achieve low premiums
In the months leading up to ACA enactment, insurers got to work developing plans designed to be sold on the exchanges that would attract consumers through low-cost premiums and still maximize profits, especially now that insurers, under the ACA, are barred from excluding sick enrollees or increasing premiums for women, in addition to other important protections.

In previous articles, we’ve explored these landmark protections. Insurers in the individual market used to be able to keep ­premiums relatively low, and profits up, through use of preexisting coverage exclusions, benefit exclusions including noncoverage for maternity care or prescription drugs, and high cost sharing. Not anymore.

Since enactment of the ACA, narrow networks seem to be the preferred, and most effective, payment negotiation tool of many insurers offering plans through the exchanges, reflecting the trend we’re already seeing in the private health insurance marketplace.

NPR spotlights the difficulty of finding a specialist
The consumer and provider problems of narrow networks have been gaining attention in the media. In July, the National Public Radio (NPR) Web site carried an article entitled, “Patients with low-cost insurance struggle to find specialists,” with a key subtitle: “So you found an exchange plan. But can you find a provider?”7

In the NPR article, author Carrie ­Feibel reported on the situation in a majority-­immigrant area of southwest Houston.

There, many patients at the local clinic have health insurance coverage for the first time, an important step toward healthier lives for themselves and their families. But many people in need of a specialist are learning that their insurance card doesn’t guarantee them access to a needed surgeon or hospital. They’ve purchased a narrow-network insurance plan, with a low premium but few specialists who accept that insurance.7

The two largest hospital chains in Houston—Houston Methodist and Memorial Hermann—as well as Houston’s MD Anderson Cancer Center, don’t participate in the Blue Cross Blue Shield HMO Silver plan, a plan popular with low-income consumers because of its low premium.7

Will the government take action?
The ACA actually guards against overly narrow networks and established the first national standard for network adequacy—a standard that needs fuller development, for sure. Plans sold on the exchanges are required to establish networks that include, among other providers, essential community providers, who typically care for mostly low-income and medically underserved populations. Networks also must include sufficient numbers and types of providers, including “providers that specialize in mental health and substance abuse services, to assure that all services will be accessible without unreasonable delay.”8

Insurers also must provide people who are considering purchasing their products with an accurate directory—both online and a hard copy—identifying providers not accepting new patients in the network. And plans are prohibited from charging out-of-network cost-sharing for emergency services.

Much of the oversight and many of the details—how much is adequate? what is unreasonable?—are left to the states, many of which have years of experience grappling with the downsides and delicate balance of networks.

The Urban Institute points out that Vermont and Delaware set standards for maximum geographic distance and drive times for primary care services. In California, plans must make it easy for consumers to reach urban providers on public transportation.6

 

 

Professional societies are taking note
Today, the misuse of narrow networks by exchange plans also has gotten the attention of the American Medical Association, ACOG, and many other national medical specialty societies, in addition to the states and federal government.

The trick, many health-care policy experts agree, is to find the right balance. How broad can the network be before premiums soar? Most agree that consumers must be able to choose between plans with confidence, without any cost or access surprises, meaning much better transparency. And many agree that provider quality, in addition to cost, has to find its way into the equation.

This year, the Center for Consumer Information and Insurance Oversight, a part of the federal Department of Health and Human Services created by the ACA to investigate these kinds of issues, is investigating access to hospital systems, mental health services, oncology, and primary care providers and is developing time, distance, and other standards that insurers will have to adhere to.

Employer groups oppose strong standards or limits on narrow networks. Recently, representatives of the US Chamber of Commerce, the ­National ­Retail Federation, and others warned ­Congress to stay out of this fight. They understand that more generous networks mean higher premiums. These employer representative groups prefer to strengthen consumer protections like directories and keep low the cost of health insurance that they provide for their employees. 

Acknowledgment
The author acknowledges the work and expertise of ACOG's state government affairs team for the state analysis—Kathryn Moore, Director, and Kate Vlach, Senior Manager—as well as advocacy partners.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

References

1. Internal Revenue Service. SOI Tax States, Table 1, Returns of Active Corporations, Form 1120S. http://www.irs.gov/uac/SOI-Tax-Stats-Table-1-Returns-of-Active-Corporations,-Form-1120S. Updated June 27, 2014. Accessed September 4, 2014.
2. DeSilver D. What is a ‘closely held corporation,’ anyway, and how many are there? Pew Research Center: Fact Tank. http://www.pewresearch.org/fact-tank/2014/07/07/what-is-a-closely-held-corporation-anyway-and-how-many-are-there/. Published July 7, 2014. Accessed September 4, 2014.
3. Murray P. Protect Women’s Health From Corporate Interference Act: Summary. http://www.murray.senate.gov/public/_cache/files/30554052-0f84-485a-babc-ccc04af85bb6/protect-women-s-health-from-corporate-interference-act---one-page-summary---final.pdf. Accessed September 4, 2014.
4. The Commonwealth Fund. New Survey: After First ACA Enrollment Period, Uninsured Rate Dropped from 20% to 15%; Largest Declines Among Young Adults, Latinos, and Low-Income People. http://www.commonwealthfund.org/publications/press-releases/2014/jul/after-first-aca -enrollment-period. Published July 10,2014. Accessed September 4, 2014.
5. Artiga S, Stephens J, Rudowitz R, Perry M. What Worked and What’s Next? Strategies in Four States Leading ACA Enrollment Efforts. Kaiser Family Foundation. http://kff.org/health-reform/issue-brief/what-worked-and-whats-next-strategies-in-four-states-leading-aca-enrollment-efforts/. Published July 16, 2014. Accessed September 4, 2014.
6. Corlette S, Volk J. Narrow Provider Networks in New Health Plans: Balancing Affordability with Access to Quality Care. Urban Institute: Georgetown University Center on Health Insurance Reforms. http://www.urban.org/UploadedPDF/413135-New-Provider-Networks-in-New-Health-Plans.pdf. Published May 2014. Accessed September 4, 2014.
7. Feibel C. Patients With Low-Cost Insurance Struggle to Find Specialists. National Public Radio. http://www.npr.org/blogs/health/2014/07/16/331419293/patients-with-low-cost-insurance-struggle-to-find-specialists. Published July 16, 2014. Accessed September 4, 2014.
8. Patient Protection and Affordable Care Act: Preexisting Condition Exclusions, Lifetime and Annual Limits, Rescissions, and Patient Protections. US Department of Health and Human Services. http://www.regulations.go/#!documentDetail;D=HHS-OS-2010-0014-0001. Published June 28, 2010. Accessed September 9, 2014.

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mmmm

When I last wrote about the Affordable Care Act (ACA), in May 2014, I focused on the contraception issue. Since then, the US Supreme Court ruled, in Burwell v. Hobby Lobby, that closely held, for-profit companies with religious objections to covering birth control can opt out of the requirement to provide contraceptive coverage to their employees.

In this article, I explore that decision and what it means for women’s health. I also present data on the uninsured rate in the United States, which has dropped significantly since enactment of the ACA, and I discuss one increasingly common barrier to access to care—the use of narrow networks by insurers.

A corporation now can hold a religious belief
The Supreme Court’s majority 5-4 ruling recognized, for the first time, that a for-profit corporation can hold a religious belief, but the Court limited this claim to closely held corporations. The Court also decided that the ACA placed a substantial burden on the corporations’ religious beliefs and concluded that there are less burdensome ways to accomplish the law’s intent, rendering the contraceptive coverage provision in the ACA in violation of the Religious Freedom Restoration Act (RFRA). The Court limited its ruling to the contraceptive coverage requirement, essentially turning the requirement into an option for many employers.



Are contraceptives abortifacients?

The religious belief at the center of Burwell v. Hobby Lobby was that life begins at conception, which the Green family—the owners of Hobby Lobby—equate to fertilization. Hobby Lobby’s attorneys also asserted that four contraceptives approved by the US Food and Drug Administration and included in the ACA mandate may prevent implantation of a fertilized egg, thereby constituting abortion.

Although there is no scientific answer as to when life begins, ACOG and the medical community agree that pregnancy begins at implantation. In its amicus brief to the US Supreme Court, ACOG asserted the medical community’s consensus that the four contraceptives prevent pregnancy rather than end it, and are not abortifacients:

  • emergency contraceptive pills: levonorgestrel (Plan B) and its generic equivalents and ulipristal acetate (ella)
  • the copper IUD (ParaGard)
  • levonorgestrel-releasing intrauterine systems (Mirena, Skyla).

What is a closely held corporation?
In general, according to the Pew Research Center, a closely held corporation is a private company (not publicly traded) with a limited number of shareholders. The Internal Revenue Service (IRS), an important source, defines a closely held corporation as one in which more than half of the stock is owned (directly or indirectly) by five or fewer individuals at any time in the second half of the year.

“S” corporations are also considered closely held. These are corporations with 100 or fewer shareholders, with all members of the same family counted as one shareholder. “S” corporations don’t pay income tax; their shareholders pay tax on their personal returns, based on the corporations’ profits and losses.

Hobby Lobby is organized as an “S” corporation. According to the IRS, in 2011, there were 4,158,572 “S” corporations, 99.4% of them with 10 or fewer shareholders.1

The US Census Bureau estimates that, in 2012, about 2.9 million “S” corporations employed more than 29 million people. Many closely held corporations are quite large.2 According to the Pew Research Center, family-owned Cargill employs 140,000 people and had $136.7 billion in revenue in fiscal 2013. Hobby Lobby has estimated revenues of $3.3 billion and 23,000 employees.2

What’s next?
ACOG helped secure coverage of contraceptives in the ACA and is working with the US Congress and our women’s health partners to restore this important care. Days after the Supreme Court decision, Senator Patty Murray (D-WA) introduced the Protect Women’s Health from Corporate Interference Act, S. 2578, with 46 cosponsors as of this writing. ACOG fully supports this bill, also known as the “Not My Boss’ Business Bill,” which would reestablish the contraceptive coverage mandate as well as other care required by federal law. This bill still maintains the exemption from contraceptive coverage for houses of worship and the accommodation for religious nonprofits.

In introducing her bill, Senator Murray pointed out that “the contraceptive coverage requirement has already made a tremendous difference in women’s lives—24 million more prescriptions for oral contraceptives were filled with no copay in 2013 than in 2012, and women have saved $483 million in out-of-pocket costs for oral contraceptives.”3

Uninsured rate is declining
The Commonwealth Fund shows that, from July–September 2013 to April–June 2014, the nation’s uninsured rate fell from 20% to 15%, resulting in 9.5 million fewer uninsured adults.4 The biggest drop occurred among young adults, with the uninsured rate falling from 28% to 18%, and in states that adopted the Medicaid expansion, where uninsured rates fell from 28% to 17%.4

 

 

States that didn’t expand their Medicaid program didn’t show any noticeable change, with the uninsured rate declining only two points, from 38% to 36%.4

Coverage resulted in access to care for the majority of the newly covered. Sixty percent of people with new coverage visited a provider or hospital or paid for a prescription. Sixty-two percent of these individuals said they wouldn’t have been able to access this care before getting this coverage. Eighty-one percent of people with new coverage said they were better off now than before.4

ACA works better in some states than others
The Kaiser Family Foundation looked at four successful states—Colorado, Connecticut, Kentucky, and Washington state—to see what lessons can be learned. Important commonalities include the fact that the states run their own marketplace, adopted the Medi-caid expansion, and conducted extensive outreach and public education, including engaging providers in patient outreach and enrollment.5

Other tools of success were developing good marketing and branding, providing consumer-friendly assistance, and attention to systems and operations.5

How the Hobby Lobby decision affects individual states

Because the Supreme Court’s decision concerned interpretation of a federal law—the Religious Freedom Restoration Act (RFRA)—it does not supersede state laws that mandate coverage of contraceptives.

Twenty-eight states have laws or rulings requiring insurers to cover contraceptives, most of them dating from the 1990s and providing some exemption for religious insurers or plans. Only Illinois allows an exemption for secular bodies.

Although these state laws remain in effect, state officials may opt to stop enforcing them with regard to certain companies. For example, after the Hobby Lobby decision, Wisconsin officials announced that they no longer will enforce contraceptive coverage when a company has a religious objection.

For companies that self-fund or self-insure worker health coverage, the state coverage laws don’t apply—only federal law does. These companies do not have to adhere to state insurance mandates.

Some states have their own version of the RFRA. See the chart at right for details on a state-by-state basis.

The Supreme Court ruling also has no effect on state laws that guarantee access to emergency contraception in hospital emergency departments and that require pharmacists to dispense contraceptives.

StateContraceptive
equity law?
Employer/insurer exemption to equity law?Religious freedom law?
Alabama
Alaska
Arizona
Arkansas
California
Colorado
Connecticut
Delaware
Florida
Georgia
Hawaii
Idaho
Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
Maine
Maryland
Massachusetts
Michigan
Minnesota
Mississippi
Missouri
Montana
Nebraska
Nevada
New Hampshire
New Jersey
New Mexico
New York
North Carolina
North Dakota
Ohio
Oklahoma
Oregon
Pennsylvania
Rhode Island
South Carolina
South Dakota
Tennessee
Texas
Utah
Vermont
Virginia
Washington
West Virginia
Wisconsin
Wyoming
TOTAL
28
20
18

Narrow networks limit access to care
Huge concerns abound regarding implementation and real-life experiences related to the ACA. A number of them—high deductibles, low payment rates, limited access to physicians, long drive and wait times—can be related to “narrow networks.” Insurers exclude certain providers and offer all providers lower payment rates (which leads some physicians to drop out of the plan); they also create tiers (charging consumers lower copays and deductibles for using inner-tier preferred providers and high out-of-pocket costs for using other providers, even though they may be in the network).

Narrow networks work for insurers as an effective tool for lowering provider payment rates to keep premiums low and gain market share. The narrower the network, the lower are physician payments and premiums.

The ACA promises expanded access to high-quality, affordable health care for millions of Americans—a promise being compromised in many areas of the country through narrow networks. In these instances, insurers offering new plans in a health-care marketplace limit patient access to the numbers, types, and locations of physicians and hospitals covered under certain plans. Insurers typically offer patients low premiums, offer selected providers a high volume of patients at low payment levels, and exclude other providers whom the insurer deems to be high-cost.

Narrow networks aren’t new
As with so many elements of the ACA, narrow networks aren’t a new phenomenon. Many of us remember the public relations price that HMOs paid in the 1980s and 1990s for exceedingly limiting patients’ access to care while charging low premiums. The consumer outcry led the National Association of Insurance Commissioners to urge states to require managed-care plans to maintain adequate networks, the approach adopted by the federal government in the ACA.6

 

 

The pendulum swung in the next decade to broader networks in which consumers had much greater access, but premiums increased by an average of 11% per year.6 Employers then pushed insurers to reduce premium costs, leading back to narrow ­networks in the years just before the ACA. Narrow network plans accounted for 23% of all employer-sponsored plans in 2012, up from 15% in 2007.6

Increasing consolidation contributes to narrow networks
The trend toward narrower networks is also linked to increasing consolidation in health care. As health systems grow and individual or small group practices disappear, insurers rely on being able to credibly threaten to exclude systems and big groups from their networks as leverage in payment negotiations. By restricting the choice of providers in a plan, the insurer can promise more customers for the doctors and hospitals that are included, and negotiate lower payments to those providers.

The downside for physicians is clear:

  • low payment rates
  • exclusion from networks and coverage
  • inability to refer patients to providers the physician determines to be best for that patient’s needs.
  • The downside for patients:
  • If they have to go out of network to get needed care, they may end up paying high out-of-pocket costs
  • If they delay or forego care, their health may suffer significantly.

The insurance industry’s position is that patients have choices. Plans with access to more hospitals and specialists are available but usually at a higher price.

Narrow networks are one way to achieve low premiums
In the months leading up to ACA enactment, insurers got to work developing plans designed to be sold on the exchanges that would attract consumers through low-cost premiums and still maximize profits, especially now that insurers, under the ACA, are barred from excluding sick enrollees or increasing premiums for women, in addition to other important protections.

In previous articles, we’ve explored these landmark protections. Insurers in the individual market used to be able to keep ­premiums relatively low, and profits up, through use of preexisting coverage exclusions, benefit exclusions including noncoverage for maternity care or prescription drugs, and high cost sharing. Not anymore.

Since enactment of the ACA, narrow networks seem to be the preferred, and most effective, payment negotiation tool of many insurers offering plans through the exchanges, reflecting the trend we’re already seeing in the private health insurance marketplace.

NPR spotlights the difficulty of finding a specialist
The consumer and provider problems of narrow networks have been gaining attention in the media. In July, the National Public Radio (NPR) Web site carried an article entitled, “Patients with low-cost insurance struggle to find specialists,” with a key subtitle: “So you found an exchange plan. But can you find a provider?”7

In the NPR article, author Carrie ­Feibel reported on the situation in a majority-­immigrant area of southwest Houston.

There, many patients at the local clinic have health insurance coverage for the first time, an important step toward healthier lives for themselves and their families. But many people in need of a specialist are learning that their insurance card doesn’t guarantee them access to a needed surgeon or hospital. They’ve purchased a narrow-network insurance plan, with a low premium but few specialists who accept that insurance.7

The two largest hospital chains in Houston—Houston Methodist and Memorial Hermann—as well as Houston’s MD Anderson Cancer Center, don’t participate in the Blue Cross Blue Shield HMO Silver plan, a plan popular with low-income consumers because of its low premium.7

Will the government take action?
The ACA actually guards against overly narrow networks and established the first national standard for network adequacy—a standard that needs fuller development, for sure. Plans sold on the exchanges are required to establish networks that include, among other providers, essential community providers, who typically care for mostly low-income and medically underserved populations. Networks also must include sufficient numbers and types of providers, including “providers that specialize in mental health and substance abuse services, to assure that all services will be accessible without unreasonable delay.”8

Insurers also must provide people who are considering purchasing their products with an accurate directory—both online and a hard copy—identifying providers not accepting new patients in the network. And plans are prohibited from charging out-of-network cost-sharing for emergency services.

Much of the oversight and many of the details—how much is adequate? what is unreasonable?—are left to the states, many of which have years of experience grappling with the downsides and delicate balance of networks.

The Urban Institute points out that Vermont and Delaware set standards for maximum geographic distance and drive times for primary care services. In California, plans must make it easy for consumers to reach urban providers on public transportation.6

 

 

Professional societies are taking note
Today, the misuse of narrow networks by exchange plans also has gotten the attention of the American Medical Association, ACOG, and many other national medical specialty societies, in addition to the states and federal government.

The trick, many health-care policy experts agree, is to find the right balance. How broad can the network be before premiums soar? Most agree that consumers must be able to choose between plans with confidence, without any cost or access surprises, meaning much better transparency. And many agree that provider quality, in addition to cost, has to find its way into the equation.

This year, the Center for Consumer Information and Insurance Oversight, a part of the federal Department of Health and Human Services created by the ACA to investigate these kinds of issues, is investigating access to hospital systems, mental health services, oncology, and primary care providers and is developing time, distance, and other standards that insurers will have to adhere to.

Employer groups oppose strong standards or limits on narrow networks. Recently, representatives of the US Chamber of Commerce, the ­National ­Retail Federation, and others warned ­Congress to stay out of this fight. They understand that more generous networks mean higher premiums. These employer representative groups prefer to strengthen consumer protections like directories and keep low the cost of health insurance that they provide for their employees. 

Acknowledgment
The author acknowledges the work and expertise of ACOG's state government affairs team for the state analysis—Kathryn Moore, Director, and Kate Vlach, Senior Manager—as well as advocacy partners.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

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When I last wrote about the Affordable Care Act (ACA), in May 2014, I focused on the contraception issue. Since then, the US Supreme Court ruled, in Burwell v. Hobby Lobby, that closely held, for-profit companies with religious objections to covering birth control can opt out of the requirement to provide contraceptive coverage to their employees.

In this article, I explore that decision and what it means for women’s health. I also present data on the uninsured rate in the United States, which has dropped significantly since enactment of the ACA, and I discuss one increasingly common barrier to access to care—the use of narrow networks by insurers.

A corporation now can hold a religious belief
The Supreme Court’s majority 5-4 ruling recognized, for the first time, that a for-profit corporation can hold a religious belief, but the Court limited this claim to closely held corporations. The Court also decided that the ACA placed a substantial burden on the corporations’ religious beliefs and concluded that there are less burdensome ways to accomplish the law’s intent, rendering the contraceptive coverage provision in the ACA in violation of the Religious Freedom Restoration Act (RFRA). The Court limited its ruling to the contraceptive coverage requirement, essentially turning the requirement into an option for many employers.



Are contraceptives abortifacients?

The religious belief at the center of Burwell v. Hobby Lobby was that life begins at conception, which the Green family—the owners of Hobby Lobby—equate to fertilization. Hobby Lobby’s attorneys also asserted that four contraceptives approved by the US Food and Drug Administration and included in the ACA mandate may prevent implantation of a fertilized egg, thereby constituting abortion.

Although there is no scientific answer as to when life begins, ACOG and the medical community agree that pregnancy begins at implantation. In its amicus brief to the US Supreme Court, ACOG asserted the medical community’s consensus that the four contraceptives prevent pregnancy rather than end it, and are not abortifacients:

  • emergency contraceptive pills: levonorgestrel (Plan B) and its generic equivalents and ulipristal acetate (ella)
  • the copper IUD (ParaGard)
  • levonorgestrel-releasing intrauterine systems (Mirena, Skyla).

What is a closely held corporation?
In general, according to the Pew Research Center, a closely held corporation is a private company (not publicly traded) with a limited number of shareholders. The Internal Revenue Service (IRS), an important source, defines a closely held corporation as one in which more than half of the stock is owned (directly or indirectly) by five or fewer individuals at any time in the second half of the year.

“S” corporations are also considered closely held. These are corporations with 100 or fewer shareholders, with all members of the same family counted as one shareholder. “S” corporations don’t pay income tax; their shareholders pay tax on their personal returns, based on the corporations’ profits and losses.

Hobby Lobby is organized as an “S” corporation. According to the IRS, in 2011, there were 4,158,572 “S” corporations, 99.4% of them with 10 or fewer shareholders.1

The US Census Bureau estimates that, in 2012, about 2.9 million “S” corporations employed more than 29 million people. Many closely held corporations are quite large.2 According to the Pew Research Center, family-owned Cargill employs 140,000 people and had $136.7 billion in revenue in fiscal 2013. Hobby Lobby has estimated revenues of $3.3 billion and 23,000 employees.2

What’s next?
ACOG helped secure coverage of contraceptives in the ACA and is working with the US Congress and our women’s health partners to restore this important care. Days after the Supreme Court decision, Senator Patty Murray (D-WA) introduced the Protect Women’s Health from Corporate Interference Act, S. 2578, with 46 cosponsors as of this writing. ACOG fully supports this bill, also known as the “Not My Boss’ Business Bill,” which would reestablish the contraceptive coverage mandate as well as other care required by federal law. This bill still maintains the exemption from contraceptive coverage for houses of worship and the accommodation for religious nonprofits.

In introducing her bill, Senator Murray pointed out that “the contraceptive coverage requirement has already made a tremendous difference in women’s lives—24 million more prescriptions for oral contraceptives were filled with no copay in 2013 than in 2012, and women have saved $483 million in out-of-pocket costs for oral contraceptives.”3

Uninsured rate is declining
The Commonwealth Fund shows that, from July–September 2013 to April–June 2014, the nation’s uninsured rate fell from 20% to 15%, resulting in 9.5 million fewer uninsured adults.4 The biggest drop occurred among young adults, with the uninsured rate falling from 28% to 18%, and in states that adopted the Medicaid expansion, where uninsured rates fell from 28% to 17%.4

 

 

States that didn’t expand their Medicaid program didn’t show any noticeable change, with the uninsured rate declining only two points, from 38% to 36%.4

Coverage resulted in access to care for the majority of the newly covered. Sixty percent of people with new coverage visited a provider or hospital or paid for a prescription. Sixty-two percent of these individuals said they wouldn’t have been able to access this care before getting this coverage. Eighty-one percent of people with new coverage said they were better off now than before.4

ACA works better in some states than others
The Kaiser Family Foundation looked at four successful states—Colorado, Connecticut, Kentucky, and Washington state—to see what lessons can be learned. Important commonalities include the fact that the states run their own marketplace, adopted the Medi-caid expansion, and conducted extensive outreach and public education, including engaging providers in patient outreach and enrollment.5

Other tools of success were developing good marketing and branding, providing consumer-friendly assistance, and attention to systems and operations.5

How the Hobby Lobby decision affects individual states

Because the Supreme Court’s decision concerned interpretation of a federal law—the Religious Freedom Restoration Act (RFRA)—it does not supersede state laws that mandate coverage of contraceptives.

Twenty-eight states have laws or rulings requiring insurers to cover contraceptives, most of them dating from the 1990s and providing some exemption for religious insurers or plans. Only Illinois allows an exemption for secular bodies.

Although these state laws remain in effect, state officials may opt to stop enforcing them with regard to certain companies. For example, after the Hobby Lobby decision, Wisconsin officials announced that they no longer will enforce contraceptive coverage when a company has a religious objection.

For companies that self-fund or self-insure worker health coverage, the state coverage laws don’t apply—only federal law does. These companies do not have to adhere to state insurance mandates.

Some states have their own version of the RFRA. See the chart at right for details on a state-by-state basis.

The Supreme Court ruling also has no effect on state laws that guarantee access to emergency contraception in hospital emergency departments and that require pharmacists to dispense contraceptives.

StateContraceptive
equity law?
Employer/insurer exemption to equity law?Religious freedom law?
Alabama
Alaska
Arizona
Arkansas
California
Colorado
Connecticut
Delaware
Florida
Georgia
Hawaii
Idaho
Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
Maine
Maryland
Massachusetts
Michigan
Minnesota
Mississippi
Missouri
Montana
Nebraska
Nevada
New Hampshire
New Jersey
New Mexico
New York
North Carolina
North Dakota
Ohio
Oklahoma
Oregon
Pennsylvania
Rhode Island
South Carolina
South Dakota
Tennessee
Texas
Utah
Vermont
Virginia
Washington
West Virginia
Wisconsin
Wyoming
TOTAL
28
20
18

Narrow networks limit access to care
Huge concerns abound regarding implementation and real-life experiences related to the ACA. A number of them—high deductibles, low payment rates, limited access to physicians, long drive and wait times—can be related to “narrow networks.” Insurers exclude certain providers and offer all providers lower payment rates (which leads some physicians to drop out of the plan); they also create tiers (charging consumers lower copays and deductibles for using inner-tier preferred providers and high out-of-pocket costs for using other providers, even though they may be in the network).

Narrow networks work for insurers as an effective tool for lowering provider payment rates to keep premiums low and gain market share. The narrower the network, the lower are physician payments and premiums.

The ACA promises expanded access to high-quality, affordable health care for millions of Americans—a promise being compromised in many areas of the country through narrow networks. In these instances, insurers offering new plans in a health-care marketplace limit patient access to the numbers, types, and locations of physicians and hospitals covered under certain plans. Insurers typically offer patients low premiums, offer selected providers a high volume of patients at low payment levels, and exclude other providers whom the insurer deems to be high-cost.

Narrow networks aren’t new
As with so many elements of the ACA, narrow networks aren’t a new phenomenon. Many of us remember the public relations price that HMOs paid in the 1980s and 1990s for exceedingly limiting patients’ access to care while charging low premiums. The consumer outcry led the National Association of Insurance Commissioners to urge states to require managed-care plans to maintain adequate networks, the approach adopted by the federal government in the ACA.6

 

 

The pendulum swung in the next decade to broader networks in which consumers had much greater access, but premiums increased by an average of 11% per year.6 Employers then pushed insurers to reduce premium costs, leading back to narrow ­networks in the years just before the ACA. Narrow network plans accounted for 23% of all employer-sponsored plans in 2012, up from 15% in 2007.6

Increasing consolidation contributes to narrow networks
The trend toward narrower networks is also linked to increasing consolidation in health care. As health systems grow and individual or small group practices disappear, insurers rely on being able to credibly threaten to exclude systems and big groups from their networks as leverage in payment negotiations. By restricting the choice of providers in a plan, the insurer can promise more customers for the doctors and hospitals that are included, and negotiate lower payments to those providers.

