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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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Update on Guidelines and Technology in the Diagnosis and Treatment of Trichomonas vaginalis

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Update on Guidelines and Technology in the Diagnosis and Treatment of Trichomonas vaginalis

The Centers for Disease Control and Prevention (CDC) published an update to the Sexually Transmitted Diseases Treatment Guidelines in June 2015.  This supplement covers the specific changes related to the diagnosis and treatment of Trichomonas vaginalis infection.

Click here to download the PDF.

Sharon L. Hillier, PhD
Professor
Departments of Obstetrics, Gynecology and
Reproductive Sciences and Microbiology
and Molecular Genetics
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania

Claire Danby, MD, MSc
Assistant Professor
Tufts University School of Medicine
Boston, Massachusetts
Department of Obstetrics and Gynecology
Maine Medical Center
Portland, Maine

Paul Nyirjesy, MD
Professor
Departments of Obstetrics and Gynecology and Medicine
Director, Drexel Vaginitis Center
Drexel University College of Medicine
Philadelphia, Pennsylvania

Maria Trent, MD, MPH
Associate Professor of Pediatrics
Division of General Pediatrics and Adolescent Medicine
Johns Hopkins School of Medicine
Baltimore, Maryland


Disclosures: Dr. Hillier reports that she is a consultant to Perrigo and Symbiomix and has an ongoing relationship with Becton Dickinson, Cepheid, and Hologic. Dr. Danby reports no financial relationships relevant to this article.  Dr. Nyirjesy reports that he is a consultant to Hologic and has received a research grant from Becton Dickinson.  Dr. Trent reports that she is the Principal Investigator of an unrestricted research grant to Johns Hopkins University (employer) from Hologic, Inc.

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This supplement was sponsored by ReachMD and Hologic.
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This supplement was sponsored by ReachMD and Hologic.

The Centers for Disease Control and Prevention (CDC) published an update to the Sexually Transmitted Diseases Treatment Guidelines in June 2015.  This supplement covers the specific changes related to the diagnosis and treatment of Trichomonas vaginalis infection.

Click here to download the PDF.

Sharon L. Hillier, PhD
Professor
Departments of Obstetrics, Gynecology and
Reproductive Sciences and Microbiology
and Molecular Genetics
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania

Claire Danby, MD, MSc
Assistant Professor
Tufts University School of Medicine
Boston, Massachusetts
Department of Obstetrics and Gynecology
Maine Medical Center
Portland, Maine

Paul Nyirjesy, MD
Professor
Departments of Obstetrics and Gynecology and Medicine
Director, Drexel Vaginitis Center
Drexel University College of Medicine
Philadelphia, Pennsylvania

Maria Trent, MD, MPH
Associate Professor of Pediatrics
Division of General Pediatrics and Adolescent Medicine
Johns Hopkins School of Medicine
Baltimore, Maryland


Disclosures: Dr. Hillier reports that she is a consultant to Perrigo and Symbiomix and has an ongoing relationship with Becton Dickinson, Cepheid, and Hologic. Dr. Danby reports no financial relationships relevant to this article.  Dr. Nyirjesy reports that he is a consultant to Hologic and has received a research grant from Becton Dickinson.  Dr. Trent reports that she is the Principal Investigator of an unrestricted research grant to Johns Hopkins University (employer) from Hologic, Inc.

The Centers for Disease Control and Prevention (CDC) published an update to the Sexually Transmitted Diseases Treatment Guidelines in June 2015.  This supplement covers the specific changes related to the diagnosis and treatment of Trichomonas vaginalis infection.

Click here to download the PDF.

Sharon L. Hillier, PhD
Professor
Departments of Obstetrics, Gynecology and
Reproductive Sciences and Microbiology
and Molecular Genetics
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania

Claire Danby, MD, MSc
Assistant Professor
Tufts University School of Medicine
Boston, Massachusetts
Department of Obstetrics and Gynecology
Maine Medical Center
Portland, Maine

Paul Nyirjesy, MD
Professor
Departments of Obstetrics and Gynecology and Medicine
Director, Drexel Vaginitis Center
Drexel University College of Medicine
Philadelphia, Pennsylvania

Maria Trent, MD, MPH
Associate Professor of Pediatrics
Division of General Pediatrics and Adolescent Medicine
Johns Hopkins School of Medicine
Baltimore, Maryland


Disclosures: Dr. Hillier reports that she is a consultant to Perrigo and Symbiomix and has an ongoing relationship with Becton Dickinson, Cepheid, and Hologic. Dr. Danby reports no financial relationships relevant to this article.  Dr. Nyirjesy reports that he is a consultant to Hologic and has received a research grant from Becton Dickinson.  Dr. Trent reports that she is the Principal Investigator of an unrestricted research grant to Johns Hopkins University (employer) from Hologic, Inc.

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Small bowel surgery for the benign gynecologist

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Small bowel surgery for the benign gynecologist

 

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Author and Disclosure Information

Dr. Muffly is currently Assistant Professor, Obstetrics and Gynecology, Female Pelvic Medicine and Reconstructive Surgery, University of Colorado School of Medicine, Aurora, Colorado. 

Dr. Strong is currently Chief, Division of Surgery – Surgical Oncology; Chief, Division of Surgery – Gastrointestinal and Endocrine, and James R. Hines, MD, Professor of Surgery, Northestern University School of Medicine, Chicago, Illinois. 

Dr. Walters is Professor and Vice Chair of Gynecology, Center for Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology and Women’s Health, Cleveland Clinic, Cleveland, Ohio.

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Tyler M. Muffly MD,Scott A. Strong MD,Mark D. Walters MD,SGS,Society of Gynecologic Surgeons,small bowel surgery,adhesions,enterolysis,bowel injury,minimally invasive surgery,entry into abdominal cavity
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Dr. Muffly is currently Assistant Professor, Obstetrics and Gynecology, Female Pelvic Medicine and Reconstructive Surgery, University of Colorado School of Medicine, Aurora, Colorado. 

Dr. Strong is currently Chief, Division of Surgery – Surgical Oncology; Chief, Division of Surgery – Gastrointestinal and Endocrine, and James R. Hines, MD, Professor of Surgery, Northestern University School of Medicine, Chicago, Illinois. 

Dr. Walters is Professor and Vice Chair of Gynecology, Center for Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology and Women’s Health, Cleveland Clinic, Cleveland, Ohio.

Author and Disclosure Information

Dr. Muffly is currently Assistant Professor, Obstetrics and Gynecology, Female Pelvic Medicine and Reconstructive Surgery, University of Colorado School of Medicine, Aurora, Colorado. 

Dr. Strong is currently Chief, Division of Surgery – Surgical Oncology; Chief, Division of Surgery – Gastrointestinal and Endocrine, and James R. Hines, MD, Professor of Surgery, Northestern University School of Medicine, Chicago, Illinois. 

Dr. Walters is Professor and Vice Chair of Gynecology, Center for Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology and Women’s Health, Cleveland Clinic, Cleveland, Ohio.

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For more videos from the Society of Gynecologic Surgeons, click here

Visit the Society of Gynecologic Surgeons online: sgsonline.org

 

Vidyard Video

 


For more videos from the Society of Gynecologic Surgeons, click here

Visit the Society of Gynecologic Surgeons online: sgsonline.org

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Small bowel surgery for the benign gynecologist
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Small bowel surgery for the benign gynecologist
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Tyler M. Muffly MD,Scott A. Strong MD,Mark D. Walters MD,SGS,Society of Gynecologic Surgeons,small bowel surgery,adhesions,enterolysis,bowel injury,minimally invasive surgery,entry into abdominal cavity
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Tyler M. Muffly MD,Scott A. Strong MD,Mark D. Walters MD,SGS,Society of Gynecologic Surgeons,small bowel surgery,adhesions,enterolysis,bowel injury,minimally invasive surgery,entry into abdominal cavity
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2016 Update on abnormal uterine bleeding

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2016 Update on abnormal uterine bleeding

How abnormal uterine bleeding (AUB) is managed has a significant impact on health care. In the United States, almost one-third of all gynecologic visits are related to AUB, with estimated annual direct costs of up to $1.55 billion and indirect costs as high as $36 billion.1 Not surprisingly, office-based procedures for AUB are being emphasized. While in the short term it is more cost efficient to perform surgery in the office rather than in the operating room, questions have arisen regarding the long-term efficacy and durability of in-office procedures. Insurers are undoubtedly raising these questions as well.

Notably, some ObGyns are early adopters of office-based surgery while others tend to adopt in-office procedures more slowly. As the literature for such procedures for AUB matures to provide more data on efficacy and acceptability, we will have a greater evidence base for understanding which procedures are more appropriate for the office. And while practice shifts sometimes occur due to cost-containment initiatives, some shifts are patient driven. Studies that address these driving variables, as well as efficacy considerations, are helpful. As we counsel women about procedures for AUB, the relative advantages and disadvantages of available treatment settings likely will become a greater part of that discussion so that they can make an informed decision.

In this Update, we discuss the results of 3 studies that examined various procedures and settings for AUB management:

 

  • outpatient vs inpatient polypectomy
  • hysteroscopic morcellation of polyps and myomas in an office vs ambulatory surgical center
  • comparative costs of endometrial ablation and hysterectomy.

Outpatient vs inpatient polypectomy: Similar success rates in the short term

Cooper NA, Clark TJ, Middleton L, et al; OPT Trial Collaborative Group. Outpatient versus inpatient uterine polyp treatment for abnormal uterine bleeding: randomised controlled non-inferiority study. BMJ. 2015;350:h1398. doi:10.1136/bmj.h1398.

A collaborative group in the United Kingdom studied the common problem of endometrial polyps. Their objective was to evaluate whether outpatient polypectomy was as effective and well accepted as polypectomy performed in the operating room (OR).

Patients with a hysteroscopically diagnosed polyp were randomly assigned to hysteroscopic polyp removal in either a hysteroscopy clinic or an OR; polyp removal was performed using miniature mechanical or electrosurgical instruments. The primary outcome was successful treatment, determined by the participants’ assessment of their bleeding at 6 months.

Overall, 73% of women (166 of 228) in the clinic group and 80% (168 of 211) in the OR group reported a successful response to surgery at 6 months, with treatment effects being maintained at 12 and 24 months. A “see and treat” approach—that is, treatment carried out at the same time as diagnosis—was possible in 72% of women (174 of 242).

Partial or failed polyp removal occurred in 46 of 242 women (19%) in the clinic group, mostly because of pain issues, and in 18 of 233 women (7%) in the OR group (relative risk, 2.5; 95% confidence interval, 1.5−4.1; P<.001). Four uterine perforations (2% of patients) occurred in the OR group.

Mean pain scores were higher in the clinic group, and treatment was unacceptable for 2% of the women in each group.

The results of this trial show that clinic polypectomy has some limitations, but the outpatient procedure was deemed noninferior to polypectomy performed in the OR for the successful alleviation of uterine bleeding associated with uterine polyps.

What this EVIDENCE means for practice
Office-based polypectomy allowed a “see and treat” model in 72% of cases. Office polypectomy had similar successful therapeutic responses as inpatient polypectomy; however, over a 2-year follow-up period, women treated in the office were twice as likely to undergo at least 1 further polyp removal and were 1.6 times more likely to have further gynecologic surgery.

 

In-office hysteroscopic morcellation of polyps and myomas improves health-related quality of life

Rubino RJ, Lukes AS. Twelve-month outcomes for patients undergoing hysteroscopic morcellation of uterine polyps and myomas in an office or ambulatory surgical center. J Minim Invasive Gynecol. 2015;22(2):285–290.

Is it feasible to morcellate fibroids, as well as polyps, in the clinic? Rubino and colleagues investigated this question in a randomized, prospective clinical trial. They examined the efficacy of hysteroscopic removal of polyps and myomas on health-related quality of life and symptom severity at 1-year postprocedure. Women aged 18 to 55 years, with hysteroscopic and saline-infusion sonogram–assessed polyps and/or type 0 or I myomas (1.5−3.0 cm), were enrolled from 9 US clinical sites. Some patient populations were excluded, such as women with a long narcotic abuse history, current intrauterine device (IUD), type II submucous myomas, and type I fundal myomas.

 

 

A total of 118 pathologies were removed in 74 patients. Forty-two women were treated in the office setting; 32 were treated in the OR setting. Among the 118 pathologies removed, 53 were removed in the office (28 myomas and 25 polyps), and 55 were removed in the OR (14 myomas and 41 polyps).

The percentage of patients who reported being satisfied or highly satisfied was higher in the OR cohort (96.5%) compared with the office cohort (83.3%), although this difference was not statistically significant (P = .06). The percentage of patients who had 100% of their pathology removed was significantly higher in those with polyps compared with patients with myomas (96.0% vs 63.6%, respectively; P<.01).

These findings indicate that there were several cases in which the majority of a myoma was removed but a small residual portion remained. This disparity was especially pronounced in the office setting, where 96% of polyps were completely removed, compared with 52% of fibroids. There was no statistically significant difference in health-related quality of life between patients with complete removal and those with residual pathology, and there was no difference in satisfaction rates between patients who were treated in the office and those treated in the OR.

What this EVIDENCE means for practice
In general, office-based hysteroscopic myomectomy and polypectomy using morcellation for small- to medium-size lesions was associated with low rates of adverse events, high physician acceptance, and significant durable health-related quality-of-life improvements for up to 12 months post­‑ procedure. Partial removal of myomas did not seem to be a significant factor in patients’ perceived outcomes.

 

Endometrial ablation for AUB costs less, has fewer complications at 1 year than hysterectomy

Miller JD, Lenhart GM, Bonafede MM, Lukes AS, Laughlin-Tommaso SK. Cost-effectiveness of global endometrial ablation vs hysterectomy for treatment of abnormal uterine bleeding: US commercial and Medicaid payer perspectives. Popul Health Manag. 2015;18(5):373–382.

Endometrial ablation often is performed in the office for AUB management. Miller and colleagues suggested that cost-effectiveness modeling studies of endometrial ablation for AUB treatment from a US perspective are lacking. They therefore designed a study to model the cost-effectiveness of endometrial ablation versus hysterectomy for treatment of AUB from both commercial and Medicaid payer perspectives.

They developed a decision-tree, state-transition (semi-Markov) model to simulate 2 hypothetical patient cohorts of women with AUB: one treated with endometrial ablation and the other with hysterectomy. Twenty-one health states were included in the model of intervention with endometrial ablation or hysterectomy; these comprised postablation reintervention with secondary ablation, tranexamic acid, or a levonorgestrel-containing IUD due to AUB, use of adjunctive pharmacotherapy following ablation, and a small probability of death from hysterectomy or actuarial death from all other causes.

The 1-year direct costs of endometrial ablation were $7,352 and $6,306 in the commercial payer and Medicaid payer perspectives, respectively; these were about half the costs of hysterectomy. The cost differential between the 2 treatments narrowed over time but, even at 5 years, endometrial ablation costs were still one-third less than hysterectomy costs.

In the first year, 35.6% of patients who had a hysterectomy and only 17.1% of patients undergoing ablation had complications. Short-term results were similar under the Medicaid perspective. By 5 years intervention/reintervention, however, complications of endometrial ablation were higher than those for hysterectomy by about 1.6%.

Over a 5-year time frame, direct costs of endometrial ablation were lower than those of hysterectomy from both the commercial payer and Medicaid perspectives. In the commercial payer analysis, the indirect costs of endometrial ablation were also lower than for hysterectomy, with 38.5 workdays lost for endometrial ablation compared with 55.3 days lost for hysterectomy, resulting in indirect costs of $8,976 versus $13,087.

What this EVIDENCE means for practice
Costs and cost-effectiveness of endometrial ablation from a US perspective are understudied. This model estimates a financial advantage for endometrial ablation over hysterectomy from both the commercial payer and Medicaid payer perspectives. Over a variety of time frames, endometrial ablation may save costs while reducing treatment complications and lost workdays. From the patient perspective, this model suggests better quality of life in the short term after endometrial ablation. It will be interesting to see whether longer term impacts show this model to be predictive.


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

References

Reference

 

  1. Liu Z, Doan QV, Blumenthal P, Dubois RW. A systematic review evaluating health-related quality of life, work impairment, and healthcare costs and utilization in abnormal uterine bleeding. Value Health. 2007;10(3):183–194.
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Dr. Sharp is Professor and Vice Chair for Clinical Activities, Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City.

 

Dr. Adelman is Assistant Professor, Department of Obstetrics and Gynecology, University of Utah Health Sciences Center.

The authors report no financial relationships relevant to this article.

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Dr. Adelman is Assistant Professor, Department of Obstetrics and Gynecology, University of Utah Health Sciences Center.

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The authors report no financial relationships relevant to this article.

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How abnormal uterine bleeding (AUB) is managed has a significant impact on health care. In the United States, almost one-third of all gynecologic visits are related to AUB, with estimated annual direct costs of up to $1.55 billion and indirect costs as high as $36 billion.1 Not surprisingly, office-based procedures for AUB are being emphasized. While in the short term it is more cost efficient to perform surgery in the office rather than in the operating room, questions have arisen regarding the long-term efficacy and durability of in-office procedures. Insurers are undoubtedly raising these questions as well.

Notably, some ObGyns are early adopters of office-based surgery while others tend to adopt in-office procedures more slowly. As the literature for such procedures for AUB matures to provide more data on efficacy and acceptability, we will have a greater evidence base for understanding which procedures are more appropriate for the office. And while practice shifts sometimes occur due to cost-containment initiatives, some shifts are patient driven. Studies that address these driving variables, as well as efficacy considerations, are helpful. As we counsel women about procedures for AUB, the relative advantages and disadvantages of available treatment settings likely will become a greater part of that discussion so that they can make an informed decision.

In this Update, we discuss the results of 3 studies that examined various procedures and settings for AUB management:

 

  • outpatient vs inpatient polypectomy
  • hysteroscopic morcellation of polyps and myomas in an office vs ambulatory surgical center
  • comparative costs of endometrial ablation and hysterectomy.

Outpatient vs inpatient polypectomy: Similar success rates in the short term

Cooper NA, Clark TJ, Middleton L, et al; OPT Trial Collaborative Group. Outpatient versus inpatient uterine polyp treatment for abnormal uterine bleeding: randomised controlled non-inferiority study. BMJ. 2015;350:h1398. doi:10.1136/bmj.h1398.

A collaborative group in the United Kingdom studied the common problem of endometrial polyps. Their objective was to evaluate whether outpatient polypectomy was as effective and well accepted as polypectomy performed in the operating room (OR).

Patients with a hysteroscopically diagnosed polyp were randomly assigned to hysteroscopic polyp removal in either a hysteroscopy clinic or an OR; polyp removal was performed using miniature mechanical or electrosurgical instruments. The primary outcome was successful treatment, determined by the participants’ assessment of their bleeding at 6 months.

Overall, 73% of women (166 of 228) in the clinic group and 80% (168 of 211) in the OR group reported a successful response to surgery at 6 months, with treatment effects being maintained at 12 and 24 months. A “see and treat” approach—that is, treatment carried out at the same time as diagnosis—was possible in 72% of women (174 of 242).

Partial or failed polyp removal occurred in 46 of 242 women (19%) in the clinic group, mostly because of pain issues, and in 18 of 233 women (7%) in the OR group (relative risk, 2.5; 95% confidence interval, 1.5−4.1; P<.001). Four uterine perforations (2% of patients) occurred in the OR group.

Mean pain scores were higher in the clinic group, and treatment was unacceptable for 2% of the women in each group.

The results of this trial show that clinic polypectomy has some limitations, but the outpatient procedure was deemed noninferior to polypectomy performed in the OR for the successful alleviation of uterine bleeding associated with uterine polyps.

What this EVIDENCE means for practice
Office-based polypectomy allowed a “see and treat” model in 72% of cases. Office polypectomy had similar successful therapeutic responses as inpatient polypectomy; however, over a 2-year follow-up period, women treated in the office were twice as likely to undergo at least 1 further polyp removal and were 1.6 times more likely to have further gynecologic surgery.

 

In-office hysteroscopic morcellation of polyps and myomas improves health-related quality of life

Rubino RJ, Lukes AS. Twelve-month outcomes for patients undergoing hysteroscopic morcellation of uterine polyps and myomas in an office or ambulatory surgical center. J Minim Invasive Gynecol. 2015;22(2):285–290.

Is it feasible to morcellate fibroids, as well as polyps, in the clinic? Rubino and colleagues investigated this question in a randomized, prospective clinical trial. They examined the efficacy of hysteroscopic removal of polyps and myomas on health-related quality of life and symptom severity at 1-year postprocedure. Women aged 18 to 55 years, with hysteroscopic and saline-infusion sonogram–assessed polyps and/or type 0 or I myomas (1.5−3.0 cm), were enrolled from 9 US clinical sites. Some patient populations were excluded, such as women with a long narcotic abuse history, current intrauterine device (IUD), type II submucous myomas, and type I fundal myomas.

 

 

A total of 118 pathologies were removed in 74 patients. Forty-two women were treated in the office setting; 32 were treated in the OR setting. Among the 118 pathologies removed, 53 were removed in the office (28 myomas and 25 polyps), and 55 were removed in the OR (14 myomas and 41 polyps).

The percentage of patients who reported being satisfied or highly satisfied was higher in the OR cohort (96.5%) compared with the office cohort (83.3%), although this difference was not statistically significant (P = .06). The percentage of patients who had 100% of their pathology removed was significantly higher in those with polyps compared with patients with myomas (96.0% vs 63.6%, respectively; P<.01).

These findings indicate that there were several cases in which the majority of a myoma was removed but a small residual portion remained. This disparity was especially pronounced in the office setting, where 96% of polyps were completely removed, compared with 52% of fibroids. There was no statistically significant difference in health-related quality of life between patients with complete removal and those with residual pathology, and there was no difference in satisfaction rates between patients who were treated in the office and those treated in the OR.

What this EVIDENCE means for practice
In general, office-based hysteroscopic myomectomy and polypectomy using morcellation for small- to medium-size lesions was associated with low rates of adverse events, high physician acceptance, and significant durable health-related quality-of-life improvements for up to 12 months post­‑ procedure. Partial removal of myomas did not seem to be a significant factor in patients’ perceived outcomes.

 

Endometrial ablation for AUB costs less, has fewer complications at 1 year than hysterectomy

Miller JD, Lenhart GM, Bonafede MM, Lukes AS, Laughlin-Tommaso SK. Cost-effectiveness of global endometrial ablation vs hysterectomy for treatment of abnormal uterine bleeding: US commercial and Medicaid payer perspectives. Popul Health Manag. 2015;18(5):373–382.

Endometrial ablation often is performed in the office for AUB management. Miller and colleagues suggested that cost-effectiveness modeling studies of endometrial ablation for AUB treatment from a US perspective are lacking. They therefore designed a study to model the cost-effectiveness of endometrial ablation versus hysterectomy for treatment of AUB from both commercial and Medicaid payer perspectives.

They developed a decision-tree, state-transition (semi-Markov) model to simulate 2 hypothetical patient cohorts of women with AUB: one treated with endometrial ablation and the other with hysterectomy. Twenty-one health states were included in the model of intervention with endometrial ablation or hysterectomy; these comprised postablation reintervention with secondary ablation, tranexamic acid, or a levonorgestrel-containing IUD due to AUB, use of adjunctive pharmacotherapy following ablation, and a small probability of death from hysterectomy or actuarial death from all other causes.

The 1-year direct costs of endometrial ablation were $7,352 and $6,306 in the commercial payer and Medicaid payer perspectives, respectively; these were about half the costs of hysterectomy. The cost differential between the 2 treatments narrowed over time but, even at 5 years, endometrial ablation costs were still one-third less than hysterectomy costs.

In the first year, 35.6% of patients who had a hysterectomy and only 17.1% of patients undergoing ablation had complications. Short-term results were similar under the Medicaid perspective. By 5 years intervention/reintervention, however, complications of endometrial ablation were higher than those for hysterectomy by about 1.6%.

Over a 5-year time frame, direct costs of endometrial ablation were lower than those of hysterectomy from both the commercial payer and Medicaid perspectives. In the commercial payer analysis, the indirect costs of endometrial ablation were also lower than for hysterectomy, with 38.5 workdays lost for endometrial ablation compared with 55.3 days lost for hysterectomy, resulting in indirect costs of $8,976 versus $13,087.

What this EVIDENCE means for practice
Costs and cost-effectiveness of endometrial ablation from a US perspective are understudied. This model estimates a financial advantage for endometrial ablation over hysterectomy from both the commercial payer and Medicaid payer perspectives. Over a variety of time frames, endometrial ablation may save costs while reducing treatment complications and lost workdays. From the patient perspective, this model suggests better quality of life in the short term after endometrial ablation. It will be interesting to see whether longer term impacts show this model to be predictive.


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

How abnormal uterine bleeding (AUB) is managed has a significant impact on health care. In the United States, almost one-third of all gynecologic visits are related to AUB, with estimated annual direct costs of up to $1.55 billion and indirect costs as high as $36 billion.1 Not surprisingly, office-based procedures for AUB are being emphasized. While in the short term it is more cost efficient to perform surgery in the office rather than in the operating room, questions have arisen regarding the long-term efficacy and durability of in-office procedures. Insurers are undoubtedly raising these questions as well.

Notably, some ObGyns are early adopters of office-based surgery while others tend to adopt in-office procedures more slowly. As the literature for such procedures for AUB matures to provide more data on efficacy and acceptability, we will have a greater evidence base for understanding which procedures are more appropriate for the office. And while practice shifts sometimes occur due to cost-containment initiatives, some shifts are patient driven. Studies that address these driving variables, as well as efficacy considerations, are helpful. As we counsel women about procedures for AUB, the relative advantages and disadvantages of available treatment settings likely will become a greater part of that discussion so that they can make an informed decision.