The downside for physicians is clear:

  • low payment rates
  • exclusion from networks and coverage
  • inability to refer patients to providers the physician determines to be best for that patient’s needs.
  • The downside for patients:
  • If they have to go out of network to get needed care, they may end up paying high out-of-pocket costs
  • If they delay or forego care, their health may suffer significantly.

The insurance industry’s position is that patients have choices. Plans with access to more hospitals and specialists are available but usually at a higher price.

Narrow networks are one way to achieve low premiums
In the months leading up to ACA enactment, insurers got to work developing plans designed to be sold on the exchanges that would attract consumers through low-cost premiums and still maximize profits, especially now that insurers, under the ACA, are barred from excluding sick enrollees or increasing premiums for women, in addition to other important protections.

In previous articles, we’ve explored these landmark protections. Insurers in the individual market used to be able to keep ­premiums relatively low, and profits up, through use of preexisting coverage exclusions, benefit exclusions including noncoverage for maternity care or prescription drugs, and high cost sharing. Not anymore.

Since enactment of the ACA, narrow networks seem to be the preferred, and most effective, payment negotiation tool of many insurers offering plans through the exchanges, reflecting the trend we’re already seeing in the private health insurance marketplace.

NPR spotlights the difficulty of finding a specialist
The consumer and provider problems of narrow networks have been gaining attention in the media. In July, the National Public Radio (NPR) Web site carried an article entitled, “Patients with low-cost insurance struggle to find specialists,” with a key subtitle: “So you found an exchange plan. But can you find a provider?”7

In the NPR article, author Carrie ­Feibel reported on the situation in a majority-­immigrant area of southwest Houston.

There, many patients at the local clinic have health insurance coverage for the first time, an important step toward healthier lives for themselves and their families. But many people in need of a specialist are learning that their insurance card doesn’t guarantee them access to a needed surgeon or hospital. They’ve purchased a narrow-network insurance plan, with a low premium but few specialists who accept that insurance.7

The two largest hospital chains in Houston—Houston Methodist and Memorial Hermann—as well as Houston’s MD Anderson Cancer Center, don’t participate in the Blue Cross Blue Shield HMO Silver plan, a plan popular with low-income consumers because of its low premium.7

Will the government take action?
The ACA actually guards against overly narrow networks and established the first national standard for network adequacy—a standard that needs fuller development, for sure. Plans sold on the exchanges are required to establish networks that include, among other providers, essential community providers, who typically care for mostly low-income and medically underserved populations. Networks also must include sufficient numbers and types of providers, including “providers that specialize in mental health and substance abuse services, to assure that all services will be accessible without unreasonable delay.”8

Insurers also must provide people who are considering purchasing their products with an accurate directory—both online and a hard copy—identifying providers not accepting new patients in the network. And plans are prohibited from charging out-of-network cost-sharing for emergency services.

Much of the oversight and many of the details—how much is adequate? what is unreasonable?—are left to the states, many of which have years of experience grappling with the downsides and delicate balance of networks.

The Urban Institute points out that Vermont and Delaware set standards for maximum geographic distance and drive times for primary care services. In California, plans must make it easy for consumers to reach urban providers on public transportation.6

 

 

Professional societies are taking note
Today, the misuse of narrow networks by exchange plans also has gotten the attention of the American Medical Association, ACOG, and many other national medical specialty societies, in addition to the states and federal government.

The trick, many health-care policy experts agree, is to find the right balance. How broad can the network be before premiums soar? Most agree that consumers must be able to choose between plans with confidence, without any cost or access surprises, meaning much better transparency. And many agree that provider quality, in addition to cost, has to find its way into the equation.

This year, the Center for Consumer Information and Insurance Oversight, a part of the federal Department of Health and Human Services created by the ACA to investigate these kinds of issues, is investigating access to hospital systems, mental health services, oncology, and primary care providers and is developing time, distance, and other standards that insurers will have to adhere to.

Employer groups oppose strong standards or limits on narrow networks. Recently, representatives of the US Chamber of Commerce, the ­National ­Retail Federation, and others warned ­Congress to stay out of this fight. They understand that more generous networks mean higher premiums. These employer representative groups prefer to strengthen consumer protections like directories and keep low the cost of health insurance that they provide for their employees. 

Acknowledgment
The author acknowledges the work and expertise of ACOG's state government affairs team for the state analysis—Kathryn Moore, Director, and Kate Vlach, Senior Manager—as well as advocacy partners.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

References

1. Internal Revenue Service. SOI Tax States, Table 1, Returns of Active Corporations, Form 1120S. http://www.irs.gov/uac/SOI-Tax-Stats-Table-1-Returns-of-Active-Corporations,-Form-1120S. Updated June 27, 2014. Accessed September 4, 2014.
2. DeSilver D. What is a ‘closely held corporation,’ anyway, and how many are there? Pew Research Center: Fact Tank. http://www.pewresearch.org/fact-tank/2014/07/07/what-is-a-closely-held-corporation-anyway-and-how-many-are-there/. Published July 7, 2014. Accessed September 4, 2014.
3. Murray P. Protect Women’s Health From Corporate Interference Act: Summary. http://www.murray.senate.gov/public/_cache/files/30554052-0f84-485a-babc-ccc04af85bb6/protect-women-s-health-from-corporate-interference-act---one-page-summary---final.pdf. Accessed September 4, 2014.
4. The Commonwealth Fund. New Survey: After First ACA Enrollment Period, Uninsured Rate Dropped from 20% to 15%; Largest Declines Among Young Adults, Latinos, and Low-Income People. http://www.commonwealthfund.org/publications/press-releases/2014/jul/after-first-aca -enrollment-period. Published July 10,2014. Accessed September 4, 2014.
5. Artiga S, Stephens J, Rudowitz R, Perry M. What Worked and What’s Next? Strategies in Four States Leading ACA Enrollment Efforts. Kaiser Family Foundation. http://kff.org/health-reform/issue-brief/what-worked-and-whats-next-strategies-in-four-states-leading-aca-enrollment-efforts/. Published July 16, 2014. Accessed September 4, 2014.
6. Corlette S, Volk J. Narrow Provider Networks in New Health Plans: Balancing Affordability with Access to Quality Care. Urban Institute: Georgetown University Center on Health Insurance Reforms. http://www.urban.org/UploadedPDF/413135-New-Provider-Networks-in-New-Health-Plans.pdf. Published May 2014. Accessed September 4, 2014.
7. Feibel C. Patients With Low-Cost Insurance Struggle to Find Specialists. National Public Radio. http://www.npr.org/blogs/health/2014/07/16/331419293/patients-with-low-cost-insurance-struggle-to-find-specialists. Published July 16, 2014. Accessed September 4, 2014.
8. Patient Protection and Affordable Care Act: Preexisting Condition Exclusions, Lifetime and Annual Limits, Rescissions, and Patient Protections. US Department of Health and Human Services. http://www.regulations.go/#!documentDetail;D=HHS-OS-2010-0014-0001. Published June 28, 2010. Accessed September 9, 2014.

References

1. Internal Revenue Service. SOI Tax States, Table 1, Returns of Active Corporations, Form 1120S. http://www.irs.gov/uac/SOI-Tax-Stats-Table-1-Returns-of-Active-Corporations,-Form-1120S. Updated June 27, 2014. Accessed September 4, 2014.
2. DeSilver D. What is a ‘closely held corporation,’ anyway, and how many are there? Pew Research Center: Fact Tank. http://www.pewresearch.org/fact-tank/2014/07/07/what-is-a-closely-held-corporation-anyway-and-how-many-are-there/. Published July 7, 2014. Accessed September 4, 2014.
3. Murray P. Protect Women’s Health From Corporate Interference Act: Summary. http://www.murray.senate.gov/public/_cache/files/30554052-0f84-485a-babc-ccc04af85bb6/protect-women-s-health-from-corporate-interference-act---one-page-summary---final.pdf. Accessed September 4, 2014.
4. The Commonwealth Fund. New Survey: After First ACA Enrollment Period, Uninsured Rate Dropped from 20% to 15%; Largest Declines Among Young Adults, Latinos, and Low-Income People. http://www.commonwealthfund.org/publications/press-releases/2014/jul/after-first-aca -enrollment-period. Published July 10,2014. Accessed September 4, 2014.
5. Artiga S, Stephens J, Rudowitz R, Perry M. What Worked and What’s Next? Strategies in Four States Leading ACA Enrollment Efforts. Kaiser Family Foundation. http://kff.org/health-reform/issue-brief/what-worked-and-whats-next-strategies-in-four-states-leading-aca-enrollment-efforts/. Published July 16, 2014. Accessed September 4, 2014.
6. Corlette S, Volk J. Narrow Provider Networks in New Health Plans: Balancing Affordability with Access to Quality Care. Urban Institute: Georgetown University Center on Health Insurance Reforms. http://www.urban.org/UploadedPDF/413135-New-Provider-Networks-in-New-Health-Plans.pdf. Published May 2014. Accessed September 4, 2014.
7. Feibel C. Patients With Low-Cost Insurance Struggle to Find Specialists. National Public Radio. http://www.npr.org/blogs/health/2014/07/16/331419293/patients-with-low-cost-insurance-struggle-to-find-specialists. Published July 16, 2014. Accessed September 4, 2014.
8. Patient Protection and Affordable Care Act: Preexisting Condition Exclusions, Lifetime and Annual Limits, Rescissions, and Patient Protections. US Department of Health and Human Services. http://www.regulations.go/#!documentDetail;D=HHS-OS-2010-0014-0001. Published June 28, 2010. Accessed September 9, 2014.

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A summary of the new ACOG report on neonatal brachial plexus palsy. Part 2: Pathophysiology and causation

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A summary of the new ACOG report on neonatal brachial plexus palsy. Part 2: Pathophysiology and causation

Obstetricians are often blamed for causing neonatal brachial plexus palsy (NBPP). For that reason, understanding the true pathophysiology and causation of this birth-related entity is of extreme importance.

In Part 1 of this two-part series, I summarized findings from the new report on NBPP from the American College of Obstetricians and Gynecologists (ACOG), focusing on whether the phenomenon of shoulder dystocia and NBPP can be predicted or prevented.1 Here, in Part 2, I focus on ACOG’s conclusions concerning pathophysiology and causation of NBPP, as well as the College’s recommendations for applying that knowledge to practice.

Some infants are more susceptible than others to the forces of labor and delivery
Babies emerge from the uterus and maternal pelvis by a combination of uterine ­contractions and maternal pushing (endogenous forces) aided by the traction forces applied by the birth attendant (exogenous forces). Research over the past 2 decades has shown that endogenous forces play a significant—if not dominant—role in the causation of NBPP.

Stretching and potential injury to the brachial plexus occur when the long axis of the fetus is pushed down the birth canal while either the maternal symphysis pubis or sacral promontory catches and holds either the anterior or posterior shoulder of the fetus, respectively. This conjunction of events generates a stretching force on the tissues that connect the fetal trunk and head—the neck—under which lies the brachial plexus. The same anatomic relationships and labor forces also vigorously compress the fetal neck against the maternal symphysis pubis or sacral promontory and may cause compression injury. Any traction applied by the clinician accentuates these stretching and pressure forces acting on the nerves of the brachial plexus.

How the neonate responds to these forces depends on the tensile strength of its tissues, the metabolic condition of the fetus after a potentially long labor (as measured by acid-base status), the degree of protective muscle tone around the fetal shoulder and neck, and other fluctuating conditions. In other words, because of the many variables involved, some fetuses are more or less susceptible to injury than others.

Maternal forces alone can cause NBPP
The ACOG report1 makes an important statement:

Maternal forces alone are an accepted cause of at least transient NBPP by most investigators.

Some plaintiff attorneys and their expert witnesses have tried to make the case that, although endogenous forces can cause temporary brachial plexus injuries, they cannot cause permanent brachial plexus injuries. However, as the ACOG report goes on to state:

No published clinical or experimental data exist to support the contention that the presence of persistent (as opposed to transient) NBPP implies the application of excessive force by the birth attendant. A single case report describes a case of persistent NBPP in a delivery in which no traction was applied by the delivering physician and no delay occurred in delivering the shoulders.2 Therefore, there is insufficient evidence to support a clear division between the causative factors of transient NBPP versus persistent NBPP.1

The report acknowledges that the clinician can increase brachial plexus stretch by applying downward lateral traction to the neonate’s head during delivery efforts. However, contrary to claims often made by the plaintiff bar, in the presence of shoulder dystocia, even properly applied axial traction will necessarily increase the stretching of the brachial plexus. The report also notes that traction applied in the plane of the fetal cervicothoracic spine typically is along a vector estimated to be 25° to 45° below the horizontal plane of a woman in lithotomy position, not in an exact straight line with the maternal trunk. This degree of delivery force below the horizon is defined as normal “axial traction.”

Exogenous forces have yet to be definitively measured
Multiple attempts have been made to quantify the amount of force applied by clinicians in various delivery scenarios. However, in the published studies in which this force has been “measured,” the accuracy of the findings has not been validated. The three studies in which delivery force was directly measured in a clinical setting “provide a limited assessment of exogenous forces” and “do not address the angle at which forces were applied.”3–5 All other studies used artificial models.

As a result, few conclusions from such studies are directly applicable to the clinical arena. Moreover, in other studies using simulated birth scenarios, there was no feedback to participating clinicians as to whether the force they applied would have been sufficient to deliver the “fetus.” It was therefore difficult for participants in such studies to “determine how the situation corresponds with the force they would apply clinically.”1

 

 

Cadaver studies have been inadequate to assess the in situ response of the brachial plexus
Many plaintiff claims regarding the cause of brachial plexus injury use cadaver studies as evidence. However, most such studies were conducted between 98 and 140 years ago. In these older studies, quantitative evaluation was rare. And in the few more recent studies, there are several reasons why the data obtained are problematic:

  • the nerves being studied were dissected free from supporting tissues
  • nerve tissue deteriorates quickly post­mortem
  • some studies used adult tissues; there may be significant differences between adult and newborn nerve tissue that obscure comparison.

The ACOG report concludes the section on cadaver studies by stating:

The cadaveric work to date to examine the in situ response of the brachial plexus has been quite crude by today’s standards of biomechanics … They do not provide a complete picture of how and why NBPP may occur during delivery.1

Physical models also fall short
The problem with the use of physical models in evaluating NBPP centers on the need to find materials that have the same or similar properties as the tissues of interest. These sorts of bioengineering limitations generally do not allow for findings that have direct clinical applicability.

Of interest, however, is the finding of at least two groups of investigators that less traction is required when simulating delivery of a model infant when rotational maneuvers (Rubin’s) are employed rather than after McRoberts repositioning. 

Computer models have yielded data on the relative effects of endogenous and exogenous forces
Sophisticated computer analysis has been used to investigate both endogenous and ­exogenous delivery forces. Results of such studies have shown that maternal endo­genous forces exert twice as much pressure on the base of the fetal neck against the maternal symphysis pubis as do deliverer-­induced ­exogenous forces.

Is there a threshold of force?
Data that include measurement of the force applied to the brachial plexus nerves of a live infant during a real delivery are almost nonexistent. One group—on the basis of a single case of transient NBPP and potentially flawed pressure measurements—has suggested that the threshold for NBPP in the human is 100 Newtons.3 However, other studies have shown that physician-applied forces in routine deliveries commonly exceed this hypothesized cutoff—yet the rate of NBPP remains low. In measuring delivery forces it must be remembered that significant variation exists between individual neonates, both in terms of mechanical properties and anatomy. Because of this ­variation—and the nonlinear behavior of nerve tissues—the specific force needed to cause a nerve injury or rupture in a given neonate has not been established.

Chapter 3 of the ACOG report closes with a statement:

In addition to research within the obstetric community, the pediatric, orthopedic, and neurologic literature now stress that the existence of NBPP following birth does not a priori indicate that exogenous forces are the cause of this injury.1

NBPP and shoulder dystocia
Shoulder dystocia is defined as a delivery that requires additional obstetric maneuvers after gentle downward traction on the fetal head fails to deliver the fetal shoulders. The ACOG report makes the important point that shoulder dystocia is not formally diagnosed until a trial of downward axial traction has been unsuccessful in delivering the anterior shoulder. This point is a refutation of the frequent plaintiff claim that, once a shoulder dystocia is thought to be present, no traction whatsoever should be applied by the clinician at any time during the remainder of the delivery.

Shoulder dystocia incidence is rising
The reported incidence of shoulder dystocia has increased over the past several decades. It is unclear whether this increase is related to maternal obesity, fetal macrosomia, or more widespread reporting. However, paradoxes exist in the relationship among risk factors, shoulder dystocia, and brachial plexus injury:

  • although there is an increased incidence of shoulder dystocia with increased birth weight, the mean birth weight of neonates with recognized shoulder dystocia is not significantly higher than the mean birth weight of all term infants
  • strategies to reduce NBPP by ­preventing shoulder dystocia—including early induction of labor and prophylactic use of McRoberts maneuver and suprapubic pressure—have not been effective in reducing the incidence of NBPP.

The ACOG report makes the statement: “Maternal and fetal factors associated with shoulder dystocia do not allow for reliable prediction of persistent NBPP.”1

What is optimal management of shoulder dystocia?
The last obstetric part of the ACOG report takes as its focus the management of shoulder dystocia. It discusses the importance of communication among members of the delivery team and with the mother whose neonate is experiencing a shoulder dystocia. The report states:

 

 

The woman in labor should be instructed to refrain from pushing during an attempted maneuver. She can then be instructed to resume pushing following performance of a maneuver to allow determination of whether the shoulder dystocia has been successfully relieved.1

This statement contrasts with claims frequently made by plaintiff medical expert witnesses that the woman experiencing a shoulder dystocia should absolutely cease from pushing.

In a section on team training, the report describes the delivery team’s priorities:

  1. resolving the shoulder dystocia
  2. avoiding neonatal hypoxic-ischemic central nervous system injury
  3. minimizing strain on the neonatal brachial plexus.

Studies evaluating process standardization, the use of checklists, teamwork training, crew resource management, and evidence-based medicine have shown that these tools improve neonatal and maternal outcomes.

Simulation training also has been shown to help reduce transient NBPP (see the box below for more on simulation programs for shoulder dystocia). Whether it also can lower the rate of permanent NBPP is unclear.1

Can simulation training reduce the rate of neonatal brachial plexus injury after shoulder dystocia?

In the new ACOG report on neonatal brachial plexus injury, simulation training is discussed as one solution to the dilemma of how clinicians can gain experience in managing obstetric events that occur infrequently.1 Simulation training also has the potential to improve teamwork, communication, and the situational awareness of the health-care team as a whole. Several studies over the past few years have shown that, in some units, the implementation of simulation training actually has decreased the number of cases of neonatal brachial plexus palsy (NBPP), compared with no simulation training.

For example, Draycott and colleagues explored the rate of neonatal injury associated with shoulder dystocia before and after implementation of a mandatory 1-day simulation training program at Southmead Hospital in Bristol, United Kingdom.2 The program consisted of practice on a shoulder dystocia training mannequin and covered risk factors, recognition of shoulder dystocia, maneuvers, and documentation. The training used a stepwise approach, beginning with a call for help and continuing through McRoberts’ positioning, suprapubic pressure, and internal maneuvers such as delivery of the posterior arm (Figure).

There were 15,908 births in the pretraining period and 13,117 in the posttraining period, with shoulder dystocia rates comparable between the two periods. Not only did clinical management of shoulder dystocia improve after training, but there was a significant reduction in neonatal injury at birth after shoulder dystocia (30 injuries of 324 shoulder dystocia cases [9.3%] before training vs six injuries of 262 shoulder dystocia cases [2.3%] afterward).2

In another study of obstetric brachial plexus injury before and after implementation of simulation training for shoulder dystocia, Inglis and colleagues found a decline in the rate of such injury from 30% to 10.67% (P<.01).3 Shoulder dystocia training remained associated with reduced obstetric brachial plexus injury after logistic-regression analysis.3

Shoulder dystocia training is now recommended by the Joint Commission on Accreditation of Healthcare Organizations in the United States. However, in its report, ACOG concludes—despite studies from Draycott and colleagues and others—that, owing to “limited data,” “there remains no evidence that introduction of simulation can reduce the frequency of persistent NBPP.”1

References

  1. American College of Obstetricians and Gynecologists. Executive summary: neonatal brachial plexus palsy. Report of the American College of Obstetricians and Gynecologists’ Task Force on neonatal brachial plexus palsy. Obstet Gynecol. 2014;123(4):902–904.
  2. Draycott TJ, Crofts FJ, Ash JP, et al. Improving neonatal outcome through practical shoulder dystocia training. Obstet Gynecol. 2008;112(1):14–20.
  3. Inglis SR, Feier N, Chetiyaar JB, et al. Effects of shoulder dystocia training on the incidence of brachial plexus palsy. Am J Obstet Gynecol. 2011;204(4):322.e1–e6.

Delivery of the posterior arm
The report reaffirms the previous statement from the ACOG practice bulletin on shoulder dystocia, which asserts that no specific sequence of maneuvers for resolving shoulder dystocia has been shown to be superior to any other.6 It does note, however, that recent studies seem to demonstrate a benefit when delivery of the posterior arm is prioritized over the usual first-line maneuvers of McRoberts positioning and the application of suprapubic pressure. If confirmed, such findings may alter the standard of care for shoulder dystocia resolution and result in a change in ACOG recommendations.

Documentation may be enhanced by use of a checklist
The ACOG report stresses the importance of accurate, contemporaneous documentation of the management of shoulder dystocia, observing that checklists and documentation reminders help ensure the completeness and relevance of notes after shoulder dystocia deliveries and NBPP. ACOG has produced such a checklist, which can be found in the appendix of the report itself.1

 

 

How long before central neurologic injury occurs?
Another issue covered in the report is how long a clinician has to resolve a shoulder dystocia before central neurologic damage occurs. Studies have shown that permanent neurologic injury can occur as soon as 2 minutes after shoulder impaction, although the risk of acidosis or severe hypoxic-ischemic encephalopathy remains low until impaction has lasted at least 5 minutes.

Other issues covered in the report
The last chapters of the ACOG report focus on orthopedic aspects of brachial plexus injury, including diagnosis, treatment, and prognosis.

The report concludes with a glossary and three appendices:

  • Royal College of Obstetricians and Gynecologists Green Top Guidebook #42 on shoulder dystocia
  • ACOG Practice Bulletin #40 on shoulder dystocia
  • ACOG Patient Safety Checklist #6 on the documentation of shoulder dystocia.

Why the ACOG report is foundational
The ACOG report on NBPP is an important and much-needed document. It includes a comprehensive review of the literature on brachial plexus injury and shoulder dystocia, written by nationally recognized experts in the field. Most important, it makes definitive statements that counteract false and dubious claims often made by the plaintiff bar in brachial plexus injury cases and provides evidence to back those statements.

The report:

  • disproves the claim that “excessive” physician traction is the only etiology of brachial plexus injuries
  • demonstrates that no differentiation can be made between the etiology of permanent versus temporary brachial plexus injuries
  • describes how brachial plexus injuries can occur in the absence of physician traction or even of shoulder dystocia
  • provides a summary of scientific information about brachial plexus injuries that will benefit obstetric clinicians
  • provides a wealth of literature documentation that will enable physician defendants to counteract many of the claims plaintiffs and their expert witnesses make in brachial plexus injury cases.

The report is—and will remain—a foundational document in obstetrics for many years to come.

Share your thoughts on this article! Send your Letter to the Editor to [email protected].

References

1. American College of Obstetricians and Gynecologists. Executive summary: neonatal brachial plexus palsy. Report of the American College of Obstetricians and Gynecologists’ Task Force on neonatal brachial plexus palsy. Obstet Gynecol. 2014;123(4):902–904.
2. Lerner HM, Salamon E. Permanent brachial plexus injury following vaginal delivery without physician traction or shoulder dystocia. Am J Obstet Gynecol. 2008;198(3):e.7–e.8.
3. Allen R, Sorab J, Gonik B. Risk factors for shoulder dystocia: an engineering study of clinician-applied forces. Obstet Gynecol. 1991;77(3):352–355.
4. Poggi SH, Allen RH, Patel CR, Ghidini A, Pezzullo JC, Spong CY. Randomized trial of McRoberts versus lithotomy positioning to decrease the force that is applied to the fetus during delivery. Am J Obstet Gynecol. 2004;191(3):874–878.
5. Poggi SH, Allen RH, Patel C, et al. Effect of epidural anaesthesia on clinician-applied force during vaginal delivery. Am J Obstet Gynecol. 2004;191(3):903–906.
6. American College of Obstetricians and Gynecologists. Practice bulletin #40: shoulder dystocia. Obstet Gynecol. 2002;100(5 pt 1):1045–1050.

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Related Articles

Obstetricians are often blamed for causing neonatal brachial plexus palsy (NBPP). For that reason, understanding the true pathophysiology and causation of this birth-related entity is of extreme importance.

In Part 1 of this two-part series, I summarized findings from the new report on NBPP from the American College of Obstetricians and Gynecologists (ACOG), focusing on whether the phenomenon of shoulder dystocia and NBPP can be predicted or prevented.1 Here, in Part 2, I focus on ACOG’s conclusions concerning pathophysiology and causation of NBPP, as well as the College’s recommendations for applying that knowledge to practice.

Some infants are more susceptible than others to the forces of labor and delivery
Babies emerge from the uterus and maternal pelvis by a combination of uterine ­contractions and maternal pushing (endogenous forces) aided by the traction forces applied by the birth attendant (exogenous forces). Research over the past 2 decades has shown that endogenous forces play a significant—if not dominant—role in the causation of NBPP.

Stretching and potential injury to the brachial plexus occur when the long axis of the fetus is pushed down the birth canal while either the maternal symphysis pubis or sacral promontory catches and holds either the anterior or posterior shoulder of the fetus, respectively. This conjunction of events generates a stretching force on the tissues that connect the fetal trunk and head—the neck—under which lies the brachial plexus. The same anatomic relationships and labor forces also vigorously compress the fetal neck against the maternal symphysis pubis or sacral promontory and may cause compression injury. Any traction applied by the clinician accentuates these stretching and pressure forces acting on the nerves of the brachial plexus.

How the neonate responds to these forces depends on the tensile strength of its tissues, the metabolic condition of the fetus after a potentially long labor (as measured by acid-base status), the degree of protective muscle tone around the fetal shoulder and neck, and other fluctuating conditions. In other words, because of the many variables involved, some fetuses are more or less susceptible to injury than others.

Maternal forces alone can cause NBPP
The ACOG report1 makes an important statement:

Maternal forces alone are an accepted cause of at least transient NBPP by most investigators.

Some plaintiff attorneys and their expert witnesses have tried to make the case that, although endogenous forces can cause temporary brachial plexus injuries, they cannot cause permanent brachial plexus injuries. However, as the ACOG report goes on to state:

No published clinical or experimental data exist to support the contention that the presence of persistent (as opposed to transient) NBPP implies the application of excessive force by the birth attendant. A single case report describes a case of persistent NBPP in a delivery in which no traction was applied by the delivering physician and no delay occurred in delivering the shoulders.2 Therefore, there is insufficient evidence to support a clear division between the causative factors of transient NBPP versus persistent NBPP.1

The report acknowledges that the clinician can increase brachial plexus stretch by applying downward lateral traction to the neonate’s head during delivery efforts. However, contrary to claims often made by the plaintiff bar, in the presence of shoulder dystocia, even properly applied axial traction will necessarily increase the stretching of the brachial plexus. The report also notes that traction applied in the plane of the fetal cervicothoracic spine typically is along a vector estimated to be 25° to 45° below the horizontal plane of a woman in lithotomy position, not in an exact straight line with the maternal trunk. This degree of delivery force below the horizon is defined as normal “axial traction.”

Exogenous forces have yet to be definitively measured
Multiple attempts have been made to quantify the amount of force applied by clinicians in various delivery scenarios. However, in the published studies in which this force has been “measured,” the accuracy of the findings has not been validated. The three studies in which delivery force was directly measured in a clinical setting “provide a limited assessment of exogenous forces” and “do not address the angle at which forces were applied.”3–5 All other studies used artificial models.

As a result, few conclusions from such studies are directly applicable to the clinical arena. Moreover, in other studies using simulated birth scenarios, there was no feedback to participating clinicians as to whether the force they applied would have been sufficient to deliver the “fetus.” It was therefore difficult for participants in such studies to “determine how the situation corresponds with the force they would apply clinically.”1

 

 

Cadaver studies have been inadequate to assess the in situ response of the brachial plexus
Many plaintiff claims regarding the cause of brachial plexus injury use cadaver studies as evidence. However, most such studies were conducted between 98 and 140 years ago. In these older studies, quantitative evaluation was rare. And in the few more recent studies, there are several reasons why the data obtained are problematic:

  • the nerves being studied were dissected free from supporting tissues
  • nerve tissue deteriorates quickly post­mortem
  • some studies used adult tissues; there may be significant differences between adult and newborn nerve tissue that obscure comparison.

The ACOG report concludes the section on cadaver studies by stating:

The cadaveric work to date to examine the in situ response of the brachial plexus has been quite crude by today’s standards of biomechanics … They do not provide a complete picture of how and why NBPP may occur during delivery.1

Physical models also fall short
The problem with the use of physical models in evaluating NBPP centers on the need to find materials that have the same or similar properties as the tissues of interest. These sorts of bioengineering limitations generally do not allow for findings that have direct clinical applicability.

Of interest, however, is the finding of at least two groups of investigators that less traction is required when simulating delivery of a model infant when rotational maneuvers (Rubin’s) are employed rather than after McRoberts repositioning. 

Computer models have yielded data on the relative effects of endogenous and exogenous forces
Sophisticated computer analysis has been used to investigate both endogenous and ­exogenous delivery forces. Results of such studies have shown that maternal endo­genous forces exert twice as much pressure on the base of the fetal neck against the maternal symphysis pubis as do deliverer-­induced ­exogenous forces.

Is there a threshold of force?
Data that include measurement of the force applied to the brachial plexus nerves of a live infant during a real delivery are almost nonexistent. One group—on the basis of a single case of transient NBPP and potentially flawed pressure measurements—has suggested that the threshold for NBPP in the human is 100 Newtons.3 However, other studies have shown that physician-applied forces in routine deliveries commonly exceed this hypothesized cutoff—yet the rate of NBPP remains low. In measuring delivery forces it must be remembered that significant variation exists between individual neonates, both in terms of mechanical properties and anatomy. Because of this ­variation—and the nonlinear behavior of nerve tissues—the specific force needed to cause a nerve injury or rupture in a given neonate has not been established.

Chapter 3 of the ACOG report closes with a statement:

In addition to research within the obstetric community, the pediatric, orthopedic, and neurologic literature now stress that the existence of NBPP following birth does not a priori indicate that exogenous forces are the cause of this injury.1

NBPP and shoulder dystocia
Shoulder dystocia is defined as a delivery that requires additional obstetric maneuvers after gentle downward traction on the fetal head fails to deliver the fetal shoulders. The ACOG report makes the important point that shoulder dystocia is not formally diagnosed until a trial of downward axial traction has been unsuccessful in delivering the anterior shoulder. This point is a refutation of the frequent plaintiff claim that, once a shoulder dystocia is thought to be present, no traction whatsoever should be applied by the clinician at any time during the remainder of the delivery.

Shoulder dystocia incidence is rising
The reported incidence of shoulder dystocia has increased over the past several decades. It is unclear whether this increase is related to maternal obesity, fetal macrosomia, or more widespread reporting. However, paradoxes exist in the relationship among risk factors, shoulder dystocia, and brachial plexus injury:

  • although there is an increased incidence of shoulder dystocia with increased birth weight, the mean birth weight of neonates with recognized shoulder dystocia is not significantly higher than the mean birth weight of all term infants
  • strategies to reduce NBPP by ­preventing shoulder dystocia—including early induction of labor and prophylactic use of McRoberts maneuver and suprapubic pressure—have not been effective in reducing the incidence of NBPP.

The ACOG report makes the statement: “Maternal and fetal factors associated with shoulder dystocia do not allow for reliable prediction of persistent NBPP.”1

What is optimal management of shoulder dystocia?
The last obstetric part of the ACOG report takes as its focus the management of shoulder dystocia. It discusses the importance of communication among members of the delivery team and with the mother whose neonate is experiencing a shoulder dystocia. The report states:

 

 

The woman in labor should be instructed to refrain from pushing during an attempted maneuver. She can then be instructed to resume pushing following performance of a maneuver to allow determination of whether the shoulder dystocia has been successfully relieved.1

This statement contrasts with claims frequently made by plaintiff medical expert witnesses that the woman experiencing a shoulder dystocia should absolutely cease from pushing.

In a section on team training, the report describes the delivery team’s priorities:

  1. resolving the shoulder dystocia
  2. avoiding neonatal hypoxic-ischemic central nervous system injury
  3. minimizing strain on the neonatal brachial plexus.

Studies evaluating process standardization, the use of checklists, teamwork training, crew resource management, and evidence-based medicine have shown that these tools improve neonatal and maternal outcomes.

Simulation training also has been shown to help reduce transient NBPP (see the box below for more on simulation programs for shoulder dystocia). Whether it also can lower the rate of permanent NBPP is unclear.1

Can simulation training reduce the rate of neonatal brachial plexus injury after shoulder dystocia?

In the new ACOG report on neonatal brachial plexus injury, simulation training is discussed as one solution to the dilemma of how clinicians can gain experience in managing obstetric events that occur infrequently.1 Simulation training also has the potential to improve teamwork, communication, and the situational awareness of the health-care team as a whole. Several studies over the past few years have shown that, in some units, the implementation of simulation training actually has decreased the number of cases of neonatal brachial plexus palsy (NBPP), compared with no simulation training.

For example, Draycott and colleagues explored the rate of neonatal injury associated with shoulder dystocia before and after implementation of a mandatory 1-day simulation training program at Southmead Hospital in Bristol, United Kingdom.2 The program consisted of practice on a shoulder dystocia training mannequin and covered risk factors, recognition of shoulder dystocia, maneuvers, and documentation. The training used a stepwise approach, beginning with a call for help and continuing through McRoberts’ positioning, suprapubic pressure, and internal maneuvers such as delivery of the posterior arm (Figure).

There were 15,908 births in the pretraining period and 13,117 in the posttraining period, with shoulder dystocia rates comparable between the two periods. Not only did clinical management of shoulder dystocia improve after training, but there was a significant reduction in neonatal injury at birth after shoulder dystocia (30 injuries of 324 shoulder dystocia cases [9.3%] before training vs six injuries of 262 shoulder dystocia cases [2.3%] afterward).2

In another study of obstetric brachial plexus injury before and after implementation of simulation training for shoulder dystocia, Inglis and colleagues found a decline in the rate of such injury from 30% to 10.67% (P<.01).3 Shoulder dystocia training remained associated with reduced obstetric brachial plexus injury after logistic-regression analysis.3

Shoulder dystocia training is now recommended by the Joint Commission on Accreditation of Healthcare Organizations in the United States. However, in its report, ACOG concludes—despite studies from Draycott and colleagues and others—that, owing to “limited data,” “there remains no evidence that introduction of simulation can reduce the frequency of persistent NBPP.”1

References

  1. American College of Obstetricians and Gynecologists. Executive summary: neonatal brachial plexus palsy. Report of the American College of Obstetricians and Gynecologists’ Task Force on neonatal brachial plexus palsy. Obstet Gynecol. 2014;123(4):902–904.
  2. Draycott TJ, Crofts FJ, Ash JP, et al. Improving neonatal outcome through practical shoulder dystocia training. Obstet Gynecol. 2008;112(1):14–20.
  3. Inglis SR, Feier N, Chetiyaar JB, et al. Effects of shoulder dystocia training on the incidence of brachial plexus palsy. Am J Obstet Gynecol. 2011;204(4):322.e1–e6.

Delivery of the posterior arm
The report reaffirms the previous statement from the ACOG practice bulletin on shoulder dystocia, which asserts that no specific sequence of maneuvers for resolving shoulder dystocia has been shown to be superior to any other.6 It does note, however, that recent studies seem to demonstrate a benefit when delivery of the posterior arm is prioritized over the usual first-line maneuvers of McRoberts positioning and the application of suprapubic pressure. If confirmed, such findings may alter the standard of care for shoulder dystocia resolution and result in a change in ACOG recommendations.

Documentation may be enhanced by use of a checklist
The ACOG report stresses the importance of accurate, contemporaneous documentation of the management of shoulder dystocia, observing that checklists and documentation reminders help ensure the completeness and relevance of notes after shoulder dystocia deliveries and NBPP. ACOG has produced such a checklist, which can be found in the appendix of the report itself.1

 

 

How long before central neurologic injury occurs?
Another issue covered in the report is how long a clinician has to resolve a shoulder dystocia before central neurologic damage occurs. Studies have shown that permanent neurologic injury can occur as soon as 2 minutes after shoulder impaction, although the risk of acidosis or severe hypoxic-ischemic encephalopathy remains low until impaction has lasted at least 5 minutes.

Other issues covered in the report
The last chapters of the ACOG report focus on orthopedic aspects of brachial plexus injury, including diagnosis, treatment, and prognosis.

The report concludes with a glossary and three appendices:

  • Royal College of Obstetricians and Gynecologists Green Top Guidebook #42 on shoulder dystocia
  • ACOG Practice Bulletin #40 on shoulder dystocia
  • ACOG Patient Safety Checklist #6 on the documentation of shoulder dystocia.

Why the ACOG report is foundational
The ACOG report on NBPP is an important and much-needed document. It includes a comprehensive review of the literature on brachial plexus injury and shoulder dystocia, written by nationally recognized experts in the field. Most important, it makes definitive statements that counteract false and dubious claims often made by the plaintiff bar in brachial plexus injury cases and provides evidence to back those statements.

The report:

  • disproves the claim that “excessive” physician traction is the only etiology of brachial plexus injuries
  • demonstrates that no differentiation can be made between the etiology of permanent versus temporary brachial plexus injuries
  • describes how brachial plexus injuries can occur in the absence of physician traction or even of shoulder dystocia
  • provides a summary of scientific information about brachial plexus injuries that will benefit obstetric clinicians
  • provides a wealth of literature documentation that will enable physician defendants to counteract many of the claims plaintiffs and their expert witnesses make in brachial plexus injury cases.

The report is—and will remain—a foundational document in obstetrics for many years to come.

Share your thoughts on this article! Send your Letter to the Editor to [email protected].

Obstetricians are often blamed for causing neonatal brachial plexus palsy (NBPP). For that reason, understanding the true pathophysiology and causation of this birth-related entity is of extreme importance.

In Part 1 of this two-part series, I summarized findings from the new report on NBPP from the American College of Obstetricians and Gynecologists (ACOG), focusing on whether the phenomenon of shoulder dystocia and NBPP can be predicted or prevented.1 Here, in Part 2, I focus on ACOG’s conclusions concerning pathophysiology and causation of NBPP, as well as the College’s recommendations for applying that knowledge to practice.

Some infants are more susceptible than others to the forces of labor and delivery
Babies emerge from the uterus and maternal pelvis by a combination of uterine ­contractions and maternal pushing (endogenous forces) aided by the traction forces applied by the birth attendant (exogenous forces). Research over the past 2 decades has shown that endogenous forces play a significant—if not dominant—role in the causation of NBPP.

Stretching and potential injury to the brachial plexus occur when the long axis of the fetus is pushed down the birth canal while either the maternal symphysis pubis or sacral promontory catches and holds either the anterior or posterior shoulder of the fetus, respectively. This conjunction of events generates a stretching force on the tissues that connect the fetal trunk and head—the neck—under which lies the brachial plexus. The same anatomic relationships and labor forces also vigorously compress the fetal neck against the maternal symphysis pubis or sacral promontory and may cause compression injury. Any traction applied by the clinician accentuates these stretching and pressure forces acting on the nerves of the brachial plexus.

How the neonate responds to these forces depends on the tensile strength of its tissues, the metabolic condition of the fetus after a potentially long labor (as measured by acid-base status), the degree of protective muscle tone around the fetal shoulder and neck, and other fluctuating conditions. In other words, because of the many variables involved, some fetuses are more or less susceptible to injury than others.

Maternal forces alone can cause NBPP
The ACOG report1 makes an important statement:

Maternal forces alone are an accepted cause of at least transient NBPP by most investigators.

Some plaintiff attorneys and their expert witnesses have tried to make the case that, although endogenous forces can cause temporary brachial plexus injuries, they cannot cause permanent brachial plexus injuries. However, as the ACOG report goes on to state:

No published clinical or experimental data exist to support the contention that the presence of persistent (as opposed to transient) NBPP implies the application of excessive force by the birth attendant. A single case report describes a case of persistent NBPP in a delivery in which no traction was applied by the delivering physician and no delay occurred in delivering the shoulders.2 Therefore, there is insufficient evidence to support a clear division between the causative factors of transient NBPP versus persistent NBPP.1

The report acknowledges that the clinician can increase brachial plexus stretch by applying downward lateral traction to the neonate’s head during delivery efforts. However, contrary to claims often made by the plaintiff bar, in the presence of shoulder dystocia, even properly applied axial traction will necessarily increase the stretching of the brachial plexus. The report also notes that traction applied in the plane of the fetal cervicothoracic spine typically is along a vector estimated to be 25° to 45° below the horizontal plane of a woman in lithotomy position, not in an exact straight line with the maternal trunk. This degree of delivery force below the horizon is defined as normal “axial traction.”

Exogenous forces have yet to be definitively measured
Multiple attempts have been made to quantify the amount of force applied by clinicians in various delivery scenarios. However, in the published studies in which this force has been “measured,” the accuracy of the findings has not been validated. The three studies in which delivery force was directly measured in a clinical setting “provide a limited assessment of exogenous forces” and “do not address the angle at which forces were applied.”3–5 All other studies used artificial models.

As a result, few conclusions from such studies are directly applicable to the clinical arena. Moreover, in other studies using simulated birth scenarios, there was no feedback to participating clinicians as to whether the force they applied would have been sufficient to deliver the “fetus.” It was therefore difficult for participants in such studies to “determine how the situation corresponds with the force they would apply clinically.”1

 

 

Cadaver studies have been inadequate to assess the in situ response of the brachial plexus
Many plaintiff claims regarding the cause of brachial plexus injury use cadaver studies as evidence. However, most such studies were conducted between 98 and 140 years ago. In these older studies, quantitative evaluation was rare. And in the few more recent studies, there are several reasons why the data obtained are problematic:

  • the nerves being studied were dissected free from supporting tissues
  • nerve tissue deteriorates quickly post­mortem
  • some studies used adult tissues; there may be significant differences between adult and newborn nerve tissue that obscure comparison.

The ACOG report concludes the section on cadaver studies by stating:

The cadaveric work to date to examine the in situ response of the brachial plexus has been quite crude by today’s standards of biomechanics … They do not provide a complete picture of how and why NBPP may occur during delivery.1

Physical models also fall short
The problem with the use of physical models in evaluating NBPP centers on the need to find materials that have the same or similar properties as the tissues of interest. These sorts of bioengineering limitations generally do not allow for findings that have direct clinical applicability.

Of interest, however, is the finding of at least two groups of investigators that less traction is required when simulating delivery of a model infant when rotational maneuvers (Rubin’s) are employed rather than after McRoberts repositioning. 

Computer models have yielded data on the relative effects of endogenous and exogenous forces
Sophisticated computer analysis has been used to investigate both endogenous and ­exogenous delivery forces. Results of such studies have shown that maternal endo­genous forces exert twice as much pressure on the base of the fetal neck against the maternal symphysis pubis as do deliverer-­induced ­exogenous forces.

Is there a threshold of force?
Data that include measurement of the force applied to the brachial plexus nerves of a live infant during a real delivery are almost nonexistent. One group—on the basis of a single case of transient NBPP and potentially flawed pressure measurements—has suggested that the threshold for NBPP in the human is 100 Newtons.3 However, other studies have shown that physician-applied forces in routine deliveries commonly exceed this hypothesized cutoff—yet the rate of NBPP remains low. In measuring delivery forces it must be remembered that significant variation exists between individual neonates, both in terms of mechanical properties and anatomy. Because of this ­variation—and the nonlinear behavior of nerve tissues—the specific force needed to cause a nerve injury or rupture in a given neonate has not been established.

Chapter 3 of the ACOG report closes with a statement:

In addition to research within the obstetric community, the pediatric, orthopedic, and neurologic literature now stress that the existence of NBPP following birth does not a priori indicate that exogenous forces are the cause of this injury.1

NBPP and shoulder dystocia
Shoulder dystocia is defined as a delivery that requires additional obstetric maneuvers after gentle downward traction on the fetal head fails to deliver the fetal shoulders. The ACOG report makes the important point that shoulder dystocia is not formally diagnosed until a trial of downward axial traction has been unsuccessful in delivering the anterior shoulder. This point is a refutation of the frequent plaintiff claim that, once a shoulder dystocia is thought to be present, no traction whatsoever should be applied by the clinician at any time during the remainder of the delivery.

Shoulder dystocia incidence is rising
The reported incidence of shoulder dystocia has increased over the past several decades. It is unclear whether this increase is related to maternal obesity, fetal macrosomia, or more widespread reporting. However, paradoxes exist in the relationship among risk factors, shoulder dystocia, and brachial plexus injury:

  • although there is an increased incidence of shoulder dystocia with increased birth weight, the mean birth weight of neonates with recognized shoulder dystocia is not significantly higher than the mean birth weight of all term infants
  • strategies to reduce NBPP by ­preventing shoulder dystocia—including early induction of labor and prophylactic use of McRoberts maneuver and suprapubic pressure—have not been effective in reducing the incidence of NBPP.

The ACOG report makes the statement: “Maternal and fetal factors associated with shoulder dystocia do not allow for reliable prediction of persistent NBPP.”1

What is optimal management of shoulder dystocia?
The last obstetric part of the ACOG report takes as its focus the management of shoulder dystocia. It discusses the importance of communication among members of the delivery team and with the mother whose neonate is experiencing a shoulder dystocia. The report states:

 

 

The woman in labor should be instructed to refrain from pushing during an attempted maneuver. She can then be instructed to resume pushing following performance of a maneuver to allow determination of whether the shoulder dystocia has been successfully relieved.1

This statement contrasts with claims frequently made by plaintiff medical expert witnesses that the woman experiencing a shoulder dystocia should absolutely cease from pushing.

In a section on team training, the report describes the delivery team’s priorities:

  1. resolving the shoulder dystocia
  2. avoiding neonatal hypoxic-ischemic central nervous system injury
  3. minimizing strain on the neonatal brachial plexus.

Studies evaluating process standardization, the use of checklists, teamwork training, crew resource management, and evidence-based medicine have shown that these tools improve neonatal and maternal outcomes.

Simulation training also has been shown to help reduce transient NBPP (see the box below for more on simulation programs for shoulder dystocia). Whether it also can lower the rate of permanent NBPP is unclear.1

Can simulation training reduce the rate of neonatal brachial plexus injury after shoulder dystocia?

In the new ACOG report on neonatal brachial plexus injury, simulation training is discussed as one solution to the dilemma of how clinicians can gain experience in managing obstetric events that occur infrequently.1 Simulation training also has the potential to improve teamwork, communication, and the situational awareness of the health-care team as a whole. Several studies over the past few years have shown that, in some units, the implementation of simulation training actually has decreased the number of cases of neonatal brachial plexus palsy (NBPP), compared with no simulation training.

For example, Draycott and colleagues explored the rate of neonatal injury associated with shoulder dystocia before and after implementation of a mandatory 1-day simulation training program at Southmead Hospital in Bristol, United Kingdom.2 The program consisted of practice on a shoulder dystocia training mannequin and covered risk factors, recognition of shoulder dystocia, maneuvers, and documentation. The training used a stepwise approach, beginning with a call for help and continuing through McRoberts’ positioning, suprapubic pressure, and internal maneuvers such as delivery of the posterior arm (Figure).

There were 15,908 births in the pretraining period and 13,117 in the posttraining period, with shoulder dystocia rates comparable between the two periods. Not only did clinical management of shoulder dystocia improve after training, but there was a significant reduction in neonatal injury at birth after shoulder dystocia (30 injuries of 324 shoulder dystocia cases [9.3%] before training vs six injuries of 262 shoulder dystocia cases [2.3%] afterward).2

In another study of obstetric brachial plexus injury before and after implementation of simulation training for shoulder dystocia, Inglis and colleagues found a decline in the rate of such injury from 30% to 10.67% (P<.01).3 Shoulder dystocia training remained associated with reduced obstetric brachial plexus injury after logistic-regression analysis.3

Shoulder dystocia training is now recommended by the Joint Commission on Accreditation of Healthcare Organizations in the United States. However, in its report, ACOG concludes—despite studies from Draycott and colleagues and others—that, owing to “limited data,” “there remains no evidence that introduction of simulation can reduce the frequency of persistent NBPP.”1

References

  1. American College of Obstetricians and Gynecologists. Executive summary: neonatal brachial plexus palsy. Report of the American College of Obstetricians and Gynecologists’ Task Force on neonatal brachial plexus palsy. Obstet Gynecol. 2014;123(4):902–904.
  2. Draycott TJ, Crofts FJ, Ash JP, et al. Improving neonatal outcome through practical shoulder dystocia training. Obstet Gynecol. 2008;112(1):14–20.
  3. Inglis SR, Feier N, Chetiyaar JB, et al. Effects of shoulder dystocia training on the incidence of brachial plexus palsy. Am J Obstet Gynecol. 2011;204(4):322.e1–e6.

Delivery of the posterior arm
The report reaffirms the previous statement from the ACOG practice bulletin on shoulder dystocia, which asserts that no specific sequence of maneuvers for resolving shoulder dystocia has been shown to be superior to any other.6 It does note, however, that recent studies seem to demonstrate a benefit when delivery of the posterior arm is prioritized over the usual first-line maneuvers of McRoberts positioning and the application of suprapubic pressure. If confirmed, such findings may alter the standard of care for shoulder dystocia resolution and result in a change in ACOG recommendations.

Documentation may be enhanced by use of a checklist
The ACOG report stresses the importance of accurate, contemporaneous documentation of the management of shoulder dystocia, observing that checklists and documentation reminders help ensure the completeness and relevance of notes after shoulder dystocia deliveries and NBPP. ACOG has produced such a checklist, which can be found in the appendix of the report itself.1

 

 

How long before central neurologic injury occurs?
Another issue covered in the report is how long a clinician has to resolve a shoulder dystocia before central neurologic damage occurs. Studies have shown that permanent neurologic injury can occur as soon as 2 minutes after shoulder impaction, although the risk of acidosis or severe hypoxic-ischemic encephalopathy remains low until impaction has lasted at least 5 minutes.

Other issues covered in the report
The last chapters of the ACOG report focus on orthopedic aspects of brachial plexus injury, including diagnosis, treatment, and prognosis.

The report concludes with a glossary and three appendices:

  • Royal College of Obstetricians and Gynecologists Green Top Guidebook #42 on shoulder dystocia
  • ACOG Practice Bulletin #40 on shoulder dystocia
  • ACOG Patient Safety Checklist #6 on the documentation of shoulder dystocia.

Why the ACOG report is foundational
The ACOG report on NBPP is an important and much-needed document. It includes a comprehensive review of the literature on brachial plexus injury and shoulder dystocia, written by nationally recognized experts in the field. Most important, it makes definitive statements that counteract false and dubious claims often made by the plaintiff bar in brachial plexus injury cases and provides evidence to back those statements.

The report:

  • disproves the claim that “excessive” physician traction is the only etiology of brachial plexus injuries
  • demonstrates that no differentiation can be made between the etiology of permanent versus temporary brachial plexus injuries
  • describes how brachial plexus injuries can occur in the absence of physician traction or even of shoulder dystocia
  • provides a summary of scientific information about brachial plexus injuries that will benefit obstetric clinicians
  • provides a wealth of literature documentation that will enable physician defendants to counteract many of the claims plaintiffs and their expert witnesses make in brachial plexus injury cases.

The report is—and will remain—a foundational document in obstetrics for many years to come.

Share your thoughts on this article! Send your Letter to the Editor to [email protected].

References

1. American College of Obstetricians and Gynecologists. Executive summary: neonatal brachial plexus palsy. Report of the American College of Obstetricians and Gynecologists’ Task Force on neonatal brachial plexus palsy. Obstet Gynecol. 2014;123(4):902–904.
2. Lerner HM, Salamon E. Permanent brachial plexus injury following vaginal delivery without physician traction or shoulder dystocia. Am J Obstet Gynecol. 2008;198(3):e.7–e.8.
3. Allen R, Sorab J, Gonik B. Risk factors for shoulder dystocia: an engineering study of clinician-applied forces. Obstet Gynecol. 1991;77(3):352–355.
4. Poggi SH, Allen RH, Patel CR, Ghidini A, Pezzullo JC, Spong CY. Randomized trial of McRoberts versus lithotomy positioning to decrease the force that is applied to the fetus during delivery. Am J Obstet Gynecol. 2004;191(3):874–878.
5. Poggi SH, Allen RH, Patel C, et al. Effect of epidural anaesthesia on clinician-applied force during vaginal delivery. Am J Obstet Gynecol. 2004;191(3):903–906.
6. American College of Obstetricians and Gynecologists. Practice bulletin #40: shoulder dystocia. Obstet Gynecol. 2002;100(5 pt 1):1045–1050.

References

1. American College of Obstetricians and Gynecologists. Executive summary: neonatal brachial plexus palsy. Report of the American College of Obstetricians and Gynecologists’ Task Force on neonatal brachial plexus palsy. Obstet Gynecol. 2014;123(4):902–904.
2. Lerner HM, Salamon E. Permanent brachial plexus injury following vaginal delivery without physician traction or shoulder dystocia. Am J Obstet Gynecol. 2008;198(3):e.7–e.8.
3. Allen R, Sorab J, Gonik B. Risk factors for shoulder dystocia: an engineering study of clinician-applied forces. Obstet Gynecol. 1991;77(3):352–355.
4. Poggi SH, Allen RH, Patel CR, Ghidini A, Pezzullo JC, Spong CY. Randomized trial of McRoberts versus lithotomy positioning to decrease the force that is applied to the fetus during delivery. Am J Obstet Gynecol. 2004;191(3):874–878.
5. Poggi SH, Allen RH, Patel C, et al. Effect of epidural anaesthesia on clinician-applied force during vaginal delivery. Am J Obstet Gynecol. 2004;191(3):903–906.
6. American College of Obstetricians and Gynecologists. Practice bulletin #40: shoulder dystocia. Obstet Gynecol. 2002;100(5 pt 1):1045–1050.

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Mucocele in cesarean scar can cause pain, bladder urgency, dyspareunia

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Mucocele in cesarean scar can cause pain, bladder urgency, dyspareunia

"UPDATE ON MINIMALLY INVASIVE GYNECOLOGY" AMY GARCIA, MD (APRIL 2014)

Mucocele in cesarean scar can cause pain, bladder urgency, dyspareunia
Like Dr. Garcia, I too, have seen many cesarean-scar defects; most were diagnosed prior to surgery by my in-house technicians during vaginal ultrasonography.

I would like to add that, in addition to these defects, some patients who have undergone cesarean delivery also may form a mucocele in the scar that causes pain, bladder urgency, and dyspareunia. These defects also can be seen by ultrasonography, but in some cases may erroneously be labeled “nabothian cysts” by a radiologist. Most mucoceles probably are caused by incorporation of endocervical glands within a very low transverse uterine incision. Discovery and removal of these mucoceles during hysterectomy result in a very satisfied patient whose pain and urinary symptoms are resolved.

David G. Bryan, MD
Monroe, Louisiana

“Q: FOLLOWING CESAREAN DELIVERY, WHAT IS THE OPTIMAL OXYTOCIN INFUSION DURATION TO PREVENT POSTPARTUM BLEEDING?” ROBERT L. BARBIERI, MD (EDITORIAL; APRIL 2014)

Oxytocin protocol decreased postpartum hemorrhage rates
We commend Dr. Barbieri for his April 2014 editorial, “Following cesarean delivery, what is the optimal oxytocin infusion duration to prevent postpartum bleeding?” because he addresses a critical gap in the evidence regarding oxytocin administration postpartum. Standardized protocols for such administration are lacking at many facilities.