In this Update, we discuss the results of 3 studies that examined various procedures and settings for AUB management:

 

  • outpatient vs inpatient polypectomy
  • hysteroscopic morcellation of polyps and myomas in an office vs ambulatory surgical center
  • comparative costs of endometrial ablation and hysterectomy.

Outpatient vs inpatient polypectomy: Similar success rates in the short term

Cooper NA, Clark TJ, Middleton L, et al; OPT Trial Collaborative Group. Outpatient versus inpatient uterine polyp treatment for abnormal uterine bleeding: randomised controlled non-inferiority study. BMJ. 2015;350:h1398. doi:10.1136/bmj.h1398.

A collaborative group in the United Kingdom studied the common problem of endometrial polyps. Their objective was to evaluate whether outpatient polypectomy was as effective and well accepted as polypectomy performed in the operating room (OR).

Patients with a hysteroscopically diagnosed polyp were randomly assigned to hysteroscopic polyp removal in either a hysteroscopy clinic or an OR; polyp removal was performed using miniature mechanical or electrosurgical instruments. The primary outcome was successful treatment, determined by the participants’ assessment of their bleeding at 6 months.

Overall, 73% of women (166 of 228) in the clinic group and 80% (168 of 211) in the OR group reported a successful response to surgery at 6 months, with treatment effects being maintained at 12 and 24 months. A “see and treat” approach—that is, treatment carried out at the same time as diagnosis—was possible in 72% of women (174 of 242).

Partial or failed polyp removal occurred in 46 of 242 women (19%) in the clinic group, mostly because of pain issues, and in 18 of 233 women (7%) in the OR group (relative risk, 2.5; 95% confidence interval, 1.5−4.1; P<.001). Four uterine perforations (2% of patients) occurred in the OR group.

Mean pain scores were higher in the clinic group, and treatment was unacceptable for 2% of the women in each group.

The results of this trial show that clinic polypectomy has some limitations, but the outpatient procedure was deemed noninferior to polypectomy performed in the OR for the successful alleviation of uterine bleeding associated with uterine polyps.

What this EVIDENCE means for practice
Office-based polypectomy allowed a “see and treat” model in 72% of cases. Office polypectomy had similar successful therapeutic responses as inpatient polypectomy; however, over a 2-year follow-up period, women treated in the office were twice as likely to undergo at least 1 further polyp removal and were 1.6 times more likely to have further gynecologic surgery.

 

In-office hysteroscopic morcellation of polyps and myomas improves health-related quality of life

Rubino RJ, Lukes AS. Twelve-month outcomes for patients undergoing hysteroscopic morcellation of uterine polyps and myomas in an office or ambulatory surgical center. J Minim Invasive Gynecol. 2015;22(2):285–290.

Is it feasible to morcellate fibroids, as well as polyps, in the clinic? Rubino and colleagues investigated this question in a randomized, prospective clinical trial. They examined the efficacy of hysteroscopic removal of polyps and myomas on health-related quality of life and symptom severity at 1-year postprocedure. Women aged 18 to 55 years, with hysteroscopic and saline-infusion sonogram–assessed polyps and/or type 0 or I myomas (1.5−3.0 cm), were enrolled from 9 US clinical sites. Some patient populations were excluded, such as women with a long narcotic abuse history, current intrauterine device (IUD), type II submucous myomas, and type I fundal myomas.

 

 

A total of 118 pathologies were removed in 74 patients. Forty-two women were treated in the office setting; 32 were treated in the OR setting. Among the 118 pathologies removed, 53 were removed in the office (28 myomas and 25 polyps), and 55 were removed in the OR (14 myomas and 41 polyps).

The percentage of patients who reported being satisfied or highly satisfied was higher in the OR cohort (96.5%) compared with the office cohort (83.3%), although this difference was not statistically significant (P = .06). The percentage of patients who had 100% of their pathology removed was significantly higher in those with polyps compared with patients with myomas (96.0% vs 63.6%, respectively; P<.01).

These findings indicate that there were several cases in which the majority of a myoma was removed but a small residual portion remained. This disparity was especially pronounced in the office setting, where 96% of polyps were completely removed, compared with 52% of fibroids. There was no statistically significant difference in health-related quality of life between patients with complete removal and those with residual pathology, and there was no difference in satisfaction rates between patients who were treated in the office and those treated in the OR.

What this EVIDENCE means for practice
In general, office-based hysteroscopic myomectomy and polypectomy using morcellation for small- to medium-size lesions was associated with low rates of adverse events, high physician acceptance, and significant durable health-related quality-of-life improvements for up to 12 months post­‑ procedure. Partial removal of myomas did not seem to be a significant factor in patients’ perceived outcomes.

 

Endometrial ablation for AUB costs less, has fewer complications at 1 year than hysterectomy

Miller JD, Lenhart GM, Bonafede MM, Lukes AS, Laughlin-Tommaso SK. Cost-effectiveness of global endometrial ablation vs hysterectomy for treatment of abnormal uterine bleeding: US commercial and Medicaid payer perspectives. Popul Health Manag. 2015;18(5):373–382.

Endometrial ablation often is performed in the office for AUB management. Miller and colleagues suggested that cost-effectiveness modeling studies of endometrial ablation for AUB treatment from a US perspective are lacking. They therefore designed a study to model the cost-effectiveness of endometrial ablation versus hysterectomy for treatment of AUB from both commercial and Medicaid payer perspectives.

They developed a decision-tree, state-transition (semi-Markov) model to simulate 2 hypothetical patient cohorts of women with AUB: one treated with endometrial ablation and the other with hysterectomy. Twenty-one health states were included in the model of intervention with endometrial ablation or hysterectomy; these comprised postablation reintervention with secondary ablation, tranexamic acid, or a levonorgestrel-containing IUD due to AUB, use of adjunctive pharmacotherapy following ablation, and a small probability of death from hysterectomy or actuarial death from all other causes.

The 1-year direct costs of endometrial ablation were $7,352 and $6,306 in the commercial payer and Medicaid payer perspectives, respectively; these were about half the costs of hysterectomy. The cost differential between the 2 treatments narrowed over time but, even at 5 years, endometrial ablation costs were still one-third less than hysterectomy costs.

In the first year, 35.6% of patients who had a hysterectomy and only 17.1% of patients undergoing ablation had complications. Short-term results were similar under the Medicaid perspective. By 5 years intervention/reintervention, however, complications of endometrial ablation were higher than those for hysterectomy by about 1.6%.

Over a 5-year time frame, direct costs of endometrial ablation were lower than those of hysterectomy from both the commercial payer and Medicaid perspectives. In the commercial payer analysis, the indirect costs of endometrial ablation were also lower than for hysterectomy, with 38.5 workdays lost for endometrial ablation compared with 55.3 days lost for hysterectomy, resulting in indirect costs of $8,976 versus $13,087.

What this EVIDENCE means for practice
Costs and cost-effectiveness of endometrial ablation from a US perspective are understudied. This model estimates a financial advantage for endometrial ablation over hysterectomy from both the commercial payer and Medicaid payer perspectives. Over a variety of time frames, endometrial ablation may save costs while reducing treatment complications and lost workdays. From the patient perspective, this model suggests better quality of life in the short term after endometrial ablation. It will be interesting to see whether longer term impacts show this model to be predictive.


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

References

Reference

 

  1. Liu Z, Doan QV, Blumenthal P, Dubois RW. A systematic review evaluating health-related quality of life, work impairment, and healthcare costs and utilization in abnormal uterine bleeding. Value Health. 2007;10(3):183–194.
References

Reference

 

  1. Liu Z, Doan QV, Blumenthal P, Dubois RW. A systematic review evaluating health-related quality of life, work impairment, and healthcare costs and utilization in abnormal uterine bleeding. Value Health. 2007;10(3):183–194.
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Howard T. Sharp MD, Marisa Adelman MD, update on abnormal uterine bleeding, AUB, in-office procedure, operating room, OR, office-based surgery, polypectomy, hysteroscopic morcellation, polyps, myomas, endometrial ablation, hysterectomy, saline-infusion sonogram
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Howard T. Sharp MD, Marisa Adelman MD, update on abnormal uterine bleeding, AUB, in-office procedure, operating room, OR, office-based surgery, polypectomy, hysteroscopic morcellation, polyps, myomas, endometrial ablation, hysterectomy, saline-infusion sonogram
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  • Polypectomy in the clinic vs OR
  • In-office polyp, fibroid morcellation
  • Cost-effectiveness of endometrial ablation
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Is expectant management a safe alternative to immediate delivery in patients with PPROM close to term?

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Preterm premature rupture of membranes (PPROM) refers to rupture of membranes prior to the onset of labor before 37 weeks’ gestation. It accounts for one-third of all preterm births.1 Pregnancy complications associated with PPROM include intrauterine infection (chorioamnionitis), preterm labor, and placental abruption. Should such complications develop, immediate delivery is indicated. When to recommend elective delivery in the absence of complications, however, remains controversial.

The American College of Obstetricians and Gynecologists (ACOG) currently recommends elective delivery at or after 34 weeks’ gestation,2 because the prevailing evidence suggests that the risk of pregnancy-related complications (especially ascending infection) exceeds the risks of iatrogenic prematurity at this gestational age. However, ACOG acknowledges that this recommendation is based on “limited and inconsistent scientific evidence.”2 To address deficiencies in the literature, investigators designed the PPROMT (preterm prelabor rupture of the membranes close to term) trial to study women with ruptured membranes before the onset of labor between 34 and 37 weeks’ gestation.

PPROMT study designMorris and colleagues present results of their multicenter, international, randomized controlled trial (RCT) of expectant management versus planned delivery in pregnancies complicated by PPROM at 34 0/7 through 36 6/7 weeks’ gestation carried out in 65 centers across 11 countries. A total of 1,839 women not requiring urgent delivery were randomly assigned to either immediate delivery (n = 924) or expectant management (n = 915).

No difference was noted in the primary outcome of neonatal sepsis between the immediate birth (n = 23 [2%]) and expectant management groups (n = 29 [3%]; relative risk [RR], 0.8; 95% confidence interval [CI], 0.5–1.3). This also was true in the subgroup of women who were colonized with group B streptococcus (RR, 0.9; 95% CI, 0.2–4.5).

There also was no difference in the secondary outcome measure, a composite metric including sepsis, ventilation for 24 or more hours, or death (73 [8%] in the immediate delivery group vs 61 [7%] in the expectant management group; RR, 1.2; 95% CI, 0.9–1.6). However, infants born to women randomly assigned to immediate delivery, versus expectant management, had a significantly higher rate of respiratory distress syndrome (RR, 1.6; 95% CI, 1.1–2.3) and mechanical ventilation (RR, 1.4; 95% CI, 1.0–1.8). In addition, the immediate-delivery infants had a longer median stay in the special care nursery/neonatal intensive care unit (4.0 days, interquartile range [IQR], 0.0–10.0 vs 2.0 days, IQR, 0.0–7.0) and total hospital stay (6.0 days, IQR, 3.0–10.0 vs 4.0 days, IQR, 3.0–8.0). As expected, women in the expectant management group had a significantly longer hospital stay than women in the immediate delivery group, because 75% (688/912) were managed as inpatients. Interestingly, women in the immediate delivery group had a higher cesarean delivery rate than those in the expectant management group (239 [26%] vs 169 [19%], respectively; RR, 1.4; 95% CI, 1.2–1.7), although no explanation was offered.

Strengths and limitationsMajor strengths of this study include the large sample size and superior study design. It is by far the largest RCT to address this question. Because this was a pragmatic RCT, certain practices (such as the choice of latency antibiotic regimen) varied across centers, although randomization would be expected to minimize the effect of such variables on study outcome.

A major limitation is that participant recruitment occurred over a period of more than 10 years, during which time antenatal and neonatal intensive care unit practices likely would have changed.

What this evidence means for practiceFew clinical studies have the potential to significantly change obstetric management. This report by Morris and colleagues is one such study. It was well designed, well executed, and powered to look at the most clinically relevant outcome, namely, neonatal sepsis. While these study results do call into question the current American College of Obstetricians and Gynecologists recommendations to electively deliver patients with PPROM at or after 34 weeks’ gestation, additional discussion is needed at the national level before these recommendations can be changed.
—Denis A. Vaughan, MBBCh, BAO, MRCPI, and Errol R. Norwitz, MD, PhD

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

References
  1. Goldenberg RL, Rouse DJ. Prevention of premature birth. N Engl J Med. 1998;339(5):313–320.
  2. American College of Obstetricians and Gynecologists Committee on Practice Bulletins–Obstetrics. ACOG Practice Bulletin No. 160: premature rupture of membranes. Obstet Gynecol. 2016;127(1):192–194.
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The authors report no financial relationships relevant to this article.

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Preterm premature rupture of membranes (PPROM) refers to rupture of membranes prior to the onset of labor before 37 weeks’ gestation. It accounts for one-third of all preterm births.1 Pregnancy complications associated with PPROM include intrauterine infection (chorioamnionitis), preterm labor, and placental abruption. Should such complications develop, immediate delivery is indicated. When to recommend elective delivery in the absence of complications, however, remains controversial.

The American College of Obstetricians and Gynecologists (ACOG) currently recommends elective delivery at or after 34 weeks’ gestation,2 because the prevailing evidence suggests that the risk of pregnancy-related complications (especially ascending infection) exceeds the risks of iatrogenic prematurity at this gestational age. However, ACOG acknowledges that this recommendation is based on “limited and inconsistent scientific evidence.”2 To address deficiencies in the literature, investigators designed the PPROMT (preterm prelabor rupture of the membranes close to term) trial to study women with ruptured membranes before the onset of labor between 34 and 37 weeks’ gestation.

PPROMT study designMorris and colleagues present results of their multicenter, international, randomized controlled trial (RCT) of expectant management versus planned delivery in pregnancies complicated by PPROM at 34 0/7 through 36 6/7 weeks’ gestation carried out in 65 centers across 11 countries. A total of 1,839 women not requiring urgent delivery were randomly assigned to either immediate delivery (n = 924) or expectant management (n = 915).

No difference was noted in the primary outcome of neonatal sepsis between the immediate birth (n = 23 [2%]) and expectant management groups (n = 29 [3%]; relative risk [RR], 0.8; 95% confidence interval [CI], 0.5–1.3). This also was true in the subgroup of women who were colonized with group B streptococcus (RR, 0.9; 95% CI, 0.2–4.5).

There also was no difference in the secondary outcome measure, a composite metric including sepsis, ventilation for 24 or more hours, or death (73 [8%] in the immediate delivery group vs 61 [7%] in the expectant management group; RR, 1.2; 95% CI, 0.9–1.6). However, infants born to women randomly assigned to immediate delivery, versus expectant management, had a significantly higher rate of respiratory distress syndrome (RR, 1.6; 95% CI, 1.1–2.3) and mechanical ventilation (RR, 1.4; 95% CI, 1.0–1.8). In addition, the immediate-delivery infants had a longer median stay in the special care nursery/neonatal intensive care unit (4.0 days, interquartile range [IQR], 0.0–10.0 vs 2.0 days, IQR, 0.0–7.0) and total hospital stay (6.0 days, IQR, 3.0–10.0 vs 4.0 days, IQR, 3.0–8.0). As expected, women in the expectant management group had a significantly longer hospital stay than women in the immediate delivery group, because 75% (688/912) were managed as inpatients. Interestingly, women in the immediate delivery group had a higher cesarean delivery rate than those in the expectant management group (239 [26%] vs 169 [19%], respectively; RR, 1.4; 95% CI, 1.2–1.7), although no explanation was offered.

Strengths and limitationsMajor strengths of this study include the large sample size and superior study design. It is by far the largest RCT to address this question. Because this was a pragmatic RCT, certain practices (such as the choice of latency antibiotic regimen) varied across centers, although randomization would be expected to minimize the effect of such variables on study outcome.

A major limitation is that participant recruitment occurred over a period of more than 10 years, during which time antenatal and neonatal intensive care unit practices likely would have changed.

What this evidence means for practiceFew clinical studies have the potential to significantly change obstetric management. This report by Morris and colleagues is one such study. It was well designed, well executed, and powered to look at the most clinically relevant outcome, namely, neonatal sepsis. While these study results do call into question the current American College of Obstetricians and Gynecologists recommendations to electively deliver patients with PPROM at or after 34 weeks’ gestation, additional discussion is needed at the national level before these recommendations can be changed.
—Denis A. Vaughan, MBBCh, BAO, MRCPI, and Errol R. Norwitz, MD, PhD

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

Preterm premature rupture of membranes (PPROM) refers to rupture of membranes prior to the onset of labor before 37 weeks’ gestation. It accounts for one-third of all preterm births.1 Pregnancy complications associated with PPROM include intrauterine infection (chorioamnionitis), preterm labor, and placental abruption. Should such complications develop, immediate delivery is indicated. When to recommend elective delivery in the absence of complications, however, remains controversial.

The American College of Obstetricians and Gynecologists (ACOG) currently recommends elective delivery at or after 34 weeks’ gestation,2 because the prevailing evidence suggests that the risk of pregnancy-related complications (especially ascending infection) exceeds the risks of iatrogenic prematurity at this gestational age. However, ACOG acknowledges that this recommendation is based on “limited and inconsistent scientific evidence.”2 To address deficiencies in the literature, investigators designed the PPROMT (preterm prelabor rupture of the membranes close to term) trial to study women with ruptured membranes before the onset of labor between 34 and 37 weeks’ gestation.

PPROMT study designMorris and colleagues present results of their multicenter, international, randomized controlled trial (RCT) of expectant management versus planned delivery in pregnancies complicated by PPROM at 34 0/7 through 36 6/7 weeks’ gestation carried out in 65 centers across 11 countries. A total of 1,839 women not requiring urgent delivery were randomly assigned to either immediate delivery (n = 924) or expectant management (n = 915).

No difference was noted in the primary outcome of neonatal sepsis between the immediate birth (n = 23 [2%]) and expectant management groups (n = 29 [3%]; relative risk [RR], 0.8; 95% confidence interval [CI], 0.5–1.3). This also was true in the subgroup of women who were colonized with group B streptococcus (RR, 0.9; 95% CI, 0.2–4.5).

There also was no difference in the secondary outcome measure, a composite metric including sepsis, ventilation for 24 or more hours, or death (73 [8%] in the immediate delivery group vs 61 [7%] in the expectant management group; RR, 1.2; 95% CI, 0.9–1.6). However, infants born to women randomly assigned to immediate delivery, versus expectant management, had a significantly higher rate of respiratory distress syndrome (RR, 1.6; 95% CI, 1.1–2.3) and mechanical ventilation (RR, 1.4; 95% CI, 1.0–1.8). In addition, the immediate-delivery infants had a longer median stay in the special care nursery/neonatal intensive care unit (4.0 days, interquartile range [IQR], 0.0–10.0 vs 2.0 days, IQR, 0.0–7.0) and total hospital stay (6.0 days, IQR, 3.0–10.0 vs 4.0 days, IQR, 3.0–8.0). As expected, women in the expectant management group had a significantly longer hospital stay than women in the immediate delivery group, because 75% (688/912) were managed as inpatients. Interestingly, women in the immediate delivery group had a higher cesarean delivery rate than those in the expectant management group (239 [26%] vs 169 [19%], respectively; RR, 1.4; 95% CI, 1.2–1.7), although no explanation was offered.

Strengths and limitationsMajor strengths of this study include the large sample size and superior study design. It is by far the largest RCT to address this question. Because this was a pragmatic RCT, certain practices (such as the choice of latency antibiotic regimen) varied across centers, although randomization would be expected to minimize the effect of such variables on study outcome.

A major limitation is that participant recruitment occurred over a period of more than 10 years, during which time antenatal and neonatal intensive care unit practices likely would have changed.

What this evidence means for practiceFew clinical studies have the potential to significantly change obstetric management. This report by Morris and colleagues is one such study. It was well designed, well executed, and powered to look at the most clinically relevant outcome, namely, neonatal sepsis. While these study results do call into question the current American College of Obstetricians and Gynecologists recommendations to electively deliver patients with PPROM at or after 34 weeks’ gestation, additional discussion is needed at the national level before these recommendations can be changed.
—Denis A. Vaughan, MBBCh, BAO, MRCPI, and Errol R. Norwitz, MD, PhD

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

References
  1. Goldenberg RL, Rouse DJ. Prevention of premature birth. N Engl J Med. 1998;339(5):313–320.
  2. American College of Obstetricians and Gynecologists Committee on Practice Bulletins–Obstetrics. ACOG Practice Bulletin No. 160: premature rupture of membranes. Obstet Gynecol. 2016;127(1):192–194.
References
  1. Goldenberg RL, Rouse DJ. Prevention of premature birth. N Engl J Med. 1998;339(5):313–320.
  2. American College of Obstetricians and Gynecologists Committee on Practice Bulletins–Obstetrics. ACOG Practice Bulletin No. 160: premature rupture of membranes. Obstet Gynecol. 2016;127(1):192–194.
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Transvaginal mesh for prolapse: Where are we in 2016?

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TRANSVAGINAL MESH FOR POP: NEW AND
NOTEWORTHY RESOURCES


Pelvic Floor Disorders Registry: Overview, registry resources, FAQs, more
Vaginal mesh manufacturer closing due to lawsuit concerns, Wall Street Journal, 2/29/16

 

Approximately 300,000 surgeries for pelvic organ prolapse (POP) are performed annually in the United States. In 2006, the peak of synthetic mesh use for prolapse surgery, one-third of all prolapse operations involved some mesh use.1,2 The use of vaginal mesh has declined since the US Food and Drug Administration (FDA) issued warnings in 2008 and 2011.

 

The US Food and Drug Administration has strengthened the data requirements for transvaginal mesh for repair of pelvic organ prolapse. Manufacturers have 30 months to submit safety and effectiveness data—data that will be captured through studies made possible by the American Urogynecologic Society−initiated Pelvic Floor Disorders Registry. The FDA advises that patients be made aware of alternatives to vaginal mesh repair, including abdominally placed sacrocolpopexy mesh.

Historically, the use of mesh for gynecologic surgery began in the 1970s, with abdominal POP repair.3 Transvaginal mesh use for POP surgeries became FDA-cleared in 2004. The first cleared mesh device was classified as class II (moderate risk).3 Subsequent mesh devices were given 510(k) clearance, which bypasses clinical trials and requires manufacturers only to show that their product is substantially equivalent to one already on the market.4 More than 40 companies began the manufacturing of mesh devices in the 10 years following the initial cleared device.3

Of course, much controversy has surrounded mesh use in recent years, with common adverse events reported, including severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation, and problems from mesh eroding into surrounding tissues.3 The FDA very recently (in January 2016) reclassified this device from moderate risk to high risk (class III), after indicating in May 2014 that such action was necessary. (See “Timeline of FDA’s actions regarding surgical mesh for pelvic organ prolapse” on page 46.) This reclassification requires a premarket approval application to be filed for each device, with safety and efficacy demonstrated. There are approximately 5 companies currently manufacturing mesh for transvaginal POP repair.3

OBG Management recently sat down with Cheryl Iglesia, MD, director of the Section of Female Pelvic Medicine and Reconstructive Surgery at MedStar Washington Hospital Center and professor in the Departments of Obstetrics/Gynecology and Urology at Georgetown University School of Medicine in Washington, DC. Dr. Iglesia serves, from 2011 through 2017, as a member on the FDA Obstetrics and Gynecology Devices Panel, and she addressed lessons learned over the past decade on synthetic and biologic mesh at the Pelvic Anatomy and Gynecologic Surgery (PAGS) symposium in Las Vegas, Nevada, this past December.

In this Q&A article, she addresses the current state of transvaginal mesh use and how it relates to the innovation adaptation curve (otherwise known as the Hype Cycle), how new mesh types differ from older ones, and how the specialty can move into a future of POP surgery in which innovation and data will rule.

OBG Management: Where is transvaginal mesh use on the so-called “Hype Cycle,” or innovation adaptation curve?
Cheryl B. Iglesia, MD: The Hype Cycle was developed and branded by the Gartner company, an information technology advisory and research firm. This cycle refers to the graphical depictions of how a technology or application will evolve over time. After all, new technologies may make bold promises, and the hype may not translate to commercial viability. Each cycle drills down into the key phases of a technology’s life cycle: the trigger, peak of inflated expectations, trough of disillusionment, slope of enlightenment, and plateau of productivity.5

If we use the Hype Cycle to drill down the phases of transvaginal mesh’s life cycle, we begin in 2004 with the FDA clearance of the first vaginal mesh system (FIGURE).6 The height of its use (the “peak of inflated expectation”) was around 2006, when essentially one-third of all annual surgeries performed for prolapse repair used some type of mesh placed either abdominally or transvaginally.2

 

Subsequently, adverse events began being reported to the Manufacturer and User Facility Device Experience (MAUDE) database. In 2008, the FDA published its first notification of serious complications associated with transvaginal placement of surgical mesh, with more than 1,000 reports from 9 surgical mesh manufacturers.7 A second alert followed in 2011.8 By this time, we had reached our “trough of disillusionment.”

In 2016, we have reached the “plateau of productivity” on the innovation adaptation curve. During this phase on the Hype Cycle the criteria for assessing the technology’s viability are clearly defined. I say we are in this phase because now we have a way of completing more postmarket surveillance on mesh devices. We now can see what applying the technology is like in the real world, generalized across many different surgeons’ hands, and we have a way of performing comparative studies with native tissue.