Our multidisciplinary team developed a standardized postpartum oxytocin administration protocol to prevent postpartum hemorrhage (PPH) based on limited evidence from trials in which 10 units to 80 or more units of oxytocin were given (from <1 to 12 hours) postpartum.1–5 Our protocol is a “middle of the road’’ approach in which a total of oxytocin 60 U is administered intravenously postdelivery, including a bolus of oxytocin 15 U in 250 mL of lactated Ringers solution (LR) at delivery followed by an additional oxytocin 15 U in 250 mL LR over the next hour, then oxytocin 30 U in 500 mL LR at a rate of 125 mL/hr for the following 4 hours. Thus, the total time for oxytocin administration postdelivery is 5 hours, within Dr. Barbieri’s recommendation of 4 to 8 hours 

We have since performed a retrospective quality improvement assessment comparing PPH rates at 6-months preprotocol (n = 1267) with rates at 6-months postprotocol (n = 1440) implementation. PPH was defined as PPH treatment by pharmaceutical, mechanical, or surgical methods. Inclusion criteria included all deliveries at greater than 23 weeks’ gestation from April 2012 to March 2013. Patient characteristics for both cohorts were similar for race, age, parity, gestational age, delivery type, and neonatal weight.

The PPH rate decreased 37% after protocol implementation (adjusted relative risk [ARR], 0.63; 95% confidence interval [CI], 0.46–0.91). Administration of misoprostol, carboprost, methylergonovine maleate, and blood products decreased postprotocol implementation by 36%, 38%, 32%, and 22%, respectively. The PPH rate for women with a vaginal delivery decreased significantly after protocol implementation (5.9% preprotocol vs 3.8% postprotocol; P = .03). The PPH rate for women undergoing cesarean delivery increased, but not significantly, after protocol implementation (6.9% preprotocol vs 8.6% postprotocol; P = .34).

We did not control for some PPH risk factors, including abnormal insertion of placenta, preeclampsia, and multiple gestation. Despite this limitation, our PPH rate for women undergoing cesarean delivery is lower than other published rates.6,7 These findings are the preliminary step in a larger, more comprehensive 4-year study.

Our team is encouraged by these results and believes our protocol warrants further study. Thank you for your attention to this topic. We hope our experience can offer support for future practice change and research.

Enas Ramih, MD, MPH; Jennifer Doyle, MSN, WHNP; Tiffany Kenny, MSN;
Michele McCarroll, PhD; Vivian von Gruenigen, MD

Summa Health System Akron City Hospital
Women’s Health Services
Akron, Ohio

References

1. Tita AT, Szychowski JM, Rouse DJ, et al. Higher-dose oxytocin and hemorrhage after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2012;119(2 pt 1):293–300.

2. Munn MB, Owen J, Vincent R, Wakefield M, Chestnut DH, Hauth JC. Comparison of two oxytocin regimens to prevent uterine atony at cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2001;98(3):386–390.

3. Murphy DJ, MacGregor H, Munishankar B, McLeod G. A randomised controlled trial of oxytocin 5IU and placebo infusion versus oxytocin 5IU and 30IU infusion for the control of blood loss at elective caesarean section: pilot study. ISRCTN 40302163. Eur J Obstet Gynecol Reprod Biol. 2009;142(1):30–33.

4. King KJ, Douglas MJ, Waldmar U, Wong A, King RAR. Five-unit bolus oxytocin at cesarean delivery in women at risk of atony: a randomized, double-blind, controlled trial. Anesth Analg. 2010;111(6):1460–1466.

5. Gungorduk K, Asicioglu O, Celikkol O, Olgac Y, Ark C. Use of additional oxytocin to reduce blood loss at elective caesarean section: a randomized control trial. Aust N Z J Obstet Gynaecol. 2010;50(1):36–39.

 

 

6. Dagraca J, Malladi V, Nunes K, Scavone B. Outcomes after institution of a new oxytocin infusion protocol during the third stage of labor and immediate postpartum period. Int J Obstet Anesth. 2013;22(3):194–199.

7. Sheehan SR, Montgomery AA, Carey M, et al. Oxytocin bolus versus oxytocin bolus and infusion for control of blood loss at elective caesarean section: double blind, placebo controlled, randomised trial. BMJ. 2011;343:d4661. doi:10.1136/bmj.d4661.

Dr. Barbieri responds
I deeply appreciate the very important clinical observation provided by the Summa Health System team. Implementation of a standardized 5-hour protocol of oxytocin administration following delivery resulted in a reduction in the rate of diagnosis of PPH following vaginal delivery, but not cesarean delivery, and a reduction in the use of adjuvant misoprostol, caboprost, and methylergonovine maleate. The quality improvement intervention initiated by the Summa Health System team and their ability to assess before and after outcomes demonstrates how high-quality clinical networks can develop and disseminate best practices, thereby improving the health of all the pregnant women in our care. Thank you for sharing this important clinical observation with our readers.

“FDA, HOSPITALS CAUTION AGAINST LAPAROSCOPIC POWER MORCELLATION DURING HYSTERECTOMY AND MYOMECTOMY”
JANELLE YATES (MAY 2014)

The right to choose the appropriate tools and techniques should remain in the capable hands of qualified surgeons!
I'm sorry to say it, but your piece on morcellators is slanted. Many of us believe the FDA is wrong. The incidence of occult sarcoma came from nowhere. In properly selected, evaluated, and surgically managed cases, the use of an open power morcellator is an excellent option and the risks of a bad outcome are extremely small (especially the risk of worsening an occult leiomyosarcoma). Incidentally, we face the same risk of finding and possibly worsening an occult cancer in every gynecologic surgery we do.

Possible spillage, contamination, or outright tumor rupture is possible no matter what route or incision size. Minimally invasive surgeons understand the risk−benefit ratio very well. We use our judgment and patient informed consent in every case and should not be unnecessarily obstructed by government agencies. The right to choose the appropriate tools and techniques should remain in the capable hands of qualified surgeons!

The controversy here is reminiscent of the issues brought up about breast implants in the 70s, IUDs in the 80s, estrogen in 2004, vaginal mesh in 2012, and robotics and hysterectomy approach recently. Show me some real data that are convincing against the use of morcellators, or support the physician’s choice in how to care for our patients.

Michael Swor, MD
Sarasota, Florida

Ms. Yates responds
I appreciate Dr. Swor’s response to the article on actions by the FDA and various hospitals to limit the use of power morcellation during hysterectomy and myomectomy. That article was not endorsing those actions, nor was it condemning them—it was simply a report of the latest events in a sea change taking place in minimally invasive gynecologic surgery.

Since the article was published, new data have become available on the likelihood of occult uterine malignancy among women who undergo minimally invasive hysterectomy with electric power morcellation. Wright and colleagues found a rate of uterine cancer of 27 cases per 10,000 women at the time of the procedure.1 That figure translates into one case of undetected uterine cancer in every 368 women undergoing hysterectomy.1

In a two-part series on tissue extraction at the time of hysterectomy and myomectomy, Dr. Jason Wright, the author of the study just mentioned, and other expert panelists discuss this issue in more depth.2,3 They also note, as does Dr. Swor, that spillage, contamination, or outright tumor rupture is possible regardless of the route of hysterectomy.

References

1. Wright JD, Tergas AI, Burke WM, et al. Uterine pathology in women undergoing minimally invasive hysterectomy using morcellation [published online ahead of print July 22, 2014]. JAMA. doi: 10.1001/jama.2014.9005.

2. Advincula AP, Bradley LD, Iglesia C, Kho K, Wright JD. Tissue extraction during minimally invasive Gyn surgery: Best practices for an environment in flux. OBG Manage. 2014;26(9):44–51.

3. Advincula AP, Bradley LD, Iglesia C, Kho K, Wright JD. Tissue extraction during minimally invasive Gyn surgery: Counseling the patient. OBG Manage. 2014;26(10):41–45. 

Share your thoughts on this or other articles! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

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"UPDATE ON MINIMALLY INVASIVE GYNECOLOGY" AMY GARCIA, MD (APRIL 2014)

Mucocele in cesarean scar can cause pain, bladder urgency, dyspareunia
Like Dr. Garcia, I too, have seen many cesarean-scar defects; most were diagnosed prior to surgery by my in-house technicians during vaginal ultrasonography.

I would like to add that, in addition to these defects, some patients who have undergone cesarean delivery also may form a mucocele in the scar that causes pain, bladder urgency, and dyspareunia. These defects also can be seen by ultrasonography, but in some cases may erroneously be labeled “nabothian cysts” by a radiologist. Most mucoceles probably are caused by incorporation of endocervical glands within a very low transverse uterine incision. Discovery and removal of these mucoceles during hysterectomy result in a very satisfied patient whose pain and urinary symptoms are resolved.

David G. Bryan, MD
Monroe, Louisiana

“Q: FOLLOWING CESAREAN DELIVERY, WHAT IS THE OPTIMAL OXYTOCIN INFUSION DURATION TO PREVENT POSTPARTUM BLEEDING?” ROBERT L. BARBIERI, MD (EDITORIAL; APRIL 2014)

Oxytocin protocol decreased postpartum hemorrhage rates
We commend Dr. Barbieri for his April 2014 editorial, “Following cesarean delivery, what is the optimal oxytocin infusion duration to prevent postpartum bleeding?” because he addresses a critical gap in the evidence regarding oxytocin administration postpartum. Standardized protocols for such administration are lacking at many facilities.

Our multidisciplinary team developed a standardized postpartum oxytocin administration protocol to prevent postpartum hemorrhage (PPH) based on limited evidence from trials in which 10 units to 80 or more units of oxytocin were given (from <1 to 12 hours) postpartum.1–5 Our protocol is a “middle of the road’’ approach in which a total of oxytocin 60 U is administered intravenously postdelivery, including a bolus of oxytocin 15 U in 250 mL of lactated Ringers solution (LR) at delivery followed by an additional oxytocin 15 U in 250 mL LR over the next hour, then oxytocin 30 U in 500 mL LR at a rate of 125 mL/hr for the following 4 hours. Thus, the total time for oxytocin administration postdelivery is 5 hours, within Dr. Barbieri’s recommendation of 4 to 8 hours 

We have since performed a retrospective quality improvement assessment comparing PPH rates at 6-months preprotocol (n = 1267) with rates at 6-months postprotocol (n = 1440) implementation. PPH was defined as PPH treatment by pharmaceutical, mechanical, or surgical methods. Inclusion criteria included all deliveries at greater than 23 weeks’ gestation from April 2012 to March 2013. Patient characteristics for both cohorts were similar for race, age, parity, gestational age, delivery type, and neonatal weight.

The PPH rate decreased 37% after protocol implementation (adjusted relative risk [ARR], 0.63; 95% confidence interval [CI], 0.46–0.91). Administration of misoprostol, carboprost, methylergonovine maleate, and blood products decreased postprotocol implementation by 36%, 38%, 32%, and 22%, respectively. The PPH rate for women with a vaginal delivery decreased significantly after protocol implementation (5.9% preprotocol vs 3.8% postprotocol; P = .03). The PPH rate for women undergoing cesarean delivery increased, but not significantly, after protocol implementation (6.9% preprotocol vs 8.6% postprotocol; P = .34).

We did not control for some PPH risk factors, including abnormal insertion of placenta, preeclampsia, and multiple gestation. Despite this limitation, our PPH rate for women undergoing cesarean delivery is lower than other published rates.6,7 These findings are the preliminary step in a larger, more comprehensive 4-year study.

Our team is encouraged by these results and believes our protocol warrants further study. Thank you for your attention to this topic. We hope our experience can offer support for future practice change and research.

Enas Ramih, MD, MPH; Jennifer Doyle, MSN, WHNP; Tiffany Kenny, MSN;
Michele McCarroll, PhD; Vivian von Gruenigen, MD

Summa Health System Akron City Hospital
Women’s Health Services
Akron, Ohio

References

1. Tita AT, Szychowski JM, Rouse DJ, et al. Higher-dose oxytocin and hemorrhage after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2012;119(2 pt 1):293–300.

2. Munn MB, Owen J, Vincent R, Wakefield M, Chestnut DH, Hauth JC. Comparison of two oxytocin regimens to prevent uterine atony at cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2001;98(3):386–390.

3. Murphy DJ, MacGregor H, Munishankar B, McLeod G. A randomised controlled trial of oxytocin 5IU and placebo infusion versus oxytocin 5IU and 30IU infusion for the control of blood loss at elective caesarean section: pilot study. ISRCTN 40302163. Eur J Obstet Gynecol Reprod Biol. 2009;142(1):30–33.

4. King KJ, Douglas MJ, Waldmar U, Wong A, King RAR. Five-unit bolus oxytocin at cesarean delivery in women at risk of atony: a randomized, double-blind, controlled trial. Anesth Analg. 2010;111(6):1460–1466.

5. Gungorduk K, Asicioglu O, Celikkol O, Olgac Y, Ark C. Use of additional oxytocin to reduce blood loss at elective caesarean section: a randomized control trial. Aust N Z J Obstet Gynaecol. 2010;50(1):36–39.

 

 

6. Dagraca J, Malladi V, Nunes K, Scavone B. Outcomes after institution of a new oxytocin infusion protocol during the third stage of labor and immediate postpartum period. Int J Obstet Anesth. 2013;22(3):194–199.

7. Sheehan SR, Montgomery AA, Carey M, et al. Oxytocin bolus versus oxytocin bolus and infusion for control of blood loss at elective caesarean section: double blind, placebo controlled, randomised trial. BMJ. 2011;343:d4661. doi:10.1136/bmj.d4661.

Dr. Barbieri responds
I deeply appreciate the very important clinical observation provided by the Summa Health System team. Implementation of a standardized 5-hour protocol of oxytocin administration following delivery resulted in a reduction in the rate of diagnosis of PPH following vaginal delivery, but not cesarean delivery, and a reduction in the use of adjuvant misoprostol, caboprost, and methylergonovine maleate. The quality improvement intervention initiated by the Summa Health System team and their ability to assess before and after outcomes demonstrates how high-quality clinical networks can develop and disseminate best practices, thereby improving the health of all the pregnant women in our care. Thank you for sharing this important clinical observation with our readers.

“FDA, HOSPITALS CAUTION AGAINST LAPAROSCOPIC POWER MORCELLATION DURING HYSTERECTOMY AND MYOMECTOMY”
JANELLE YATES (MAY 2014)

The right to choose the appropriate tools and techniques should remain in the capable hands of qualified surgeons!
I'm sorry to say it, but your piece on morcellators is slanted. Many of us believe the FDA is wrong. The incidence of occult sarcoma came from nowhere. In properly selected, evaluated, and surgically managed cases, the use of an open power morcellator is an excellent option and the risks of a bad outcome are extremely small (especially the risk of worsening an occult leiomyosarcoma). Incidentally, we face the same risk of finding and possibly worsening an occult cancer in every gynecologic surgery we do.

Possible spillage, contamination, or outright tumor rupture is possible no matter what route or incision size. Minimally invasive surgeons understand the risk−benefit ratio very well. We use our judgment and patient informed consent in every case and should not be unnecessarily obstructed by government agencies. The right to choose the appropriate tools and techniques should remain in the capable hands of qualified surgeons!

The controversy here is reminiscent of the issues brought up about breast implants in the 70s, IUDs in the 80s, estrogen in 2004, vaginal mesh in 2012, and robotics and hysterectomy approach recently. Show me some real data that are convincing against the use of morcellators, or support the physician’s choice in how to care for our patients.

Michael Swor, MD
Sarasota, Florida

Ms. Yates responds
I appreciate Dr. Swor’s response to the article on actions by the FDA and various hospitals to limit the use of power morcellation during hysterectomy and myomectomy. That article was not endorsing those actions, nor was it condemning them—it was simply a report of the latest events in a sea change taking place in minimally invasive gynecologic surgery.

Since the article was published, new data have become available on the likelihood of occult uterine malignancy among women who undergo minimally invasive hysterectomy with electric power morcellation. Wright and colleagues found a rate of uterine cancer of 27 cases per 10,000 women at the time of the procedure.1 That figure translates into one case of undetected uterine cancer in every 368 women undergoing hysterectomy.1

In a two-part series on tissue extraction at the time of hysterectomy and myomectomy, Dr. Jason Wright, the author of the study just mentioned, and other expert panelists discuss this issue in more depth.2,3 They also note, as does Dr. Swor, that spillage, contamination, or outright tumor rupture is possible regardless of the route of hysterectomy.

References

1. Wright JD, Tergas AI, Burke WM, et al. Uterine pathology in women undergoing minimally invasive hysterectomy using morcellation [published online ahead of print July 22, 2014]. JAMA. doi: 10.1001/jama.2014.9005.

2. Advincula AP, Bradley LD, Iglesia C, Kho K, Wright JD. Tissue extraction during minimally invasive Gyn surgery: Best practices for an environment in flux. OBG Manage. 2014;26(9):44–51.

3. Advincula AP, Bradley LD, Iglesia C, Kho K, Wright JD. Tissue extraction during minimally invasive Gyn surgery: Counseling the patient. OBG Manage. 2014;26(10):41–45. 

Share your thoughts on this or other articles! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

"UPDATE ON MINIMALLY INVASIVE GYNECOLOGY" AMY GARCIA, MD (APRIL 2014)

Mucocele in cesarean scar can cause pain, bladder urgency, dyspareunia
Like Dr. Garcia, I too, have seen many cesarean-scar defects; most were diagnosed prior to surgery by my in-house technicians during vaginal ultrasonography.

I would like to add that, in addition to these defects, some patients who have undergone cesarean delivery also may form a mucocele in the scar that causes pain, bladder urgency, and dyspareunia. These defects also can be seen by ultrasonography, but in some cases may erroneously be labeled “nabothian cysts” by a radiologist. Most mucoceles probably are caused by incorporation of endocervical glands within a very low transverse uterine incision. Discovery and removal of these mucoceles during hysterectomy result in a very satisfied patient whose pain and urinary symptoms are resolved.

David G. Bryan, MD
Monroe, Louisiana

“Q: FOLLOWING CESAREAN DELIVERY, WHAT IS THE OPTIMAL OXYTOCIN INFUSION DURATION TO PREVENT POSTPARTUM BLEEDING?” ROBERT L. BARBIERI, MD (EDITORIAL; APRIL 2014)

Oxytocin protocol decreased postpartum hemorrhage rates
We commend Dr. Barbieri for his April 2014 editorial, “Following cesarean delivery, what is the optimal oxytocin infusion duration to prevent postpartum bleeding?” because he addresses a critical gap in the evidence regarding oxytocin administration postpartum. Standardized protocols for such administration are lacking at many facilities.

Our multidisciplinary team developed a standardized postpartum oxytocin administration protocol to prevent postpartum hemorrhage (PPH) based on limited evidence from trials in which 10 units to 80 or more units of oxytocin were given (from <1 to 12 hours) postpartum.1–5 Our protocol is a “middle of the road’’ approach in which a total of oxytocin 60 U is administered intravenously postdelivery, including a bolus of oxytocin 15 U in 250 mL of lactated Ringers solution (LR) at delivery followed by an additional oxytocin 15 U in 250 mL LR over the next hour, then oxytocin 30 U in 500 mL LR at a rate of 125 mL/hr for the following 4 hours. Thus, the total time for oxytocin administration postdelivery is 5 hours, within Dr. Barbieri’s recommendation of 4 to 8 hours 

We have since performed a retrospective quality improvement assessment comparing PPH rates at 6-months preprotocol (n = 1267) with rates at 6-months postprotocol (n = 1440) implementation. PPH was defined as PPH treatment by pharmaceutical, mechanical, or surgical methods. Inclusion criteria included all deliveries at greater than 23 weeks’ gestation from April 2012 to March 2013. Patient characteristics for both cohorts were similar for race, age, parity, gestational age, delivery type, and neonatal weight.

The PPH rate decreased 37% after protocol implementation (adjusted relative risk [ARR], 0.63; 95% confidence interval [CI], 0.46–0.91). Administration of misoprostol, carboprost, methylergonovine maleate, and blood products decreased postprotocol implementation by 36%, 38%, 32%, and 22%, respectively. The PPH rate for women with a vaginal delivery decreased significantly after protocol implementation (5.9% preprotocol vs 3.8% postprotocol; P = .03). The PPH rate for women undergoing cesarean delivery increased, but not significantly, after protocol implementation (6.9% preprotocol vs 8.6% postprotocol; P = .34).

We did not control for some PPH risk factors, including abnormal insertion of placenta, preeclampsia, and multiple gestation. Despite this limitation, our PPH rate for women undergoing cesarean delivery is lower than other published rates.6,7 These findings are the preliminary step in a larger, more comprehensive 4-year study.

Our team is encouraged by these results and believes our protocol warrants further study. Thank you for your attention to this topic. We hope our experience can offer support for future practice change and research.

Enas Ramih, MD, MPH; Jennifer Doyle, MSN, WHNP; Tiffany Kenny, MSN;
Michele McCarroll, PhD; Vivian von Gruenigen, MD

Summa Health System Akron City Hospital
Women’s Health Services
Akron, Ohio

References

1. Tita AT, Szychowski JM, Rouse DJ, et al. Higher-dose oxytocin and hemorrhage after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2012;119(2 pt 1):293–300.

2. Munn MB, Owen J, Vincent R, Wakefield M, Chestnut DH, Hauth JC. Comparison of two oxytocin regimens to prevent uterine atony at cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2001;98(3):386–390.

3. Murphy DJ, MacGregor H, Munishankar B, McLeod G. A randomised controlled trial of oxytocin 5IU and placebo infusion versus oxytocin 5IU and 30IU infusion for the control of blood loss at elective caesarean section: pilot study. ISRCTN 40302163. Eur J Obstet Gynecol Reprod Biol. 2009;142(1):30–33.

4. King KJ, Douglas MJ, Waldmar U, Wong A, King RAR. Five-unit bolus oxytocin at cesarean delivery in women at risk of atony: a randomized, double-blind, controlled trial. Anesth Analg. 2010;111(6):1460–1466.

5. Gungorduk K, Asicioglu O, Celikkol O, Olgac Y, Ark C. Use of additional oxytocin to reduce blood loss at elective caesarean section: a randomized control trial. Aust N Z J Obstet Gynaecol. 2010;50(1):36–39.

 

 

6. Dagraca J, Malladi V, Nunes K, Scavone B. Outcomes after institution of a new oxytocin infusion protocol during the third stage of labor and immediate postpartum period. Int J Obstet Anesth. 2013;22(3):194–199.

7. Sheehan SR, Montgomery AA, Carey M, et al. Oxytocin bolus versus oxytocin bolus and infusion for control of blood loss at elective caesarean section: double blind, placebo controlled, randomised trial. BMJ. 2011;343:d4661. doi:10.1136/bmj.d4661.

Dr. Barbieri responds
I deeply appreciate the very important clinical observation provided by the Summa Health System team. Implementation of a standardized 5-hour protocol of oxytocin administration following delivery resulted in a reduction in the rate of diagnosis of PPH following vaginal delivery, but not cesarean delivery, and a reduction in the use of adjuvant misoprostol, caboprost, and methylergonovine maleate. The quality improvement intervention initiated by the Summa Health System team and their ability to assess before and after outcomes demonstrates how high-quality clinical networks can develop and disseminate best practices, thereby improving the health of all the pregnant women in our care. Thank you for sharing this important clinical observation with our readers.

“FDA, HOSPITALS CAUTION AGAINST LAPAROSCOPIC POWER MORCELLATION DURING HYSTERECTOMY AND MYOMECTOMY”
JANELLE YATES (MAY 2014)

The right to choose the appropriate tools and techniques should remain in the capable hands of qualified surgeons!
I'm sorry to say it, but your piece on morcellators is slanted. Many of us believe the FDA is wrong. The incidence of occult sarcoma came from nowhere. In properly selected, evaluated, and surgically managed cases, the use of an open power morcellator is an excellent option and the risks of a bad outcome are extremely small (especially the risk of worsening an occult leiomyosarcoma). Incidentally, we face the same risk of finding and possibly worsening an occult cancer in every gynecologic surgery we do.

Possible spillage, contamination, or outright tumor rupture is possible no matter what route or incision size. Minimally invasive surgeons understand the risk−benefit ratio very well. We use our judgment and patient informed consent in every case and should not be unnecessarily obstructed by government agencies. The right to choose the appropriate tools and techniques should remain in the capable hands of qualified surgeons!

The controversy here is reminiscent of the issues brought up about breast implants in the 70s, IUDs in the 80s, estrogen in 2004, vaginal mesh in 2012, and robotics and hysterectomy approach recently. Show me some real data that are convincing against the use of morcellators, or support the physician’s choice in how to care for our patients.

Michael Swor, MD
Sarasota, Florida

Ms. Yates responds
I appreciate Dr. Swor’s response to the article on actions by the FDA and various hospitals to limit the use of power morcellation during hysterectomy and myomectomy. That article was not endorsing those actions, nor was it condemning them—it was simply a report of the latest events in a sea change taking place in minimally invasive gynecologic surgery.

Since the article was published, new data have become available on the likelihood of occult uterine malignancy among women who undergo minimally invasive hysterectomy with electric power morcellation. Wright and colleagues found a rate of uterine cancer of 27 cases per 10,000 women at the time of the procedure.1 That figure translates into one case of undetected uterine cancer in every 368 women undergoing hysterectomy.1

In a two-part series on tissue extraction at the time of hysterectomy and myomectomy, Dr. Jason Wright, the author of the study just mentioned, and other expert panelists discuss this issue in more depth.2,3 They also note, as does Dr. Swor, that spillage, contamination, or outright tumor rupture is possible regardless of the route of hysterectomy.

References

1. Wright JD, Tergas AI, Burke WM, et al. Uterine pathology in women undergoing minimally invasive hysterectomy using morcellation [published online ahead of print July 22, 2014]. JAMA. doi: 10.1001/jama.2014.9005.

2. Advincula AP, Bradley LD, Iglesia C, Kho K, Wright JD. Tissue extraction during minimally invasive Gyn surgery: Best practices for an environment in flux. OBG Manage. 2014;26(9):44–51.

3. Advincula AP, Bradley LD, Iglesia C, Kho K, Wright JD. Tissue extraction during minimally invasive Gyn surgery: Counseling the patient. OBG Manage. 2014;26(10):41–45. 

Share your thoughts on this or other articles! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

References

References

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Tissue extraction during minimally invasive Gyn surgery. Second of 2 Parts: Counseling the patient

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Tissue extraction during minimally invasive Gyn surgery. Second of 2 Parts: Counseling the patient

In the absence of a definitive FDA decision on the future of power morcellation in minimally invasive gynecologic surgery, many surgeons have stopped offering the option, often in response to constraints placed by their institutions, or have greatly expanded the informed consent discussion.

In Part 1 of this two-part roundtable discussion, which appeared in the September 2014 issue of OBG Management, our expert panelists discussed their current approach to tissue extraction during hysterectomy and myomectomy, as well as their preferred approach to both procedures amid this changing surgical environment. Here, in Part 2, they discuss patient counseling and the likely effects of FDA action.

How has your counseling changed?
OBG Management:
Given recent concerns about the use of power morcellation, how has your counseling of the patient changed?

Kimberly Kho, MD, MPH: Though I look forward to the development of instruments and techniques that will make contained power morcellation safer, I am not using it currently and have been able to find minimally invasive alternatives such as minilaparotomy and vaginal removal of masses for the cases I would have considered for power morcellation.

Certainly, with power morcellation or any type of morcellation, it’s important to discuss the risks and benefits, as well as alternatives. Discussion should include the potential for:

  • iatrogenic injury and tissue seeding of both benign and malignant tissue
  • exacerbation of any occult malignancy and possible worsening of prognosis
  • missing or mischaracterizing an occult malignancy.

Although there is no surefire way to avoid cellular dissemination with any type of surgery, I think it’s equally important to explain that, often, the only way to completely avoid fragmenting a large mass is to remove it en bloc, which would mean a large laparotomy for many patients. Women should understand the risks of laparotomy as well, including more frequent wound complications, longer hospitalization, and slower recovery.

Arnold P. Advincula, MD: If a clinician anticipates or plans the use of power morcellation, he or she certainly needs to go through an informed consent process with the patient. This process may include a separate form specific to power morcellation as well as detailed documentation during the preoperative visit.

OBG Management: What elements of the preoperative visit do you believe are important to document?

Dr. Advincula: It is important to clearly document the indications and alternatives for the surgery, as well as the decision-making process that led to the selection of a particular procedure and route of access. If any type of morcellation (power-driven or not) is anticipated, then the risks associated with it must be thoroughly discussed and documented in addition to the standard risks associated with any type of abdominal-pelvic surgery. No surgical procedure is without risks. Therefore, the process of informed consent cannot be taken lightly and is a critical part of the process that allows a patient to decide upon a particular intervention.

Jason D. Wright, MD: I believe the current role of power morcellation is limited. Patients considering the procedure should be counseled about the risks of cancer as well as other adverse pathologic abnormalities, including smooth muscle tumors of uncertain malignant potential, disseminated leiomyomatosis, and endometrial hyperplasia that may be associated with an occult cancer.

OBG Management: Do you recommend a separate consent form for power morcellation, as Dr. Advincula suggested?

Dr. Wright: Given the risk of adverse pathology, I think the role of electric power morcellation is limited. Patients should be carefully counseled about alternative surgical approaches that avoid tissue disruption and understand that the sensitivity of preoperative testing and intraoperative evaluation of smooth muscle neoplasms is limited. Further, patients considering contained morcellation also should be informed that the data examining the efficacy of these techniques are sparse.

Linda D. Bradley, MD: As I mentioned in Part 1 of our discussion, I’m giving patients new information about our concerns regarding occult malignancy, quoting the risk estimates given by the FDA this year.1 And the fact that we no longer use power morcellation at the Cleveland Clinic means that I no longer discuss it as an option, although one or two patients have asked for it in recent months.

I think many patients have read about it in the news or, once hysterectomy or myomectomy was planned, found discussion of the controversy surrounding it during their research. I’ve even had patients who underwent hysteroscopic myomectomy 2 or more years ago contacting me to find out whether power morcellation was used, and I have had to explain that hysteroscopic morcellation is different from the laparoscopic variant.

Patients are critical readers and are much more knowledgeable as a result of social media, so I do find myself spending more time discussing their procedure with them.

 

 

For myomectomy in particular, we send for a frozen section intraoperatively. Although that approach still is not 100% sensitive, it does guide what we do during surgery. If a sarcoma is found, for example, we call in the oncologists. I discuss that possibility with the patient as well. So I am spending more time with patients, but I don’t go into power morcellation because that is no longer an option for me.

OBG Management: Dr. Iglesia, has your counseling of patients changed in any way?

Cheryl Iglesia, MD: I do not routinely use power morcellation. However, the findings from the FDA and Dr. Wright about the higher risk of occult malignancy in fibroids is information I share with patients preoperatively.1,2

For women with fibroids who want uterine conservation procedures or who desire medical management, such as focused ultrasound or uterine fibroid embolization, MRI is routine. However, we make patients aware that this imaging modality is not 100% sensitive in detecting occult cancer—and neither are random biopsies of fibroids. Patients also need to be made aware that treatment with fibroid embolization or other medical options also could delay the detection of cancer and sarcoma. Any morcellation technique (power, hand, vaginal) does have the risk of potential cancer spread and upstaging, so morcellation should not be used in any women with suspected or known malignancy.

Effects of likely FDA actions
OBG Management:
If the FDA decides to ban power morcellation outright, in some ways the approach to patient counseling will be simpler, as one option will have been permanently eliminated. But if the FDA allows power morcellation to continue, with stricter labeling, would that affect how you counsel patients? And would you reconsider power morcellation in that light?

Dr. Kho: I think the current discussion has highlighted again how important the informed consent process is as an opportunity for information sharing. It’s an ongoing discussion of risks, benefits, and alternatives. It also offers us an opportunity to understand the patient’s values and perspectives throughout the process of surgical planning. So, no, I don’t think the FDA’s actions will change how I counsel patients. Regardless of the FDA’s decisions, I think open power morcellation as we currently know it may be obviated as new instruments for contained morcellation—as well as other techniques we’ve discussed—become more popular. But it’s critical that we meaningfully monitor these techniques for long-term safety. In order to make evidence-based decisions, we will need good data.

Dr. Iglesia: I cannot comment on a final FDA decision. However, my feeling is that any information that patients can use to become educated about treatment alternatives—including the risks and benefits of each option—will help inform and improve the shared decision-making process.

Dr. Advincula: Regardless of the verdict rendered by the FDA, the way we approach tissue extraction in minimally invasive surgery has been changed forever. It is always important to take a critical look at the way things are done, but not at the expense of throwing the proverbial baby out with the bath water. If power morcellation were to remain a viable option, my counseling would remain as is, as it already has been modified and quite detailed in the wake of this whole controversy. I still believe there is a role for power morcellation, albeit modified from its current iteration, when applied by the right physician in a properly evaluated patient with the right indication.

Summing up
OBG Management:
Do you have any additional comments about this issue?

Dr. Advincula: The ability to accurately and reliably detect an occult uterine malignancy—specifically, leiomyosarcoma—is lacking at present. Whether or not power morcellation remains a viable option in the future, the bottom line is that patients will still present with occult uterine malignancy. Minimizing the mishandling of this unfortunate diagnosis will depend on sound clinical judgment as well as improvements in diagnosis. It always will be important to avoid blaming the lack of sound clinical practice on surgical devices that, when used appropriately, have the potential to benefit the majority of women.

Dr. Kho: The current attention on power morcellators presents an opportunity to improve upon our current practices and find solutions to the issues we are encountering. I think this is an exciting time for examining preoperative risk stratification, the innovation of new techniques, repopularization and improvement of older ones such as vaginal tissue extraction, and, overall, to improve our system of safety monitoring and surgical device surveillance.

Dr. Iglesia: Intraperitoneal power morcellation should not be used in cases of malignancy or suspected malignancy or in postmenopausal patients with bleeding or growing fibroids. The availability of power morcellators may be limited as manufacturers
 cease distribution, hospitals ban use, or insurers refuse payment for use.

 

 

Alternative minimally invasive approaches—especially the transvaginal approach—should be considered, since there are fewer complications associated with vaginal surgery, especially compared with open and laparoscopic surgery.

Dr. Wright: Although electric power morcellation may allow some women to undergo a minimally invasive procedure, the data currently available clearly suggest that adverse pathology is more common in women who undergo morcellation than was previously thought.

Although the debate around morcellation has focused on leiomyosarcoma, epithelial endometrial tumors and other preinvasive abnormalities are also common. These unexpected pathologic findings in women who underwent electric power morcellation highlight the importance of performing more rigorous evaluation of new methods of tissue extraction.

Quick Poll:
If you are using, plan to use, or anticipate the possibility of using power morcellation during minimally invasive gynecologic surgery, does your consent process include a separate form specific to power morcellation?
Please provide your answer to this question in the Quick Poll on the OBG Management home page, and then see how your peers have voted.
Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

References

1. US Food and Drug Administration. Laparoscopic uterine power morcellation in hysterectomy and myomectomy: FDA safety communication.http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm393576.htm. Published April 17, 2014. Accessed September 18, 2014.
2. Wright JD, Tergas AI, Burke WM, et al. Uterine pathology in women undergoing minimally invasive hysterectomy with morcellation [published online ahead of print July 22, 2014]. JAMA. doi:10.1001/jama.2014.9005.

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Arnold P. Advincula, MD; Linda D. Bradley, MD; Cheryl Iglesia, MD; Kimberly Kho, MD, MPH; and Jason D. Wright, MD

Our expert panel

Arnold P. Advincula, MD, is Vice-Chair of Women’s Health and Chief of Gynecology, Department of ­Obstetrics and Gynecology, at Columbia University Medical Center in New York, New York. He serves on the OBG Management Board of Editors.

Linda D. Bradley, MD, is Professor of Surgery; Vice Chairman of the Obstetrics, Gynecology and Women’s Health Institute; and Director of the Center for ­Menstrual Disorders, Fibroids & Hysteroscopic Services at Cleveland Clinic in Cleveland, Ohio. She serves on the OBG Management Board of Editors.

Cheryl Iglesia, MD, is Director of the Section of Female Pelvic Medicine and Reconstructive Surgery at MedStar Washington Hospital Center and Professor, Departments of ObGyn and Urology, at Georgetown University School of Medicine in Washington, DC. She serves on the OBG Management Board of Editors.

Kimberly Kho, MD, MPH, is Assistant Professor, Department of Obstetrics and Gynecology, and Director of the Southwestern Center for Minimally Invasive Surgery, Gynecology, at the University of Texas Southwestern Medical Center in Dallas, Texas.

Jason D. Wright, MD, is Sol Goldman Associate Professor of Obstetrics and Gynecology and Chief of the Division of Gynecologic Oncology at Columbia University College of Physicians and Surgeons and New York ­Presbyterian Hospital in New York, New York.

Dr. Advincula reports that he is a consultant to Blue Endo, CooperSurgical, Intuitive Surgical, and SurgiQuest. He also receives royalties from CooperSurgical. Dr. Bradley reports that she receives grant or research support from Bayer Research as a principal investigator and contributor; is a consultant to BlueSpire, Boston Scientific, Endoceutics, Hologic, and Smith & Nephew; and is a speaker for Bayer Healthcare. Other reported financial relationships: royalties from Elsevier; as a member of the Editorial Advisory Board of MedScape and WebMD; and for articles published in Wolters Kluwer Health and UpToDate. Dr. Iglesia reports that she is a member of the FDA ObGyn Devices Panel. Dr. Kho reports no financial relationships relevant to this article. Dr. Wright reports that he receives grant or research support from Genentech.

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Arnold P. Advincula, MD; Linda D. Bradley, MD; Cheryl Iglesia, MD; Kimberly Kho, MD, MPH; and Jason D. Wright, MD

Our expert panel

Arnold P. Advincula, MD, is Vice-Chair of Women’s Health and Chief of Gynecology, Department of ­Obstetrics and Gynecology, at Columbia University Medical Center in New York, New York. He serves on the OBG Management Board of Editors.

Linda D. Bradley, MD, is Professor of Surgery; Vice Chairman of the Obstetrics, Gynecology and Women’s Health Institute; and Director of the Center for ­Menstrual Disorders, Fibroids & Hysteroscopic Services at Cleveland Clinic in Cleveland, Ohio. She serves on the OBG Management Board of Editors.

Cheryl Iglesia, MD, is Director of the Section of Female Pelvic Medicine and Reconstructive Surgery at MedStar Washington Hospital Center and Professor, Departments of ObGyn and Urology, at Georgetown University School of Medicine in Washington, DC. She serves on the OBG Management Board of Editors.

Kimberly Kho, MD, MPH, is Assistant Professor, Department of Obstetrics and Gynecology, and Director of the Southwestern Center for Minimally Invasive Surgery, Gynecology, at the University of Texas Southwestern Medical Center in Dallas, Texas.

Jason D. Wright, MD, is Sol Goldman Associate Professor of Obstetrics and Gynecology and Chief of the Division of Gynecologic Oncology at Columbia University College of Physicians and Surgeons and New York ­Presbyterian Hospital in New York, New York.

Dr. Advincula reports that he is a consultant to Blue Endo, CooperSurgical, Intuitive Surgical, and SurgiQuest. He also receives royalties from CooperSurgical. Dr. Bradley reports that she receives grant or research support from Bayer Research as a principal investigator and contributor; is a consultant to BlueSpire, Boston Scientific, Endoceutics, Hologic, and Smith & Nephew; and is a speaker for Bayer Healthcare. Other reported financial relationships: royalties from Elsevier; as a member of the Editorial Advisory Board of MedScape and WebMD; and for articles published in Wolters Kluwer Health and UpToDate. Dr. Iglesia reports that she is a member of the FDA ObGyn Devices Panel. Dr. Kho reports no financial relationships relevant to this article. Dr. Wright reports that he receives grant or research support from Genentech.

Author and Disclosure Information

Arnold P. Advincula, MD; Linda D. Bradley, MD; Cheryl Iglesia, MD; Kimberly Kho, MD, MPH; and Jason D. Wright, MD

Our expert panel

Arnold P. Advincula, MD, is Vice-Chair of Women’s Health and Chief of Gynecology, Department of ­Obstetrics and Gynecology, at Columbia University Medical Center in New York, New York. He serves on the OBG Management Board of Editors.

Linda D. Bradley, MD, is Professor of Surgery; Vice Chairman of the Obstetrics, Gynecology and Women’s Health Institute; and Director of the Center for ­Menstrual Disorders, Fibroids & Hysteroscopic Services at Cleveland Clinic in Cleveland, Ohio. She serves on the OBG Management Board of Editors.

Cheryl Iglesia, MD, is Director of the Section of Female Pelvic Medicine and Reconstructive Surgery at MedStar Washington Hospital Center and Professor, Departments of ObGyn and Urology, at Georgetown University School of Medicine in Washington, DC. She serves on the OBG Management Board of Editors.

Kimberly Kho, MD, MPH, is Assistant Professor, Department of Obstetrics and Gynecology, and Director of the Southwestern Center for Minimally Invasive Surgery, Gynecology, at the University of Texas Southwestern Medical Center in Dallas, Texas.

Jason D. Wright, MD, is Sol Goldman Associate Professor of Obstetrics and Gynecology and Chief of the Division of Gynecologic Oncology at Columbia University College of Physicians and Surgeons and New York ­Presbyterian Hospital in New York, New York.

Dr. Advincula reports that he is a consultant to Blue Endo, CooperSurgical, Intuitive Surgical, and SurgiQuest. He also receives royalties from CooperSurgical. Dr. Bradley reports that she receives grant or research support from Bayer Research as a principal investigator and contributor; is a consultant to BlueSpire, Boston Scientific, Endoceutics, Hologic, and Smith & Nephew; and is a speaker for Bayer Healthcare. Other reported financial relationships: royalties from Elsevier; as a member of the Editorial Advisory Board of MedScape and WebMD; and for articles published in Wolters Kluwer Health and UpToDate. Dr. Iglesia reports that she is a member of the FDA ObGyn Devices Panel. Dr. Kho reports no financial relationships relevant to this article. Dr. Wright reports that he receives grant or research support from Genentech.

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In the absence of a definitive FDA decision on the future of power morcellation in minimally invasive gynecologic surgery, many surgeons have stopped offering the option, often in response to constraints placed by their institutions, or have greatly expanded the informed consent discussion.

In Part 1 of this two-part roundtable discussion, which appeared in the September 2014 issue of OBG Management, our expert panelists discussed their current approach to tissue extraction during hysterectomy and myomectomy, as well as their preferred approach to both procedures amid this changing surgical environment. Here, in Part 2, they discuss patient counseling and the likely effects of FDA action.

How has your counseling changed?
OBG Management:
Given recent concerns about the use of power morcellation, how has your counseling of the patient changed?

Kimberly Kho, MD, MPH: Though I look forward to the development of instruments and techniques that will make contained power morcellation safer, I am not using it currently and have been able to find minimally invasive alternatives such as minilaparotomy and vaginal removal of masses for the cases I would have considered for power morcellation.

Certainly, with power morcellation or any type of morcellation, it’s important to discuss the risks and benefits, as well as alternatives. Discussion should include the potential for:

  • iatrogenic injury and tissue seeding of both benign and malignant tissue
  • exacerbation of any occult malignancy and possible worsening of prognosis
  • missing or mischaracterizing an occult malignancy.

Although there is no surefire way to avoid cellular dissemination with any type of surgery, I think it’s equally important to explain that, often, the only way to completely avoid fragmenting a large mass is to remove it en bloc, which would mean a large laparotomy for many patients. Women should understand the risks of laparotomy as well, including more frequent wound complications, longer hospitalization, and slower recovery.

Arnold P. Advincula, MD: If a clinician anticipates or plans the use of power morcellation, he or she certainly needs to go through an informed consent process with the patient. This process may include a separate form specific to power morcellation as well as detailed documentation during the preoperative visit.

OBG Management: What elements of the preoperative visit do you believe are important to document?

Dr. Advincula: It is important to clearly document the indications and alternatives for the surgery, as well as the decision-making process that led to the selection of a particular procedure and route of access. If any type of morcellation (power-driven or not) is anticipated, then the risks associated with it must be thoroughly discussed and documented in addition to the standard risks associated with any type of abdominal-pelvic surgery. No surgical procedure is without risks. Therefore, the process of informed consent cannot be taken lightly and is a critical part of the process that allows a patient to decide upon a particular intervention.

Jason D. Wright, MD: I believe the current role of power morcellation is limited. Patients considering the procedure should be counseled about the risks of cancer as well as other adverse pathologic abnormalities, including smooth muscle tumors of uncertain malignant potential, disseminated leiomyomatosis, and endometrial hyperplasia that may be associated with an occult cancer.

OBG Management: Do you recommend a separate consent form for power morcellation, as Dr. Advincula suggested?

Dr. Wright: Given the risk of adverse pathology, I think the role of electric power morcellation is limited. Patients should be carefully counseled about alternative surgical approaches that avoid tissue disruption and understand that the sensitivity of preoperative testing and intraoperative evaluation of smooth muscle neoplasms is limited. Further, patients considering contained morcellation also should be informed that the data examining the efficacy of these techniques are sparse.

Linda D. Bradley, MD: As I mentioned in Part 1 of our discussion, I’m giving patients new information about our concerns regarding occult malignancy, quoting the risk estimates given by the FDA this year.1 And the fact that we no longer use power morcellation at the Cleveland Clinic means that I no longer discuss it as an option, although one or two patients have asked for it in recent months.

I think many patients have read about it in the news or, once hysterectomy or myomectomy was planned, found discussion of the controversy surrounding it during their research. I’ve even had patients who underwent hysteroscopic myomectomy 2 or more years ago contacting me to find out whether power morcellation was used, and I have had to explain that hysteroscopic morcellation is different from the laparoscopic variant.

Patients are critical readers and are much more knowledgeable as a result of social media, so I do find myself spending more time discussing their procedure with them.

 

 

For myomectomy in particular, we send for a frozen section intraoperatively. Although that approach still is not 100% sensitive, it does guide what we do during surgery. If a sarcoma is found, for example, we call in the oncologists. I discuss that possibility with the patient as well. So I am spending more time with patients, but I don’t go into power morcellation because that is no longer an option for me.

OBG Management: Dr. Iglesia, has your counseling of patients changed in any way?

Cheryl Iglesia, MD: I do not routinely use power morcellation. However, the findings from the FDA and Dr. Wright about the higher risk of occult malignancy in fibroids is information I share with patients preoperatively.1,2

For women with fibroids who want uterine conservation procedures or who desire medical management, such as focused ultrasound or uterine fibroid embolization, MRI is routine. However, we make patients aware that this imaging modality is not 100% sensitive in detecting occult cancer—and neither are random biopsies of fibroids. Patients also need to be made aware that treatment with fibroid embolization or other medical options also could delay the detection of cancer and sarcoma. Any morcellation technique (power, hand, vaginal) does have the risk of potential cancer spread and upstaging, so morcellation should not be used in any women with suspected or known malignancy.

Effects of likely FDA actions
OBG Management:
If the FDA decides to ban power morcellation outright, in some ways the approach to patient counseling will be simpler, as one option will have been permanently eliminated. But if the FDA allows power morcellation to continue, with stricter labeling, would that affect how you counsel patients? And would you reconsider power morcellation in that light?

Dr. Kho: I think the current discussion has highlighted again how important the informed consent process is as an opportunity for information sharing. It’s an ongoing discussion of risks, benefits, and alternatives. It also offers us an opportunity to understand the patient’s values and perspectives throughout the process of surgical planning. So, no, I don’t think the FDA’s actions will change how I counsel patients. Regardless of the FDA’s decisions, I think open power morcellation as we currently know it may be obviated as new instruments for contained morcellation—as well as other techniques we’ve discussed—become more popular. But it’s critical that we meaningfully monitor these techniques for long-term safety. In order to make evidence-based decisions, we will need good data.

Dr. Iglesia: I cannot comment on a final FDA decision. However, my feeling is that any information that patients can use to become educated about treatment alternatives—including the risks and benefits of each option—will help inform and improve the shared decision-making process.

Dr. Advincula: Regardless of the verdict rendered by the FDA, the way we approach tissue extraction in minimally invasive surgery has been changed forever. It is always important to take a critical look at the way things are done, but not at the expense of throwing the proverbial baby out with the bath water. If power morcellation were to remain a viable option, my counseling would remain as is, as it already has been modified and quite detailed in the wake of this whole controversy. I still believe there is a role for power morcellation, albeit modified from its current iteration, when applied by the right physician in a properly evaluated patient with the right indication.

Summing up
OBG Management:
Do you have any additional comments about this issue?

Dr. Advincula: The ability to accurately and reliably detect an occult uterine malignancy—specifically, leiomyosarcoma—is lacking at present. Whether or not power morcellation remains a viable option in the future, the bottom line is that patients will still present with occult uterine malignancy. Minimizing the mishandling of this unfortunate diagnosis will depend on sound clinical judgment as well as improvements in diagnosis. It always will be important to avoid blaming the lack of sound clinical practice on surgical devices that, when used appropriately, have the potential to benefit the majority of women.

Dr. Kho: The current attention on power morcellators presents an opportunity to improve upon our current practices and find solutions to the issues we are encountering. I think this is an exciting time for examining preoperative risk stratification, the innovation of new techniques, repopularization and improvement of older ones such as vaginal tissue extraction, and, overall, to improve our system of safety monitoring and surgical device surveillance.

Dr. Iglesia: Intraperitoneal power morcellation should not be used in cases of malignancy or suspected malignancy or in postmenopausal patients with bleeding or growing fibroids. The availability of power morcellators may be limited as manufacturers
 cease distribution, hospitals ban use, or insurers refuse payment for use.

 

 

Alternative minimally invasive approaches—especially the transvaginal approach—should be considered, since there are fewer complications associated with vaginal surgery, especially compared with open and laparoscopic surgery.

Dr. Wright: Although electric power morcellation may allow some women to undergo a minimally invasive procedure, the data currently available clearly suggest that adverse pathology is more common in women who undergo morcellation than was previously thought.

Although the debate around morcellation has focused on leiomyosarcoma, epithelial endometrial tumors and other preinvasive abnormalities are also common. These unexpected pathologic findings in women who underwent electric power morcellation highlight the importance of performing more rigorous evaluation of new methods of tissue extraction.

Quick Poll:
If you are using, plan to use, or anticipate the possibility of using power morcellation during minimally invasive gynecologic surgery, does your consent process include a separate form specific to power morcellation?
Please provide your answer to this question in the Quick Poll on the OBG Management home page, and then see how your peers have voted.
Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

In the absence of a definitive FDA decision on the future of power morcellation in minimally invasive gynecologic surgery, many surgeons have stopped offering the option, often in response to constraints placed by their institutions, or have greatly expanded the informed consent discussion.

In Part 1 of this two-part roundtable discussion, which appeared in the September 2014 issue of OBG Management, our expert panelists discussed their current approach to tissue extraction during hysterectomy and myomectomy, as well as their preferred approach to both procedures amid this changing surgical environment. Here, in Part 2, they discuss patient counseling and the likely effects of FDA action.

How has your counseling changed?
OBG Management:
Given recent concerns about the use of power morcellation, how has your counseling of the patient changed?

Kimberly Kho, MD, MPH: Though I look forward to the development of instruments and techniques that will make contained power morcellation safer, I am not using it currently and have been able to find minimally invasive alternatives such as minilaparotomy and vaginal removal of masses for the cases I would have considered for power morcellation.

Certainly, with power morcellation or any type of morcellation, it’s important to discuss the risks and benefits, as well as alternatives. Discussion should include the potential for:

  • iatrogenic injury and tissue seeding of both benign and malignant tissue
  • exacerbation of any occult malignancy and possible worsening of prognosis
  • missing or mischaracterizing an occult malignancy.

Although there is no surefire way to avoid cellular dissemination with any type of surgery, I think it’s equally important to explain that, often, the only way to completely avoid fragmenting a large mass is to remove it en bloc, which would mean a large laparotomy for many patients. Women should understand the risks of laparotomy as well, including more frequent wound complications, longer hospitalization, and slower recovery.

Arnold P. Advincula, MD: If a clinician anticipates or plans the use of power morcellation, he or she certainly needs to go through an informed consent process with the patient. This process may include a separate form specific to power morcellation as well as detailed documentation during the preoperative visit.

OBG Management: What elements of the preoperative visit do you believe are important to document?

Dr. Advincula: It is important to clearly document the indications and alternatives for the surgery, as well as the decision-making process that led to the selection of a particular procedure and route of access. If any type of morcellation (power-driven or not) is anticipated, then the risks associated with it must be thoroughly discussed and documented in addition to the standard risks associated with any type of abdominal-pelvic surgery. No surgical procedure is without risks. Therefore, the process of informed consent cannot be taken lightly and is a critical part of the process that allows a patient to decide upon a particular intervention.

Jason D. Wright, MD: I believe the current role of power morcellation is limited. Patients considering the procedure should be counseled about the risks of cancer as well as other adverse pathologic abnormalities, including smooth muscle tumors of uncertain malignant potential, disseminated leiomyomatosis, and endometrial hyperplasia that may be associated with an occult cancer.

OBG Management: Do you recommend a separate consent form for power morcellation, as Dr. Advincula suggested?

Dr. Wright: Given the risk of adverse pathology, I think the role of electric power morcellation is limited. Patients should be carefully counseled about alternative surgical approaches that avoid tissue disruption and understand that the sensitivity of preoperative testing and intraoperative evaluation of smooth muscle neoplasms is limited. Further, patients considering contained morcellation also should be informed that the data examining the efficacy of these techniques are sparse.

Linda D. Bradley, MD: As I mentioned in Part 1 of our discussion, I’m giving patients new information about our concerns regarding occult malignancy, quoting the risk estimates given by the FDA this year.1 And the fact that we no longer use power morcellation at the Cleveland Clinic means that I no longer discuss it as an option, although one or two patients have asked for it in recent months.

I think many patients have read about it in the news or, once hysterectomy or myomectomy was planned, found discussion of the controversy surrounding it during their research. I’ve even had patients who underwent hysteroscopic myomectomy 2 or more years ago contacting me to find out whether power morcellation was used, and I have had to explain that hysteroscopic morcellation is different from the laparoscopic variant.

Patients are critical readers and are much more knowledgeable as a result of social media, so I do find myself spending more time discussing their procedure with them.

 

 

For myomectomy in particular, we send for a frozen section intraoperatively. Although that approach still is not 100% sensitive, it does guide what we do during surgery. If a sarcoma is found, for example, we call in the oncologists. I discuss that possibility with the patient as well. So I am spending more time with patients, but I don’t go into power morcellation because that is no longer an option for me.

OBG Management: Dr. Iglesia, has your counseling of patients changed in any way?

Cheryl Iglesia, MD: I do not routinely use power morcellation. However, the findings from the FDA and Dr. Wright about the higher risk of occult malignancy in fibroids is information I share with patients preoperatively.1,2

For women with fibroids who want uterine conservation procedures or who desire medical management, such as focused ultrasound or uterine fibroid embolization, MRI is routine. However, we make patients aware that this imaging modality is not 100% sensitive in detecting occult cancer—and neither are random biopsies of fibroids. Patients also need to be made aware that treatment with fibroid embolization or other medical options also could delay the detection of cancer and sarcoma. Any morcellation technique (power, hand, vaginal) does have the risk of potential cancer spread and upstaging, so morcellation should not be used in any women with suspected or known malignancy.

Effects of likely FDA actions
OBG Management:
If the FDA decides to ban power morcellation outright, in some ways the approach to patient counseling will be simpler, as one option will have been permanently eliminated. But if the FDA allows power morcellation to continue, with stricter labeling, would that affect how you counsel patients? And would you reconsider power morcellation in that light?

Dr. Kho: I think the current discussion has highlighted again how important the informed consent process is as an opportunity for information sharing. It’s an ongoing discussion of risks, benefits, and alternatives. It also offers us an opportunity to understand the patient’s values and perspectives throughout the process of surgical planning. So, no, I don’t think the FDA’s actions will change how I counsel patients. Regardless of the FDA’s decisions, I think open power morcellation as we currently know it may be obviated as new instruments for contained morcellation—as well as other techniques we’ve discussed—become more popular. But it’s critical that we meaningfully monitor these techniques for long-term safety. In order to make evidence-based decisions, we will need good data.

Dr. Iglesia: I cannot comment on a final FDA decision. However, my feeling is that any information that patients can use to become educated about treatment alternatives—including the risks and benefits of each option—will help inform and improve the shared decision-making process.

Dr. Advincula: Regardless of the verdict rendered by the FDA, the way we approach tissue extraction in minimally invasive surgery has been changed forever. It is always important to take a critical look at the way things are done, but not at the expense of throwing the proverbial baby out with the bath water. If power morcellation were to remain a viable option, my counseling would remain as is, as it already has been modified and quite detailed in the wake of this whole controversy. I still believe there is a role for power morcellation, albeit modified from its current iteration, when applied by the right physician in a properly evaluated patient with the right indication.