 

 

OBG Management: How do the new types of mesh differ from those that have been removed from the market?
Dr. Iglesia: In January 2012, there were about 40 types of surgical mesh available from more than 30 manufacturers of transvaginal mesh. At that time, the FDA imposed 522 orders on these companies, requiring them to provide up to 3 years of postmarket data on the safety and effectiveness of their devices.9 Some companies ceased production, including Johnson and Johnson and CR Bard. Today, there are about a half-dozen mesh types on the market, and these are undergoing evaluation.

First-generation meshes were the size of a sheet of paper; now, meshes can fit on the palm of your hand. They also do not have the legs or the arms that are placed using trocars through the transobturator or ischioanal fossae, which can approach nearby nerves, arteries, or other vital structures. They are significantly lighter weight, and some have color to make the native tissue and mesh interface more apparent.

 

Mesh contraction,10 inflammation of the mesh involving surrounding soft tissue,11 and stress shearing at the mesh/soft tissue interface12 have been implicated as potential causes of pain with synthetic mesh. The most commonly available synthetic mesh today is type 1 polypropylene (macroporous monofilament), with a large pore size (usually greater than 75 microns).

Non−cross linked biologic grafts also are available currently, with several cross-linked grafts removed from the market by 2013 because their design was associated with graft stiffness and shrinkage, which had the potential to distort the pelvic anatomy.

Non−cross linked biologic grafts may be associated with fewer mesh-related complications compared with synthetic mesh, but there are limited data on their use in POP repair and there are many unanswered questions. The current concerns with biologics are their tensile properties, foreign body reactions, and documented autolysis. Modifications to them may affect their soft tissue reactivity, but outcomes depend on the technique used for implantation.

OBG Management: When do you consider vaginal mesh use for prolapse?
Dr. Iglesia: A recent Cochrane review shows that some data favor mesh for decreased recurrence, but there are trade-offs.13 I consider mesh use in the setting of recurrent prolapse, especially anterior, for advanced-stageprolapse, and under certain situations, including when there is a known collagen deficiency and there are contraindications to abdominal surgery. However, pelvic pain always is a concern, and surgeons should be extremely careful when choosing to use mesh in patients with known chronic pelvic pain.

The FDA recommends that clinicians treating patients with POP recognize that POP can be treated successfully without mesh and that this native tissue repair will avoid completely the risk of mesh-related complications (TABLE 1).14 Patients should be made aware of alternatives to vaginal mesh when deciding on surgical repair, including nonsurgical options, native tissue repair, and abdominally (laparoscopic, robotic, or open) placed sacrocolpopexy mesh.

 

OBG Management: How does the Pelvic Floor Disorders Registry solve issues that existed prior to the mesh controversy?
Dr. Iglesia: The Pelvic Floor Disorders Registry (PFDR), which can be accessed online (http://www.pfdr.org), is a private and public collaboration including many medical societies: the American Urogynecologic Society (AUGS), the American College of Obstetricians and Gynecologists, the American Urologic Association, the National Institutes of Health, the FDA, and industry. Its objectives are 3-fold15:

 

  1. to collect, store, and analyze clinical data related to POP treatment
  2. to establish common data elements and quality metrics
  3. to provide a framework for external stakeholders to conduct POP research (TABLE 2).

All involved PFDR partners, which also includes patient advocates, reached consensus on the outcomes that matter scientifically in terms of objective cure rates and complications as well as on subjective outcomes that matter most to patien

 

Quite frankly, subjective patient-reported outcomes probably trump any other outcome because, in general, patients are risk averse—which is to say that they are much more easily accepting of recurrence or failure than of a serious adverse event from a mesh-related complication. With the PFDR, we are able to capture not only that objective data but also the critically important patient-centered outcomes.16

With the PFDR, a patient who goes to surgeon B following a complication with surgeon A can still be followed. I look forward to the tracking capability within the registry and the many prospective comparative trials that can be conducted.

Unfortunately, differences between older and newer transvaginal mesh delivery systems will not be evaluated as part of the required 522 studies within the PFDR; however, I really look forward to seeing the data roll out on the second generation vaginal mesh kits compared to native tissue repai

 

 

The PFDR has 2 options for volunteer registry participation, the PFDR-Quality Improvement and PFDR-Research. I encourage specialists who are board-certified in Female Pelvic Medicine and Reconstructive Surgery to be involved in the quality improvement research. For this, physicians basically can track their own success and complication rates, including nonsurgical outcomes. This information could be helpful to achieving our ongoing goal of getting better at what we do surgically. If you are doing well, it will be very validating. Your patients will be happy, you will have good outcomes, and that probably will not be bad for marketing your practice.

There may be some opportunities to reach the health-related quality indicators that we need to meet right now as part of government-mandated initiatives. For many reasons, it is important for surgeons who are performing a high volume of POP surgeries per year to get involved in the PFDR. In fact, even if you are not performing surgery, you still can get involved with the nonsurgical pessary side. This also is important information for us to move forward with as a specialty as we seek to understand the natural history of POP.

The PFDR will serve many different purposes—one of the best of which is that we are going to be able to safely promote mesh technology for the most appropriate cases and not stifle innovation. The comparison groups, already built in to the registry, will allow for native tissue arms to be compared head to head with the currently available meshes. In addition, we will be able to see signals sooner if certain products or patient profiles, and even individual surgeon outcomes, are concerning.

Cheryl B. Iglesia, MD, was the Keynote Speaker at the Pelvic Anatomy and Gynecologic Surgery (PAGS) Symposium held in Las Vegas, Nevada, December 10–12, 2015. This article was developed from Dr. Iglesia's presentation titled "The How, Why and Where of Synthetic and Biologic Mesh: Lessons Learned."

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

References

 

 

  1. Urogynecologic surgical mesh: Update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. Washington DC: US Food and Drug Administration, Centers for Devices and Radiological Health; July 2011.
  2. Rogo-Gupta L, Rodriguez LV, Litwin MS, et al. Trends in surgical mesh use for pelvic organ prolapse from 2000 to 2010. Obstet Gynecol. 2012;120(5):1105–1115.
  3. FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks. US Food and Drug Administration website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm. Updated January 6, 2016. Accessed February 12, 2016.
  4. Premarket notification 510(k). US Food and Drug Administration website. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm. Updated September, 16, 2016. Accessed February 11, 2016.
  5. Gartner Hype Cycle. Gartner website. http://www.gartner.com/technology/research/methodologies/hype-cycle.jsp. Accessed February 12, 2016.
  6. Barber MD. Thirty-third American Urogynecologic Society Annual Meeting Presidential Address: the end of the beginning. Female Pelvic Med Reconstr Surg. 2013;19(1):2−7.
  7. FDA public health notification: Serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence. US Food and Drug Administration website. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm. Updated August 6, 2015. Accessed February 12, 2016.
  8. Update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse: FDA safety communication. US Food and Drug Administration website. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm. Updated October 6, 2014. Accessed February 12, 2016.
  9. Hughes C. FDA issues 522 orders for postmarket surveillance studies: urogynecologic surgical mesh implants. American Urogynecologic Society website. . Published January 5, 2012. Accessed February 12, 2016.
  10. Feiner B, Maher C. Vaginal mesh contraction: definition, clinical presentation, and management. Obstet Gynecol. 2010;115(2 pt 1):325–330.
  11. Ozkan N, Kayaoglu HA, Ersoy OF, Celik A, Kurt GS, Arabaci E. Effects of two different meshes used in hernia repair on nerve transport. J Am Coll Surg. 2008;207(5):670–675.
  12. Clemons JL, Weinstein M, Guess MK, et al; AUGS Research Committee. Impact of the 2011 FDA transvaginal mesh safety update on AUGS members’ use of synthetic mesh and biologic grafts in pelvic reconstructive surgery. Female Pelvic Med Reconstr Surg. 2013;19(4):191–198.
  13. Maher C, Feiner B, Baessler K, Haya N, Marjoribanks J. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cocrane Database Syst Rev. 2016;2;CD012079.
  14. Information for Health Care Providers for POP. US Food and Drug Administration website. http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/urogynsurgicalmesh/ucm345204.htm. Updated January 4, 2016. Accessed February 13, 2016.
  15. Bradley CS, Visco AG, Weber LeBrun EE, Barber MD. The Pelvic Floor Disorders Registry: purpose and development [published online ahead of print January 30, 2016]. Female Pelvic Med Reconstr Surg.
  16. FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks. US Food and Drug Administration website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncementsFeiner B, Maher C. Vaginal mesh contraction: definition, clinical presentation, and management.
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Q&A with Cheryl B. Iglesia, MD

Dr. Iglesia is Director, Section of Female Pelvic Medicine and Reconstructive Surgery, MedStar Washington Hospital Center, and Professor, Departments of Obstetrics/Gynecology and Urology, Georgetown University School of Medicine, Washington, DC. She also serves on the OBG Management Board of Editors.

The author reports no financial relationships relevant to this article.

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Cheryl Iglesia MD, mesh, transvaginal mesh, pelvic organ prolapse, POP, US Food and Drug Administration, FDA, 510(k), Hype Cycle, Manufacturer and User Facility Device Experience database, MAUDE, synthetic mesh, biologic grafts, Pelvic Floor Disorders Registry, PFDR
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Q&A with Cheryl B. Iglesia, MD

Dr. Iglesia is Director, Section of Female Pelvic Medicine and Reconstructive Surgery, MedStar Washington Hospital Center, and Professor, Departments of Obstetrics/Gynecology and Urology, Georgetown University School of Medicine, Washington, DC. She also serves on the OBG Management Board of Editors.

The author reports no financial relationships relevant to this article.

Author and Disclosure Information

 

Q&A with Cheryl B. Iglesia, MD

Dr. Iglesia is Director, Section of Female Pelvic Medicine and Reconstructive Surgery, MedStar Washington Hospital Center, and Professor, Departments of Obstetrics/Gynecology and Urology, Georgetown University School of Medicine, Washington, DC. She also serves on the OBG Management Board of Editors.

The author reports no financial relationships relevant to this article.

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TRANSVAGINAL MESH FOR POP: NEW AND
NOTEWORTHY RESOURCES


Pelvic Floor Disorders Registry: Overview, registry resources, FAQs, more
Vaginal mesh manufacturer closing due to lawsuit concerns, Wall Street Journal, 2/29/16

 

Approximately 300,000 surgeries for pelvic organ prolapse (POP) are performed annually in the United States. In 2006, the peak of synthetic mesh use for prolapse surgery, one-third of all prolapse operations involved some mesh use.1,2 The use of vaginal mesh has declined since the US Food and Drug Administration (FDA) issued warnings in 2008 and 2011.

 

The US Food and Drug Administration has strengthened the data requirements for transvaginal mesh for repair of pelvic organ prolapse. Manufacturers have 30 months to submit safety and effectiveness data—data that will be captured through studies made possible by the American Urogynecologic Society−initiated Pelvic Floor Disorders Registry. The FDA advises that patients be made aware of alternatives to vaginal mesh repair, including abdominally placed sacrocolpopexy mesh.

Historically, the use of mesh for gynecologic surgery began in the 1970s, with abdominal POP repair.3 Transvaginal mesh use for POP surgeries became FDA-cleared in 2004. The first cleared mesh device was classified as class II (moderate risk).3 Subsequent mesh devices were given 510(k) clearance, which bypasses clinical trials and requires manufacturers only to show that their product is substantially equivalent to one already on the market.4 More than 40 companies began the manufacturing of mesh devices in the 10 years following the initial cleared device.3

Of course, much controversy has surrounded mesh use in recent years, with common adverse events reported, including severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation, and problems from mesh eroding into surrounding tissues.3 The FDA very recently (in January 2016) reclassified this device from moderate risk to high risk (class III), after indicating in May 2014 that such action was necessary. (See “Timeline of FDA’s actions regarding surgical mesh for pelvic organ prolapse” on page 46.) This reclassification requires a premarket approval application to be filed for each device, with safety and efficacy demonstrated. There are approximately 5 companies currently manufacturing mesh for transvaginal POP repair.3

OBG Management recently sat down with Cheryl Iglesia, MD, director of the Section of Female Pelvic Medicine and Reconstructive Surgery at MedStar Washington Hospital Center and professor in the Departments of Obstetrics/Gynecology and Urology at Georgetown University School of Medicine in Washington, DC. Dr. Iglesia serves, from 2011 through 2017, as a member on the FDA Obstetrics and Gynecology Devices Panel, and she addressed lessons learned over the past decade on synthetic and biologic mesh at the Pelvic Anatomy and Gynecologic Surgery (PAGS) symposium in Las Vegas, Nevada, this past December.

In this Q&A article, she addresses the current state of transvaginal mesh use and how it relates to the innovation adaptation curve (otherwise known as the Hype Cycle), how new mesh types differ from older ones, and how the specialty can move into a future of POP surgery in which innovation and data will rule.

OBG Management: Where is transvaginal mesh use on the so-called “Hype Cycle,” or innovation adaptation curve?
Cheryl B. Iglesia, MD: The Hype Cycle was developed and branded by the Gartner company, an information technology advisory and research firm. This cycle refers to the graphical depictions of how a technology or application will evolve over time. After all, new technologies may make bold promises, and the hype may not translate to commercial viability. Each cycle drills down into the key phases of a technology’s life cycle: the trigger, peak of inflated expectations, trough of disillusionment, slope of enlightenment, and plateau of productivity.5

If we use the Hype Cycle to drill down the phases of transvaginal mesh’s life cycle, we begin in 2004 with the FDA clearance of the first vaginal mesh system (FIGURE).6 The height of its use (the “peak of inflated expectation”) was around 2006, when essentially one-third of all annual surgeries performed for prolapse repair used some type of mesh placed either abdominally or transvaginally.2

 

Subsequently, adverse events began being reported to the Manufacturer and User Facility Device Experience (MAUDE) database. In 2008, the FDA published its first notification of serious complications associated with transvaginal placement of surgical mesh, with more than 1,000 reports from 9 surgical mesh manufacturers.7 A second alert followed in 2011.8 By this time, we had reached our “trough of disillusionment.”

In 2016, we have reached the “plateau of productivity” on the innovation adaptation curve. During this phase on the Hype Cycle the criteria for assessing the technology’s viability are clearly defined. I say we are in this phase because now we have a way of completing more postmarket surveillance on mesh devices. We now can see what applying the technology is like in the real world, generalized across many different surgeons’ hands, and we have a way of performing comparative studies with native tissue.

 

 

OBG Management: How do the new types of mesh differ from those that have been removed from the market?
Dr. Iglesia: In January 2012, there were about 40 types of surgical mesh available from more than 30 manufacturers of transvaginal mesh. At that time, the FDA imposed 522 orders on these companies, requiring them to provide up to 3 years of postmarket data on the safety and effectiveness of their devices.9 Some companies ceased production, including Johnson and Johnson and CR Bard. Today, there are about a half-dozen mesh types on the market, and these are undergoing evaluation.

First-generation meshes were the size of a sheet of paper; now, meshes can fit on the palm of your hand. They also do not have the legs or the arms that are placed using trocars through the transobturator or ischioanal fossae, which can approach nearby nerves, arteries, or other vital structures. They are significantly lighter weight, and some have color to make the native tissue and mesh interface more apparent.

 

Mesh contraction,10 inflammation of the mesh involving surrounding soft tissue,11 and stress shearing at the mesh/soft tissue interface12 have been implicated as potential causes of pain with synthetic mesh. The most commonly available synthetic mesh today is type 1 polypropylene (macroporous monofilament), with a large pore size (usually greater than 75 microns).

Non−cross linked biologic grafts also are available currently, with several cross-linked grafts removed from the market by 2013 because their design was associated with graft stiffness and shrinkage, which had the potential to distort the pelvic anatomy.

Non−cross linked biologic grafts may be associated with fewer mesh-related complications compared with synthetic mesh, but there are limited data on their use in POP repair and there are many unanswered questions. The current concerns with biologics are their tensile properties, foreign body reactions, and documented autolysis. Modifications to them may affect their soft tissue reactivity, but outcomes depend on the technique used for implantation.

OBG Management: When do you consider vaginal mesh use for prolapse?
Dr. Iglesia: A recent Cochrane review shows that some data favor mesh for decreased recurrence, but there are trade-offs.13 I consider mesh use in the setting of recurrent prolapse, especially anterior, for advanced-stageprolapse, and under certain situations, including when there is a known collagen deficiency and there are contraindications to abdominal surgery. However, pelvic pain always is a concern, and surgeons should be extremely careful when choosing to use mesh in patients with known chronic pelvic pain.

The FDA recommends that clinicians treating patients with POP recognize that POP can be treated successfully without mesh and that this native tissue repair will avoid completely the risk of mesh-related complications (TABLE 1).14 Patients should be made aware of alternatives to vaginal mesh when deciding on surgical repair, including nonsurgical options, native tissue repair, and abdominally (laparoscopic, robotic, or open) placed sacrocolpopexy mesh.

 

OBG Management: How does the Pelvic Floor Disorders Registry solve issues that existed prior to the mesh controversy?
Dr. Iglesia: The Pelvic Floor Disorders Registry (PFDR), which can be accessed online (http://www.pfdr.org), is a private and public collaboration including many medical societies: the American Urogynecologic Society (AUGS), the American College of Obstetricians and Gynecologists, the American Urologic Association, the National Institutes of Health, the FDA, and industry. Its objectives are 3-fold15:

 

  1. to collect, store, and analyze clinical data related to POP treatment
  2. to establish common data elements and quality metrics
  3. to provide a framework for external stakeholders to conduct POP research (TABLE 2).

All involved PFDR partners, which also includes patient advocates, reached consensus on the outcomes that matter scientifically in terms of objective cure rates and complications as well as on subjective outcomes that matter most to patien

 

Quite frankly, subjective patient-reported outcomes probably trump any other outcome because, in general, patients are risk averse—which is to say that they are much more easily accepting of recurrence or failure than of a serious adverse event from a mesh-related complication. With the PFDR, we are able to capture not only that objective data but also the critically important patient-centered outcomes.16

With the PFDR, a patient who goes to surgeon B following a complication with surgeon A can still be followed. I look forward to the tracking capability within the registry and the many prospective comparative trials that can be conducted.

Unfortunately, differences between older and newer transvaginal mesh delivery systems will not be evaluated as part of the required 522 studies within the PFDR; however, I really look forward to seeing the data roll out on the second generation vaginal mesh kits compared to native tissue repai

 

 

The PFDR has 2 options for volunteer registry participation, the PFDR-Quality Improvement and PFDR-Research. I encourage specialists who are board-certified in Female Pelvic Medicine and Reconstructive Surgery to be involved in the quality improvement research. For this, physicians basically can track their own success and complication rates, including nonsurgical outcomes. This information could be helpful to achieving our ongoing goal of getting better at what we do surgically. If you are doing well, it will be very validating. Your patients will be happy, you will have good outcomes, and that probably will not be bad for marketing your practice.

There may be some opportunities to reach the health-related quality indicators that we need to meet right now as part of government-mandated initiatives. For many reasons, it is important for surgeons who are performing a high volume of POP surgeries per year to get involved in the PFDR. In fact, even if you are not performing surgery, you still can get involved with the nonsurgical pessary side. This also is important information for us to move forward with as a specialty as we seek to understand the natural history of POP.

The PFDR will serve many different purposes—one of the best of which is that we are going to be able to safely promote mesh technology for the most appropriate cases and not stifle innovation. The comparison groups, already built in to the registry, will allow for native tissue arms to be compared head to head with the currently available meshes. In addition, we will be able to see signals sooner if certain products or patient profiles, and even individual surgeon outcomes, are concerning.

Cheryl B. Iglesia, MD, was the Keynote Speaker at the Pelvic Anatomy and Gynecologic Surgery (PAGS) Symposium held in Las Vegas, Nevada, December 10–12, 2015. This article was developed from Dr. Iglesia's presentation titled "The How, Why and Where of Synthetic and Biologic Mesh: Lessons Learned."

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

TRANSVAGINAL MESH FOR POP: NEW AND
NOTEWORTHY RESOURCES


Pelvic Floor Disorders Registry: Overview, registry resources, FAQs, more
Vaginal mesh manufacturer closing due to lawsuit concerns, Wall Street Journal, 2/29/16

 

Approximately 300,000 surgeries for pelvic organ prolapse (POP) are performed annually in the United States. In 2006, the peak of synthetic mesh use for prolapse surgery, one-third of all prolapse operations involved some mesh use.1,2 The use of vaginal mesh has declined since the US Food and Drug Administration (FDA) issued warnings in 2008 and 2011.

 

The US Food and Drug Administration has strengthened the data requirements for transvaginal mesh for repair of pelvic organ prolapse. Manufacturers have 30 months to submit safety and effectiveness data—data that will be captured through studies made possible by the American Urogynecologic Society−initiated Pelvic Floor Disorders Registry. The FDA advises that patients be made aware of alternatives to vaginal mesh repair, including abdominally placed sacrocolpopexy mesh.

Historically, the use of mesh for gynecologic surgery began in the 1970s, with abdominal POP repair.3 Transvaginal mesh use for POP surgeries became FDA-cleared in 2004. The first cleared mesh device was classified as class II (moderate risk).3 Subsequent mesh devices were given 510(k) clearance, which bypasses clinical trials and requires manufacturers only to show that their product is substantially equivalent to one already on the market.4 More than 40 companies began the manufacturing of mesh devices in the 10 years following the initial cleared device.3

Of course, much controversy has surrounded mesh use in recent years, with common adverse events reported, including severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation, and problems from mesh eroding into surrounding tissues.3 The FDA very recently (in January 2016) reclassified this device from moderate risk to high risk (class III), after indicating in May 2014 that such action was necessary. (See “Timeline of FDA’s actions regarding surgical mesh for pelvic organ prolapse” on page 46.) This reclassification requires a premarket approval application to be filed for each device, with safety and efficacy demonstrated. There are approximately 5 companies currently manufacturing mesh for transvaginal POP repair.3

OBG Management recently sat down with Cheryl Iglesia, MD, director of the Section of Female Pelvic Medicine and Reconstructive Surgery at MedStar Washington Hospital Center and professor in the Departments of Obstetrics/Gynecology and Urology at Georgetown University School of Medicine in Washington, DC. Dr. Iglesia serves, from 2011 through 2017, as a member on the FDA Obstetrics and Gynecology Devices Panel, and she addressed lessons learned over the past decade on synthetic and biologic mesh at the Pelvic Anatomy and Gynecologic Surgery (PAGS) symposium in Las Vegas, Nevada, this past December.

In this Q&A article, she addresses the current state of transvaginal mesh use and how it relates to the innovation adaptation curve (otherwise known as the Hype Cycle), how new mesh types differ from older ones, and how the specialty can move into a future of POP surgery in which innovation and data will rule.

OBG Management: Where is transvaginal mesh use on the so-called “Hype Cycle,” or innovation adaptation curve?
Cheryl B. Iglesia, MD: The Hype Cycle was developed and branded by the Gartner company, an information technology advisory and research firm. This cycle refers to the graphical depictions of how a technology or application will evolve over time. After all, new technologies may make bold promises, and the hype may not translate to commercial viability. Each cycle drills down into the key phases of a technology’s life cycle: the trigger, peak of inflated expectations, trough of disillusionment, slope of enlightenment, and plateau of productivity.5

If we use the Hype Cycle to drill down the phases of transvaginal mesh’s life cycle, we begin in 2004 with the FDA clearance of the first vaginal mesh system (FIGURE).6 The height of its use (the “peak of inflated expectation”) was around 2006, when essentially one-third of all annual surgeries performed for prolapse repair used some type of mesh placed either abdominally or transvaginally.2

 

Subsequently, adverse events began being reported to the Manufacturer and User Facility Device Experience (MAUDE) database. In 2008, the FDA published its first notification of serious complications associated with transvaginal placement of surgical mesh, with more than 1,000 reports from 9 surgical mesh manufacturers.7 A second alert followed in 2011.8 By this time, we had reached our “trough of disillusionment.”

In 2016, we have reached the “plateau of productivity” on the innovation adaptation curve. During this phase on the Hype Cycle the criteria for assessing the technology’s viability are clearly defined. I say we are in this phase because now we have a way of completing more postmarket surveillance on mesh devices. We now can see what applying the technology is like in the real world, generalized across many different surgeons’ hands, and we have a way of performing comparative studies with native tissue.

 

 

OBG Management: How do the new types of mesh differ from those that have been removed from the market?
Dr. Iglesia: In January 2012, there were about 40 types of surgical mesh available from more than 30 manufacturers of transvaginal mesh. At that time, the FDA imposed 522 orders on these companies, requiring them to provide up to 3 years of postmarket data on the safety and effectiveness of their devices.9 Some companies ceased production, including Johnson and Johnson and CR Bard. Today, there are about a half-dozen mesh types on the market, and these are undergoing evaluation.

First-generation meshes were the size of a sheet of paper; now, meshes can fit on the palm of your hand. They also do not have the legs or the arms that are placed using trocars through the transobturator or ischioanal fossae, which can approach nearby nerves, arteries, or other vital structures. They are significantly lighter weight, and some have color to make the native tissue and mesh interface more apparent.

 

Mesh contraction,10 inflammation of the mesh involving surrounding soft tissue,11 and stress shearing at the mesh/soft tissue interface12 have been implicated as potential causes of pain with synthetic mesh. The most commonly available synthetic mesh today is type 1 polypropylene (macroporous monofilament), with a large pore size (usually greater than 75 microns).

Non−cross linked biologic grafts also are available currently, with several cross-linked grafts removed from the market by 2013 because their design was associated with graft stiffness and shrinkage, which had the potential to distort the pelvic anatomy.