Summing up
OBG Management:
Do you have any additional comments about this issue?

Dr. Advincula: The ability to accurately and reliably detect an occult uterine malignancy—specifically, leiomyosarcoma—is lacking at present. Whether or not power morcellation remains a viable option in the future, the bottom line is that patients will still present with occult uterine malignancy. Minimizing the mishandling of this unfortunate diagnosis will depend on sound clinical judgment as well as improvements in diagnosis. It always will be important to avoid blaming the lack of sound clinical practice on surgical devices that, when used appropriately, have the potential to benefit the majority of women.

Dr. Kho: The current attention on power morcellators presents an opportunity to improve upon our current practices and find solutions to the issues we are encountering. I think this is an exciting time for examining preoperative risk stratification, the innovation of new techniques, repopularization and improvement of older ones such as vaginal tissue extraction, and, overall, to improve our system of safety monitoring and surgical device surveillance.

Dr. Iglesia: Intraperitoneal power morcellation should not be used in cases of malignancy or suspected malignancy or in postmenopausal patients with bleeding or growing fibroids. The availability of power morcellators may be limited as manufacturers
 cease distribution, hospitals ban use, or insurers refuse payment for use.

 

 

Alternative minimally invasive approaches—especially the transvaginal approach—should be considered, since there are fewer complications associated with vaginal surgery, especially compared with open and laparoscopic surgery.

Dr. Wright: Although electric power morcellation may allow some women to undergo a minimally invasive procedure, the data currently available clearly suggest that adverse pathology is more common in women who undergo morcellation than was previously thought.

Although the debate around morcellation has focused on leiomyosarcoma, epithelial endometrial tumors and other preinvasive abnormalities are also common. These unexpected pathologic findings in women who underwent electric power morcellation highlight the importance of performing more rigorous evaluation of new methods of tissue extraction.

Quick Poll:
If you are using, plan to use, or anticipate the possibility of using power morcellation during minimally invasive gynecologic surgery, does your consent process include a separate form specific to power morcellation?
Please provide your answer to this question in the Quick Poll on the OBG Management home page, and then see how your peers have voted.
Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

References

1. US Food and Drug Administration. Laparoscopic uterine power morcellation in hysterectomy and myomectomy: FDA safety communication.http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm393576.htm. Published April 17, 2014. Accessed September 18, 2014.
2. Wright JD, Tergas AI, Burke WM, et al. Uterine pathology in women undergoing minimally invasive hysterectomy with morcellation [published online ahead of print July 22, 2014]. JAMA. doi:10.1001/jama.2014.9005.

References

1. US Food and Drug Administration. Laparoscopic uterine power morcellation in hysterectomy and myomectomy: FDA safety communication.http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm393576.htm. Published April 17, 2014. Accessed September 18, 2014.
2. Wright JD, Tergas AI, Burke WM, et al. Uterine pathology in women undergoing minimally invasive hysterectomy with morcellation [published online ahead of print July 22, 2014]. JAMA. doi:10.1001/jama.2014.9005.

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Arnold Advincula MD,Linda Bradley MD,Cheryl Iglesia MD,Kimberly Kho MD,Jason Wright MD,tissue extraction,surgical experts,minimally invasive gynecologic surgery,MIGS,power morcellation,hysterectomy,myomectomy,patient counseling,minilaparotomy,vaginal hysterectomy,risks and benefits,iatrogenic injury,tissue seeding,occult malignancy,remove tumor en bloc,laparotomy,wound complications,longer hospitalization,slower recovery,informed consent process,preoperative visit documentation,smooth muscle tumors,disseminated leiomyomatosis,endometrial hyperplasia,FDA,uterine conservation,focused ultrasound,uterine fibroid embolization,MRI,evidence-based decisions
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Tackle the challenging shoulder dystocia emergency by practicing delivery of the posterior arm

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Tackle the challenging shoulder dystocia emergency by practicing delivery of the posterior arm

CASE: McRobert’s maneuver fails
You are attempting an early term vaginal delivery of a 31-year-old G2P1 woman with type 2 diabetes mellitus and an estimated fetal weight of 4,100 g. The fetal head has delivered but retracted against the perineum, producing the “turtle sign.”

You call a shoulder dystocia emergency and request help. In sequence, you tell the mother to stop pushing, check for a nuchal cord, and cut a mediolateral episiotomy. Working seamlessly with your nurse, you place the patient at the edge of the bed, perform the McRobert’s maneuver, provide suprapubic pressure and apply gentle downward guidance to the fetal head. Unfortunately, with these maneuvers the baby does not deliver.

What is your next obstetric maneuver?

With alacrity, move on to an advanced maneuver. In this article, I outline your options for this advanced maneuver and describe the technique for execution. First, however, I discuss the amount of time you have to work with.

How long do you have to perform advanced maneuvers?
In managing a difficult shoulder dystocia, critical goals are to avoid permanent injury to the newborn, including brachial plexus injury, fetal asphyxia, central nervous system injury, and death. Many experts believe that the accoucheur has approximately 4 or 5 minutes to deliver the impacted fetus before the risk of these adverse outcomes rises substantially.1-3 In one study, a head-to-body delivery interval of less than 5 minutes and 5 minutes or longer were associated with rates of hypoxic ischemic encephalopathy of 0.5% and 24%, respectively.2

Stay calm, move on. Given the time pressure for management, it is important to initiate an advanced maneuver, such as rotation of the fetal body or delivery of the posterior arm, when the initial sequence of McRobert’s maneuver, suprapubic pressure, and gentle downward guidance on the fetal head do not result in delivery. Repetitively repeating these initial maneuvers will increase the risk of an adverse fetal outcome. Stay calm and quickly move on to an advanced maneuver.

Advanced maneuvers
The two advanced shoulder dystocia maneuvers that often result in a successful birth are:

  • rotation of the fetal shoulders
  • delivery of the posterior arm.4,5

In a prior editorial, I described in detail the Woods and Rubin rotational maneuvers.6 In this editorial, I focus on the technique for delivery of the posterior arm.

Delivery of the posterior arm
This maneuver to resolve difficult shoulder dystocia deliveries has been in the armamentarium of obstetricians since at least the mid-18th Century.7 The delivery of the posterior arm reduces the presenting fetal diameter from the larger bisacromial diameter to the smaller axilloacromial diameter. Experts estimate that this change results in a 2-cm decrease in the presenting fetal diameter, thereby facilitating delivery.8,9

In describing posterior arm delivery, it is important to clearly define the anatomy of the upper extremity. The arm is the portion of the upper extremity from the shoulder to the elbow joint.  The long bone of the arm is the humerus. The forearm is the portion of the upper extremity from the elbow to the wrist. The long bones of the forearm are the radius and ulna.

Descriptions of how to deliver the posterior arm range from concise to detailed. A concise description recommends “inserting a hand in the vagina, grasping the fetal arm, and sweeping it across the chest.”9

These detailed instructions are provided by Dr. John Rodis, Chief of Obstetrics and Gynecology at St. Francis Hospital in Hartford Connecticut, in UpToDate:

Introduce a hand into the vagina to locate the posterior shoulder and arm. If the fetal abdomen faces the maternal right, the operator’s left hand should be used; if the fetal abdomen faces the maternal left, the right hand is used. The posterior arm should be identified and followed to the elbow. If the elbow is flexed, the operator can grasp the forearm and hand and pull out the arm. If it is extended, pressure is applied in the antecubital fossa. This flexes the elbow across the fetal chest and allows the forearm or hand to be grasped. The arm is then pulled out of the vagina, which brings the posterior shoulder out of the pelvis and reduces the shoulder diameter by 2 to 3 cm. If the anterior shoulder cannot be delivered at this point, the fetus can be rotated and the procedure repeated for the anterior (now posterior) arm.10

Additional technical guidance. After grasping the fetal wrist and hand, pull the upper extremity against the fetal chest. Approaching the vaginal introitus, pull the wrist and hand toward the fetal ear nearest the maternal symphysis pubis.11 These maneuvers may result in a fracture to the humerus, but this complication is acceptable given the risk of fetal asphyxia and death.

 

 


Newborn injuries associated with shoulder dystocia

In a large retrospective study of 132,098 vaginal cephalic singleton births there were 2,018 cases of shoulder dystocia, representing a 1.5% rate of shoulder dystocia during vaginal birth.5A total of 101 neonatal injuries were reported in association with a shoulder dystocia, the most common being Erb’s palsy, clavicular fracture, and hypoxic ischemic encephalopathy. Some newborns incurred multiple injuries.
Type of injury No. of newborns with injury Rate of injury per 100 shoulder dystocias
Erb’s palsy
60
3
Clavicular fracture
39
1.9
Hypoxic ischemic encephalopathy
  6
0.3
Klumpke’s palsy
  4
0.2
Humerus fracture
  2
0.1
Neonatal death
  0
0

Source: Hoffman, et al. Obstet Gynecol. 2011;117(6):1272–1278.

Approaches to grasping the posterior arm
The posterior arm may be in one of three positions, and your approach to each position will be different.

Fetal hand near the chin. Delivery of the posterior arm is relatively easy when the fetal hand is in this position. Grasp the wrist gently and guide it out of the vagina. The fetal wrist should be pulled toward the fetal ear closest to the maternal symphysis.

Fetal hand on the abdomen. In this position, the operator can exert pressure on the antecubital fossa with the index and middle fingers, resulting in flexion of the forearm at the elbow. This will bring the fetal hand and wrist to the upper chest. The wrist then can be grasped and pronated over the fetal chest. The wrist and forearm are then pulled upward along the chest toward the fetal ear closest to the maternal symphysis. 

Fetal upper extremity is extended with the hand next to the thigh. The most challenging situation is when the upper extremity of the fetus is extended along the trunk or behind the buttocks. In this situation the hand and wrist may be near the fetal thigh and very difficult to reach. In addition, the upper extremity may be tightly pinned between fetal trunk and maternal tissues, making it impossible to flex the forearm by gentle pressure on the antecubital fossa.

In this situation the operator’s hand must reach the fetal wrist and distal forearm, grasp these structures, and pull hard across the trunk to free the pinned upper extremity. The fetal wrist and distal forearm can be securely grasped using techniques pictured in the Figure. It can take 30 to 90 seconds for the operator to place a hand in the vagina, identify the posterior shoulder, follow the extended arm to the hand, and secure the wrist. Given the amount of time that it may take to accomplish the first steps of the maneuver, the nurse in the room should call out the time elapsed since the birth of the head at regular intervals to assist the obstetrician in pacing the speed of the intervention.

___________________________________________________________________________________________________

 

Figure. When the fetal upper extremity is extended and the hand is near the fetal thigh the fetal upper extremity may be tightly pinned between maternal and fetal tissues. Gentle pressure in the antecubital fossa may not cause the forearm to flex toward the vaginal introitus. In this situation it may be very difficult to grasp the fetal wrist or forearm. The operator should be prepared to place their entire hand and forearm into the vagina to reach the fetal wrist (Top left). Two options for grasping the fetal wrist are with the index finger and middle finger (Top right), or by encircling the wrist with the thumb and index finger (Bottom left). For many obstetricians, the index and middle fingers extend much further from their wrist than the thumb. Consequently, when the fetal wrist and hand are against the fetal thigh it may be easier to reach the fetal wrist with the operator’s index and middle finger. However, many obstetricians find that the thumb and index finger provide a more secure grip of the fetal wrist.

______________________________________________________________________________________________________

When the posterior arm is fully extended and pinned between fetal trunk and maternal tissues it can be very difficult to reach the fetal wrist. To help successfully complete the maneuver, the obstetrician should visualize placing his or her hand and entire forearm up to the elbow in the vagina to reach the fetal wrist. It may not be necessary to insert the entire forearm in the vagina, but the operator should visualize this step so he or she is prepared for the possibility.Surprisingly, the hollow of the sacrum often provides sufficient space for inserting the hand and entire forearm of the operator. In this process the operator’s hand and forearm may be strongly compressed by maternal and fetal tissues, cutting off circulation to the upper extremity. The operator’s upper extremity may quickly become numb, resulting in a reduction in tactile sensation and strength.

 

 

If the posterior arm is positioned behind the back of the fetus, maneuvers similar to those described above can be used to grasp the wrist and pull the arm to the anterior side of the fetal trunk, followed by delivery of the posterior arm.

Practice, practice, and practice some more
Obstetric emergencies create a rush of adrenaline and great stress for the obstetrician. This may adversely impact motor performance, decision-making, and communication skills.12 Low- and high-fidelity simulation exercises permit the obstetrics team to practice the sequence of maneuvers necessary to successfully resolve a shoulder dystocia, thereby reducing stress and improving performance when the emergency actually occurs.13 Simulating obstetric emergencies and visualizing the steps necessary to resolve an emergency are good approaches to prepare obstetricians for the most challenging emergencies. For the difficult to resolve shoulder dystocia, my recommendation is: “Deliver the posterior arm.”

Use this checklist to document a shoulder dystocia event

The American College of Obstetricians and Gynecologists (ACOG) has prepared an excellent checklist for documenting a shoulder dystocia case in the medical record. I use this checklist whenever I have a delivery complicated by a shoulder dystocia. This, and more, ACOG obstetric checklists are available at this publically accessible Web site: http://www.acog.org/Resources-And-Publications/Patient
-Safety Checklists


Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

References

1. Allen RH, Rosenbaum TC, Ghidini A, Poggi SH, Spong CY. Correlating head-to-body delivery intervals with neonatal depression in vaginal births that result in permanent brachial plexus injury. Am J Obstet Gynecol. 2002;187(4):839–842.
2. Leung TY, Stuart O, Sahota DS, Suen SS, Lau TK, Lao TT.  Head-to-body delivery interval and risk of fetal acidosis and hypoxic ischaemic encephalopathy in shoulder dystocia: a retrospective review. BJOG. 2011;118(4):474–479.
3. Lerner H, Durlacher K, Smith S, Hamilton E. Relationship between head-to-body delivery interval in shoulder dystocia and neonatal depression. Obstet Gynecol. 2011;118(2 pt 1):318–322.
4. Leung TY, Stuart O, Suen SS, Sahota DS, Lau TK, Lao TT. Comparison of perinatal outcomes of shoulder dystocia alleviated by different type and sequence of manoeuvres: a retrospective review. BJOG. 2011;118(8):985–990.
5. Hoffman MK, Bailit KL, Branch DW, et al. A comparison of obstetric maneuvers for the acute management of should dystocia. Obstet Gynecol. 2011;117(6):1272–1278.
6. Barbieri RL. You are the second responder to a shoulder dystocia emergency. What do you do first? OBG Manag. 2013;25(????):10, 12, 15.
7. Beer E. History of extraction of the posterior arm to resolve shoulder dystocia. Obstet Gynecol Surv. 2006;61(3):149–151.
8. Kung J, Swan AV, Arulkumaran S. Delivery of the posterior arm reduces shoulder dimensions in shoulder dystocia. Int J Gynaecol Obstet. 2006;93(3):233–237.
9. Poggi SH, Spong CY, Allen RH. Prioritizing posterior arm delivery during severe shoulder dystocia. Obstet Gynecol. 2003;101(5 pt 2):1068–1072.
10. Rodis JF. Shoulder dystocia, intrapartum diagnosis, management and outcome. UpToDate, Waltham MA.
11. Mazzanti GA. Delivery of the anterior shoulder; a neglected art. Obstet Gynecol. 1959;13(5):603–607.
12. Wetzel CM, Kneebone RL, Woloshynowych M, et al. The effects of stress on surgical performance. Am J Surg. 2006;191(1):5–10.
13. Grobman WA, Miller D, Burke C, Hornbogen A, Tam K, Costello R. Outcomes associated with introduction of a shoulder dystocia protocol. Am J Obstet Gynecol. 2011;205(6):513–517.

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Robert L. Barbieri, MD

Dr. Barbieri is Editor in Chief, OBG Management; Chair, Obstetrics and Gynecology at Brigham and Women’s Hospital, Boston, Massachusetts; and Kate Macy Ladd Professor of Obstetrics, Gynecology, and Reproductive Biology at Harvard Medical School, Boston.

Dr. Barbieri reports no financial relationships relevant to this article.

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Robert L. Barbieri MD,shoulder dystocia,delivery of posterior arm,McRobert’s maneuver,turtle sign,shoulder dystocia emergency,nuchal cord,mediolateral episiotomy,suprapubic pressure,gentle downward guidance,fetal head,brachial plexus injury,fetal asphyxia,central nervous system injury,head-to-body delivery interval,hypoxic ischemic encephalopathy,rotation of fetal body,adverse fetal outcome,Woods and Rubin rotational maneuvers,Erb’s palsy,clavicular fracture,Klumpke’s palsy,humerus fracture,neonatal death,ACOG checklist
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Dr. Barbieri reports no financial relationships relevant to this article.

Author and Disclosure Information

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Dr. Barbieri is Editor in Chief, OBG Management; Chair, Obstetrics and Gynecology at Brigham and Women’s Hospital, Boston, Massachusetts; and Kate Macy Ladd Professor of Obstetrics, Gynecology, and Reproductive Biology at Harvard Medical School, Boston.

Dr. Barbieri reports no financial relationships relevant to this article.

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Related Articles

CASE: McRobert’s maneuver fails
You are attempting an early term vaginal delivery of a 31-year-old G2P1 woman with type 2 diabetes mellitus and an estimated fetal weight of 4,100 g. The fetal head has delivered but retracted against the perineum, producing the “turtle sign.”

You call a shoulder dystocia emergency and request help. In sequence, you tell the mother to stop pushing, check for a nuchal cord, and cut a mediolateral episiotomy. Working seamlessly with your nurse, you place the patient at the edge of the bed, perform the McRobert’s maneuver, provide suprapubic pressure and apply gentle downward guidance to the fetal head. Unfortunately, with these maneuvers the baby does not deliver.

What is your next obstetric maneuver?

With alacrity, move on to an advanced maneuver. In this article, I outline your options for this advanced maneuver and describe the technique for execution. First, however, I discuss the amount of time you have to work with.

How long do you have to perform advanced maneuvers?
In managing a difficult shoulder dystocia, critical goals are to avoid permanent injury to the newborn, including brachial plexus injury, fetal asphyxia, central nervous system injury, and death. Many experts believe that the accoucheur has approximately 4 or 5 minutes to deliver the impacted fetus before the risk of these adverse outcomes rises substantially.1-3 In one study, a head-to-body delivery interval of less than 5 minutes and 5 minutes or longer were associated with rates of hypoxic ischemic encephalopathy of 0.5% and 24%, respectively.2

Stay calm, move on. Given the time pressure for management, it is important to initiate an advanced maneuver, such as rotation of the fetal body or delivery of the posterior arm, when the initial sequence of McRobert’s maneuver, suprapubic pressure, and gentle downward guidance on the fetal head do not result in delivery. Repetitively repeating these initial maneuvers will increase the risk of an adverse fetal outcome. Stay calm and quickly move on to an advanced maneuver.

Advanced maneuvers
The two advanced shoulder dystocia maneuvers that often result in a successful birth are:

  • rotation of the fetal shoulders
  • delivery of the posterior arm.4,5

In a prior editorial, I described in detail the Woods and Rubin rotational maneuvers.6 In this editorial, I focus on the technique for delivery of the posterior arm.

Delivery of the posterior arm
This maneuver to resolve difficult shoulder dystocia deliveries has been in the armamentarium of obstetricians since at least the mid-18th Century.7 The delivery of the posterior arm reduces the presenting fetal diameter from the larger bisacromial diameter to the smaller axilloacromial diameter. Experts estimate that this change results in a 2-cm decrease in the presenting fetal diameter, thereby facilitating delivery.8,9

In describing posterior arm delivery, it is important to clearly define the anatomy of the upper extremity. The arm is the portion of the upper extremity from the shoulder to the elbow joint.  The long bone of the arm is the humerus. The forearm is the portion of the upper extremity from the elbow to the wrist. The long bones of the forearm are the radius and ulna.

Descriptions of how to deliver the posterior arm range from concise to detailed. A concise description recommends “inserting a hand in the vagina, grasping the fetal arm, and sweeping it across the chest.”9

These detailed instructions are provided by Dr. John Rodis, Chief of Obstetrics and Gynecology at St. Francis Hospital in Hartford Connecticut, in UpToDate:

Introduce a hand into the vagina to locate the posterior shoulder and arm. If the fetal abdomen faces the maternal right, the operator’s left hand should be used; if the fetal abdomen faces the maternal left, the right hand is used. The posterior arm should be identified and followed to the elbow. If the elbow is flexed, the operator can grasp the forearm and hand and pull out the arm. If it is extended, pressure is applied in the antecubital fossa. This flexes the elbow across the fetal chest and allows the forearm or hand to be grasped. The arm is then pulled out of the vagina, which brings the posterior shoulder out of the pelvis and reduces the shoulder diameter by 2 to 3 cm. If the anterior shoulder cannot be delivered at this point, the fetus can be rotated and the procedure repeated for the anterior (now posterior) arm.10

Additional technical guidance. After grasping the fetal wrist and hand, pull the upper extremity against the fetal chest. Approaching the vaginal introitus, pull the wrist and hand toward the fetal ear nearest the maternal symphysis pubis.11 These maneuvers may result in a fracture to the humerus, but this complication is acceptable given the risk of fetal asphyxia and death.

 

 


Newborn injuries associated with shoulder dystocia

In a large retrospective study of 132,098 vaginal cephalic singleton births there were 2,018 cases of shoulder dystocia, representing a 1.5% rate of shoulder dystocia during vaginal birth.5A total of 101 neonatal injuries were reported in association with a shoulder dystocia, the most common being Erb’s palsy, clavicular fracture, and hypoxic ischemic encephalopathy. Some newborns incurred multiple injuries.
Type of injury No. of newborns with injury Rate of injury per 100 shoulder dystocias
Erb’s palsy
60
3
Clavicular fracture
39
1.9
Hypoxic ischemic encephalopathy
  6
0.3
Klumpke’s palsy
  4
0.2
Humerus fracture
  2
0.1
Neonatal death
  0
0

Source: Hoffman, et al. Obstet Gynecol. 2011;117(6):1272–1278.

Approaches to grasping the posterior arm
The posterior arm may be in one of three positions, and your approach to each position will be different.

Fetal hand near the chin. Delivery of the posterior arm is relatively easy when the fetal hand is in this position. Grasp the wrist gently and guide it out of the vagina. The fetal wrist should be pulled toward the fetal ear closest to the maternal symphysis.

Fetal hand on the abdomen. In this position, the operator can exert pressure on the antecubital fossa with the index and middle fingers, resulting in flexion of the forearm at the elbow. This will bring the fetal hand and wrist to the upper chest. The wrist then can be grasped and pronated over the fetal chest. The wrist and forearm are then pulled upward along the chest toward the fetal ear closest to the maternal symphysis. 

Fetal upper extremity is extended with the hand next to the thigh. The most challenging situation is when the upper extremity of the fetus is extended along the trunk or behind the buttocks. In this situation the hand and wrist may be near the fetal thigh and very difficult to reach. In addition, the upper extremity may be tightly pinned between fetal trunk and maternal tissues, making it impossible to flex the forearm by gentle pressure on the antecubital fossa.

In this situation the operator’s hand must reach the fetal wrist and distal forearm, grasp these structures, and pull hard across the trunk to free the pinned upper extremity. The fetal wrist and distal forearm can be securely grasped using techniques pictured in the Figure. It can take 30 to 90 seconds for the operator to place a hand in the vagina, identify the posterior shoulder, follow the extended arm to the hand, and secure the wrist. Given the amount of time that it may take to accomplish the first steps of the maneuver, the nurse in the room should call out the time elapsed since the birth of the head at regular intervals to assist the obstetrician in pacing the speed of the intervention.

___________________________________________________________________________________________________

 

Figure. When the fetal upper extremity is extended and the hand is near the fetal thigh the fetal upper extremity may be tightly pinned between maternal and fetal tissues. Gentle pressure in the antecubital fossa may not cause the forearm to flex toward the vaginal introitus. In this situation it may be very difficult to grasp the fetal wrist or forearm. The operator should be prepared to place their entire hand and forearm into the vagina to reach the fetal wrist (Top left). Two options for grasping the fetal wrist are with the index finger and middle finger (Top right), or by encircling the wrist with the thumb and index finger (Bottom left). For many obstetricians, the index and middle fingers extend much further from their wrist than the thumb. Consequently, when the fetal wrist and hand are against the fetal thigh it may be easier to reach the fetal wrist with the operator’s index and middle finger. However, many obstetricians find that the thumb and index finger provide a more secure grip of the fetal wrist.

______________________________________________________________________________________________________

When the posterior arm is fully extended and pinned between fetal trunk and maternal tissues it can be very difficult to reach the fetal wrist. To help successfully complete the maneuver, the obstetrician should visualize placing his or her hand and entire forearm up to the elbow in the vagina to reach the fetal wrist. It may not be necessary to insert the entire forearm in the vagina, but the operator should visualize this step so he or she is prepared for the possibility.Surprisingly, the hollow of the sacrum often provides sufficient space for inserting the hand and entire forearm of the operator. In this process the operator’s hand and forearm may be strongly compressed by maternal and fetal tissues, cutting off circulation to the upper extremity. The operator’s upper extremity may quickly become numb, resulting in a reduction in tactile sensation and strength.

 

 

If the posterior arm is positioned behind the back of the fetus, maneuvers similar to those described above can be used to grasp the wrist and pull the arm to the anterior side of the fetal trunk, followed by delivery of the posterior arm.

Practice, practice, and practice some more
Obstetric emergencies create a rush of adrenaline and great stress for the obstetrician. This may adversely impact motor performance, decision-making, and communication skills.12 Low- and high-fidelity simulation exercises permit the obstetrics team to practice the sequence of maneuvers necessary to successfully resolve a shoulder dystocia, thereby reducing stress and improving performance when the emergency actually occurs.13 Simulating obstetric emergencies and visualizing the steps necessary to resolve an emergency are good approaches to prepare obstetricians for the most challenging emergencies. For the difficult to resolve shoulder dystocia, my recommendation is: “Deliver the posterior arm.”

Use this checklist to document a shoulder dystocia event

The American College of Obstetricians and Gynecologists (ACOG) has prepared an excellent checklist for documenting a shoulder dystocia case in the medical record. I use this checklist whenever I have a delivery complicated by a shoulder dystocia. This, and more, ACOG obstetric checklists are available at this publically accessible Web site: http://www.acog.org/Resources-And-Publications/Patient
-Safety Checklists


Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

CASE: McRobert’s maneuver fails
You are attempting an early term vaginal delivery of a 31-year-old G2P1 woman with type 2 diabetes mellitus and an estimated fetal weight of 4,100 g. The fetal head has delivered but retracted against the perineum, producing the “turtle sign.”

You call a shoulder dystocia emergency and request help. In sequence, you tell the mother to stop pushing, check for a nuchal cord, and cut a mediolateral episiotomy. Working seamlessly with your nurse, you place the patient at the edge of the bed, perform the McRobert’s maneuver, provide suprapubic pressure and apply gentle downward guidance to the fetal head. Unfortunately, with these maneuvers the baby does not deliver.

What is your next obstetric maneuver?

With alacrity, move on to an advanced maneuver. In this article, I outline your options for this advanced maneuver and describe the technique for execution. First, however, I discuss the amount of time you have to work with.

How long do you have to perform advanced maneuvers?
In managing a difficult shoulder dystocia, critical goals are to avoid permanent injury to the newborn, including brachial plexus injury, fetal asphyxia, central nervous system injury, and death. Many experts believe that the accoucheur has approximately 4 or 5 minutes to deliver the impacted fetus before the risk of these adverse outcomes rises substantially.1-3 In one study, a head-to-body delivery interval of less than 5 minutes and 5 minutes or longer were associated with rates of hypoxic ischemic encephalopathy of 0.5% and 24%, respectively.2

Stay calm, move on. Given the time pressure for management, it is important to initiate an advanced maneuver, such as rotation of the fetal body or delivery of the posterior arm, when the initial sequence of McRobert’s maneuver, suprapubic pressure, and gentle downward guidance on the fetal head do not result in delivery. Repetitively repeating these initial maneuvers will increase the risk of an adverse fetal outcome. Stay calm and quickly move on to an advanced maneuver.