Non−cross linked biologic grafts may be associated with fewer mesh-related complications compared with synthetic mesh, but there are limited data on their use in POP repair and there are many unanswered questions. The current concerns with biologics are their tensile properties, foreign body reactions, and documented autolysis. Modifications to them may affect their soft tissue reactivity, but outcomes depend on the technique used for implantation.

OBG Management: When do you consider vaginal mesh use for prolapse?
Dr. Iglesia: A recent Cochrane review shows that some data favor mesh for decreased recurrence, but there are trade-offs.13 I consider mesh use in the setting of recurrent prolapse, especially anterior, for advanced-stageprolapse, and under certain situations, including when there is a known collagen deficiency and there are contraindications to abdominal surgery. However, pelvic pain always is a concern, and surgeons should be extremely careful when choosing to use mesh in patients with known chronic pelvic pain.

The FDA recommends that clinicians treating patients with POP recognize that POP can be treated successfully without mesh and that this native tissue repair will avoid completely the risk of mesh-related complications (TABLE 1).14 Patients should be made aware of alternatives to vaginal mesh when deciding on surgical repair, including nonsurgical options, native tissue repair, and abdominally (laparoscopic, robotic, or open) placed sacrocolpopexy mesh.

 

OBG Management: How does the Pelvic Floor Disorders Registry solve issues that existed prior to the mesh controversy?
Dr. Iglesia: The Pelvic Floor Disorders Registry (PFDR), which can be accessed online (http://www.pfdr.org), is a private and public collaboration including many medical societies: the American Urogynecologic Society (AUGS), the American College of Obstetricians and Gynecologists, the American Urologic Association, the National Institutes of Health, the FDA, and industry. Its objectives are 3-fold15:

 

  1. to collect, store, and analyze clinical data related to POP treatment
  2. to establish common data elements and quality metrics
  3. to provide a framework for external stakeholders to conduct POP research (TABLE 2).

All involved PFDR partners, which also includes patient advocates, reached consensus on the outcomes that matter scientifically in terms of objective cure rates and complications as well as on subjective outcomes that matter most to patien

 

Quite frankly, subjective patient-reported outcomes probably trump any other outcome because, in general, patients are risk averse—which is to say that they are much more easily accepting of recurrence or failure than of a serious adverse event from a mesh-related complication. With the PFDR, we are able to capture not only that objective data but also the critically important patient-centered outcomes.16

With the PFDR, a patient who goes to surgeon B following a complication with surgeon A can still be followed. I look forward to the tracking capability within the registry and the many prospective comparative trials that can be conducted.

Unfortunately, differences between older and newer transvaginal mesh delivery systems will not be evaluated as part of the required 522 studies within the PFDR; however, I really look forward to seeing the data roll out on the second generation vaginal mesh kits compared to native tissue repai

 

 

The PFDR has 2 options for volunteer registry participation, the PFDR-Quality Improvement and PFDR-Research. I encourage specialists who are board-certified in Female Pelvic Medicine and Reconstructive Surgery to be involved in the quality improvement research. For this, physicians basically can track their own success and complication rates, including nonsurgical outcomes. This information could be helpful to achieving our ongoing goal of getting better at what we do surgically. If you are doing well, it will be very validating. Your patients will be happy, you will have good outcomes, and that probably will not be bad for marketing your practice.

There may be some opportunities to reach the health-related quality indicators that we need to meet right now as part of government-mandated initiatives. For many reasons, it is important for surgeons who are performing a high volume of POP surgeries per year to get involved in the PFDR. In fact, even if you are not performing surgery, you still can get involved with the nonsurgical pessary side. This also is important information for us to move forward with as a specialty as we seek to understand the natural history of POP.

The PFDR will serve many different purposes—one of the best of which is that we are going to be able to safely promote mesh technology for the most appropriate cases and not stifle innovation. The comparison groups, already built in to the registry, will allow for native tissue arms to be compared head to head with the currently available meshes. In addition, we will be able to see signals sooner if certain products or patient profiles, and even individual surgeon outcomes, are concerning.

Cheryl B. Iglesia, MD, was the Keynote Speaker at the Pelvic Anatomy and Gynecologic Surgery (PAGS) Symposium held in Las Vegas, Nevada, December 10–12, 2015. This article was developed from Dr. Iglesia's presentation titled "The How, Why and Where of Synthetic and Biologic Mesh: Lessons Learned."

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

References

 

 

  1. Urogynecologic surgical mesh: Update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. Washington DC: US Food and Drug Administration, Centers for Devices and Radiological Health; July 2011.
  2. Rogo-Gupta L, Rodriguez LV, Litwin MS, et al. Trends in surgical mesh use for pelvic organ prolapse from 2000 to 2010. Obstet Gynecol. 2012;120(5):1105–1115.
  3. FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks. US Food and Drug Administration website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm. Updated January 6, 2016. Accessed February 12, 2016.
  4. Premarket notification 510(k). US Food and Drug Administration website. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm. Updated September, 16, 2016. Accessed February 11, 2016.
  5. Gartner Hype Cycle. Gartner website. http://www.gartner.com/technology/research/methodologies/hype-cycle.jsp. Accessed February 12, 2016.
  6. Barber MD. Thirty-third American Urogynecologic Society Annual Meeting Presidential Address: the end of the beginning. Female Pelvic Med Reconstr Surg. 2013;19(1):2−7.
  7. FDA public health notification: Serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence. US Food and Drug Administration website. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm. Updated August 6, 2015. Accessed February 12, 2016.
  8. Update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse: FDA safety communication. US Food and Drug Administration website. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm. Updated October 6, 2014. Accessed February 12, 2016.
  9. Hughes C. FDA issues 522 orders for postmarket surveillance studies: urogynecologic surgical mesh implants. American Urogynecologic Society website. . Published January 5, 2012. Accessed February 12, 2016.
  10. Feiner B, Maher C. Vaginal mesh contraction: definition, clinical presentation, and management. Obstet Gynecol. 2010;115(2 pt 1):325–330.
  11. Ozkan N, Kayaoglu HA, Ersoy OF, Celik A, Kurt GS, Arabaci E. Effects of two different meshes used in hernia repair on nerve transport. J Am Coll Surg. 2008;207(5):670–675.
  12. Clemons JL, Weinstein M, Guess MK, et al; AUGS Research Committee. Impact of the 2011 FDA transvaginal mesh safety update on AUGS members’ use of synthetic mesh and biologic grafts in pelvic reconstructive surgery. Female Pelvic Med Reconstr Surg. 2013;19(4):191–198.
  13. Maher C, Feiner B, Baessler K, Haya N, Marjoribanks J. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cocrane Database Syst Rev. 2016;2;CD012079.
  14. Information for Health Care Providers for POP. US Food and Drug Administration website. http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/urogynsurgicalmesh/ucm345204.htm. Updated January 4, 2016. Accessed February 13, 2016.
  15. Bradley CS, Visco AG, Weber LeBrun EE, Barber MD. The Pelvic Floor Disorders Registry: purpose and development [published online ahead of print January 30, 2016]. Female Pelvic Med Reconstr Surg.
  16. FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks. US Food and Drug Administration website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncementsFeiner B, Maher C. Vaginal mesh contraction: definition, clinical presentation, and management.
References

 

 

  1. Urogynecologic surgical mesh: Update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. Washington DC: US Food and Drug Administration, Centers for Devices and Radiological Health; July 2011.
  2. Rogo-Gupta L, Rodriguez LV, Litwin MS, et al. Trends in surgical mesh use for pelvic organ prolapse from 2000 to 2010. Obstet Gynecol. 2012;120(5):1105–1115.
  3. FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks. US Food and Drug Administration website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm. Updated January 6, 2016. Accessed February 12, 2016.
  4. Premarket notification 510(k). US Food and Drug Administration website. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm. Updated September, 16, 2016. Accessed February 11, 2016.
  5. Gartner Hype Cycle. Gartner website. http://www.gartner.com/technology/research/methodologies/hype-cycle.jsp. Accessed February 12, 2016.
  6. Barber MD. Thirty-third American Urogynecologic Society Annual Meeting Presidential Address: the end of the beginning. Female Pelvic Med Reconstr Surg. 2013;19(1):2−7.
  7. FDA public health notification: Serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence. US Food and Drug Administration website. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm. Updated August 6, 2015. Accessed February 12, 2016.
  8. Update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse: FDA safety communication. US Food and Drug Administration website. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm. Updated October 6, 2014. Accessed February 12, 2016.
  9. Hughes C. FDA issues 522 orders for postmarket surveillance studies: urogynecologic surgical mesh implants. American Urogynecologic Society website. . Published January 5, 2012. Accessed February 12, 2016.
  10. Feiner B, Maher C. Vaginal mesh contraction: definition, clinical presentation, and management. Obstet Gynecol. 2010;115(2 pt 1):325–330.
  11. Ozkan N, Kayaoglu HA, Ersoy OF, Celik A, Kurt GS, Arabaci E. Effects of two different meshes used in hernia repair on nerve transport. J Am Coll Surg. 2008;207(5):670–675.
  12. Clemons JL, Weinstein M, Guess MK, et al; AUGS Research Committee. Impact of the 2011 FDA transvaginal mesh safety update on AUGS members’ use of synthetic mesh and biologic grafts in pelvic reconstructive surgery. Female Pelvic Med Reconstr Surg. 2013;19(4):191–198.
  13. Maher C, Feiner B, Baessler K, Haya N, Marjoribanks J. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cocrane Database Syst Rev. 2016;2;CD012079.
  14. Information for Health Care Providers for POP. US Food and Drug Administration website. http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/urogynsurgicalmesh/ucm345204.htm. Updated January 4, 2016. Accessed February 13, 2016.
  15. Bradley CS, Visco AG, Weber LeBrun EE, Barber MD. The Pelvic Floor Disorders Registry: purpose and development [published online ahead of print January 30, 2016]. Female Pelvic Med Reconstr Surg.
  16. FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks. US Food and Drug Administration website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncementsFeiner B, Maher C. Vaginal mesh contraction: definition, clinical presentation, and management.
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  • Transvaginal mesh and the “Hype Cycle”
  • Newer vs older mesh types
  • Solutions offered by the Pelvic Floor Disorders Registry

Cheryl B. Iglesia, MD, was the Keynote Speaker at the Pelvic Anatomy and Gynecologic Surgery (PAGS) Symposium held in Las Vegas, Nevada, December 10–12, 2015. This article was developed from Dr. Iglesia's presentation titled "The How, Why and Where of Synthetic and Biologic Mesh: Lessons Learned."

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CASE: Patient discloses personal information in electronic communication. How to respond and what’s at stake?
Your nurse comes to you with a dilemma. Last Friday she received an email from a patient, sent to the nurse’s personal email account (G-mail) that conveyed information regarding the patient’s recent treatment for a herpetic vulvar lesion. The text details presumed exposure, date and time, number of sexual partners, concernfor “spread of disease,” and the patient’s desire to have a comprehensive sexually transmitted infection screening as soon as possible.

Your nurse has years of professional experience, but she is perhaps not the most savvy with regard to current information technology and social media. Nonetheless, she knows it is best not to immediately respond to the patient’s email without checking with you. She tracks you down on Monday morning to review the email and the dilemma she feels she has been placed in. What’s the best next step?

While discussing the general question with the staff, another nurse notes that there have been some reviews of the office on social media. It seems that this second nurse tweets and texts with patients all the time. The office manager strongly suggests that the office “join the 21st Century” by setting up a Facebook page and using their webpage to attract new patients and communicate with current patients.

How do you prepare for this? Is your staff knowledgeable about the dos and don’ts of social media?

The use of social media by health care providers has been growing for several years. Back in 2011 a large survey by QuantiaMD revealed that 87% of physicians used social media for personal reasons, and 67% of them used it professionally.1 How they used it for professional purposes also was explored in 2011, with almost 3 of 4 physicians using it for social networking and more than half engaging with their own institution’s social media (FIGURE).2 In 2013, 53% of physicians indicated that their practice had a Facebook platform, 28% had a presence on LinkedIn, and 21% were on Twitter.3 Not surprisingly, social media use is higher among younger physicians4; the 2016 equivalents to these percentages most likely are higher.
 

 

Health providers’ use of social media for professional reasons2

 In 2011, a survey found that most health providers used social networking, their institutions’ own social media, and Internet forums, boards, and communities for professional reasons.

Patients’ outreach through social media regarding health care information continues to grow, with 33.8% asking for health advice using social media.5 While email and other social media open the possibility of improved communication with patients, they also present a number of important professional and legal issues that deserve special consideration.6 Each medium presents its own challenges, but there are 4 categories of concern related to basic values and rights that we consider important to review:

 

  • confidentiality
  • dual relationships and conflicts of interest
  • quality of care and advice
  • general professionalism (including advertising).

Confidentiality
Few values of the medical profession are of longer standing than the commitment to maintain patient privacy. Fifth Century BC obligations continue to apply to the technology of the 21st Century AD. And the challenges are significant.

Email is not secure
In the opening case, the choice to email her clinician was apparently the patient’s. She probably does not realize that email is not very confidential, although it is undoubtedly in the Terms of Service Agreement she clicked through. Her email was likely scanned by her email service provider—Google, in this case—as well as the nurse. If, however, the physician’s office responds by email, it may well compound the confidentiality problem by further distributing the information through yet another email provider.

If, as a physician, you encourage email communication by your patients, a smart approach is to emphasize that such communications are not very confidential. At a minimum, until a secure email system can be established, it is best not to transmit medical information via email and to inform patients of the risk of such communication. In the case above, the nurse who received the email should respond to the patient by telephone (much more secure). Or she can respond to the patient by email (not including the patient’s message in the return), writing that, because email communications are inherently not confidential, she suggests a phone call or personal visit.

This case also notes that the patient sent the email to the nurse’s personal account, not to an office email account. Sending medical emails to an employee’s personal account raises additional problems of confidentiality and appropriate controls. It should be made clear that employees should not be discussing private medical matters via their own email accounts.

 

 

Other forms of social media are also not secure
Similar concerns arise about texting and using Twitter by the second nurse. These activities apparently had been unknown to the physician, but the practice still may be responsible for her actions. These are insecure forms of communication and raise serious ethical and legal concerns.

Other social media pose confidentiality risks as well. For example, a physician was dismissed from a position and reprimanded by the medical board for posting patient information on Facebook,7 and an ObGyn caused problems by posting a nasty note about a patient who showed up late for an appointment.8 Too many patients may not understand that posting on social media is the equivalent of standing on a street corner yelling private information. Social media sites that invite the discussion of personal matters are an invitation to trouble.

Physicians are ethically obliged to protect confidentiality
Professional standards place significant ethical obligations on physicians to protect patient confidentiality. The American Medical Association (AMA) has an ethics opinion on professionalism with social media,9 as does the American College of Obstetricians and Gynecologists (ACOG).10 Another excellent discussion of ethical and practical issues is a joint position paper by the American College of Physicians and the Federation of State Medical Boards.11 Both documents focus attention on issues of confidentiality.

Physicians are legally obliged to protect confidentiality
There are many legal protections for confidentiality that can be implicated by electronic communications and social media. All states provide protection for unwarranted disclosure of private patient information. Such disclosures made electronically are included.12 Indeed, because electronic disclosures may be broadcast more widely, they may be especially dangerous. The misuse of social media may result in license discipline by the state board, regulatory sanctions, or civil liability (rare, but criminal sanctions are a possibility in extreme circumstances).

In addition to state laws regarding confidentiality, there are a number of federal laws that cover confidential medical information. None is more important than the Health Insurance Portability and Accountability Act (HIPAA) and the more recent HITECH amendments (Health Information Technology for Economic and Clinical Health).13 These laws have both privacy provisions and security (including “encryption”) requirements. These are complicated laws but at their core are the notions that health care providers and some others:

 

  1. are responsible for maintaining the security and privacy of health information
  2. may not transmit (even unintentionally) such information to others without patient permission or legal authority.14
  3. may not transmit (even unintentionally) such information to others without patient permission or legal authority.

A good source of step-by-step information about these laws is “Health information privacy: Covered entities and business associates,” on the US Health and Human Services website.14

HITECH also provides for notice to patients when health information is inappropriately transmitted. Thus, a missing USB flash drive with patient information may require notification to thousands of patients.15 Any consideration of the use of email or social media in medical practice must take into account the HIPAA/HITECH obligations to protect the security of patient health information. There can be serious professional consequences for failing to follow the HIPAA requirements.16

 

Dual relationships and conflicts of interest
In our hypothetical case, the office manager’s suggestion that the office use Facebook and their website to attract new patients also may raise confidentiality problems. The Facebook suggestion especially needs to be considered carefully. Facebook use is estimated to be 63% to 96% among students and 13% to 47% among health care professionals.17 Facebook is most often seen as an interactive social site; it risks blurring the lines between personal and professional relationships.9 There is a consensus that a physician should not “friend” patients on Facebook. The AMA ethics opinion notes that “physicians must maintain appropriate boundaries of the patient-physician relationship in accordance with professional ethical guidelines, just as they would in any other context.”9

Separate personal and professional contacts
Difficulties with interactive social media are not limited to the physicians in a practice. The problems increase with the number of staff members who post or respond on social media. Control of social media is essential. The practice must ensure that staff members do not slip into inappropriate personal comments and relationships. Staff should understand (and be reminded of) the necessity of separating personal and professional contacts.

Avoid misunderstandings
In addition, whatever the intent of the physician and staff may be, it is essentially impossible to know how patients will interpret interactions on these social media. The very informal, off-the-cuff, chatty way in which Facebook and similar sites are used invites misunderstandings, and maintaining professional boundaries is necessary.

 

 

Ground rules
All of this is not to say that professionals should never use Facebook or similar sites. Rather, if used, ground rules need to be established.

Social media communications must:

 

  • be professional and not related to personal matters
  • not be used to give medical advice
  • be controlled by high level staff
  • be reviewed periodically.

Staff training
Particularly for interactive social media (email, texts, Twitter, Facebook, etc), it is essential that there be both clear policies and good staff training (TABLE).9–11,18 There really should be no “making it up as we go along.” Staff on a social media lark of their own can be disastrous for the practice. Policies need to be updated frequently, and staff training reinforced and repeated periodically.

 

Quality of care and advice
Start with your website
Institutions’ websites are major sources of health care information: Nearly 32% of US adults would be very likely to prefer a hospital based on its website.5 Your website can be an important face of your practice to the community—for good or for bad. On one hand, the practice can control what is on a website and, unlike some social media, it will not be directed to individual patients. Done well, it “provides golden opportunities for marketing physician services, as well as for contributing to public health by providing high-quality online content that is both accurate and understandable to laypeople.”19 Done badly, it can convey incorrect and harmful information and discredit the medical practice that established it.

Your website introduces the practice and settings, but it will serve another purpose to thousands of people who likely will see it over time as a source of credible health information. The importance of ensuring that your website is carefully constructed to provide, or link to, good medical advice that contributes to quality of care cannot be overstated.

A good website begins with a clear statement of the reasons and goals for having the site. Professional design assistance generally is used to create the site, but that design process needs to be overseen by a medical professional to ensure that it conveys the sense of the practice and provides completely accurate information. A homepage of dancing clowns with stethoscopes may seem good to a 20-something-year-old designer, but it is not appropriate for a physician. It will be the practice, not the designer, who is held accountable for the site content. Links to other sites need to be vetted and used with care. Patients and other members of the public may well take the links as carrying the endorsement of the practice and its physicians.

Perhaps the greatest risk of a website is that it will not be kept current. Unfortunately, they do not update themselves. Some knowledgeable staff member must frequently review it to update everything from office hours and personnel to links to other sites. In addition, the physicians periodically must review it to ensure that all medical information is up to date and accurate. Old, outdated information about the office can put off potential patients. Outdated medical information may be harmful to patients who rely on it.

Any professional website should include disclaimers informing users that the site is not intended to establish a professional relationship or to give professional advice. The nature and extent of the disclaimer will depend on the type of information on the site. An example of a particularly thorough disclaimer is the Mayo Clinic disclaimer and terms of use (http://www.mayoclinic.org/about-this-site/terms-conditions-use-policy).

General professionalism
At the end of the day, social media are an outreach from a medical practice and from the profession to the public.20 Failure to treat these platforms with appropriate professional standards may result in professional discipline, damages, or civil penalties. Almost all of the reviews of social media use in health care practice note that the risks of inappropriate use are not only to the individual physician but also to the general medical profession, which may be undermined. Consider posting policies of the relevent state medical boards, the AMA, and ACOG in your office after you have had a discussion with your staff about them.21

The AMA statement includes a provision that a physician seeing unprofessional social media conduct by a colleague has the responsibility to bring that to the attention of the colleague. If the colleague does not correct a significant problem, “the physician should report the matter to appropriate authorities.”9

Bottom line
Any practitioner considering the use of social media must view it as a major step that requires caution, expert assistance, and constant attention to potential privacy, quality, and professionalism issues. If you are considering it, ensure that all staff associated with the practice understand and agree to the established limits on social media use.

 

 

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. Modahl M, Tompsett L, Moorhead T. Doctors, patients, & social media. Quantia MD website. http://www.quantiamd.com/q-qcp/DoctorsPatientSocialMedia.pdf. Published September 2011. Accessed February 18, 2016.
  2. Kuberacka A, Wengrojj J, Fabozzi N. Social media use in U.S. healthcare provider institutions: Insights from Frost & Sullivan and iHT2 survey. Frost and Sullivan website. http://ihealthtran.com/pdf/frostiht2survey.pdf. Published August 30, 2011. Accessed February 18, 2016.
  3. O’Connor ME. How do tech savvy physicians use health technology and social media? Health Care Social Media website. http://hcsmmonitor.com/2014/01/08/how-do-tech-savvy-physicians-use-health-technology-and-social-media/. Published January 8, 2014. Accessed February 18, 2016.
  4. American Medical Association (AMA) Insurance. 2014 work/life profiles of today’s U.S. physician. AMA Insurance website. https://www.amainsure.com/work-life-profiles-of-todays-us-physician.html. Published April 2014. Accessed February 18, 2016.
  5. National Research Corporation. 2013 National Market Insights Survey: Health care social media website. https://healthcaresocialmedia.files.wordpress.com/2014/04/nrc-infographiclong.jpg. Accessed February 18, 2016.
  6. Suby C. Social media in health care: benefits, concerns and guidelines for use. Creat Nurs. 2013;19(3):140–147.
  7. Conaboy C. For doctors, social media a tricky case. Boston Globe. http://www.boston.com/lifestyle/health/articles/2011/04/20/for_doctors_social_media_a_tricky_case/?page=full. Published April 20, 2011. Accessed February 18, 2016.
  8. Matyszczyk C. Outcry as ob-gyn uses Facebook to complain about patient. CNET. http://www.cnet.com/news/outcry-as-ob-gyn-uses-facebook-to-complain-about-patient/Minion Pro. Published February 9, 2013. Accessed February 18, 2016.
  9. American Medical Association (AMA). Opinion 9.124: Professionalism in the use of social media. AMA website. http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion9124.page? Published June 2011. Accessed February 18, 2016.
  10. American College of Obstetricians and Gynecologists (ACOG) Committee on Professional Liability. ACOG Committee Opinion No. 622: professional use of digital and social media. Obstet Gynecol. 2015;125(2):516-520.
  11. Farnan JM, Sulmasy LS, Worster BK, et al. Online medical professionalism: patient and public relationships: Policy Statement From the American College of Physicians and the Federation of State Medical Boards. Ann Intern Med. 2013;158(8):620–627.
  12. Hader A, Drown E. Patient privacy and social media. AANA J. 2010;78(4):270–274.
  13. Kavoussi SC, Huang JJ, Tsai JC, Kempton JE. HIPAA for physicians in the information age. Conn Med. 2014;78(7):425–427.
  14. U.S. Department of Health & Human Services (HHS). Health information privacy: Covered entities and business associates. HHS website. http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/. Published March 14, 2012. Accessed February 18, 2016.
  15. Perna G. Breach report: lost flash drive at Kaiser Permanente affects 49,000 patients. Healthcare Informatics website. http://www.healthcare-informatics.com/news-item/breach-report-lost-flash-drive-kaiser-permanente-affects-49000-patients. Published December 11, 2013. Accessed February 18, 2016.
  16. McBride M. How to ensure your social media efforts are HIPAA-compliant. Med Econ. 2012;89:70–74.
  17. Von Muhlen M, Ohno-Machado L. Reviewing social media use by clinicians. J Am Med Inform Assoc. 2012;19(5):777–781.
  18. Omurtag K, Turek P. Incorporating social media into practice: a blueprint for reproductive health providers. Clin Obstet Gynecol. 2013;56(3):463–470.
  19. Radmanesh A, Duszak R, Fitzgerald R. Social media and public outreach: a physician primer. Am J Neuroradiol. 2015;36(7):1223–1224.
  20. Grajales FJ 3rd, Sheps S, Ho K, Novak-Lauscher H, Eysenbach G. Social media: a review and tutorial of applications in medicine and health care. J Med Internet Res. 2014;16(2):e13.
  21. ACOG Today. Social media guide: how to comment with patients and spread women’s health messages. American Congress of Obstetricians and Gynecologists website. http://www.acog.org/-/media/ACOG-Today/acogToday201211.pdf. Published November 2012. Accessed February 18, 2016.
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In this quarterly column, these medical and legal experts and educators present a case-based* discussion and provide clear teaching points and takeaways for your practice.

Joseph S. Sanfilippo, MD, MBA, and Steven R. Smith, JD

Dr. Sanfilippo is Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh; Dr. Sanfilippo is a member of the OBG Management Board of Editors.


Mr. Smith is Dean Emeritus, California Western School of Law, San Diego.

The authors report no financial relationships relevant to this article.

*The “facts” of this case are based on actual cases but are a composite of several events and do not reflect a specific case.

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Joseph S. Sanfilippo MD, Steven R. Smith JD, medicolegal, social media, privacy, Facebook, Twitter, email, confidentiality, HIPAA, AMA, ACOG, Health Information Technology for Economic and Clinical Health, HITECH, clear policies, staff training, website
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In this quarterly column, these medical and legal experts and educators present a case-based* discussion and provide clear teaching points and takeaways for your practice.

Joseph S. Sanfilippo, MD, MBA, and Steven R. Smith, JD

Dr. Sanfilippo is Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh; Dr. Sanfilippo is a member of the OBG Management Board of Editors.


Mr. Smith is Dean Emeritus, California Western School of Law, San Diego.

The authors report no financial relationships relevant to this article.

*The “facts” of this case are based on actual cases but are a composite of several events and do not reflect a specific case.

Author and Disclosure Information

 

In this quarterly column, these medical and legal experts and educators present a case-based* discussion and provide clear teaching points and takeaways for your practice.

Joseph S. Sanfilippo, MD, MBA, and Steven R. Smith, JD

Dr. Sanfilippo is Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh; Dr. Sanfilippo is a member of the OBG Management Board of Editors.


Mr. Smith is Dean Emeritus, California Western School of Law, San Diego.

The authors report no financial relationships relevant to this article.

*The “facts” of this case are based on actual cases but are a composite of several events and do not reflect a specific case.

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Related Articles

CASE: Patient discloses personal information in electronic communication. How to respond and what’s at stake?
Your nurse comes to you with a dilemma. Last Friday she received an email from a patient, sent to the nurse’s personal email account (G-mail) that conveyed information regarding the patient’s recent treatment for a herpetic vulvar lesion. The text details presumed exposure, date and time, number of sexual partners, concernfor “spread of disease,” and the patient’s desire to have a comprehensive sexually transmitted infection screening as soon as possible.

Your nurse has years of professional experience, but she is perhaps not the most savvy with regard to current information technology and social media. Nonetheless, she knows it is best not to immediately respond to the patient’s email without checking with you. She tracks you down on Monday morning to review the email and the dilemma she feels she has been placed in. What’s the best next step?

While discussing the general question with the staff, another nurse notes that there have been some reviews of the office on social media. It seems that this second nurse tweets and texts with patients all the time. The office manager strongly suggests that the office “join the 21st Century” by setting up a Facebook page and using their webpage to attract new patients and communicate with current patients.

How do you prepare for this? Is your staff knowledgeable about the dos and don’ts of social media?

The use of social media by health care providers has been growing for several years. Back in 2011 a large survey by QuantiaMD revealed that 87% of physicians used social media for personal reasons, and 67% of them used it professionally.1 How they used it for professional purposes also was explored in 2011, with almost 3 of 4 physicians using it for social networking and more than half engaging with their own institution’s social media (FIGURE).2 In 2013, 53% of physicians indicated that their practice had a Facebook platform, 28% had a presence on LinkedIn, and 21% were on Twitter.3 Not surprisingly, social media use is higher among younger physicians4; the 2016 equivalents to these percentages most likely are higher.
 

 

Health providers’ use of social media for professional reasons2

 In 2011, a survey found that most health providers used social networking, their institutions’ own social media, and Internet forums, boards, and communities for professional reasons.

Patients’ outreach through social media regarding health care information continues to grow, with 33.8% asking for health advice using social media.5 While email and other social media open the possibility of improved communication with patients, they also present a number of important professional and legal issues that deserve special consideration.6 Each medium presents its own challenges, but there are 4 categories of concern related to basic values and rights that we consider important to review:

 

  • confidentiality
  • dual relationships and conflicts of interest
  • quality of care and advice
  • general professionalism (including advertising).

Confidentiality
Few values of the medical profession are of longer standing than the commitment to maintain patient privacy. Fifth Century BC obligations continue to apply to the technology of the 21st Century AD. And the challenges are significant.

Email is not secure
In the opening case, the choice to email her clinician was apparently the patient’s. She probably does not realize that email is not very confidential, although it is undoubtedly in the Terms of Service Agreement she clicked through. Her email was likely scanned by her email service provider—Google, in this case—as well as the nurse. If, however, the physician’s office responds by email, it may well compound the confidentiality problem by further distributing the information through yet another email provider.

If, as a physician, you encourage email communication by your patients, a smart approach is to emphasize that such communications are not very confidential. At a minimum, until a secure email system can be established, it is best not to transmit medical information via email and to inform patients of the risk of such communication. In the case above, the nurse who received the email should respond to the patient by telephone (much more secure). Or she can respond to the patient by email (not including the patient’s message in the return), writing that, because email communications are inherently not confidential, she suggests a phone call or personal visit.

This case also notes that the patient sent the email to the nurse’s personal account, not to an office email account. Sending medical emails to an employee’s personal account raises additional problems of confidentiality and appropriate controls. It should be made clear that employees should not be discussing private medical matters via their own email accounts.

 

 

Other forms of social media are also not secure
Similar concerns arise about texting and using Twitter by the second nurse. These activities apparently had been unknown to the physician, but the practice still may be responsible for her actions. These are insecure forms of communication and raise serious ethical and legal concerns.

Other social media pose confidentiality risks as well. For example, a physician was dismissed from a position and reprimanded by the medical board for posting patient information on Facebook,7 and an ObGyn caused problems by posting a nasty note about a patient who showed up late for an appointment.8 Too many patients may not understand that posting on social media is the equivalent of standing on a street corner yelling private information. Social media sites that invite the discussion of personal matters are an invitation to trouble.

Physicians are ethically obliged to protect confidentiality
Professional standards place significant ethical obligations on physicians to protect patient confidentiality. The American Medical Association (AMA) has an ethics opinion on professionalism with social media,9 as does the American College of Obstetricians and Gynecologists (ACOG).10 Another excellent discussion of ethical and practical issues is a joint position paper by the American College of Physicians and the Federation of State Medical Boards.11 Both documents focus attention on issues of confidentiality.

Physicians are legally obliged to protect confidentiality
There are many legal protections for confidentiality that can be implicated by electronic communications and social media. All states provide protection for unwarranted disclosure of private patient information. Such disclosures made electronically are included.12 Indeed, because electronic disclosures may be broadcast more widely, they may be especially dangerous. The misuse of social media may result in license discipline by the state board, regulatory sanctions, or civil liability (rare, but criminal sanctions are a possibility in extreme circumstances).

In addition to state laws regarding confidentiality, there are a number of federal laws that cover confidential medical information. None is more important than the Health Insurance Portability and Accountability Act (HIPAA) and the more recent HITECH amendments (Health Information Technology for Economic and Clinical Health).13 These laws have both privacy provisions and security (including “encryption”) requirements. These are complicated laws but at their core are the notions that health care providers and some others:

 

  1. are responsible for maintaining the security and privacy of health information
  2. may not transmit (even unintentionally) such information to others without patient permission or legal authority.14
  3. may not transmit (even unintentionally) such information to others without patient permission or legal authority.

A good source of step-by-step information about these laws is “Health information privacy: Covered entities and business associates,” on the US Health and Human Services website.14

HITECH also provides for notice to patients when health information is inappropriately transmitted. Thus, a missing USB flash drive with patient information may require notification to thousands of patients.15 Any consideration of the use of email or social media in medical practice must take into account the HIPAA/HITECH obligations to protect the security of patient health information. There can be serious professional consequences for failing to follow the HIPAA requirements.16

 

Dual relationships and conflicts of interest
In our hypothetical case, the office manager’s suggestion that the office use Facebook and their website to attract new patients also may raise confidentiality problems. The Facebook suggestion especially needs to be considered carefully. Facebook use is estimated to be 63% to 96% among students and 13% to 47% among health care professionals.17 Facebook is most often seen as an interactive social site; it risks blurring the lines between personal and professional relationships.9 There is a consensus that a physician should not “friend” patients on Facebook. The AMA ethics opinion notes that “physicians must maintain appropriate boundaries of the patient-physician relationship in accordance with professional ethical guidelines, just as they would in any other context.”9

Separate personal and professional contacts
Difficulties with interactive social media are not limited to the physicians in a practice. The problems increase with the number of staff members who post or respond on social media. Control of social media is essential. The practice must ensure that staff members do not slip into inappropriate personal comments and relationships. Staff should understand (and be reminded of) the necessity of separating personal and professional contacts.

Avoid misunderstandings
In addition, whatever the intent of the physician and staff may be, it is essentially impossible to know how patients will interpret interactions on these social media. The very informal, off-the-cuff, chatty way in which Facebook and similar sites are used invites misunderstandings, and maintaining professional boundaries is necessary.

 

 

Ground rules
All of this is not to say that professionals should never use Facebook or similar sites. Rather, if used, ground rules need to be established.

Social media communications must:

 

  • be professional and not related to personal matters
  • not be used to give medical advice
  • be controlled by high level staff
  • be reviewed periodically.

Staff training
Particularly for interactive social media (email, texts, Twitter, Facebook, etc), it is essential that there be both clear policies and good staff training (TABLE).9–11,18 There really should be no “making it up as we go along.” Staff on a social media lark of their own can be disastrous for the practice. Policies need to be updated frequently, and staff training reinforced and repeated periodically.

 

Quality of care and advice
Start with your website
Institutions’ websites are major sources of health care information: Nearly 32% of US adults would be very likely to prefer a hospital based on its website.5 Your website can be an important face of your practice to the community—for good or for bad. On one hand, the practice can control what is on a website and, unlike some social media, it will not be directed to individual patients. Done well, it “provides golden opportunities for marketing physician services, as well as for contributing to public health by providing high-quality online content that is both accurate and understandable to laypeople.”19 Done badly, it can convey incorrect and harmful information and discredit the medical practice that established it.

Your website introduces the practice and settings, but it will serve another purpose to thousands of people who likely will see it over time as a source of credible health information. The importance of ensuring that your website is carefully constructed to provide, or link to, good medical advice that contributes to quality of care cannot be overstated.

A good website begins with a clear statement of the reasons and goals for having the site. Professional design assistance generally is used to create the site, but that design process needs to be overseen by a medical professional to ensure that it conveys the sense of the practice and provides completely accurate information. A homepage of dancing clowns with stethoscopes may seem good to a 20-something-year-old designer, but it is not appropriate for a physician. It will be the practice, not the designer, who is held accountable for the site content. Links to other sites need to be vetted and used with care. Patients and other members of the public may well take the links as carrying the endorsement of the practice and its physicians.

Perhaps the greatest risk of a website is that it will not be kept current. Unfortunately, they do not update themselves. Some knowledgeable staff member must frequently review it to update everything from office hours and personnel to links to other sites. In addition, the physicians periodically must review it to ensure that all medical information is up to date and accurate. Old, outdated information about the office can put off potential patients. Outdated medical information may be harmful to patients who rely on it.

Any professional website should include disclaimers informing users that the site is not intended to establish a professional relationship or to give professional advice. The nature and extent of the disclaimer will depend on the type of information on the site. An example of a particularly thorough disclaimer is the Mayo Clinic disclaimer and terms of use (http://www.mayoclinic.org/about-this-site/terms-conditions-use-policy).

General professionalism
At the end of the day, social media are an outreach from a medical practice and from the profession to the public.20 Failure to treat these platforms with appropriate professional standards may result in professional discipline, damages, or civil penalties. Almost all of the reviews of social media use in health care practice note that the risks of inappropriate use are not only to the individual physician but also to the general medical profession, which may be undermined. Consider posting policies of the relevent state medical boards, the AMA, and ACOG in your office after you have had a discussion with your staff about them.21

The AMA statement includes a provision that a physician seeing unprofessional social media conduct by a colleague has the responsibility to bring that to the attention of the colleague. If the colleague does not correct a significant problem, “the physician should report the matter to appropriate authorities.”9

Bottom line
Any practitioner considering the use of social media must view it as a major step that requires caution, expert assistance, and constant attention to potential privacy, quality, and professionalism issues. If you are considering it, ensure that all staff associated with the practice understand and agree to the established limits on social media use.

 

 

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: Patient discloses personal information in electronic communication. How to respond and what’s at stake?
Your nurse comes to you with a dilemma. Last Friday she received an email from a patient, sent to the nurse’s personal email account (G-mail) that conveyed information regarding the patient’s recent treatment for a herpetic vulvar lesion. The text details presumed exposure, date and time, number of sexual partners, concernfor “spread of disease,” and the patient’s desire to have a comprehensive sexually transmitted infection screening as soon as possible.

Your nurse has years of professional experience, but she is perhaps not the most savvy with regard to current information technology and social media. Nonetheless, she knows it is best not to immediately respond to the patient’s email without checking with you. She tracks you down on Monday morning to review the email and the dilemma she feels she has been placed in. What’s the best next step?

While discussing the general question with the staff, another nurse notes that there have been some reviews of the office on social media. It seems that this second nurse tweets and texts with patients all the time. The office manager strongly suggests that the office “join the 21st Century” by setting up a Facebook page and using their webpage to attract new patients and communicate with current patients.

How do you prepare for this? Is your staff knowledgeable about the dos and don’ts of social media?

The use of social media by health care providers has been growing for several years. Back in 2011 a large survey by QuantiaMD revealed that 87% of physicians used social media for personal reasons, and 67% of them used it professionally.1 How they used it for professional purposes also was explored in 2011, with almost 3 of 4 physicians using it for social networking and more than half engaging with their own institution’s social media (FIGURE).2 In 2013, 53% of physicians indicated that their practice had a Facebook platform, 28% had a presence on LinkedIn, and 21% were on Twitter.3 Not surprisingly, social media use is higher among younger physicians4; the 2016 equivalents to these percentages most likely are higher.
 

 

Health providers’ use of social media for professional reasons2

 In 2011, a survey found that most health providers used social networking, their institutions’ own social media, and Internet forums, boards, and communities for professional reasons.

Patients’ outreach through social media regarding health care information continues to grow, with 33.8% asking for health advice using social media.5 While email and other social media open the possibility of improved communication with patients, they also present a number of important professional and legal issues that deserve special consideration.6 Each medium presents its own challenges, but there are 4 categories of concern related to basic values and rights that we consider important to review:

 

  • confidentiality
  • dual relationships and conflicts of interest
  • quality of care and advice
  • general professionalism (including advertising).

Confidentiality
Few values of the medical profession are of longer standing than the commitment to maintain patient privacy. Fifth Century BC obligations continue to apply to the technology of the 21st Century AD. And the challenges are significant.

Email is not secure
In the opening case, the choice to email her clinician was apparently the patient’s. She probably does not realize that email is not very confidential, although it is undoubtedly in the Terms of Service Agreement she clicked through. Her email was likely scanned by her email service provider—Google, in this case—as well as the nurse. If, however, the physician’s office responds by email, it may well compound the confidentiality problem by further distributing the information through yet another email provider.

If, as a physician, you encourage email communication by your patients, a smart approach is to emphasize that such communications are not very confidential. At a minimum, until a secure email system can be established, it is best not to transmit medical information via email and to inform patients of the risk of such communication. In the case above, the nurse who received the email should respond to the patient by telephone (much more secure). Or she can respond to the patient by email (not including the patient’s message in the return), writing that, because email communications are inherently not confidential, she suggests a phone call or personal visit.

This case also notes that the patient sent the email to the nurse’s personal account, not to an office email account. Sending medical emails to an employee’s personal account raises additional problems of confidentiality and appropriate controls. It should be made clear that employees should not be discussing private medical matters via their own email accounts.

 

 

Other forms of social media are also not secure
Similar concerns arise about texting and using Twitter by the second nurse. These activities apparently had been unknown to the physician, but the practice still may be responsible for her actions. These are insecure forms of communication and raise serious ethical and legal concerns.

Other social media pose confidentiality risks as well. For example, a physician was dismissed from a position and reprimanded by the medical board for posting patient information on Facebook,7 and an ObGyn caused problems by posting a nasty note about a patient who showed up late for an appointment.8 Too many patients may not understand that posting on social media is the equivalent of standing on a street corner yelling private information. Social media sites that invite the discussion of personal matters are an invitation to trouble.

Physicians are ethically obliged to protect confidentiality
Professional standards place significant ethical obligations on physicians to protect patient confidentiality. The American Medical Association (AMA) has an ethics opinion on professionalism with social media,9 as does the American College of Obstetricians and Gynecologists (ACOG).10 Another excellent discussion of ethical and practical issues is a joint position paper by the American College of Physicians and the Federation of State Medical Boards.11 Both documents focus attention on issues of confidentiality.

Physicians are legally obliged to protect confidentiality
There are many legal protections for confidentiality that can be implicated by electronic communications and social media. All states provide protection for unwarranted disclosure of private patient information. Such disclosures made electronically are included.12 Indeed, because electronic disclosures may be broadcast more widely, they may be especially dangerous. The misuse of social media may result in license discipline by the state board, regulatory sanctions, or civil liability (rare, but criminal sanctions are a possibility in extreme circumstances).

In addition to state laws regarding confidentiality, there are a number of federal laws that cover confidential medical information. None is more important than the Health Insurance Portability and Accountability Act (HIPAA) and the more recent HITECH amendments (Health Information Technology for Economic and Clinical Health).13 These laws have both privacy provisions and security (including “encryption”) requirements. These are complicated laws but at their core are the notions that health care providers and some others:

 

  1. are responsible for maintaining the security and privacy of health information
  2. may not transmit (even unintentionally) such information to others without patient permission or legal authority.14
  3. may not transmit (even unintentionally) such information to others without patient permission or legal authority.

A good source of step-by-step information about these laws is “Health information privacy: Covered entities and business associates,” on the US Health and Human Services website.14

HITECH also provides for notice to patients when health information is inappropriately transmitted. Thus, a missing USB flash drive with patient information may require notification to thousands of patients.15 Any consideration of the use of email or social media in medical practice must take into account the HIPAA/HITECH obligations to protect the security of patient health information. There can be serious professional consequences for failing to follow the HIPAA requirements.16

 

Dual relationships and conflicts of interest
In our hypothetical case, the office manager’s suggestion that the office use Facebook and their website to attract new patients also may raise confidentiality problems. The Facebook suggestion especially needs to be considered carefully. Facebook use is estimated to be 63% to 96% among students and 13% to 47% among health care professionals.17 Facebook is most often seen as an interactive social site; it risks blurring the lines between personal and professional relationships.9 There is a consensus that a physician should not “friend” patients on Facebook. The AMA ethics opinion notes that “physicians must maintain appropriate boundaries of the patient-physician relationship in accordance with professional ethical guidelines, just as they would in any other context.”9

Separate personal and professional contacts
Difficulties with interactive social media are not limited to the physicians in a practice. The problems increase with the number of staff members who post or respond on social media. Control of social media is essential. The practice must ensure that staff members do not slip into inappropriate personal comments and relationships. Staff should understand (and be reminded of) the necessity of separating personal and professional contacts.

Avoid misunderstandings
In addition, whatever the intent of the physician and staff may be, it is essentially impossible to know how patients will interpret interactions on these social media. The very informal, off-the-cuff, chatty way in which Facebook and similar sites are used invites misunderstandings, and maintaining professional boundaries is necessary.

 

 

Ground rules
All of this is not to say that professionals should never use Facebook or similar sites. Rather, if used, ground rules need to be established.

Social media communications must:

 

  • be professional and not related to personal matters
  • not be used to give medical advice
  • be controlled by high level staff
  • be reviewed periodically.

Staff training
Particularly for interactive social media (email, texts, Twitter, Facebook, etc), it is essential that there be both clear policies and good staff training (TABLE).9–11,18 There really should be no “making it up as we go along.” Staff on a social media lark of their own can be disastrous for the practice. Policies need to be updated frequently, and staff training reinforced and repeated periodically.

 

Quality of care and advice
Start with your website
Institutions’ websites are major sources of health care information: Nearly 32% of US adults would be very likely to prefer a hospital based on its website.5 Your website can be an important face of your practice to the community—for good or for bad. On one hand, the practice can control what is on a website and, unlike some social media, it will not be directed to individual patients. Done well, it “provides golden opportunities for marketing physician services, as well as for contributing to public health by providing high-quality online content that is both accurate and understandable to laypeople.”19 Done badly, it can convey incorrect and harmful information and discredit the medical practice that established it.

Your website introduces the practice and settings, but it will serve another purpose to thousands of people who likely will see it over time as a source of credible health information. The importance of ensuring that your website is carefully constructed to provide, or link to, good medical advice that contributes to quality of care cannot be overstated.

A good website begins with a clear statement of the reasons and goals for having the site. Professional design assistance generally is used to create the site, but that design process needs to be overseen by a medical professional to ensure that it conveys the sense of the practice and provides completely accurate information. A homepage of dancing clowns with stethoscopes may seem good to a 20-something-year-old designer, but it is not appropriate for a physician. It will be the practice, not the designer, who is held accountable for the site content. Links to other sites need to be vetted and used with care. Patients and other members of the public may well take the links as carrying the endorsement of the practice and its physicians.

Perhaps the greatest risk of a website is that it will not be kept current. Unfortunately, they do not update themselves. Some knowledgeable staff member must frequently review it to update everything from office hours and personnel to links to other sites. In addition, the physicians periodically must review it to ensure that all medical information is up to date and accurate. Old, outdated information about the office can put off potential patients. Outdated medical information may be harmful to patients who rely on it.

Any professional website should include disclaimers informing users that the site is not intended to establish a professional relationship or to give professional advice. The nature and extent of the disclaimer will depend on the type of information on the site. An example of a particularly thorough disclaimer is the Mayo Clinic disclaimer and terms of use (http://www.mayoclinic.org/about-this-site/terms-conditions-use-policy).

General professionalism
At the end of the day, social media are an outreach from a medical practice and from the profession to the public.20 Failure to treat these platforms with appropriate professional standards may result in professional discipline, damages, or civil penalties. Almost all of the reviews of social media use in health care practice note that the risks of inappropriate use are not only to the individual physician but also to the general medical profession, which may be undermined. Consider posting policies of the relevent state medical boards, the AMA, and ACOG in your office after you have had a discussion with your staff about them.21

The AMA statement includes a provision that a physician seeing unprofessional social media conduct by a colleague has the responsibility to bring that to the attention of the colleague. If the colleague does not correct a significant problem, “the physician should report the matter to appropriate authorities.”9

Bottom line
Any practitioner considering the use of social media must view it as a major step that requires caution, expert assistance, and constant attention to potential privacy, quality, and professionalism issues. If you are considering it, ensure that all staff associated with the practice understand and agree to the established limits on social media use.