Advanced maneuvers
The two advanced shoulder dystocia maneuvers that often result in a successful birth are:

  • rotation of the fetal shoulders
  • delivery of the posterior arm.4,5

In a prior editorial, I described in detail the Woods and Rubin rotational maneuvers.6 In this editorial, I focus on the technique for delivery of the posterior arm.

Delivery of the posterior arm
This maneuver to resolve difficult shoulder dystocia deliveries has been in the armamentarium of obstetricians since at least the mid-18th Century.7 The delivery of the posterior arm reduces the presenting fetal diameter from the larger bisacromial diameter to the smaller axilloacromial diameter. Experts estimate that this change results in a 2-cm decrease in the presenting fetal diameter, thereby facilitating delivery.8,9

In describing posterior arm delivery, it is important to clearly define the anatomy of the upper extremity. The arm is the portion of the upper extremity from the shoulder to the elbow joint.  The long bone of the arm is the humerus. The forearm is the portion of the upper extremity from the elbow to the wrist. The long bones of the forearm are the radius and ulna.

Descriptions of how to deliver the posterior arm range from concise to detailed. A concise description recommends “inserting a hand in the vagina, grasping the fetal arm, and sweeping it across the chest.”9

These detailed instructions are provided by Dr. John Rodis, Chief of Obstetrics and Gynecology at St. Francis Hospital in Hartford Connecticut, in UpToDate:

Introduce a hand into the vagina to locate the posterior shoulder and arm. If the fetal abdomen faces the maternal right, the operator’s left hand should be used; if the fetal abdomen faces the maternal left, the right hand is used. The posterior arm should be identified and followed to the elbow. If the elbow is flexed, the operator can grasp the forearm and hand and pull out the arm. If it is extended, pressure is applied in the antecubital fossa. This flexes the elbow across the fetal chest and allows the forearm or hand to be grasped. The arm is then pulled out of the vagina, which brings the posterior shoulder out of the pelvis and reduces the shoulder diameter by 2 to 3 cm. If the anterior shoulder cannot be delivered at this point, the fetus can be rotated and the procedure repeated for the anterior (now posterior) arm.10

Additional technical guidance. After grasping the fetal wrist and hand, pull the upper extremity against the fetal chest. Approaching the vaginal introitus, pull the wrist and hand toward the fetal ear nearest the maternal symphysis pubis.11 These maneuvers may result in a fracture to the humerus, but this complication is acceptable given the risk of fetal asphyxia and death.

 

 


Newborn injuries associated with shoulder dystocia

In a large retrospective study of 132,098 vaginal cephalic singleton births there were 2,018 cases of shoulder dystocia, representing a 1.5% rate of shoulder dystocia during vaginal birth.5A total of 101 neonatal injuries were reported in association with a shoulder dystocia, the most common being Erb’s palsy, clavicular fracture, and hypoxic ischemic encephalopathy. Some newborns incurred multiple injuries.
Type of injury No. of newborns with injury Rate of injury per 100 shoulder dystocias
Erb’s palsy
60
3
Clavicular fracture
39
1.9
Hypoxic ischemic encephalopathy
  6
0.3
Klumpke’s palsy
  4
0.2
Humerus fracture
  2
0.1
Neonatal death
  0
0

Source: Hoffman, et al. Obstet Gynecol. 2011;117(6):1272–1278.

Approaches to grasping the posterior arm
The posterior arm may be in one of three positions, and your approach to each position will be different.

Fetal hand near the chin. Delivery of the posterior arm is relatively easy when the fetal hand is in this position. Grasp the wrist gently and guide it out of the vagina. The fetal wrist should be pulled toward the fetal ear closest to the maternal symphysis.

Fetal hand on the abdomen. In this position, the operator can exert pressure on the antecubital fossa with the index and middle fingers, resulting in flexion of the forearm at the elbow. This will bring the fetal hand and wrist to the upper chest. The wrist then can be grasped and pronated over the fetal chest. The wrist and forearm are then pulled upward along the chest toward the fetal ear closest to the maternal symphysis. 

Fetal upper extremity is extended with the hand next to the thigh. The most challenging situation is when the upper extremity of the fetus is extended along the trunk or behind the buttocks. In this situation the hand and wrist may be near the fetal thigh and very difficult to reach. In addition, the upper extremity may be tightly pinned between fetal trunk and maternal tissues, making it impossible to flex the forearm by gentle pressure on the antecubital fossa.

In this situation the operator’s hand must reach the fetal wrist and distal forearm, grasp these structures, and pull hard across the trunk to free the pinned upper extremity. The fetal wrist and distal forearm can be securely grasped using techniques pictured in the Figure. It can take 30 to 90 seconds for the operator to place a hand in the vagina, identify the posterior shoulder, follow the extended arm to the hand, and secure the wrist. Given the amount of time that it may take to accomplish the first steps of the maneuver, the nurse in the room should call out the time elapsed since the birth of the head at regular intervals to assist the obstetrician in pacing the speed of the intervention.

___________________________________________________________________________________________________

 

Figure. When the fetal upper extremity is extended and the hand is near the fetal thigh the fetal upper extremity may be tightly pinned between maternal and fetal tissues. Gentle pressure in the antecubital fossa may not cause the forearm to flex toward the vaginal introitus. In this situation it may be very difficult to grasp the fetal wrist or forearm. The operator should be prepared to place their entire hand and forearm into the vagina to reach the fetal wrist (Top left). Two options for grasping the fetal wrist are with the index finger and middle finger (Top right), or by encircling the wrist with the thumb and index finger (Bottom left). For many obstetricians, the index and middle fingers extend much further from their wrist than the thumb. Consequently, when the fetal wrist and hand are against the fetal thigh it may be easier to reach the fetal wrist with the operator’s index and middle finger. However, many obstetricians find that the thumb and index finger provide a more secure grip of the fetal wrist.

______________________________________________________________________________________________________

When the posterior arm is fully extended and pinned between fetal trunk and maternal tissues it can be very difficult to reach the fetal wrist. To help successfully complete the maneuver, the obstetrician should visualize placing his or her hand and entire forearm up to the elbow in the vagina to reach the fetal wrist. It may not be necessary to insert the entire forearm in the vagina, but the operator should visualize this step so he or she is prepared for the possibility.Surprisingly, the hollow of the sacrum often provides sufficient space for inserting the hand and entire forearm of the operator. In this process the operator’s hand and forearm may be strongly compressed by maternal and fetal tissues, cutting off circulation to the upper extremity. The operator’s upper extremity may quickly become numb, resulting in a reduction in tactile sensation and strength.

 

 

If the posterior arm is positioned behind the back of the fetus, maneuvers similar to those described above can be used to grasp the wrist and pull the arm to the anterior side of the fetal trunk, followed by delivery of the posterior arm.

Practice, practice, and practice some more
Obstetric emergencies create a rush of adrenaline and great stress for the obstetrician. This may adversely impact motor performance, decision-making, and communication skills.12 Low- and high-fidelity simulation exercises permit the obstetrics team to practice the sequence of maneuvers necessary to successfully resolve a shoulder dystocia, thereby reducing stress and improving performance when the emergency actually occurs.13 Simulating obstetric emergencies and visualizing the steps necessary to resolve an emergency are good approaches to prepare obstetricians for the most challenging emergencies. For the difficult to resolve shoulder dystocia, my recommendation is: “Deliver the posterior arm.”

Use this checklist to document a shoulder dystocia event

The American College of Obstetricians and Gynecologists (ACOG) has prepared an excellent checklist for documenting a shoulder dystocia case in the medical record. I use this checklist whenever I have a delivery complicated by a shoulder dystocia. This, and more, ACOG obstetric checklists are available at this publically accessible Web site: http://www.acog.org/Resources-And-Publications/Patient
-Safety Checklists


Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

References

1. Allen RH, Rosenbaum TC, Ghidini A, Poggi SH, Spong CY. Correlating head-to-body delivery intervals with neonatal depression in vaginal births that result in permanent brachial plexus injury. Am J Obstet Gynecol. 2002;187(4):839–842.
2. Leung TY, Stuart O, Sahota DS, Suen SS, Lau TK, Lao TT.  Head-to-body delivery interval and risk of fetal acidosis and hypoxic ischaemic encephalopathy in shoulder dystocia: a retrospective review. BJOG. 2011;118(4):474–479.
3. Lerner H, Durlacher K, Smith S, Hamilton E. Relationship between head-to-body delivery interval in shoulder dystocia and neonatal depression. Obstet Gynecol. 2011;118(2 pt 1):318–322.
4. Leung TY, Stuart O, Suen SS, Sahota DS, Lau TK, Lao TT. Comparison of perinatal outcomes of shoulder dystocia alleviated by different type and sequence of manoeuvres: a retrospective review. BJOG. 2011;118(8):985–990.
5. Hoffman MK, Bailit KL, Branch DW, et al. A comparison of obstetric maneuvers for the acute management of should dystocia. Obstet Gynecol. 2011;117(6):1272–1278.
6. Barbieri RL. You are the second responder to a shoulder dystocia emergency. What do you do first? OBG Manag. 2013;25(????):10, 12, 15.
7. Beer E. History of extraction of the posterior arm to resolve shoulder dystocia. Obstet Gynecol Surv. 2006;61(3):149–151.
8. Kung J, Swan AV, Arulkumaran S. Delivery of the posterior arm reduces shoulder dimensions in shoulder dystocia. Int J Gynaecol Obstet. 2006;93(3):233–237.
9. Poggi SH, Spong CY, Allen RH. Prioritizing posterior arm delivery during severe shoulder dystocia. Obstet Gynecol. 2003;101(5 pt 2):1068–1072.
10. Rodis JF. Shoulder dystocia, intrapartum diagnosis, management and outcome. UpToDate, Waltham MA.
11. Mazzanti GA. Delivery of the anterior shoulder; a neglected art. Obstet Gynecol. 1959;13(5):603–607.
12. Wetzel CM, Kneebone RL, Woloshynowych M, et al. The effects of stress on surgical performance. Am J Surg. 2006;191(1):5–10.
13. Grobman WA, Miller D, Burke C, Hornbogen A, Tam K, Costello R. Outcomes associated with introduction of a shoulder dystocia protocol. Am J Obstet Gynecol. 2011;205(6):513–517.

References

1. Allen RH, Rosenbaum TC, Ghidini A, Poggi SH, Spong CY. Correlating head-to-body delivery intervals with neonatal depression in vaginal births that result in permanent brachial plexus injury. Am J Obstet Gynecol. 2002;187(4):839–842.
2. Leung TY, Stuart O, Sahota DS, Suen SS, Lau TK, Lao TT.  Head-to-body delivery interval and risk of fetal acidosis and hypoxic ischaemic encephalopathy in shoulder dystocia: a retrospective review. BJOG. 2011;118(4):474–479.
3. Lerner H, Durlacher K, Smith S, Hamilton E. Relationship between head-to-body delivery interval in shoulder dystocia and neonatal depression. Obstet Gynecol. 2011;118(2 pt 1):318–322.
4. Leung TY, Stuart O, Suen SS, Sahota DS, Lau TK, Lao TT. Comparison of perinatal outcomes of shoulder dystocia alleviated by different type and sequence of manoeuvres: a retrospective review. BJOG. 2011;118(8):985–990.
5. Hoffman MK, Bailit KL, Branch DW, et al. A comparison of obstetric maneuvers for the acute management of should dystocia. Obstet Gynecol. 2011;117(6):1272–1278.
6. Barbieri RL. You are the second responder to a shoulder dystocia emergency. What do you do first? OBG Manag. 2013;25(????):10, 12, 15.
7. Beer E. History of extraction of the posterior arm to resolve shoulder dystocia. Obstet Gynecol Surv. 2006;61(3):149–151.
8. Kung J, Swan AV, Arulkumaran S. Delivery of the posterior arm reduces shoulder dimensions in shoulder dystocia. Int J Gynaecol Obstet. 2006;93(3):233–237.
9. Poggi SH, Spong CY, Allen RH. Prioritizing posterior arm delivery during severe shoulder dystocia. Obstet Gynecol. 2003;101(5 pt 2):1068–1072.
10. Rodis JF. Shoulder dystocia, intrapartum diagnosis, management and outcome. UpToDate, Waltham MA.
11. Mazzanti GA. Delivery of the anterior shoulder; a neglected art. Obstet Gynecol. 1959;13(5):603–607.
12. Wetzel CM, Kneebone RL, Woloshynowych M, et al. The effects of stress on surgical performance. Am J Surg. 2006;191(1):5–10.
13. Grobman WA, Miller D, Burke C, Hornbogen A, Tam K, Costello R. Outcomes associated with introduction of a shoulder dystocia protocol. Am J Obstet Gynecol. 2011;205(6):513–517.

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Tackle the challenging shoulder dystocia emergency by practicing delivery of the posterior arm
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Robert L. Barbieri MD,shoulder dystocia,delivery of posterior arm,McRobert’s maneuver,turtle sign,shoulder dystocia emergency,nuchal cord,mediolateral episiotomy,suprapubic pressure,gentle downward guidance,fetal head,brachial plexus injury,fetal asphyxia,central nervous system injury,head-to-body delivery interval,hypoxic ischemic encephalopathy,rotation of fetal body,adverse fetal outcome,Woods and Rubin rotational maneuvers,Erb’s palsy,clavicular fracture,Klumpke’s palsy,humerus fracture,neonatal death,ACOG checklist
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Robert L. Barbieri MD,shoulder dystocia,delivery of posterior arm,McRobert’s maneuver,turtle sign,shoulder dystocia emergency,nuchal cord,mediolateral episiotomy,suprapubic pressure,gentle downward guidance,fetal head,brachial plexus injury,fetal asphyxia,central nervous system injury,head-to-body delivery interval,hypoxic ischemic encephalopathy,rotation of fetal body,adverse fetal outcome,Woods and Rubin rotational maneuvers,Erb’s palsy,clavicular fracture,Klumpke’s palsy,humerus fracture,neonatal death,ACOG checklist
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Conjugated estrogen plus bazedoxifene—a new approach to estrogen therapy

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Conjugated estrogen plus bazedoxifene—a new approach to estrogen therapy

In this special installment of Cases in Menopause, I interview series contributor and menopause expert JoAnn V. Pinkerton, MD. We discuss a fairly new therapy: the combination conjugated estrogen and bazedoxifene (CE/BZA; Duavee) for the treatment of moderate to severe hot flashes due to menopause and the prevention of menopausal osteoporosis.

Much of my practice has focused on the treatment of menopausal women, but which of my patients can benefit from this particular combination of CE 0.45 mg plus BZA 20 mg? I asked Dr. Pinkerton this question, and more.

Which patients can benefit most?
Dr. Pinkerton CE/BZA was tested in healthy postmenopausal women with a uterus at risk for bone loss who were reporting 50 or more moderate to severe hot flashes per week. The combination of CE and BZA is a good choice for women who have bothersome menopausal symptoms: hot flashes, night sweats, and sleep disruption or symptomatic vulvovaginal atrophy (VVA)—although it’s not approved for VVA.

Efficacy and safety data show that compared with placebo:

 

  • CE/BZA decreases the frequency and severity of hot flashes at 12 weeks, and those decreases are maintained at 12 months.1,2
  • Women taking CE/BZA have greater improvements in sleep, with both decreased sleep disturbance and time to fall asleep.3
  • CE/BZA maintained or prevented lumbar spine and hip bone loss in postmenopausal women at risk for osteoporosis. 1,4,5

Although fracture data were not captured and the drug was not tested in osteoporotic women, study results showed bone loss prevention at 12 months, which was sustained at 24 months. The improvement in bone mineral density from baseline was about 1% to 1.5%. This was compared with a bone loss of 1.8% in women taking placebo (P<.01).

In clinical studies, women taking CE/BZA versus placebo also have reported a lower incidence of painful intercourse,6 and some improvement in health-related quality of life and treatment satisfaction.7,8

In short, CE/BZA is a good option for symptomatic menopausal women with a uterus who have bothersome hot flashes, night sweats, and sleep disruptions and want to prevent bone loss.

What about adverse effects?
Dr. Pinkerton In general, CE/BZA has a favorable safety and tolerability profile, with an overall incidence of adverse events similar to placebo. The rates of cardiovascular and cerebrovascular events, cancers (breast, endometrial, and ovarian), and mortality are comparable to placebo in 2-year trials. These data are limited; studies have been conducted in healthy postmenopausal women. Future studies need to define the full risk profile, particularly among overweight or obese women and different ethnic groups and for longer-term use.

Is there a role among women with breast cancer?
Dr. Pinkerton CE/BZA has not been tested in women at risk for or with prior breast cancer. In preclinical trials of up to 2 years, involving healthy postmenopausal women, the rates for breast cancer with CE/BZA were similar to placebo. There are no long-term data, however, and there are no data in women at risk for breast cancer. I recommend that women who have or are at high risk for breast cancer consider nonhormonal treatment options.9–11

Has there been an associated increase in breast density with CE/BZA?
Dr. Pinkerton No. Data from two randomized clinical trials showed that the breast density changes with 12-month CE/BZA treatment was similar to placebo—which is markedly different from comparisons of placebo and combination estrogen-progestin therapy (EPT), where EPT increased breast density. If indeed this lack of an association translates into fewer breast cancers, it would be wonderful, but we do not have long-term data. We can tell our patients that using CE/BZA has not been shown to increase the risk of breast cancer, at least up to 2 years.

What makes CE/BZA different from traditional EPT?
Dr. Pinkerton There are two exciting differences:

 

  1. The incidences of breast pain and tenderness were found to be similar to placebo, and were significantly less than those with the comparator EPT (conjugated estrogens 0.45 mg plus medroxyprogesterone acetate [CE/MPA] 1.5 mg).9,10,12
  2. Bleeding and spotting rates were significantly less than those found with CE/MPA.13

In addition, high rates of amenorrhea have been found—comparable to placebo.13

CE/BZA is similar to traditional EPT in several ways. For instance, compared with placebo, at 2 years, CE/BZA was not found to increase the incidence of endometrial hyperplasia, endometrial thickness (increase from baseline was <1 mm and comparable to placebo), or endometrial cancers.14 Lastly, similar to EPT, there is probably a twofold risk of venous thromboembolism (VTE) with BZA 20 mg alone.15 Importantly, there has been no additive effect on VTE risk when combining CE with BZA; however, we will need longer studies, in older women, to fully evaluate this risk.1

 

 

Overall, in symptomatic postmenopausal women with a uterus, randomized controlled data show the same improvement with CE/BZA as that seen with traditional oral EPTs, with improvements in hot flashes; night sweats, with fewer sleep disruptions; and prevention of bone loss. In addition, the changes in cholesterol (an increase in triglyceride levels) and effect on the vagina are the same. Yet, CE/BZA appears to have a neutral effect on the breast and protects against endometrial hyperplasia and endometrial cancer without causing bleeding.9,10 CE/BZA’s VTE and stroke risks are expected to be similar to traditional oral EPT.

Therefore, the major benefit of CE/BZA for women who have a uterus is the lack of significant breast tenderness, lack of changes in breast density, and lack of vaginal bleeding that is often seen with traditional EPT.12

Then, is progestogen the harmful agent in traditional HT options?
Dr. Pinkerton There is evidence that estrogen plus progestogen therapy has more risk for breast cancer than estrogen alone. But in women who have a uterus, you need to protect against uterine cancer so, up until now, the only option was to add progestogen. Some studies suggest the risk of breast cancer may differ depending on the type of progestogen. So it’s a laudable goal to try to protect the endometrium without using a progestogen.

Given its safety profile, do you see CE/BZA being indicated for women without a uterus?
Dr. Pinkerton CE/BZA has been tested only in women with a uterus; there is no indication for using it in hysterectomized women. In the future, unless trial data show a benefit to hysterectomized women—by a reduction in breast cancer compared with estrogen alone—there would be no reason to add BZA to the CE for these women. You would just use CE or another type of estrogen alone.

Do you anticipate BZA being used alone?
Dr. Pinkerton For treating osteoporosis in postmenopausal women at increased fracture risk, BZA alone has greater benefits than risks. It is approved in other countries to prevent or treat osteoporosis. In 2008, Wyeth received an approval letter from the US Food and Drug Administration for BZA alone but, for whatever reason, the drug was not brought to market. BZA reduces the number of new lumbar spine fractures by 4% (vs 2% for placebo), with efficacy better in those with a higher risk of fractures. Like raloxifene, it has not been shown effective at reducing nonvertebral fractures, although it maintains spinal bone density.16

BZA available as monotherapy could tempt clinicians to pair it with other estrogens. We must recognize that the combination of the specific estrogen and BZA dose and type need to be balanced to provide endometrial hyperplasia protection. It would not be safe or effective to take BZA as a selective estrogen-receptor modulator and pair it with any other untested systemic estrogen. I do not anticipate, in this country, that BZA will become available as monotherapy.

New options are welcome
Dr. Moore Novel strategies for clinicians to optimally treat menopausal symptoms are always welcome. I look forward to more data from the SMART trials on CE/BZA and to moving forward as we gain experience with using this new treatment option.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

References

 

1. Lobo RA, Pinkerton JV, Gass ML, et al. Evaluation of bazedoxifene/conjugated estrogens for the treatment of menopausal symptoms and effects on metabolic bone parameters and overall safety profile. Fertil Steril. 2009;92(3):1025–1038.
2. Pinkerton JV, Utian WH, Constantine GD, Olivier S, Pickar JH. Relief of vasomotor symptoms with the tissue-selective estrogen complex containing bazedoxifene/conjugated estrogens. Menopause. 2009;16:(6)1116–1124.
3. Pinkerton JV, Pan K, Abraham L, et al. Sleep parameters and health-related quality of life with bazedoxifene/conjugated estrogens. Menopause. 2014;21(3):252–259.
4. Lindsay R, Gallagher JC, Kagan R, Pickar JH, Constantine G. Efficacy of tissue-selective estrogen complex (TSEC) of bazedoxifene/conjugated estrogens (BZA/CE) for osteoporosis prevention in at-risk postmenopausal women. Fertil Steril. 2009;92(3):1045–1052.
5. Pinkerton JV, Harvey JA, Lindsay R, et al; SMART-5 Investigators. Effects of bazedoxifene/conjugated estrogens on the endometrium and bone. J Clin Endocrinol Metab. 2014;99(2):E189–E198.
6. Kagan R, Williams RS, Pan K, Mirkin S, Pickar JH. A randomized, placebo- and active-controlled trial of bazedoxifene/conjugated estrogens (BZA/CE) for treatment of moderate to severe vulvar/vaginal atrophy in postmenopausal women. Menopause. 2010;17(2):281–289.
7. Utian W, Yu H, Bobula J, Mirkin S, Olivier S, Pickar JH. Bazedoxifene/conjugated estrogens and quality of life in postmenopausal women. Maturitas. 2009;63:(4)329–335.
8. Abraham L, Pinkerton JV, Messig M, Ryan KA, Komm BS, Mirkin S. Menopause-specific quality of life across varying menopausal populations with conjugated estrogens/bazedoxifene. Maturitas. 2014;78(3):212–218.
9. Harvey JA, Pinkerton JV, Baracat EC, Shi H, Chines AA, Mirkin S. Breast density changes in a randomized controlled trial evaluating bazedoxifene/conjugated estrogens. Menopause. 2013;20:(2)138–145.
10. Pinkerton JV, Harvey JA, Pan K, et al. Breast effects of bazedoxifene-conjugated estrogens. Obstet Gynecol. 2013;121(5):959–968.
11. Kaunitz AM. When should a menopausal woman discontinue hormone therapy? OBG Manag. 2014;26(2):59–65.
12. Pinkerton JV, Pickar JH,  Racketa J, Mirkin S. Bazedoxifene/conjugated estrogens for menopausal symptom treatment and osteoporosis prevention. Climacteric. 2012;15:(5)411–418.
13. Archer DF, Lewis V, Carr BR, Olivier S, Pickar JH. Bazedoxifene/conjugated estrogens (BZA/CE): incidence of uterine bleeding in postmenopausal women. Fertil Steril. 2009;92:1039–1044.
14. Pickar JH, Yeh I-T, Bachmann G, Speroff L. Endometrial effects of a tissue selective estrogen complex (TSEC) containing bazedoxifene/conjugated estrogens as a menopausal therapy. Fertil Steril. 2009; 92(3):1018–1024.
15. Mirkin S, Komm BS. Tissue-selective estrogen complexes for postmenopausal women. Maturitas. 2013;76(3):213–220.
16. Ellis AG, Reginster JY, Luo X, et al. Bazedoxifene versus oral bisphosphonates for the prevention of nonvertebral fractures in postmenopausal women with osteoporosis at higher risk of fracture. Value Health. 2014;17(4):424–432.

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Anne A. Moore, DNP, APN

CASES IN MENOPAUSE
Brought to you by the menopause experts

Dr. Moore is Women’s Health Clinical Trainer, Tennessee Department of Health, Nashville, Tennessee. She serves on the OBG Management Board of Editors.

Dr. Pinkerton is Professor, Department of Obstetrics and Gynecology, and Director, Division of Midlife Women’s Health, at the University of Virginia in Charlottesville. She is a NAMS past president and certified menopause practitioner and serves on the OBG Management Board of ­Editors.

Disclosures
Dr. Moore reports no financial relationships relevant to this article. Dr. Pinkerton reports that her institution receives consulting fees from DepoMed, Noven, NovoNordisk, Pfizer, and Shionogi; current grant or research support from Therapeutics MD, prior support from DepoMed, Bionova, and Endoceutics, and, several years ago, support from Pfizer; and travel funds from DepoMed, Noven, NovoNordisk, Pfizer, Therapeutics MD, and Shionogi.

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Anne A. Moore DNP,JoAnn V. Pinkerton MD,conjugated estrogen,CE,bazedoxifene,BZA,Duavee,menopause experts,Cases in Menopause,CE/BZA,postmenopausal women,hot flashes,menopausal symptoms,night sweats,sleep disruption,symptomatic vulvovaginal atrophy,VVA,osteoporosis,bone loss prevention,bone mineral density,painful intercourse,cardiovascular events,breast cancer,cerebrovascular events,endometrial cancer,ovarian cancer,obesity,estrogen-progestin therapy,EPT,breast density,medroxyprogesterone acetate,MPA,CE/MPA,amenorrhea,breast tenderness,vaginal bleeding,stroke risk,VTE,venous thromboembolism,cholesterol,hysterectomy,monotherapy,SMART
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Anne A. Moore, DNP, APN

CASES IN MENOPAUSE
Brought to you by the menopause experts

Dr. Moore is Women’s Health Clinical Trainer, Tennessee Department of Health, Nashville, Tennessee. She serves on the OBG Management Board of Editors.

Dr. Pinkerton is Professor, Department of Obstetrics and Gynecology, and Director, Division of Midlife Women’s Health, at the University of Virginia in Charlottesville. She is a NAMS past president and certified menopause practitioner and serves on the OBG Management Board of ­Editors.

Disclosures
Dr. Moore reports no financial relationships relevant to this article. Dr. Pinkerton reports that her institution receives consulting fees from DepoMed, Noven, NovoNordisk, Pfizer, and Shionogi; current grant or research support from Therapeutics MD, prior support from DepoMed, Bionova, and Endoceutics, and, several years ago, support from Pfizer; and travel funds from DepoMed, Noven, NovoNordisk, Pfizer, Therapeutics MD, and Shionogi.

Author and Disclosure Information

Anne A. Moore, DNP, APN

CASES IN MENOPAUSE
Brought to you by the menopause experts

Dr. Moore is Women’s Health Clinical Trainer, Tennessee Department of Health, Nashville, Tennessee. She serves on the OBG Management Board of Editors.

Dr. Pinkerton is Professor, Department of Obstetrics and Gynecology, and Director, Division of Midlife Women’s Health, at the University of Virginia in Charlottesville. She is a NAMS past president and certified menopause practitioner and serves on the OBG Management Board of ­Editors.

Disclosures
Dr. Moore reports no financial relationships relevant to this article. Dr. Pinkerton reports that her institution receives consulting fees from DepoMed, Noven, NovoNordisk, Pfizer, and Shionogi; current grant or research support from Therapeutics MD, prior support from DepoMed, Bionova, and Endoceutics, and, several years ago, support from Pfizer; and travel funds from DepoMed, Noven, NovoNordisk, Pfizer, Therapeutics MD, and Shionogi.