 

 

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. Modahl M, Tompsett L, Moorhead T. Doctors, patients, & social media. Quantia MD website. http://www.quantiamd.com/q-qcp/DoctorsPatientSocialMedia.pdf. Published September 2011. Accessed February 18, 2016.
  2. Kuberacka A, Wengrojj J, Fabozzi N. Social media use in U.S. healthcare provider institutions: Insights from Frost & Sullivan and iHT2 survey. Frost and Sullivan website. http://ihealthtran.com/pdf/frostiht2survey.pdf. Published August 30, 2011. Accessed February 18, 2016.
  3. O’Connor ME. How do tech savvy physicians use health technology and social media? Health Care Social Media website. http://hcsmmonitor.com/2014/01/08/how-do-tech-savvy-physicians-use-health-technology-and-social-media/. Published January 8, 2014. Accessed February 18, 2016.
  4. American Medical Association (AMA) Insurance. 2014 work/life profiles of today’s U.S. physician. AMA Insurance website. https://www.amainsure.com/work-life-profiles-of-todays-us-physician.html. Published April 2014. Accessed February 18, 2016.
  5. National Research Corporation. 2013 National Market Insights Survey: Health care social media website. https://healthcaresocialmedia.files.wordpress.com/2014/04/nrc-infographiclong.jpg. Accessed February 18, 2016.
  6. Suby C. Social media in health care: benefits, concerns and guidelines for use. Creat Nurs. 2013;19(3):140–147.
  7. Conaboy C. For doctors, social media a tricky case. Boston Globe. http://www.boston.com/lifestyle/health/articles/2011/04/20/for_doctors_social_media_a_tricky_case/?page=full. Published April 20, 2011. Accessed February 18, 2016.
  8. Matyszczyk C. Outcry as ob-gyn uses Facebook to complain about patient. CNET. http://www.cnet.com/news/outcry-as-ob-gyn-uses-facebook-to-complain-about-patient/Minion Pro. Published February 9, 2013. Accessed February 18, 2016.
  9. American Medical Association (AMA). Opinion 9.124: Professionalism in the use of social media. AMA website. http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion9124.page? Published June 2011. Accessed February 18, 2016.
  10. American College of Obstetricians and Gynecologists (ACOG) Committee on Professional Liability. ACOG Committee Opinion No. 622: professional use of digital and social media. Obstet Gynecol. 2015;125(2):516-520.
  11. Farnan JM, Sulmasy LS, Worster BK, et al. Online medical professionalism: patient and public relationships: Policy Statement From the American College of Physicians and the Federation of State Medical Boards. Ann Intern Med. 2013;158(8):620–627.
  12. Hader A, Drown E. Patient privacy and social media. AANA J. 2010;78(4):270–274.
  13. Kavoussi SC, Huang JJ, Tsai JC, Kempton JE. HIPAA for physicians in the information age. Conn Med. 2014;78(7):425–427.
  14. U.S. Department of Health & Human Services (HHS). Health information privacy: Covered entities and business associates. HHS website. http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/. Published March 14, 2012. Accessed February 18, 2016.
  15. Perna G. Breach report: lost flash drive at Kaiser Permanente affects 49,000 patients. Healthcare Informatics website. http://www.healthcare-informatics.com/news-item/breach-report-lost-flash-drive-kaiser-permanente-affects-49000-patients. Published December 11, 2013. Accessed February 18, 2016.
  16. McBride M. How to ensure your social media efforts are HIPAA-compliant. Med Econ. 2012;89:70–74.
  17. Von Muhlen M, Ohno-Machado L. Reviewing social media use by clinicians. J Am Med Inform Assoc. 2012;19(5):777–781.
  18. Omurtag K, Turek P. Incorporating social media into practice: a blueprint for reproductive health providers. Clin Obstet Gynecol. 2013;56(3):463–470.
  19. Radmanesh A, Duszak R, Fitzgerald R. Social media and public outreach: a physician primer. Am J Neuroradiol. 2015;36(7):1223–1224.
  20. Grajales FJ 3rd, Sheps S, Ho K, Novak-Lauscher H, Eysenbach G. Social media: a review and tutorial of applications in medicine and health care. J Med Internet Res. 2014;16(2):e13.
  21. ACOG Today. Social media guide: how to comment with patients and spread women’s health messages. American Congress of Obstetricians and Gynecologists website. http://www.acog.org/-/media/ACOG-Today/acogToday201211.pdf. Published November 2012. Accessed February 18, 2016.
References

 

 

  1. Modahl M, Tompsett L, Moorhead T. Doctors, patients, & social media. Quantia MD website. http://www.quantiamd.com/q-qcp/DoctorsPatientSocialMedia.pdf. Published September 2011. Accessed February 18, 2016.
  2. Kuberacka A, Wengrojj J, Fabozzi N. Social media use in U.S. healthcare provider institutions: Insights from Frost & Sullivan and iHT2 survey. Frost and Sullivan website. http://ihealthtran.com/pdf/frostiht2survey.pdf. Published August 30, 2011. Accessed February 18, 2016.
  3. O’Connor ME. How do tech savvy physicians use health technology and social media? Health Care Social Media website. http://hcsmmonitor.com/2014/01/08/how-do-tech-savvy-physicians-use-health-technology-and-social-media/. Published January 8, 2014. Accessed February 18, 2016.
  4. American Medical Association (AMA) Insurance. 2014 work/life profiles of today’s U.S. physician. AMA Insurance website. https://www.amainsure.com/work-life-profiles-of-todays-us-physician.html. Published April 2014. Accessed February 18, 2016.
  5. National Research Corporation. 2013 National Market Insights Survey: Health care social media website. https://healthcaresocialmedia.files.wordpress.com/2014/04/nrc-infographiclong.jpg. Accessed February 18, 2016.
  6. Suby C. Social media in health care: benefits, concerns and guidelines for use. Creat Nurs. 2013;19(3):140–147.
  7. Conaboy C. For doctors, social media a tricky case. Boston Globe. http://www.boston.com/lifestyle/health/articles/2011/04/20/for_doctors_social_media_a_tricky_case/?page=full. Published April 20, 2011. Accessed February 18, 2016.
  8. Matyszczyk C. Outcry as ob-gyn uses Facebook to complain about patient. CNET. http://www.cnet.com/news/outcry-as-ob-gyn-uses-facebook-to-complain-about-patient/Minion Pro. Published February 9, 2013. Accessed February 18, 2016.
  9. American Medical Association (AMA). Opinion 9.124: Professionalism in the use of social media. AMA website. http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion9124.page? Published June 2011. Accessed February 18, 2016.
  10. American College of Obstetricians and Gynecologists (ACOG) Committee on Professional Liability. ACOG Committee Opinion No. 622: professional use of digital and social media. Obstet Gynecol. 2015;125(2):516-520.
  11. Farnan JM, Sulmasy LS, Worster BK, et al. Online medical professionalism: patient and public relationships: Policy Statement From the American College of Physicians and the Federation of State Medical Boards. Ann Intern Med. 2013;158(8):620–627.
  12. Hader A, Drown E. Patient privacy and social media. AANA J. 2010;78(4):270–274.
  13. Kavoussi SC, Huang JJ, Tsai JC, Kempton JE. HIPAA for physicians in the information age. Conn Med. 2014;78(7):425–427.
  14. U.S. Department of Health & Human Services (HHS). Health information privacy: Covered entities and business associates. HHS website. http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/. Published March 14, 2012. Accessed February 18, 2016.
  15. Perna G. Breach report: lost flash drive at Kaiser Permanente affects 49,000 patients. Healthcare Informatics website. http://www.healthcare-informatics.com/news-item/breach-report-lost-flash-drive-kaiser-permanente-affects-49000-patients. Published December 11, 2013. Accessed February 18, 2016.
  16. McBride M. How to ensure your social media efforts are HIPAA-compliant. Med Econ. 2012;89:70–74.
  17. Von Muhlen M, Ohno-Machado L. Reviewing social media use by clinicians. J Am Med Inform Assoc. 2012;19(5):777–781.
  18. Omurtag K, Turek P. Incorporating social media into practice: a blueprint for reproductive health providers. Clin Obstet Gynecol. 2013;56(3):463–470.
  19. Radmanesh A, Duszak R, Fitzgerald R. Social media and public outreach: a physician primer. Am J Neuroradiol. 2015;36(7):1223–1224.
  20. Grajales FJ 3rd, Sheps S, Ho K, Novak-Lauscher H, Eysenbach G. Social media: a review and tutorial of applications in medicine and health care. J Med Internet Res. 2014;16(2):e13.
  21. ACOG Today. Social media guide: how to comment with patients and spread women’s health messages. American Congress of Obstetricians and Gynecologists website. http://www.acog.org/-/media/ACOG-Today/acogToday201211.pdf. Published November 2012. Accessed February 18, 2016.
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Joseph S. Sanfilippo MD, Steven R. Smith JD, medicolegal, social media, privacy, Facebook, Twitter, email, confidentiality, HIPAA, AMA, ACOG, Health Information Technology for Economic and Clinical Health, HITECH, clear policies, staff training, website
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Joseph S. Sanfilippo MD, Steven R. Smith JD, medicolegal, social media, privacy, Facebook, Twitter, email, confidentiality, HIPAA, AMA, ACOG, Health Information Technology for Economic and Clinical Health, HITECH, clear policies, staff training, website
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  • Health providers’ use of social media
  • Protecting confidentiality
  • Creating a social media policy
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Postpartum life-threatening strep infection

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Postpartum life-threatening strep infection

Postpartum life-threatening strep infection
A pregnant woman received prenatal care from a midwifery practice. A week before her scheduled delivery, the patient became ill with fever and vomiting and visited her midwife. While tests were still pending, the midwife decided to admit the mother to the hospital for induction of labor. The baby was born by vaginal delivery under the midwife’s care. The mother remained in the hospital for observation.

Two days after delivery, the mother began to have nausea, vomiting, and a low-grade fever. The nurse called the midwife, who ordered acetaminophen (Tylenol) but did not come to examine the patient. Two hours later, the nurse notified the midwife that the patient’s condition had worsened and that she was experiencing abdominal pain; the midwife ordered oxycodone. Over the next few hours, the midwife was apprised of the patient’s condition several times by telephone, but she never came to examine the patient nor did she ask her supervising ObGyn to examine the patient.

The next morning, a second midwife noted that the patient was experiencing an itchy rash on her extremities and abdomen. A complete blood count (CBC) showed a “critical lab value” of 44% band neutrophils (normal, 0% to 10% for the hospital laboratory). The second midwife and nurse told the supervising ObGyn that the patient otherwise looked well; he discharged the patient.

At home, the patient’s condition worsened. Her husband called the ObGyn several times and took her to the emergency department (ED) that evening. Her condition deteriorated and she was transferred to another facility where she was diagnosed with a life-threatening Group A Streptococcus (GAS) infection. After weeks of treatment for sepsis, the patient’s foot was amputated.

Patient's claim: The first midwife was negligent in her postpartum treatment of the patient; she should have come to the hospital to examine the patient or have requested that the supervising ObGyn examine the patient. The rash and CBC test results should have initiated further treatment and investigation; the patient should not have been discharged. GAS was not found or treated in a timely manner, resulting in sepsis and amputation.

Defendants' defense: The case was settled during the trial.

Verdict: A $2,500,000 Massachusetts settlement was reached with the midwife, her practice, and the ObGyn.

 

Failure to follow-up on abnormal Pap
A woman in her 50s reported abnormal bleeding to her gynecologist. Results of an endometrial biopsy were negative for cancer; the gynecologist prescribed hormone therapy. The patient continued to bleed until she entered menopause.

Ten years later, the bleeding returned. Results of a Pap test indicated atypical endometrial cells; an ultrasound showed a markedly abnormal endometrium. The gynecologist recommended a hysteroscopic dilation and curettage (D&C). When he attempted the procedure it ended prematurely because he was unable to enter the patient’s endometrium. The patient’s discharge instructions indicated that she should call the physician for follow up. In a letter to the patient written a month later, the physician discussed the abnormal Pap test results and indicated that the patient had 2 options: another D&C under ultrasound guidance or hysterectomy. He also noted that he would contact the patient’s primary care physician (PCP) for input.

Two years later, the patient returned to the gynecologist because the bleeding, which had never stopped, had increased in intensity. Endometrial cancer was diagnosed.

Patient's claim: The gynecologist never followed up with the patient or her PCP after the incomplete D&C. There is no record that communication ever occurred between the gynecologist and PCP. Lack of follow-up and treatment resulted in progression of the cancer from stage 1 to stage 3C, with a 5-year survivability of 47% (stage 1 survivability is 83%).

Physician's defense: The gynecologist was surprised that no one had ever followed up with the patient. The patient was comparatively negligent for failing to seek medical care for the 2-year period.

Verdict: A $430,000 Minnesota settlement was reached at mediation.

 

LIVER DISEASE LED TO STILLBIRTH
A 37-year-old woman reported nausea, vomiting, headaches, heartburn, and upper abdominal pain to her ObGyn several times during her third trimester. She had been pregnant before and knew that this pregnancy “felt” different. She went to the ED 1 week before the birth of her child, but she was discharged. The child was stillborn.

Parent's claim: Neither the ObGyn who provided prenatal care nor the on-call ED ObGyn ordered laboratory testing, which would have revealed a rare disease: acute fatty liver of pregnancy. Action could have saved the life of her child.

The patient’s ObGyn disregarded the patient’s reported symptoms; no blood work or liver testing was done. The ObGyn should have recognized the symptoms of liver disease that presented during the third trimester. A diagnosis of liver disease would have initiated induction of labor.

 

 

The patient’s expert witness noted that the severity of the third trimester symptoms warranted follow-up testing; the patient should not have had all of those symptoms so late in pregnancy. Testing would have revealed that, by not functioning properly, the liver was creating a toxic environment for the fetus. Labor should have been induced at 36 weeks when the fetal heart testing was still normal.

The ED nurses contacted the on-call ObGyn by telephone to discuss the patient’s symptoms; the ObGyn did not come to the ED to examine the patient or order testing.

The patient suffered emotional distress as a result of the loss of her child.

Defendants' defense: The medical center and the on-call ObGyn settled prior to trial.

The ObGyn claimed that the patient’s symptoms were common for pregnancy and that the disease could not be diagnosed based on the presented symptoms. It was not a violation of the standard of care for the extremely rare liver disease to not be diagnosed. The defense’s expert claimed that the symptoms reported by the patient did not warrant follow-up blood work. There was no way to determine whether or not the fetus died as a result of the mother’s liver disease or nuchal cord involvement.

A placental pathologist noted that the placenta was injured by thrombosis; the fetus’ death was most likely idiopathic. He later acknowledged that thrombosis can be related to liver disease.

Verdict: Jurors were instructed to consider this a personal injury case for the mother due to an unborn fetus’ lacks standing for injury or death under California law. A $160,090 California verdict was returned against the ObGyn who provided prenatal care.

 

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! 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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Postpartum life-threatening strep infection
A pregnant woman received prenatal care from a midwifery practice. A week before her scheduled delivery, the patient became ill with fever and vomiting and visited her midwife. While tests were still pending, the midwife decided to admit the mother to the hospital for induction of labor. The baby was born by vaginal delivery under the midwife’s care. The mother remained in the hospital for observation.

Two days after delivery, the mother began to have nausea, vomiting, and a low-grade fever. The nurse called the midwife, who ordered acetaminophen (Tylenol) but did not come to examine the patient. Two hours later, the nurse notified the midwife that the patient’s condition had worsened and that she was experiencing abdominal pain; the midwife ordered oxycodone. Over the next few hours, the midwife was apprised of the patient’s condition several times by telephone, but she never came to examine the patient nor did she ask her supervising ObGyn to examine the patient.

The next morning, a second midwife noted that the patient was experiencing an itchy rash on her extremities and abdomen. A complete blood count (CBC) showed a “critical lab value” of 44% band neutrophils (normal, 0% to 10% for the hospital laboratory). The second midwife and nurse told the supervising ObGyn that the patient otherwise looked well; he discharged the patient.

At home, the patient’s condition worsened. Her husband called the ObGyn several times and took her to the emergency department (ED) that evening. Her condition deteriorated and she was transferred to another facility where she was diagnosed with a life-threatening Group A Streptococcus (GAS) infection. After weeks of treatment for sepsis, the patient’s foot was amputated.

Patient's claim: The first midwife was negligent in her postpartum treatment of the patient; she should have come to the hospital to examine the patient or have requested that the supervising ObGyn examine the patient. The rash and CBC test results should have initiated further treatment and investigation; the patient should not have been discharged. GAS was not found or treated in a timely manner, resulting in sepsis and amputation.

Defendants' defense: The case was settled during the trial.

Verdict: A $2,500,000 Massachusetts settlement was reached with the midwife, her practice, and the ObGyn.

 

Failure to follow-up on abnormal Pap
A woman in her 50s reported abnormal bleeding to her gynecologist. Results of an endometrial biopsy were negative for cancer; the gynecologist prescribed hormone therapy. The patient continued to bleed until she entered menopause.

Ten years later, the bleeding returned. Results of a Pap test indicated atypical endometrial cells; an ultrasound showed a markedly abnormal endometrium. The gynecologist recommended a hysteroscopic dilation and curettage (D&C). When he attempted the procedure it ended prematurely because he was unable to enter the patient’s endometrium. The patient’s discharge instructions indicated that she should call the physician for follow up. In a letter to the patient written a month later, the physician discussed the abnormal Pap test results and indicated that the patient had 2 options: another D&C under ultrasound guidance or hysterectomy. He also noted that he would contact the patient’s primary care physician (PCP) for input.

Two years later, the patient returned to the gynecologist because the bleeding, which had never stopped, had increased in intensity. Endometrial cancer was diagnosed.

Patient's claim: The gynecologist never followed up with the patient or her PCP after the incomplete D&C. There is no record that communication ever occurred between the gynecologist and PCP. Lack of follow-up and treatment resulted in progression of the cancer from stage 1 to stage 3C, with a 5-year survivability of 47% (stage 1 survivability is 83%).

Physician's defense: The gynecologist was surprised that no one had ever followed up with the patient. The patient was comparatively negligent for failing to seek medical care for the 2-year period.

Verdict: A $430,000 Minnesota settlement was reached at mediation.

 

LIVER DISEASE LED TO STILLBIRTH
A 37-year-old woman reported nausea, vomiting, headaches, heartburn, and upper abdominal pain to her ObGyn several times during her third trimester. She had been pregnant before and knew that this pregnancy “felt” different. She went to the ED 1 week before the birth of her child, but she was discharged. The child was stillborn.

Parent's claim: Neither the ObGyn who provided prenatal care nor the on-call ED ObGyn ordered laboratory testing, which would have revealed a rare disease: acute fatty liver of pregnancy. Action could have saved the life of her child.

The patient’s ObGyn disregarded the patient’s reported symptoms; no blood work or liver testing was done. The ObGyn should have recognized the symptoms of liver disease that presented during the third trimester. A diagnosis of liver disease would have initiated induction of labor.

 

 

The patient’s expert witness noted that the severity of the third trimester symptoms warranted follow-up testing; the patient should not have had all of those symptoms so late in pregnancy. Testing would have revealed that, by not functioning properly, the liver was creating a toxic environment for the fetus. Labor should have been induced at 36 weeks when the fetal heart testing was still normal.

The ED nurses contacted the on-call ObGyn by telephone to discuss the patient’s symptoms; the ObGyn did not come to the ED to examine the patient or order testing.

The patient suffered emotional distress as a result of the loss of her child.

Defendants' defense: The medical center and the on-call ObGyn settled prior to trial.

The ObGyn claimed that the patient’s symptoms were common for pregnancy and that the disease could not be diagnosed based on the presented symptoms. It was not a violation of the standard of care for the extremely rare liver disease to not be diagnosed. The defense’s expert claimed that the symptoms reported by the patient did not warrant follow-up blood work. There was no way to determine whether or not the fetus died as a result of the mother’s liver disease or nuchal cord involvement.

A placental pathologist noted that the placenta was injured by thrombosis; the fetus’ death was most likely idiopathic. He later acknowledged that thrombosis can be related to liver disease.

Verdict: Jurors were instructed to consider this a personal injury case for the mother due to an unborn fetus’ lacks standing for injury or death under California law. A $160,090 California verdict was returned against the ObGyn who provided prenatal care.

 

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

Postpartum life-threatening strep infection
A pregnant woman received prenatal care from a midwifery practice. A week before her scheduled delivery, the patient became ill with fever and vomiting and visited her midwife. While tests were still pending, the midwife decided to admit the mother to the hospital for induction of labor. The baby was born by vaginal delivery under the midwife’s care. The mother remained in the hospital for observation.

Two days after delivery, the mother began to have nausea, vomiting, and a low-grade fever. The nurse called the midwife, who ordered acetaminophen (Tylenol) but did not come to examine the patient. Two hours later, the nurse notified the midwife that the patient’s condition had worsened and that she was experiencing abdominal pain; the midwife ordered oxycodone. Over the next few hours, the midwife was apprised of the patient’s condition several times by telephone, but she never came to examine the patient nor did she ask her supervising ObGyn to examine the patient.

The next morning, a second midwife noted that the patient was experiencing an itchy rash on her extremities and abdomen. A complete blood count (CBC) showed a “critical lab value” of 44% band neutrophils (normal, 0% to 10% for the hospital laboratory). The second midwife and nurse told the supervising ObGyn that the patient otherwise looked well; he discharged the patient.

At home, the patient’s condition worsened. Her husband called the ObGyn several times and took her to the emergency department (ED) that evening. Her condition deteriorated and she was transferred to another facility where she was diagnosed with a life-threatening Group A Streptococcus (GAS) infection. After weeks of treatment for sepsis, the patient’s foot was amputated.

Patient's claim: The first midwife was negligent in her postpartum treatment of the patient; she should have come to the hospital to examine the patient or have requested that the supervising ObGyn examine the patient. The rash and CBC test results should have initiated further treatment and investigation; the patient should not have been discharged. GAS was not found or treated in a timely manner, resulting in sepsis and amputation.

Defendants' defense: The case was settled during the trial.

Verdict: A $2,500,000 Massachusetts settlement was reached with the midwife, her practice, and the ObGyn.

 

Failure to follow-up on abnormal Pap
A woman in her 50s reported abnormal bleeding to her gynecologist. Results of an endometrial biopsy were negative for cancer; the gynecologist prescribed hormone therapy. The patient continued to bleed until she entered menopause.

Ten years later, the bleeding returned. Results of a Pap test indicated atypical endometrial cells; an ultrasound showed a markedly abnormal endometrium. The gynecologist recommended a hysteroscopic dilation and curettage (D&C). When he attempted the procedure it ended prematurely because he was unable to enter the patient’s endometrium. The patient’s discharge instructions indicated that she should call the physician for follow up. In a letter to the patient written a month later, the physician discussed the abnormal Pap test results and indicated that the patient had 2 options: another D&C under ultrasound guidance or hysterectomy. He also noted that he would contact the patient’s primary care physician (PCP) for input.

Two years later, the patient returned to the gynecologist because the bleeding, which had never stopped, had increased in intensity. Endometrial cancer was diagnosed.

Patient's claim: The gynecologist never followed up with the patient or her PCP after the incomplete D&C. There is no record that communication ever occurred between the gynecologist and PCP. Lack of follow-up and treatment resulted in progression of the cancer from stage 1 to stage 3C, with a 5-year survivability of 47% (stage 1 survivability is 83%).

Physician's defense: The gynecologist was surprised that no one had ever followed up with the patient. The patient was comparatively negligent for failing to seek medical care for the 2-year period.

Verdict: A $430,000 Minnesota settlement was reached at mediation.

 

LIVER DISEASE LED TO STILLBIRTH
A 37-year-old woman reported nausea, vomiting, headaches, heartburn, and upper abdominal pain to her ObGyn several times during her third trimester. She had been pregnant before and knew that this pregnancy “felt” different. She went to the ED 1 week before the birth of her child, but she was discharged. The child was stillborn.

Parent's claim: Neither the ObGyn who provided prenatal care nor the on-call ED ObGyn ordered laboratory testing, which would have revealed a rare disease: acute fatty liver of pregnancy. Action could have saved the life of her child.

The patient’s ObGyn disregarded the patient’s reported symptoms; no blood work or liver testing was done. The ObGyn should have recognized the symptoms of liver disease that presented during the third trimester. A diagnosis of liver disease would have initiated induction of labor.

 

 

The patient’s expert witness noted that the severity of the third trimester symptoms warranted follow-up testing; the patient should not have had all of those symptoms so late in pregnancy. Testing would have revealed that, by not functioning properly, the liver was creating a toxic environment for the fetus. Labor should have been induced at 36 weeks when the fetal heart testing was still normal.

The ED nurses contacted the on-call ObGyn by telephone to discuss the patient’s symptoms; the ObGyn did not come to the ED to examine the patient or order testing.

The patient suffered emotional distress as a result of the loss of her child.

Defendants' defense: The medical center and the on-call ObGyn settled prior to trial.

The ObGyn claimed that the patient’s symptoms were common for pregnancy and that the disease could not be diagnosed based on the presented symptoms. It was not a violation of the standard of care for the extremely rare liver disease to not be diagnosed. The defense’s expert claimed that the symptoms reported by the patient did not warrant follow-up blood work. There was no way to determine whether or not the fetus died as a result of the mother’s liver disease or nuchal cord involvement.

A placental pathologist noted that the placenta was injured by thrombosis; the fetus’ death was most likely idiopathic. He later acknowledged that thrombosis can be related to liver disease.

Verdict: Jurors were instructed to consider this a personal injury case for the mother due to an unborn fetus’ lacks standing for injury or death under California law. A $160,090 California verdict was returned against the ObGyn who provided prenatal care.

 

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! 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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Zika virus: Counseling considerations for this emerging perinatal threat

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Zika virus infection in the news

- CDC: Zika virus disease cases by US state or territory, updated periodically
- CDC: Q&As for ObGyns on pregnant women and Zika virus, 2/9/16
- CDC: Zika virus infection among US pregnant travelers, 2/26/16
- CDC: Interim guidelines for health care providers caring for infants and children with possible Zika virus infection, 2/19/16
- SMFM statement: Ultrasound screening for fetal microcephaly following Zika virus exposure, 2/16/16
- FDA approves first Zika diagnostic test for commercial use. Newsweek, 2/26/16
- NIH accelerates timeline for human trials of Zika vaccine. The Washington Post, 2/17/16
- Patient resource: Zika virus and pregnancy fact sheet from MotherToBaby.org
- Zika virus article collection from New England Journal of Medicine
- Zika infection diagnosed in 18 pregnant US women who traveled to Zika-affected areas
- FDA grants emergency approval to new 3-in-1 lab test for Zika
- ACOG Practice Advisory: Updated interim guidance for care of women of reproductive age during a Zika virus outbreak, 3/31/16
- MMWR: Patterns in Zika virus testing and infection, 4/22/16
- What insect repellents are safe during pregnancy? 5/19/16
- Zika virus and complications: Q&A from WHO, 5/31/16 
- WHO strengthens guidelines to prevent sexual transmission of Zika virus, 5/31/16
- Ultrasound screening for fetal microcephaly following Zika virus exposure (from AJOG), 6/1/16
- CDC: Interim guidance for interpretation of Zika virus antibody test results, 6/3/16
- First Zika vaccine to begin testing in human trials, The Washington Post, 6/20/16
- NIH launches the Zika in Infants and Pregnancy (ZIP) international study, 6/21/16

CASE 1: Pregnant traveler asks: Should I be tested for Zika virus?
A 28-year-old Hispanic woman (G3P2) at 15 weeks’ gestation visits your office for a routine prenatal care appointment. She reports having returned from a 3-week holiday in Brazil 2 days ago, and she is concerned about having experienced fever, malaise, arthralgias, and a disseminated erythematous rash. She has since heard about the Zika virus and asks you if she and her baby are in danger and whether she should be tested for the disease.

What should you tell this patient?

The Zika virus is an RNA Flavivirus, transmitted primarily by the Aedes aegypti mosquito.1 This virus is closely related to the organisms that cause dengue fever, yellow fever, chikungunya infection, and West Nile infection. By feeding on infected prey, mosquitoes can transmit the virus to humans through bites. They breed near pools of stagnant water, can survive both indoors and outdoors, and prefer to be near people. These mosquitoes bite mostly during daylight hours, so it is essential that people use insect repellent throughout the day while in endemic areas.2 These mosquitoes live only in tropical regions; however, the Aedes albopictus mosquito, also known as the Asian tiger mosquito, lives in temperate regions and can transmit the Zika virus as well3 (FIGURE 1).

FIGURE 1 Aedes aegypti and Aedes albopictus mosquitoes
  

Aedes aegypti (left) and Aedes albopictus (right) mosquitoes. Aedes mosquitoes are the main transmission vector for the Zika virus.

The Zika virus was first discovered in 1947 when it was isolated from a rhesus monkey in Uganda. It subsequently spread to Southeast Asia and eventually caused major outbreaks in the Yap Islands of Micronesia (2007)4 and French Polynesia (2013).5 In 2015, local transmission of the Zika virus infection was noted in Brazil, and, most recently, a pandemic of Zika virus infection has occurred throughout South America, Central America, and the Caribbean islands. To date, local mosquito-borne virus transmission has not occurred in the continental United States, although at least 82 cases acquired during travel to infected areas have been reported.6

Additionally, there have been rare cases involving spread of this virus from infected blood transfusions and through sexual contact.7 In February 2016, the first case of locally acquired Zika virus infection was reported in Texas following sexual transmission of the disease.8

Clinical manifestations of Zika virus infection
Eighty percent of patients infected with Zika virus remain asymptomatic. The illness is short-lived, occurring 2 to 12 days following the mosquito bite, and infected individuals usually do not require hospitalization or experience serious morbidity. When symptoms are present, they typically include low-grade fever (37.8° to 38.5°C), maculopapular rash, arthralgias of the hands and feet, and nonpurulent conjunctivitis. Patients also may experience headache, retro-orbital pain, myalgia, and, rarely, abdominal pain, nausea, vomiting, diarrhea, ulcerations of mucous membranes, and pruritus.9 Guillain-Barré syndrome has been reported in association with Zika virus infection10; however, a definitive cause-effect relationship has not been proven.

If a pregnant woman is infected with the Zika virus, perinatal transmission can occur, either through uteroplacental transmission or vertically from mother to child at the time of delivery. Zika virus RNA has been detected in blood, amniotic fluid, semen, saliva, cerebrospinal fluid, urine, and breast milk. Although the virus has been shown to be present in breast milk, there has been no evidence of viral replication in milk or reported transmission in breastfed infants.11 Pregnant women are not known to have increased susceptibility to Zika virus infection when compared with the general population, and there is no evidence to suggest pregnant women will have a more serious illness if infected.

 

 

The Zika virus has been strongly associated with congenital microcephaly and fetal loss among women infected during pregnancy.12 Following the recent large outbreak in Brazil, an alarmingly high number of Brazilian newborns with microcephaly have been observed. The total now exceeds 4,000. Because of these ominous findings, fetuses and neonates born to women with a history of infection should be evaluated for adverse effects of congenital infection.

Management strategies for Zika virus exposure during pregnancy
The incidence of Zika virus infection during pregnancy remains unknown. However, a pregnant woman may be infected in any trimester, and maternal-fetal transmission of the virus can occur throughout pregnancy. If a patient is pregnant and has travelled to areas of Zika virus transmission, or has had unprotected sexual contact with a partner who has had exposure, she should be carefully screened with a detailed review of systems and ultrasonography to evaluate for fetal microcephaly or intracranial calcifications. The US Centers for Disease Control and Prevention (CDC) initially recommended that, if a patient exhibited 2 or more symptoms consistent with Zika virus infection within 2 weeks of exposure or if sonographic evidence revealed fetal microcephaly or intracranial calcifications, she should be tested for Zika virus infection.11

More recently, the CDC issued new guidelines recommending that even asymptomatic women with exposure have serologic testing for infection and that all exposed women undergo serial ultrasound assessments.13 The CDC also recommends offering retesting in the mid second trimester for women who were exposed very early in gestation.

The best diagnostic test for infection is reverse transcriptase-polymerase chain reaction (RT-PCR), and, ideally, it should be completed within 4 days of symptom onset. Beyond 4 days after symptom onset, testing for Zika virus immunoglobulin M (IgM)-specific antibody and neutralizing antibody should be performed in addition to the RT-PCR test. At times, interpretation of antibody testing can be problematic because cross-reaction with related arboviruses is common. Moreover, Zika viremia decreases rapidly over time; therefore, if serum is collected even 5 to 7 days after symptom onset, a negative test does not definitively exclude infection (TABLE 1).

In the United States, local health departments should be contacted to facilitate testing, as the tests described above are not currently commercially available. If the local health department is unable to perform this testing, clinicians should contact the CDC’s Division of Vector-Borne Diseases (telephone: 1-970-221-6400) or visit their website (http://www.cdc.gov/ncezid/dvbd/specimensub/arboviral-shipping.html) for detailed instructions on specimen submission.

Testing is not indicated for women without a history of travel to areas where Zika virus infection is endemic or without a history of unprotected sexual contact with someone who has been exposed to the infection.

Following the delivery of a live infant to an infected or exposed mother, detailed histopathologic evaluation of the placenta and umbilical cord should be performed. Frozen sections of placental and cord tissue should be tested for Zika virus RNA, and cord serum should be tested for Zika and dengue virus IgM and neutralizing antibodies. In cases of fetal loss in the setting of relevant travel history or exposure (particularly maternal symptoms or sonographic evidence of microcephaly), RT-PCR testing and immunohistochemistry should be completed on fetal tissues, umbilical cord, and placenta.2

Treatment is supportive
At present, there is no vaccine for the Zika virus, and no hyperimmune globulin or anti‑ viral chemotherapy is available. Treatment is therefore supportive. Patients should be encouraged to rest and maintain hydration. The preferred antipyretic and analgesic is acetaminophen (650 mg orally every 6 hours or 1,000 mg orally every 8 hours). Aspirin should be avoided until dengue infection has been ruled out because of the related risk of bleeding with hemorrhagic fever. Nonsteroidal anti-inflammatory drugs should be avoided in the second half of pregnancy because of their effect on fetal renal blood flow (oligohydramnios) and stricture of the ductus arteriosus.

CASE 1 Continued
Given this patient’s recent travel, exposure to mosquito-borne illness, and clinical manifestations of malaise, rash, and joint pain, you proceed with serologic testing. The RT-PCR test is positive for Zika virus.

What should be the next step in the management of this patient?

Prenatal diagnosis and fetal surveillance
The recent epidemic of microcephaly and poor pregnancy outcomes reported in Brazil has been alarming and demonstrates an almost 20-fold increase in incidence of this condition between 2014–2015.14 Careful surveillance is needed for this birth defect and other poor pregnancy outcomes in association with the Zika virus. To date, a direct causal relationship between Zika virus infection and microcephaly has not been unequivocally established15; however; these microcephaly cases have yet to be attributed to any other cause (FIGURE 2)

 

 

FIGURE 2 Microcephaly: associated with Zika virus infection in pregnancy

Illustration depicts a child with congenital microcephaly (left) and one with head circumference within the mean SD (right).

Following the outbreak in Brazil, a task force and registry were established to investigate microcephaly and other birth defects associated with Zika virus infection. In one small investigation, 35 cases of microcephaly were reported, and 71% of the infants were seriously affected (head circumference >3 SD below the mean). Fifty percent of babies had at least one neurologic abnormality, and, of the 27 patients who had neuroimaging studies, all had distinct abnormalities, including widespread brain calcifications and cell migration abnormalities, such as lissencephaly, pachgyria, and ventriculomegaly due to cortical atrophy.16

In addition to microcephaly, fetal ultrasound monitoring has revealed focal brain abnormalities, such as asymmetric cerebral hemispheres, ventriculomegaly, displacement of the midline, failure to visualize the corpus callosum, failure of thalamic development, and the presence of intraocular and brain calcifications.17

In collaboration with the CDC, the American College of Obstetricians and Gynecologists and the Society for Maternal Fetal-Medicine have developed guidelines to monitor fetal growth in women with laboratory evidence of Zika virus infection.18 Recommendations include having a detailed anatomy ultrasound and serial growth sonograms every 3 to 4 weeks, along with referral to a maternal-fetal medicine or infectious disease specialist.

If the pregnancy is beyond 15 weeks’ gestational age, an amniocentesis should be performed in symptomatic patients and in those with abnormal ultrasound findings. Amniotic fluid should be tested for Zika virus with RT-PCR (FIGURE 3).12 The sensitivity and specificity of amniotic fluid RT-PCR in detecting congenital infection, as well as the predictive value of a fetal anomaly, remain unknown at this time. For this reason, a patient must be counseled carefully regarding the benefits of confirming intrauterine infection versus the slight risks of premature rupture of membranes, infection, and pregnancy loss related to amniocentesis.

Once diagnosed, microcephaly cannot be “fixed.” However, pregnancy termination is an option that some parents may choose once they are aware of the diagnosis and prognosis of microcephaly. Moreover, even for parents who would not choose abortion, there may be considerable value in being prepared for the care of a severely disabled child. Microcephaly has many possible causes, Zika virus infection being just one. Others include genetic syndromes and other congenital infections, such as cytomegalovirus (CMV) infection and toxoplasmosis. Amniocentesis therefore may help the clinician sort through these causes. For both CMV infection and toxoplasmosis, certain antenatal treatments may be helpful in lessening the severity of fetal injury.

CASE 2 Pregnant patient has travel plans
A 34-year-old woman (G1P0) presents to you for her first prenatal visit. She mentions she plans to take a cruise through the Eastern Caribbean in 2 weeks. Following the history and physical examination, what should you tell this patient?

Perinatal counseling: Limiting exposure is best
As mentioned, there is currently no treatment, prophylactic medication, or vaccination for Zika virus infection. Because of the virus’s significant associations with adverse pregnancy outcomes, birth defects, and fetal loss, the CDC has issued a travel advisory urging pregnant women to avoid travel to areas when Zika virus infection is prevalent. Currently, Zika virus outbreaks are occurring throughout South and Central America, the Pacific Islands, and Africa, and the infection is expected to spread, mainly due to international air travel. If travel to these areas is inevitable, women should take rigorous precautions to avoid exposure to mosquito bites and infection (TABLE 2).

If a woman was infected with laboratory-confirmed Zika virus infection in a prior pregnancy, she should not be at risk for congenital infection during her next pregnancy. This is mainly because the period of viremia is short-lived and lasts approximately 5 to 7 days.2

Further, based on documented sexual transmission of the virus, pregnant women should abstain from sexual activity or should consistently and correctly use condoms with partners who have Zika virus infection or exposure to the virus until further evidence is available.

Stay informed
Zika virus infection is now pandemic; it has evolved from an isolated disease of the tropics to one that is sweeping the Western hemisphere. It is being reported daily in new locations around the world. Given the unsettling association of Zika virus infection with birth defects, careful obstetric surveillance of exposed or symptomatic patients is imperative. Clinicians must carefully screen patients with potential risk of exposure and be prepared to offer appropriate perinatal counseling and diagnostic testing during pregnancy.

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

References

  1. Dyer O. Zika virus spreads across Americas as concerns mount over birth defects. BMJ. 2015;351:h6983.
  2. Centers for Disease Control and Prevention. Zika virus. Atlanta, GA: US Dept of Health and Human Services; 2015. http://www.cdc.gov/zika/index.html. Accessed February 12, 2016.
  3. Bogoch II, Brady OJ, Kraemer MU, et al. Anticipating the international spread of Zika virus from Brazil. Lancet. 2016;387(10016):335–336.
  4. Duffy MR, Chen TH, Hancock WT, et al. Zika virus outbreak on Yap Island, Federated States of Micronesia. N Engl J Med. 2009;360(24):2536–2543.
  5. Besnard M, Lastere S, Teissier A, Cao-Lormeau V, Musso D. Evidence of perinatal transmission of Zika virus, French Polynesia, December 2013 and February 2014. Euro Surveill. 2014;19(13):pii:20751.
  6. Centers for Disease Control and Prevention. Zika virus disease in the United States, 2015–2016. http://www.cdc.gov/zika/geo/united-states.html. Accessed February 12, 2016.
  7. Foy BD, Kobylinski KC, Chilson Foy JL, et al. Probable non-vector-borne transmission of Zika virus, Colorado, USA. Emerg Infect Dis. 2011;17(5):880–882.
  8. Dallas County Health and Human Services. DCHHS reports first Zika virus case in Dallas County acquired through sexual transmission. http://www.dallascounty.org/department/hhs /press/documents/PR2-2-16DCHHSReportsFirstCaseofZikaVirusThroughSexualTransmission.pdf. Accessed February 3, 2016.
  9. Ministry of Health, Manuatu Hauora. Zika virus. http://www.health.govt.nz/our-work/diseases-and-conditions/zika -virus. Accessed January 13, 2016.
  10. Oehler E, Watrin L, Larre P, et al. Zika virus infection complicated by Guillain-Barre syndrome—case report, French Polynesia, December 2013. Euro Surveill. 2014;19:4–6.
  11. Centers for Disease Control and Prevention. Zika virus: transmission. http://www.cdc.gov/zika/transmission/index.html. Accessed January 20, 2016.
  12. Petersen EE, Staples JE, Meaney-Delamn, D et al. Interim guidelines for pregnant women during a Zika virus outbreak—United States, 2016. MMWR Morb Mortal Wkly Rep. 2016;65(2):30–33.
  13. Oduyebo T, Petersen EE, Rasmussen SA, et al. Update: interim guidelines for health care providers caring for pregnant women and women of reproductive age with possible Zika virus exposure—United States, 2016. MMWR Morb Mortal Wkly Rep. 2016;65(5):122–127.
  14. Pan American Health Organization, World Health Organization. Epidemiological alert: neurological syndrome, congenital malformations, and Zika virus infection. Implications for public health in the Americas. December 1,2015. http://www.paho.org/hq/index.php?option=com_doc man&task=doc_view&Itemid=270&gid=32405&lang=en. Accessed January 13, 2016.
  15. European Centre for Disease Prevention and Control. Rapid risk assessment: Zika virus epidemic in the Americas: potential associations with microcephaly and Guillain-Barré syndrome. December 10, 2015. http://ecdc.europa.eu/en/publications/Publications/zika-virus-americas-association -with-microcephaly-rapid-risk-assessment.pdf. Accessed January 13, 2016.
  16. Schuler-Faccini L, Ribeiro EM, Feitosa IM, et al; Brazilian Medical Genetics Society—Zika Embryopathy Task Force. Possible association between Zika virus infection and microcephaly—Brazil, 2015. MMWR Morb Mortal Wkly Rep. 2016;65(3):59–62.
  17. Oliveira Melo AS, Malinger G, Ximenes R, Szejnfeld PO, Alves Sampaio S, Bispo de Filippis AM. Zika virus intrauterine infection causes fetal brain abnormality and microcephaly: tip of the iceberg? Ultrasound Obstet Gynecol. 2016;47(1):6–7.
  18. European Centre for Disease Prevention and Control. Rapid risk assessment: Zika virus epidemic in the Americas: potential associations with microcephaly and Guillain-Barré syndrome. December 10, 2015. http://ecdc.europa.eu/en/publications/Publications/zika-virus-americas-association.
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Anushka Chelliah, MD, and Patrick Duff, MD


Dr. Chelliah is a Maternal Fetal Medicine Fellow in the Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, University of Florida College of Medicine, Gainesville.


Dr. Duff is Associate Dean for Student Affairs and Professor of Obstetrics and Gynecology in the Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, University of Florida College of Medicine.

The authors report no financial relationships relevant to this article.

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Anushka Chelliah MD, Patrick Duff MD, Zika virus, perinatal threat, pregnancy, pandemic, virus transmission, RNA Flavivirus, Aedes aegypti mosquito, Aedes albopictus mosquito, microcephaly, CDC, reverse transcription-polymerase chain reaction, RT-PCR
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Dr. Duff is Associate Dean for Student Affairs and Professor of Obstetrics and Gynecology in the Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, University of Florida College of Medicine.

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Dr. Chelliah is a Maternal Fetal Medicine Fellow in the Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, University of Florida College of Medicine, Gainesville.


Dr. Duff is Associate Dean for Student Affairs and Professor of Obstetrics and Gynecology in the Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, University of Florida College of Medicine.

The authors report no financial relationships relevant to this article.

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Related Articles

Zika virus infection in the news

- CDC: Zika virus disease cases by US state or territory, updated periodically
- CDC: Q&As for ObGyns on pregnant women and Zika virus, 2/9/16
- CDC: Zika virus infection among US pregnant travelers, 2/26/16
- CDC: Interim guidelines for health care providers caring for infants and children with possible Zika virus infection, 2/19/16
- SMFM statement: Ultrasound screening for fetal microcephaly following Zika virus exposure, 2/16/16
- FDA approves first Zika diagnostic test for commercial use. Newsweek, 2/26/16
- NIH accelerates timeline for human trials of Zika vaccine. The Washington Post, 2/17/16
- Patient resource: Zika virus and pregnancy fact sheet from MotherToBaby.org
- Zika virus article collection from New England Journal of Medicine
- Zika infection diagnosed in 18 pregnant US women who traveled to Zika-affected areas
- FDA grants emergency approval to new 3-in-1 lab test for Zika
- ACOG Practice Advisory: Updated interim guidance for care of women of reproductive age during a Zika virus outbreak, 3/31/16
- MMWR: Patterns in Zika virus testing and infection, 4/22/16
- What insect repellents are safe during pregnancy? 5/19/16
- Zika virus and complications: Q&A from WHO, 5/31/16 
- WHO strengthens guidelines to prevent sexual transmission of Zika virus, 5/31/16
- Ultrasound screening for fetal microcephaly following Zika virus exposure (from AJOG), 6/1/16
- CDC: Interim guidance for interpretation of Zika virus antibody test results, 6/3/16
- First Zika vaccine to begin testing in human trials, The Washington Post, 6/20/16
- NIH launches the Zika in Infants and Pregnancy (ZIP) international study, 6/21/16

CASE 1: Pregnant traveler asks: Should I be tested for Zika virus?
A 28-year-old Hispanic woman (G3P2) at 15 weeks’ gestation visits your office for a routine prenatal care appointment. She reports having returned from a 3-week holiday in Brazil 2 days ago, and she is concerned about having experienced fever, malaise, arthralgias, and a disseminated erythematous rash. She has since heard about the Zika virus and asks you if she and her baby are in danger and whether she should be tested for the disease.

What should you tell this patient?

The Zika virus is an RNA Flavivirus, transmitted primarily by the Aedes aegypti mosquito.1 This virus is closely related to the organisms that cause dengue fever, yellow fever, chikungunya infection, and West Nile infection. By feeding on infected prey, mosquitoes can transmit the virus to humans through bites. They breed near pools of stagnant water, can survive both indoors and outdoors, and prefer to be near people. These mosquitoes bite mostly during daylight hours, so it is essential that people use insect repellent throughout the day while in endemic areas.2 These mosquitoes live only in tropical regions; however, the Aedes albopictus mosquito, also known as the Asian tiger mosquito, lives in temperate regions and can transmit the Zika virus as well3 (FIGURE 1).

FIGURE 1 Aedes aegypti and Aedes albopictus mosquitoes
  

Aedes aegypti (left) and Aedes albopictus (right) mosquitoes. Aedes mosquitoes are the main transmission vector for the Zika virus.

The Zika virus was first discovered in 1947 when it was isolated from a rhesus monkey in Uganda. It subsequently spread to Southeast Asia and eventually caused major outbreaks in the Yap Islands of Micronesia (2007)4 and French Polynesia (2013).5 In 2015, local transmission of the Zika virus infection was noted in Brazil, and, most recently, a pandemic of Zika virus infection has occurred throughout South America, Central America, and the Caribbean islands. To date, local mosquito-borne virus transmission has not occurred in the continental United States, although at least 82 cases acquired during travel to infected areas have been reported.6

Additionally, there have been rare cases involving spread of this virus from infected blood transfusions and through sexual contact.7 In February 2016, the first case of locally acquired Zika virus infection was reported in Texas following sexual transmission of the disease.8

Clinical manifestations of Zika virus infection
Eighty percent of patients infected with Zika virus remain asymptomatic. The illness is short-lived, occurring 2 to 12 days following the mosquito bite, and infected individuals usually do not require hospitalization or experience serious morbidity. When symptoms are present, they typically include low-grade fever (37.8° to 38.5°C), maculopapular rash, arthralgias of the hands and feet, and nonpurulent conjunctivitis. Patients also may experience headache, retro-orbital pain, myalgia, and, rarely, abdominal pain, nausea, vomiting, diarrhea, ulcerations of mucous membranes, and pruritus.9 Guillain-Barré syndrome has been reported in association with Zika virus infection10; however, a definitive cause-effect relationship has not been proven.

If a pregnant woman is infected with the Zika virus, perinatal transmission can occur, either through uteroplacental transmission or vertically from mother to child at the time of delivery. Zika virus RNA has been detected in blood, amniotic fluid, semen, saliva, cerebrospinal fluid, urine, and breast milk. Although the virus has been shown to be present in breast milk, there has been no evidence of viral replication in milk or reported transmission in breastfed infants.11 Pregnant women are not known to have increased susceptibility to Zika virus infection when compared with the general population, and there is no evidence to suggest pregnant women will have a more serious illness if infected.

 

 

The Zika virus has been strongly associated with congenital microcephaly and fetal loss among women infected during pregnancy.12 Following the recent large outbreak in Brazil, an alarmingly high number of Brazilian newborns with microcephaly have been observed. The total now exceeds 4,000. Because of these ominous findings, fetuses and neonates born to women with a history of infection should be evaluated for adverse effects of congenital infection.

Management strategies for Zika virus exposure during pregnancy
The incidence of Zika virus infection during pregnancy remains unknown. However, a pregnant woman may be infected in any trimester, and maternal-fetal transmission of the virus can occur throughout pregnancy. If a patient is pregnant and has travelled to areas of Zika virus transmission, or has had unprotected sexual contact with a partner who has had exposure, she should be carefully screened with a detailed review of systems and ultrasonography to evaluate for fetal microcephaly or intracranial calcifications. The US Centers for Disease Control and Prevention (CDC) initially recommended that, if a patient exhibited 2 or more symptoms consistent with Zika virus infection within 2 weeks of exposure or if sonographic evidence revealed fetal microcephaly or intracranial calcifications, she should be tested for Zika virus infection.11

More recently, the CDC issued new guidelines recommending that even asymptomatic women with exposure have serologic testing for infection and that all exposed women undergo serial ultrasound assessments.13 The CDC also recommends offering retesting in the mid second trimester for women who were exposed very early in gestation.

The best diagnostic test for infection is reverse transcriptase-polymerase chain reaction (RT-PCR), and, ideally, it should be completed within 4 days of symptom onset. Beyond 4 days after symptom onset, testing for Zika virus immunoglobulin M (IgM)-specific antibody and neutralizing antibody should be performed in addition to the RT-PCR test. At times, interpretation of antibody testing can be problematic because cross-reaction with related arboviruses is common. Moreover, Zika viremia decreases rapidly over time; therefore, if serum is collected even 5 to 7 days after symptom onset, a negative test does not definitively exclude infection (TABLE 1).

In the United States, local health departments should be contacted to facilitate testing, as the tests described above are not currently commercially available. If the local health department is unable to perform this testing, clinicians should contact the CDC’s Division of Vector-Borne Diseases (telephone: 1-970-221-6400) or visit their website (http://www.cdc.gov/ncezid/dvbd/specimensub/arboviral-shipping.html) for detailed instructions on specimen submission.

Testing is not indicated for women without a history of travel to areas where Zika virus infection is endemic or without a history of unprotected sexual contact with someone who has been exposed to the infection.

Following the delivery of a live infant to an infected or exposed mother, detailed histopathologic evaluation of the placenta and umbilical cord should be performed. Frozen sections of placental and cord tissue should be tested for Zika virus RNA, and cord serum should be tested for Zika and dengue virus IgM and neutralizing antibodies. In cases of fetal loss in the setting of relevant travel history or exposure (particularly maternal symptoms or sonographic evidence of microcephaly), RT-PCR testing and immunohistochemistry should be completed on fetal tissues, umbilical cord, and placenta.2

Treatment is supportive
At present, there is no vaccine for the Zika virus, and no hyperimmune globulin or anti‑ viral chemotherapy is available. Treatment is therefore supportive. Patients should be encouraged to rest and maintain hydration. The preferred antipyretic and analgesic is acetaminophen (650 mg orally every 6 hours or 1,000 mg orally every 8 hours). Aspirin should be avoided until dengue infection has been ruled out because of the related risk of bleeding with hemorrhagic fever. Nonsteroidal anti-inflammatory drugs should be avoided in the second half of pregnancy because of their effect on fetal renal blood flow (oligohydramnios) and stricture of the ductus arteriosus.

CASE 1 Continued
Given this patient’s recent travel, exposure to mosquito-borne illness, and clinical manifestations of malaise, rash, and joint pain, you proceed with serologic testing. The RT-PCR test is positive for Zika virus.

What should be the next step in the management of this patient?

Prenatal diagnosis and fetal surveillance
The recent epidemic of microcephaly and poor pregnancy outcomes reported in Brazil has been alarming and demonstrates an almost 20-fold increase in incidence of this condition between 2014–2015.14 Careful surveillance is needed for this birth defect and other poor pregnancy outcomes in association with the Zika virus. To date, a direct causal relationship between Zika virus infection and microcephaly has not been unequivocally established15; however; these microcephaly cases have yet to be attributed to any other cause (FIGURE 2)

 

 

FIGURE 2 Microcephaly: associated with Zika virus infection in pregnancy

Illustration depicts a child with congenital microcephaly (left) and one with head circumference within the mean SD (right).