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In this special installment of Cases in Menopause, I interview series contributor and menopause expert JoAnn V. Pinkerton, MD. We discuss a fairly new therapy: the combination conjugated estrogen and bazedoxifene (CE/BZA; Duavee) for the treatment of moderate to severe hot flashes due to menopause and the prevention of menopausal osteoporosis.

Much of my practice has focused on the treatment of menopausal women, but which of my patients can benefit from this particular combination of CE 0.45 mg plus BZA 20 mg? I asked Dr. Pinkerton this question, and more.

Which patients can benefit most?
Dr. Pinkerton CE/BZA was tested in healthy postmenopausal women with a uterus at risk for bone loss who were reporting 50 or more moderate to severe hot flashes per week. The combination of CE and BZA is a good choice for women who have bothersome menopausal symptoms: hot flashes, night sweats, and sleep disruption or symptomatic vulvovaginal atrophy (VVA)—although it’s not approved for VVA.

Efficacy and safety data show that compared with placebo:

 

  • CE/BZA decreases the frequency and severity of hot flashes at 12 weeks, and those decreases are maintained at 12 months.1,2
  • Women taking CE/BZA have greater improvements in sleep, with both decreased sleep disturbance and time to fall asleep.3
  • CE/BZA maintained or prevented lumbar spine and hip bone loss in postmenopausal women at risk for osteoporosis. 1,4,5

Although fracture data were not captured and the drug was not tested in osteoporotic women, study results showed bone loss prevention at 12 months, which was sustained at 24 months. The improvement in bone mineral density from baseline was about 1% to 1.5%. This was compared with a bone loss of 1.8% in women taking placebo (P<.01).

In clinical studies, women taking CE/BZA versus placebo also have reported a lower incidence of painful intercourse,6 and some improvement in health-related quality of life and treatment satisfaction.7,8

In short, CE/BZA is a good option for symptomatic menopausal women with a uterus who have bothersome hot flashes, night sweats, and sleep disruptions and want to prevent bone loss.

What about adverse effects?
Dr. Pinkerton In general, CE/BZA has a favorable safety and tolerability profile, with an overall incidence of adverse events similar to placebo. The rates of cardiovascular and cerebrovascular events, cancers (breast, endometrial, and ovarian), and mortality are comparable to placebo in 2-year trials. These data are limited; studies have been conducted in healthy postmenopausal women. Future studies need to define the full risk profile, particularly among overweight or obese women and different ethnic groups and for longer-term use.

Is there a role among women with breast cancer?
Dr. Pinkerton CE/BZA has not been tested in women at risk for or with prior breast cancer. In preclinical trials of up to 2 years, involving healthy postmenopausal women, the rates for breast cancer with CE/BZA were similar to placebo. There are no long-term data, however, and there are no data in women at risk for breast cancer. I recommend that women who have or are at high risk for breast cancer consider nonhormonal treatment options.9–11

Has there been an associated increase in breast density with CE/BZA?
Dr. Pinkerton No. Data from two randomized clinical trials showed that the breast density changes with 12-month CE/BZA treatment was similar to placebo—which is markedly different from comparisons of placebo and combination estrogen-progestin therapy (EPT), where EPT increased breast density. If indeed this lack of an association translates into fewer breast cancers, it would be wonderful, but we do not have long-term data. We can tell our patients that using CE/BZA has not been shown to increase the risk of breast cancer, at least up to 2 years.

What makes CE/BZA different from traditional EPT?
Dr. Pinkerton There are two exciting differences:

 

  1. The incidences of breast pain and tenderness were found to be similar to placebo, and were significantly less than those with the comparator EPT (conjugated estrogens 0.45 mg plus medroxyprogesterone acetate [CE/MPA] 1.5 mg).9,10,12
  2. Bleeding and spotting rates were significantly less than those found with CE/MPA.13

In addition, high rates of amenorrhea have been found—comparable to placebo.13

CE/BZA is similar to traditional EPT in several ways. For instance, compared with placebo, at 2 years, CE/BZA was not found to increase the incidence of endometrial hyperplasia, endometrial thickness (increase from baseline was <1 mm and comparable to placebo), or endometrial cancers.14 Lastly, similar to EPT, there is probably a twofold risk of venous thromboembolism (VTE) with BZA 20 mg alone.15 Importantly, there has been no additive effect on VTE risk when combining CE with BZA; however, we will need longer studies, in older women, to fully evaluate this risk.1

 

 

Overall, in symptomatic postmenopausal women with a uterus, randomized controlled data show the same improvement with CE/BZA as that seen with traditional oral EPTs, with improvements in hot flashes; night sweats, with fewer sleep disruptions; and prevention of bone loss. In addition, the changes in cholesterol (an increase in triglyceride levels) and effect on the vagina are the same. Yet, CE/BZA appears to have a neutral effect on the breast and protects against endometrial hyperplasia and endometrial cancer without causing bleeding.9,10 CE/BZA’s VTE and stroke risks are expected to be similar to traditional oral EPT.

Therefore, the major benefit of CE/BZA for women who have a uterus is the lack of significant breast tenderness, lack of changes in breast density, and lack of vaginal bleeding that is often seen with traditional EPT.12

Then, is progestogen the harmful agent in traditional HT options?
Dr. Pinkerton There is evidence that estrogen plus progestogen therapy has more risk for breast cancer than estrogen alone. But in women who have a uterus, you need to protect against uterine cancer so, up until now, the only option was to add progestogen. Some studies suggest the risk of breast cancer may differ depending on the type of progestogen. So it’s a laudable goal to try to protect the endometrium without using a progestogen.

Given its safety profile, do you see CE/BZA being indicated for women without a uterus?
Dr. Pinkerton CE/BZA has been tested only in women with a uterus; there is no indication for using it in hysterectomized women. In the future, unless trial data show a benefit to hysterectomized women—by a reduction in breast cancer compared with estrogen alone—there would be no reason to add BZA to the CE for these women. You would just use CE or another type of estrogen alone.

Do you anticipate BZA being used alone?
Dr. Pinkerton For treating osteoporosis in postmenopausal women at increased fracture risk, BZA alone has greater benefits than risks. It is approved in other countries to prevent or treat osteoporosis. In 2008, Wyeth received an approval letter from the US Food and Drug Administration for BZA alone but, for whatever reason, the drug was not brought to market. BZA reduces the number of new lumbar spine fractures by 4% (vs 2% for placebo), with efficacy better in those with a higher risk of fractures. Like raloxifene, it has not been shown effective at reducing nonvertebral fractures, although it maintains spinal bone density.16

BZA available as monotherapy could tempt clinicians to pair it with other estrogens. We must recognize that the combination of the specific estrogen and BZA dose and type need to be balanced to provide endometrial hyperplasia protection. It would not be safe or effective to take BZA as a selective estrogen-receptor modulator and pair it with any other untested systemic estrogen. I do not anticipate, in this country, that BZA will become available as monotherapy.

New options are welcome
Dr. Moore Novel strategies for clinicians to optimally treat menopausal symptoms are always welcome. I look forward to more data from the SMART trials on CE/BZA and to moving forward as we gain experience with using this new treatment option.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

In this special installment of Cases in Menopause, I interview series contributor and menopause expert JoAnn V. Pinkerton, MD. We discuss a fairly new therapy: the combination conjugated estrogen and bazedoxifene (CE/BZA; Duavee) for the treatment of moderate to severe hot flashes due to menopause and the prevention of menopausal osteoporosis.

Much of my practice has focused on the treatment of menopausal women, but which of my patients can benefit from this particular combination of CE 0.45 mg plus BZA 20 mg? I asked Dr. Pinkerton this question, and more.

Which patients can benefit most?
Dr. Pinkerton CE/BZA was tested in healthy postmenopausal women with a uterus at risk for bone loss who were reporting 50 or more moderate to severe hot flashes per week. The combination of CE and BZA is a good choice for women who have bothersome menopausal symptoms: hot flashes, night sweats, and sleep disruption or symptomatic vulvovaginal atrophy (VVA)—although it’s not approved for VVA.

Efficacy and safety data show that compared with placebo:

 

  • CE/BZA decreases the frequency and severity of hot flashes at 12 weeks, and those decreases are maintained at 12 months.1,2
  • Women taking CE/BZA have greater improvements in sleep, with both decreased sleep disturbance and time to fall asleep.3
  • CE/BZA maintained or prevented lumbar spine and hip bone loss in postmenopausal women at risk for osteoporosis. 1,4,5

Although fracture data were not captured and the drug was not tested in osteoporotic women, study results showed bone loss prevention at 12 months, which was sustained at 24 months. The improvement in bone mineral density from baseline was about 1% to 1.5%. This was compared with a bone loss of 1.8% in women taking placebo (P<.01).

In clinical studies, women taking CE/BZA versus placebo also have reported a lower incidence of painful intercourse,6 and some improvement in health-related quality of life and treatment satisfaction.7,8

In short, CE/BZA is a good option for symptomatic menopausal women with a uterus who have bothersome hot flashes, night sweats, and sleep disruptions and want to prevent bone loss.

What about adverse effects?
Dr. Pinkerton In general, CE/BZA has a favorable safety and tolerability profile, with an overall incidence of adverse events similar to placebo. The rates of cardiovascular and cerebrovascular events, cancers (breast, endometrial, and ovarian), and mortality are comparable to placebo in 2-year trials. These data are limited; studies have been conducted in healthy postmenopausal women. Future studies need to define the full risk profile, particularly among overweight or obese women and different ethnic groups and for longer-term use.

Is there a role among women with breast cancer?
Dr. Pinkerton CE/BZA has not been tested in women at risk for or with prior breast cancer. In preclinical trials of up to 2 years, involving healthy postmenopausal women, the rates for breast cancer with CE/BZA were similar to placebo. There are no long-term data, however, and there are no data in women at risk for breast cancer. I recommend that women who have or are at high risk for breast cancer consider nonhormonal treatment options.9–11

Has there been an associated increase in breast density with CE/BZA?
Dr. Pinkerton No. Data from two randomized clinical trials showed that the breast density changes with 12-month CE/BZA treatment was similar to placebo—which is markedly different from comparisons of placebo and combination estrogen-progestin therapy (EPT), where EPT increased breast density. If indeed this lack of an association translates into fewer breast cancers, it would be wonderful, but we do not have long-term data. We can tell our patients that using CE/BZA has not been shown to increase the risk of breast cancer, at least up to 2 years.

What makes CE/BZA different from traditional EPT?
Dr. Pinkerton There are two exciting differences:

 

  1. The incidences of breast pain and tenderness were found to be similar to placebo, and were significantly less than those with the comparator EPT (conjugated estrogens 0.45 mg plus medroxyprogesterone acetate [CE/MPA] 1.5 mg).9,10,12
  2. Bleeding and spotting rates were significantly less than those found with CE/MPA.13

In addition, high rates of amenorrhea have been found—comparable to placebo.13

CE/BZA is similar to traditional EPT in several ways. For instance, compared with placebo, at 2 years, CE/BZA was not found to increase the incidence of endometrial hyperplasia, endometrial thickness (increase from baseline was <1 mm and comparable to placebo), or endometrial cancers.14 Lastly, similar to EPT, there is probably a twofold risk of venous thromboembolism (VTE) with BZA 20 mg alone.15 Importantly, there has been no additive effect on VTE risk when combining CE with BZA; however, we will need longer studies, in older women, to fully evaluate this risk.1

 

 

Overall, in symptomatic postmenopausal women with a uterus, randomized controlled data show the same improvement with CE/BZA as that seen with traditional oral EPTs, with improvements in hot flashes; night sweats, with fewer sleep disruptions; and prevention of bone loss. In addition, the changes in cholesterol (an increase in triglyceride levels) and effect on the vagina are the same. Yet, CE/BZA appears to have a neutral effect on the breast and protects against endometrial hyperplasia and endometrial cancer without causing bleeding.9,10 CE/BZA’s VTE and stroke risks are expected to be similar to traditional oral EPT.

Therefore, the major benefit of CE/BZA for women who have a uterus is the lack of significant breast tenderness, lack of changes in breast density, and lack of vaginal bleeding that is often seen with traditional EPT.12

Then, is progestogen the harmful agent in traditional HT options?
Dr. Pinkerton There is evidence that estrogen plus progestogen therapy has more risk for breast cancer than estrogen alone. But in women who have a uterus, you need to protect against uterine cancer so, up until now, the only option was to add progestogen. Some studies suggest the risk of breast cancer may differ depending on the type of progestogen. So it’s a laudable goal to try to protect the endometrium without using a progestogen.

Given its safety profile, do you see CE/BZA being indicated for women without a uterus?
Dr. Pinkerton CE/BZA has been tested only in women with a uterus; there is no indication for using it in hysterectomized women. In the future, unless trial data show a benefit to hysterectomized women—by a reduction in breast cancer compared with estrogen alone—there would be no reason to add BZA to the CE for these women. You would just use CE or another type of estrogen alone.

Do you anticipate BZA being used alone?
Dr. Pinkerton For treating osteoporosis in postmenopausal women at increased fracture risk, BZA alone has greater benefits than risks. It is approved in other countries to prevent or treat osteoporosis. In 2008, Wyeth received an approval letter from the US Food and Drug Administration for BZA alone but, for whatever reason, the drug was not brought to market. BZA reduces the number of new lumbar spine fractures by 4% (vs 2% for placebo), with efficacy better in those with a higher risk of fractures. Like raloxifene, it has not been shown effective at reducing nonvertebral fractures, although it maintains spinal bone density.16

BZA available as monotherapy could tempt clinicians to pair it with other estrogens. We must recognize that the combination of the specific estrogen and BZA dose and type need to be balanced to provide endometrial hyperplasia protection. It would not be safe or effective to take BZA as a selective estrogen-receptor modulator and pair it with any other untested systemic estrogen. I do not anticipate, in this country, that BZA will become available as monotherapy.

New options are welcome
Dr. Moore Novel strategies for clinicians to optimally treat menopausal symptoms are always welcome. I look forward to more data from the SMART trials on CE/BZA and to moving forward as we gain experience with using this new treatment option.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

References

 

1. Lobo RA, Pinkerton JV, Gass ML, et al. Evaluation of bazedoxifene/conjugated estrogens for the treatment of menopausal symptoms and effects on metabolic bone parameters and overall safety profile. Fertil Steril. 2009;92(3):1025–1038.
2. Pinkerton JV, Utian WH, Constantine GD, Olivier S, Pickar JH. Relief of vasomotor symptoms with the tissue-selective estrogen complex containing bazedoxifene/conjugated estrogens. Menopause. 2009;16:(6)1116–1124.
3. Pinkerton JV, Pan K, Abraham L, et al. Sleep parameters and health-related quality of life with bazedoxifene/conjugated estrogens. Menopause. 2014;21(3):252–259.
4. Lindsay R, Gallagher JC, Kagan R, Pickar JH, Constantine G. Efficacy of tissue-selective estrogen complex (TSEC) of bazedoxifene/conjugated estrogens (BZA/CE) for osteoporosis prevention in at-risk postmenopausal women. Fertil Steril. 2009;92(3):1045–1052.
5. Pinkerton JV, Harvey JA, Lindsay R, et al; SMART-5 Investigators. Effects of bazedoxifene/conjugated estrogens on the endometrium and bone. J Clin Endocrinol Metab. 2014;99(2):E189–E198.
6. Kagan R, Williams RS, Pan K, Mirkin S, Pickar JH. A randomized, placebo- and active-controlled trial of bazedoxifene/conjugated estrogens (BZA/CE) for treatment of moderate to severe vulvar/vaginal atrophy in postmenopausal women. Menopause. 2010;17(2):281–289.
7. Utian W, Yu H, Bobula J, Mirkin S, Olivier S, Pickar JH. Bazedoxifene/conjugated estrogens and quality of life in postmenopausal women. Maturitas. 2009;63:(4)329–335.
8. Abraham L, Pinkerton JV, Messig M, Ryan KA, Komm BS, Mirkin S. Menopause-specific quality of life across varying menopausal populations with conjugated estrogens/bazedoxifene. Maturitas. 2014;78(3):212–218.
9. Harvey JA, Pinkerton JV, Baracat EC, Shi H, Chines AA, Mirkin S. Breast density changes in a randomized controlled trial evaluating bazedoxifene/conjugated estrogens. Menopause. 2013;20:(2)138–145.
10. Pinkerton JV, Harvey JA, Pan K, et al. Breast effects of bazedoxifene-conjugated estrogens. Obstet Gynecol. 2013;121(5):959–968.
11. Kaunitz AM. When should a menopausal woman discontinue hormone therapy? OBG Manag. 2014;26(2):59–65.
12. Pinkerton JV, Pickar JH,  Racketa J, Mirkin S. Bazedoxifene/conjugated estrogens for menopausal symptom treatment and osteoporosis prevention. Climacteric. 2012;15:(5)411–418.
13. Archer DF, Lewis V, Carr BR, Olivier S, Pickar JH. Bazedoxifene/conjugated estrogens (BZA/CE): incidence of uterine bleeding in postmenopausal women. Fertil Steril. 2009;92:1039–1044.
14. Pickar JH, Yeh I-T, Bachmann G, Speroff L. Endometrial effects of a tissue selective estrogen complex (TSEC) containing bazedoxifene/conjugated estrogens as a menopausal therapy. Fertil Steril. 2009; 92(3):1018–1024.
15. Mirkin S, Komm BS. Tissue-selective estrogen complexes for postmenopausal women. Maturitas. 2013;76(3):213–220.
16. Ellis AG, Reginster JY, Luo X, et al. Bazedoxifene versus oral bisphosphonates for the prevention of nonvertebral fractures in postmenopausal women with osteoporosis at higher risk of fracture. Value Health. 2014;17(4):424–432.

References

 

1. Lobo RA, Pinkerton JV, Gass ML, et al. Evaluation of bazedoxifene/conjugated estrogens for the treatment of menopausal symptoms and effects on metabolic bone parameters and overall safety profile. Fertil Steril. 2009;92(3):1025–1038.
2. Pinkerton JV, Utian WH, Constantine GD, Olivier S, Pickar JH. Relief of vasomotor symptoms with the tissue-selective estrogen complex containing bazedoxifene/conjugated estrogens. Menopause. 2009;16:(6)1116–1124.
3. Pinkerton JV, Pan K, Abraham L, et al. Sleep parameters and health-related quality of life with bazedoxifene/conjugated estrogens. Menopause. 2014;21(3):252–259.
4. Lindsay R, Gallagher JC, Kagan R, Pickar JH, Constantine G. Efficacy of tissue-selective estrogen complex (TSEC) of bazedoxifene/conjugated estrogens (BZA/CE) for osteoporosis prevention in at-risk postmenopausal women. Fertil Steril. 2009;92(3):1045–1052.
5. Pinkerton JV, Harvey JA, Lindsay R, et al; SMART-5 Investigators. Effects of bazedoxifene/conjugated estrogens on the endometrium and bone. J Clin Endocrinol Metab. 2014;99(2):E189–E198.
6. Kagan R, Williams RS, Pan K, Mirkin S, Pickar JH. A randomized, placebo- and active-controlled trial of bazedoxifene/conjugated estrogens (BZA/CE) for treatment of moderate to severe vulvar/vaginal atrophy in postmenopausal women. Menopause. 2010;17(2):281–289.
7. Utian W, Yu H, Bobula J, Mirkin S, Olivier S, Pickar JH. Bazedoxifene/conjugated estrogens and quality of life in postmenopausal women. Maturitas. 2009;63:(4)329–335.
8. Abraham L, Pinkerton JV, Messig M, Ryan KA, Komm BS, Mirkin S. Menopause-specific quality of life across varying menopausal populations with conjugated estrogens/bazedoxifene. Maturitas. 2014;78(3):212–218.
9. Harvey JA, Pinkerton JV, Baracat EC, Shi H, Chines AA, Mirkin S. Breast density changes in a randomized controlled trial evaluating bazedoxifene/conjugated estrogens. Menopause. 2013;20:(2)138–145.
10. Pinkerton JV, Harvey JA, Pan K, et al. Breast effects of bazedoxifene-conjugated estrogens. Obstet Gynecol. 2013;121(5):959–968.
11. Kaunitz AM. When should a menopausal woman discontinue hormone therapy? OBG Manag. 2014;26(2):59–65.
12. Pinkerton JV, Pickar JH,  Racketa J, Mirkin S. Bazedoxifene/conjugated estrogens for menopausal symptom treatment and osteoporosis prevention. Climacteric. 2012;15:(5)411–418.
13. Archer DF, Lewis V, Carr BR, Olivier S, Pickar JH. Bazedoxifene/conjugated estrogens (BZA/CE): incidence of uterine bleeding in postmenopausal women. Fertil Steril. 2009;92:1039–1044.
14. Pickar JH, Yeh I-T, Bachmann G, Speroff L. Endometrial effects of a tissue selective estrogen complex (TSEC) containing bazedoxifene/conjugated estrogens as a menopausal therapy. Fertil Steril. 2009; 92(3):1018–1024.
15. Mirkin S, Komm BS. Tissue-selective estrogen complexes for postmenopausal women. Maturitas. 2013;76(3):213–220.
16. Ellis AG, Reginster JY, Luo X, et al. Bazedoxifene versus oral bisphosphonates for the prevention of nonvertebral fractures in postmenopausal women with osteoporosis at higher risk of fracture. Value Health. 2014;17(4):424–432.

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Conjugated estrogen plus bazedoxifene—a new approach to estrogen therapy
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Total laparoscopic versus laparoscopic supracervical hysterectomy

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It gives me great pleasure to introduce this month’s surgical video. The following feature presentation was produced by my third-year fellow, Mireille Truong, MD, and my third-year resident, Sarah Horvath, MD. The focus of this surgical video is to compare and contrast total laparoscopic hysterectomy (TLH) with laparoscopic supracervical hysterectomy (LSH). The indication for the TLH case was refractory dysmenorrhea and for the LSH case was as part of a concomitant sacrocervicopexy. The particular methods for specimen removal demonstrated include through the colpotomy for TLH and cold knife manual morcellation within a bag using an Alexis retractor for LSH. 

The objectives of this surgical video are to:

  • Highlight the clinical advantages and disadvantages between cervical removal or retention at the time of a minimally invasive laparoscopic hysterectomy
  • Demonstrate the surgical nuances between TLH and LSH
  • Provide a potential resource for patient counseling as well as medical student and resident education.

I encourage you to share this video as an educational resource with your colleagues, residents, students, and patients alike.

 

Vidyard Video

 

 

I hope to see you at the AAGL Global Congress on Minimally Invasive Gynecology in Vancouver, November 17–21, 2014. Visit www.aagl.org/globalcongress for more information.
  — Dr. Arnold Advincula, AAGL 2014 Scientific Program Chair
 

Share your thoughts on this video! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

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Dr. Truong is Fellow in Minimally Invasive Gynecologic Surgery, Columbia University Medical Center, New York, New York.

Dr. Horvath is PGY-3 Resident, Department of Obstetrics and Gynecology, Columbia University Medical Center. 

Dr. Advincula is Levine Family Professor of Women’s Health, Vice-Chair, Department of Obstetrics and Gynecology, and Chief of Gynecology, Sloane Hospital for Women, Columbia University Medical Center, New York, New York. He also serves on the OBG Management Board of Editors.

Dr. Advincula reports being a consultant to Blue Endo, Cooper Surgical, Intuitive Surgical, and Surgiquest and receiving royalties from Cooper Surgical. The other authors report no financial relationships relevant to this article.

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laparoscopic hysterectomy,TLH,Sarah Horvath MD,laparoscopic supracervical hysterectomy,LSH,sacrocervicopexy,colpotomy,cold knife manual morcellation,Alexis retractor,Arnold Advincula MD,Mireille D. Truong MD,
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Dr. Truong is Fellow in Minimally Invasive Gynecologic Surgery, Columbia University Medical Center, New York, New York.

Dr. Horvath is PGY-3 Resident, Department of Obstetrics and Gynecology, Columbia University Medical Center. 

Dr. Advincula is Levine Family Professor of Women’s Health, Vice-Chair, Department of Obstetrics and Gynecology, and Chief of Gynecology, Sloane Hospital for Women, Columbia University Medical Center, New York, New York. He also serves on the OBG Management Board of Editors.

Dr. Advincula reports being a consultant to Blue Endo, Cooper Surgical, Intuitive Surgical, and Surgiquest and receiving royalties from Cooper Surgical. The other authors report no financial relationships relevant to this article.

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Dr. Truong is Fellow in Minimally Invasive Gynecologic Surgery, Columbia University Medical Center, New York, New York.

Dr. Horvath is PGY-3 Resident, Department of Obstetrics and Gynecology, Columbia University Medical Center. 

Dr. Advincula is Levine Family Professor of Women’s Health, Vice-Chair, Department of Obstetrics and Gynecology, and Chief of Gynecology, Sloane Hospital for Women, Columbia University Medical Center, New York, New York. He also serves on the OBG Management Board of Editors.

Dr. Advincula reports being a consultant to Blue Endo, Cooper Surgical, Intuitive Surgical, and Surgiquest and receiving royalties from Cooper Surgical. The other authors report no financial relationships relevant to this article.

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It gives me great pleasure to introduce this month’s surgical video. The following feature presentation was produced by my third-year fellow, Mireille Truong, MD, and my third-year resident, Sarah Horvath, MD. The focus of this surgical video is to compare and contrast total laparoscopic hysterectomy (TLH) with laparoscopic supracervical hysterectomy (LSH). The indication for the TLH case was refractory dysmenorrhea and for the LSH case was as part of a concomitant sacrocervicopexy. The particular methods for specimen removal demonstrated include through the colpotomy for TLH and cold knife manual morcellation within a bag using an Alexis retractor for LSH. 

The objectives of this surgical video are to:

  • Highlight the clinical advantages and disadvantages between cervical removal or retention at the time of a minimally invasive laparoscopic hysterectomy
  • Demonstrate the surgical nuances between TLH and LSH
  • Provide a potential resource for patient counseling as well as medical student and resident education.

I encourage you to share this video as an educational resource with your colleagues, residents, students, and patients alike.

 

Vidyard Video

 

 

I hope to see you at the AAGL Global Congress on Minimally Invasive Gynecology in Vancouver, November 17–21, 2014. Visit www.aagl.org/globalcongress for more information.
  — Dr. Arnold Advincula, AAGL 2014 Scientific Program Chair
 

Share your thoughts on this video! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

It gives me great pleasure to introduce this month’s surgical video. The following feature presentation was produced by my third-year fellow, Mireille Truong, MD, and my third-year resident, Sarah Horvath, MD. The focus of this surgical video is to compare and contrast total laparoscopic hysterectomy (TLH) with laparoscopic supracervical hysterectomy (LSH). The indication for the TLH case was refractory dysmenorrhea and for the LSH case was as part of a concomitant sacrocervicopexy. The particular methods for specimen removal demonstrated include through the colpotomy for TLH and cold knife manual morcellation within a bag using an Alexis retractor for LSH. 

The objectives of this surgical video are to:

  • Highlight the clinical advantages and disadvantages between cervical removal or retention at the time of a minimally invasive laparoscopic hysterectomy
  • Demonstrate the surgical nuances between TLH and LSH
  • Provide a potential resource for patient counseling as well as medical student and resident education.

I encourage you to share this video as an educational resource with your colleagues, residents, students, and patients alike.

 

Vidyard Video

 

 

I hope to see you at the AAGL Global Congress on Minimally Invasive Gynecology in Vancouver, November 17–21, 2014. Visit www.aagl.org/globalcongress for more information.
  — Dr. Arnold Advincula, AAGL 2014 Scientific Program Chair
 

Share your thoughts on this video! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Issue
OBG Management - 26(10)
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60
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Total laparoscopic versus laparoscopic supracervical hysterectomy
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Total laparoscopic versus laparoscopic supracervical hysterectomy
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laparoscopic hysterectomy,TLH,Sarah Horvath MD,laparoscopic supracervical hysterectomy,LSH,sacrocervicopexy,colpotomy,cold knife manual morcellation,Alexis retractor,Arnold Advincula MD,Mireille D. Truong MD,
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laparoscopic hysterectomy,TLH,Sarah Horvath MD,laparoscopic supracervical hysterectomy,LSH,sacrocervicopexy,colpotomy,cold knife manual morcellation,Alexis retractor,Arnold Advincula MD,Mireille D. Truong MD,
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