Following the outbreak in Brazil, a task force and registry were established to investigate microcephaly and other birth defects associated with Zika virus infection. In one small investigation, 35 cases of microcephaly were reported, and 71% of the infants were seriously affected (head circumference >3 SD below the mean). Fifty percent of babies had at least one neurologic abnormality, and, of the 27 patients who had neuroimaging studies, all had distinct abnormalities, including widespread brain calcifications and cell migration abnormalities, such as lissencephaly, pachgyria, and ventriculomegaly due to cortical atrophy.16

In addition to microcephaly, fetal ultrasound monitoring has revealed focal brain abnormalities, such as asymmetric cerebral hemispheres, ventriculomegaly, displacement of the midline, failure to visualize the corpus callosum, failure of thalamic development, and the presence of intraocular and brain calcifications.17

In collaboration with the CDC, the American College of Obstetricians and Gynecologists and the Society for Maternal Fetal-Medicine have developed guidelines to monitor fetal growth in women with laboratory evidence of Zika virus infection.18 Recommendations include having a detailed anatomy ultrasound and serial growth sonograms every 3 to 4 weeks, along with referral to a maternal-fetal medicine or infectious disease specialist.

If the pregnancy is beyond 15 weeks’ gestational age, an amniocentesis should be performed in symptomatic patients and in those with abnormal ultrasound findings. Amniotic fluid should be tested for Zika virus with RT-PCR (FIGURE 3).12 The sensitivity and specificity of amniotic fluid RT-PCR in detecting congenital infection, as well as the predictive value of a fetal anomaly, remain unknown at this time. For this reason, a patient must be counseled carefully regarding the benefits of confirming intrauterine infection versus the slight risks of premature rupture of membranes, infection, and pregnancy loss related to amniocentesis.

Once diagnosed, microcephaly cannot be “fixed.” However, pregnancy termination is an option that some parents may choose once they are aware of the diagnosis and prognosis of microcephaly. Moreover, even for parents who would not choose abortion, there may be considerable value in being prepared for the care of a severely disabled child. Microcephaly has many possible causes, Zika virus infection being just one. Others include genetic syndromes and other congenital infections, such as cytomegalovirus (CMV) infection and toxoplasmosis. Amniocentesis therefore may help the clinician sort through these causes. For both CMV infection and toxoplasmosis, certain antenatal treatments may be helpful in lessening the severity of fetal injury.

CASE 2 Pregnant patient has travel plans
A 34-year-old woman (G1P0) presents to you for her first prenatal visit. She mentions she plans to take a cruise through the Eastern Caribbean in 2 weeks. Following the history and physical examination, what should you tell this patient?

Perinatal counseling: Limiting exposure is best
As mentioned, there is currently no treatment, prophylactic medication, or vaccination for Zika virus infection. Because of the virus’s significant associations with adverse pregnancy outcomes, birth defects, and fetal loss, the CDC has issued a travel advisory urging pregnant women to avoid travel to areas when Zika virus infection is prevalent. Currently, Zika virus outbreaks are occurring throughout South and Central America, the Pacific Islands, and Africa, and the infection is expected to spread, mainly due to international air travel. If travel to these areas is inevitable, women should take rigorous precautions to avoid exposure to mosquito bites and infection (TABLE 2).

If a woman was infected with laboratory-confirmed Zika virus infection in a prior pregnancy, she should not be at risk for congenital infection during her next pregnancy. This is mainly because the period of viremia is short-lived and lasts approximately 5 to 7 days.2

Further, based on documented sexual transmission of the virus, pregnant women should abstain from sexual activity or should consistently and correctly use condoms with partners who have Zika virus infection or exposure to the virus until further evidence is available.

Stay informed
Zika virus infection is now pandemic; it has evolved from an isolated disease of the tropics to one that is sweeping the Western hemisphere. It is being reported daily in new locations around the world. Given the unsettling association of Zika virus infection with birth defects, careful obstetric surveillance of exposed or symptomatic patients is imperative. Clinicians must carefully screen patients with potential risk of exposure and be prepared to offer appropriate perinatal counseling and diagnostic testing during pregnancy.

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

Zika virus infection in the news

- CDC: Zika virus disease cases by US state or territory, updated periodically
- CDC: Q&As for ObGyns on pregnant women and Zika virus, 2/9/16
- CDC: Zika virus infection among US pregnant travelers, 2/26/16
- CDC: Interim guidelines for health care providers caring for infants and children with possible Zika virus infection, 2/19/16
- SMFM statement: Ultrasound screening for fetal microcephaly following Zika virus exposure, 2/16/16
- FDA approves first Zika diagnostic test for commercial use. Newsweek, 2/26/16
- NIH accelerates timeline for human trials of Zika vaccine. The Washington Post, 2/17/16
- Patient resource: Zika virus and pregnancy fact sheet from MotherToBaby.org
- Zika virus article collection from New England Journal of Medicine
- Zika infection diagnosed in 18 pregnant US women who traveled to Zika-affected areas
- FDA grants emergency approval to new 3-in-1 lab test for Zika
- ACOG Practice Advisory: Updated interim guidance for care of women of reproductive age during a Zika virus outbreak, 3/31/16
- MMWR: Patterns in Zika virus testing and infection, 4/22/16
- What insect repellents are safe during pregnancy? 5/19/16
- Zika virus and complications: Q&A from WHO, 5/31/16 
- WHO strengthens guidelines to prevent sexual transmission of Zika virus, 5/31/16
- Ultrasound screening for fetal microcephaly following Zika virus exposure (from AJOG), 6/1/16
- CDC: Interim guidance for interpretation of Zika virus antibody test results, 6/3/16
- First Zika vaccine to begin testing in human trials, The Washington Post, 6/20/16
- NIH launches the Zika in Infants and Pregnancy (ZIP) international study, 6/21/16

CASE 1: Pregnant traveler asks: Should I be tested for Zika virus?
A 28-year-old Hispanic woman (G3P2) at 15 weeks’ gestation visits your office for a routine prenatal care appointment. She reports having returned from a 3-week holiday in Brazil 2 days ago, and she is concerned about having experienced fever, malaise, arthralgias, and a disseminated erythematous rash. She has since heard about the Zika virus and asks you if she and her baby are in danger and whether she should be tested for the disease.

What should you tell this patient?

The Zika virus is an RNA Flavivirus, transmitted primarily by the Aedes aegypti mosquito.1 This virus is closely related to the organisms that cause dengue fever, yellow fever, chikungunya infection, and West Nile infection. By feeding on infected prey, mosquitoes can transmit the virus to humans through bites. They breed near pools of stagnant water, can survive both indoors and outdoors, and prefer to be near people. These mosquitoes bite mostly during daylight hours, so it is essential that people use insect repellent throughout the day while in endemic areas.2 These mosquitoes live only in tropical regions; however, the Aedes albopictus mosquito, also known as the Asian tiger mosquito, lives in temperate regions and can transmit the Zika virus as well3 (FIGURE 1).

FIGURE 1 Aedes aegypti and Aedes albopictus mosquitoes
  

Aedes aegypti (left) and Aedes albopictus (right) mosquitoes. Aedes mosquitoes are the main transmission vector for the Zika virus.

The Zika virus was first discovered in 1947 when it was isolated from a rhesus monkey in Uganda. It subsequently spread to Southeast Asia and eventually caused major outbreaks in the Yap Islands of Micronesia (2007)4 and French Polynesia (2013).5 In 2015, local transmission of the Zika virus infection was noted in Brazil, and, most recently, a pandemic of Zika virus infection has occurred throughout South America, Central America, and the Caribbean islands. To date, local mosquito-borne virus transmission has not occurred in the continental United States, although at least 82 cases acquired during travel to infected areas have been reported.6

Additionally, there have been rare cases involving spread of this virus from infected blood transfusions and through sexual contact.7 In February 2016, the first case of locally acquired Zika virus infection was reported in Texas following sexual transmission of the disease.8

Clinical manifestations of Zika virus infection
Eighty percent of patients infected with Zika virus remain asymptomatic. The illness is short-lived, occurring 2 to 12 days following the mosquito bite, and infected individuals usually do not require hospitalization or experience serious morbidity. When symptoms are present, they typically include low-grade fever (37.8° to 38.5°C), maculopapular rash, arthralgias of the hands and feet, and nonpurulent conjunctivitis. Patients also may experience headache, retro-orbital pain, myalgia, and, rarely, abdominal pain, nausea, vomiting, diarrhea, ulcerations of mucous membranes, and pruritus.9 Guillain-Barré syndrome has been reported in association with Zika virus infection10; however, a definitive cause-effect relationship has not been proven.

If a pregnant woman is infected with the Zika virus, perinatal transmission can occur, either through uteroplacental transmission or vertically from mother to child at the time of delivery. Zika virus RNA has been detected in blood, amniotic fluid, semen, saliva, cerebrospinal fluid, urine, and breast milk. Although the virus has been shown to be present in breast milk, there has been no evidence of viral replication in milk or reported transmission in breastfed infants.11 Pregnant women are not known to have increased susceptibility to Zika virus infection when compared with the general population, and there is no evidence to suggest pregnant women will have a more serious illness if infected.

 

 

The Zika virus has been strongly associated with congenital microcephaly and fetal loss among women infected during pregnancy.12 Following the recent large outbreak in Brazil, an alarmingly high number of Brazilian newborns with microcephaly have been observed. The total now exceeds 4,000. Because of these ominous findings, fetuses and neonates born to women with a history of infection should be evaluated for adverse effects of congenital infection.

Management strategies for Zika virus exposure during pregnancy
The incidence of Zika virus infection during pregnancy remains unknown. However, a pregnant woman may be infected in any trimester, and maternal-fetal transmission of the virus can occur throughout pregnancy. If a patient is pregnant and has travelled to areas of Zika virus transmission, or has had unprotected sexual contact with a partner who has had exposure, she should be carefully screened with a detailed review of systems and ultrasonography to evaluate for fetal microcephaly or intracranial calcifications. The US Centers for Disease Control and Prevention (CDC) initially recommended that, if a patient exhibited 2 or more symptoms consistent with Zika virus infection within 2 weeks of exposure or if sonographic evidence revealed fetal microcephaly or intracranial calcifications, she should be tested for Zika virus infection.11

More recently, the CDC issued new guidelines recommending that even asymptomatic women with exposure have serologic testing for infection and that all exposed women undergo serial ultrasound assessments.13 The CDC also recommends offering retesting in the mid second trimester for women who were exposed very early in gestation.

The best diagnostic test for infection is reverse transcriptase-polymerase chain reaction (RT-PCR), and, ideally, it should be completed within 4 days of symptom onset. Beyond 4 days after symptom onset, testing for Zika virus immunoglobulin M (IgM)-specific antibody and neutralizing antibody should be performed in addition to the RT-PCR test. At times, interpretation of antibody testing can be problematic because cross-reaction with related arboviruses is common. Moreover, Zika viremia decreases rapidly over time; therefore, if serum is collected even 5 to 7 days after symptom onset, a negative test does not definitively exclude infection (TABLE 1).

In the United States, local health departments should be contacted to facilitate testing, as the tests described above are not currently commercially available. If the local health department is unable to perform this testing, clinicians should contact the CDC’s Division of Vector-Borne Diseases (telephone: 1-970-221-6400) or visit their website (http://www.cdc.gov/ncezid/dvbd/specimensub/arboviral-shipping.html) for detailed instructions on specimen submission.

Testing is not indicated for women without a history of travel to areas where Zika virus infection is endemic or without a history of unprotected sexual contact with someone who has been exposed to the infection.

Following the delivery of a live infant to an infected or exposed mother, detailed histopathologic evaluation of the placenta and umbilical cord should be performed. Frozen sections of placental and cord tissue should be tested for Zika virus RNA, and cord serum should be tested for Zika and dengue virus IgM and neutralizing antibodies. In cases of fetal loss in the setting of relevant travel history or exposure (particularly maternal symptoms or sonographic evidence of microcephaly), RT-PCR testing and immunohistochemistry should be completed on fetal tissues, umbilical cord, and placenta.2

Treatment is supportive
At present, there is no vaccine for the Zika virus, and no hyperimmune globulin or anti‑ viral chemotherapy is available. Treatment is therefore supportive. Patients should be encouraged to rest and maintain hydration. The preferred antipyretic and analgesic is acetaminophen (650 mg orally every 6 hours or 1,000 mg orally every 8 hours). Aspirin should be avoided until dengue infection has been ruled out because of the related risk of bleeding with hemorrhagic fever. Nonsteroidal anti-inflammatory drugs should be avoided in the second half of pregnancy because of their effect on fetal renal blood flow (oligohydramnios) and stricture of the ductus arteriosus.

CASE 1 Continued
Given this patient’s recent travel, exposure to mosquito-borne illness, and clinical manifestations of malaise, rash, and joint pain, you proceed with serologic testing. The RT-PCR test is positive for Zika virus.

What should be the next step in the management of this patient?

Prenatal diagnosis and fetal surveillance
The recent epidemic of microcephaly and poor pregnancy outcomes reported in Brazil has been alarming and demonstrates an almost 20-fold increase in incidence of this condition between 2014–2015.14 Careful surveillance is needed for this birth defect and other poor pregnancy outcomes in association with the Zika virus. To date, a direct causal relationship between Zika virus infection and microcephaly has not been unequivocally established15; however; these microcephaly cases have yet to be attributed to any other cause (FIGURE 2)

 

 

FIGURE 2 Microcephaly: associated with Zika virus infection in pregnancy

Illustration depicts a child with congenital microcephaly (left) and one with head circumference within the mean SD (right).

Following the outbreak in Brazil, a task force and registry were established to investigate microcephaly and other birth defects associated with Zika virus infection. In one small investigation, 35 cases of microcephaly were reported, and 71% of the infants were seriously affected (head circumference >3 SD below the mean). Fifty percent of babies had at least one neurologic abnormality, and, of the 27 patients who had neuroimaging studies, all had distinct abnormalities, including widespread brain calcifications and cell migration abnormalities, such as lissencephaly, pachgyria, and ventriculomegaly due to cortical atrophy.16

In addition to microcephaly, fetal ultrasound monitoring has revealed focal brain abnormalities, such as asymmetric cerebral hemispheres, ventriculomegaly, displacement of the midline, failure to visualize the corpus callosum, failure of thalamic development, and the presence of intraocular and brain calcifications.17

In collaboration with the CDC, the American College of Obstetricians and Gynecologists and the Society for Maternal Fetal-Medicine have developed guidelines to monitor fetal growth in women with laboratory evidence of Zika virus infection.18 Recommendations include having a detailed anatomy ultrasound and serial growth sonograms every 3 to 4 weeks, along with referral to a maternal-fetal medicine or infectious disease specialist.

If the pregnancy is beyond 15 weeks’ gestational age, an amniocentesis should be performed in symptomatic patients and in those with abnormal ultrasound findings. Amniotic fluid should be tested for Zika virus with RT-PCR (FIGURE 3).12 The sensitivity and specificity of amniotic fluid RT-PCR in detecting congenital infection, as well as the predictive value of a fetal anomaly, remain unknown at this time. For this reason, a patient must be counseled carefully regarding the benefits of confirming intrauterine infection versus the slight risks of premature rupture of membranes, infection, and pregnancy loss related to amniocentesis.

Once diagnosed, microcephaly cannot be “fixed.” However, pregnancy termination is an option that some parents may choose once they are aware of the diagnosis and prognosis of microcephaly. Moreover, even for parents who would not choose abortion, there may be considerable value in being prepared for the care of a severely disabled child. Microcephaly has many possible causes, Zika virus infection being just one. Others include genetic syndromes and other congenital infections, such as cytomegalovirus (CMV) infection and toxoplasmosis. Amniocentesis therefore may help the clinician sort through these causes. For both CMV infection and toxoplasmosis, certain antenatal treatments may be helpful in lessening the severity of fetal injury.

CASE 2 Pregnant patient has travel plans
A 34-year-old woman (G1P0) presents to you for her first prenatal visit. She mentions she plans to take a cruise through the Eastern Caribbean in 2 weeks. Following the history and physical examination, what should you tell this patient?

Perinatal counseling: Limiting exposure is best
As mentioned, there is currently no treatment, prophylactic medication, or vaccination for Zika virus infection. Because of the virus’s significant associations with adverse pregnancy outcomes, birth defects, and fetal loss, the CDC has issued a travel advisory urging pregnant women to avoid travel to areas when Zika virus infection is prevalent. Currently, Zika virus outbreaks are occurring throughout South and Central America, the Pacific Islands, and Africa, and the infection is expected to spread, mainly due to international air travel. If travel to these areas is inevitable, women should take rigorous precautions to avoid exposure to mosquito bites and infection (TABLE 2).

If a woman was infected with laboratory-confirmed Zika virus infection in a prior pregnancy, she should not be at risk for congenital infection during her next pregnancy. This is mainly because the period of viremia is short-lived and lasts approximately 5 to 7 days.2

Further, based on documented sexual transmission of the virus, pregnant women should abstain from sexual activity or should consistently and correctly use condoms with partners who have Zika virus infection or exposure to the virus until further evidence is available.

Stay informed
Zika virus infection is now pandemic; it has evolved from an isolated disease of the tropics to one that is sweeping the Western hemisphere. It is being reported daily in new locations around the world. Given the unsettling association of Zika virus infection with birth defects, careful obstetric surveillance of exposed or symptomatic patients is imperative. Clinicians must carefully screen patients with potential risk of exposure and be prepared to offer appropriate perinatal counseling and diagnostic testing during pregnancy.

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

References

  1. Dyer O. Zika virus spreads across Americas as concerns mount over birth defects. BMJ. 2015;351:h6983.
  2. Centers for Disease Control and Prevention. Zika virus. Atlanta, GA: US Dept of Health and Human Services; 2015. http://www.cdc.gov/zika/index.html. Accessed February 12, 2016.
  3. Bogoch II, Brady OJ, Kraemer MU, et al. Anticipating the international spread of Zika virus from Brazil. Lancet. 2016;387(10016):335–336.
  4. Duffy MR, Chen TH, Hancock WT, et al. Zika virus outbreak on Yap Island, Federated States of Micronesia. N Engl J Med. 2009;360(24):2536–2543.
  5. Besnard M, Lastere S, Teissier A, Cao-Lormeau V, Musso D. Evidence of perinatal transmission of Zika virus, French Polynesia, December 2013 and February 2014. Euro Surveill. 2014;19(13):pii:20751.
  6. Centers for Disease Control and Prevention. Zika virus disease in the United States, 2015–2016. http://www.cdc.gov/zika/geo/united-states.html. Accessed February 12, 2016.
  7. Foy BD, Kobylinski KC, Chilson Foy JL, et al. Probable non-vector-borne transmission of Zika virus, Colorado, USA. Emerg Infect Dis. 2011;17(5):880–882.
  8. Dallas County Health and Human Services. DCHHS reports first Zika virus case in Dallas County acquired through sexual transmission. http://www.dallascounty.org/department/hhs /press/documents/PR2-2-16DCHHSReportsFirstCaseofZikaVirusThroughSexualTransmission.pdf. Accessed February 3, 2016.
  9. Ministry of Health, Manuatu Hauora. Zika virus. http://www.health.govt.nz/our-work/diseases-and-conditions/zika -virus. Accessed January 13, 2016.
  10. Oehler E, Watrin L, Larre P, et al. Zika virus infection complicated by Guillain-Barre syndrome—case report, French Polynesia, December 2013. Euro Surveill. 2014;19:4–6.
  11. Centers for Disease Control and Prevention. Zika virus: transmission. http://www.cdc.gov/zika/transmission/index.html. Accessed January 20, 2016.
  12. Petersen EE, Staples JE, Meaney-Delamn, D et al. Interim guidelines for pregnant women during a Zika virus outbreak—United States, 2016. MMWR Morb Mortal Wkly Rep. 2016;65(2):30–33.
  13. Oduyebo T, Petersen EE, Rasmussen SA, et al. Update: interim guidelines for health care providers caring for pregnant women and women of reproductive age with possible Zika virus exposure—United States, 2016. MMWR Morb Mortal Wkly Rep. 2016;65(5):122–127.
  14. Pan American Health Organization, World Health Organization. Epidemiological alert: neurological syndrome, congenital malformations, and Zika virus infection. Implications for public health in the Americas. December 1,2015. http://www.paho.org/hq/index.php?option=com_doc man&task=doc_view&Itemid=270&gid=32405&lang=en. Accessed January 13, 2016.
  15. European Centre for Disease Prevention and Control. Rapid risk assessment: Zika virus epidemic in the Americas: potential associations with microcephaly and Guillain-Barré syndrome. December 10, 2015. http://ecdc.europa.eu/en/publications/Publications/zika-virus-americas-association -with-microcephaly-rapid-risk-assessment.pdf. Accessed January 13, 2016.
  16. Schuler-Faccini L, Ribeiro EM, Feitosa IM, et al; Brazilian Medical Genetics Society—Zika Embryopathy Task Force. Possible association between Zika virus infection and microcephaly—Brazil, 2015. MMWR Morb Mortal Wkly Rep. 2016;65(3):59–62.
  17. Oliveira Melo AS, Malinger G, Ximenes R, Szejnfeld PO, Alves Sampaio S, Bispo de Filippis AM. Zika virus intrauterine infection causes fetal brain abnormality and microcephaly: tip of the iceberg? Ultrasound Obstet Gynecol. 2016;47(1):6–7.
  18. European Centre for Disease Prevention and Control. Rapid risk assessment: Zika virus epidemic in the Americas: potential associations with microcephaly and Guillain-Barré syndrome. December 10, 2015. http://ecdc.europa.eu/en/publications/Publications/zika-virus-americas-association.
References

  1. Dyer O. Zika virus spreads across Americas as concerns mount over birth defects. BMJ. 2015;351:h6983.
  2. Centers for Disease Control and Prevention. Zika virus. Atlanta, GA: US Dept of Health and Human Services; 2015. http://www.cdc.gov/zika/index.html. Accessed February 12, 2016.
  3. Bogoch II, Brady OJ, Kraemer MU, et al. Anticipating the international spread of Zika virus from Brazil. Lancet. 2016;387(10016):335–336.
  4. Duffy MR, Chen TH, Hancock WT, et al. Zika virus outbreak on Yap Island, Federated States of Micronesia. N Engl J Med. 2009;360(24):2536–2543.
  5. Besnard M, Lastere S, Teissier A, Cao-Lormeau V, Musso D. Evidence of perinatal transmission of Zika virus, French Polynesia, December 2013 and February 2014. Euro Surveill. 2014;19(13):pii:20751.
  6. Centers for Disease Control and Prevention. Zika virus disease in the United States, 2015–2016. http://www.cdc.gov/zika/geo/united-states.html. Accessed February 12, 2016.
  7. Foy BD, Kobylinski KC, Chilson Foy JL, et al. Probable non-vector-borne transmission of Zika virus, Colorado, USA. Emerg Infect Dis. 2011;17(5):880–882.
  8. Dallas County Health and Human Services. DCHHS reports first Zika virus case in Dallas County acquired through sexual transmission. http://www.dallascounty.org/department/hhs /press/documents/PR2-2-16DCHHSReportsFirstCaseofZikaVirusThroughSexualTransmission.pdf. Accessed February 3, 2016.
  9. Ministry of Health, Manuatu Hauora. Zika virus. http://www.health.govt.nz/our-work/diseases-and-conditions/zika -virus. Accessed January 13, 2016.
  10. Oehler E, Watrin L, Larre P, et al. Zika virus infection complicated by Guillain-Barre syndrome—case report, French Polynesia, December 2013. Euro Surveill. 2014;19:4–6.
  11. Centers for Disease Control and Prevention. Zika virus: transmission. http://www.cdc.gov/zika/transmission/index.html. Accessed January 20, 2016.
  12. Petersen EE, Staples JE, Meaney-Delamn, D et al. Interim guidelines for pregnant women during a Zika virus outbreak—United States, 2016. MMWR Morb Mortal Wkly Rep. 2016;65(2):30–33.
  13. Oduyebo T, Petersen EE, Rasmussen SA, et al. Update: interim guidelines for health care providers caring for pregnant women and women of reproductive age with possible Zika virus exposure—United States, 2016. MMWR Morb Mortal Wkly Rep. 2016;65(5):122–127.
  14. Pan American Health Organization, World Health Organization. Epidemiological alert: neurological syndrome, congenital malformations, and Zika virus infection. Implications for public health in the Americas. December 1,2015. http://www.paho.org/hq/index.php?option=com_doc man&task=doc_view&Itemid=270&gid=32405&lang=en. Accessed January 13, 2016.
  15. European Centre for Disease Prevention and Control. Rapid risk assessment: Zika virus epidemic in the Americas: potential associations with microcephaly and Guillain-Barré syndrome. December 10, 2015. http://ecdc.europa.eu/en/publications/Publications/zika-virus-americas-association -with-microcephaly-rapid-risk-assessment.pdf. Accessed January 13, 2016.
  16. Schuler-Faccini L, Ribeiro EM, Feitosa IM, et al; Brazilian Medical Genetics Society—Zika Embryopathy Task Force. Possible association between Zika virus infection and microcephaly—Brazil, 2015. MMWR Morb Mortal Wkly Rep. 2016;65(3):59–62.
  17. Oliveira Melo AS, Malinger G, Ximenes R, Szejnfeld PO, Alves Sampaio S, Bispo de Filippis AM. Zika virus intrauterine infection causes fetal brain abnormality and microcephaly: tip of the iceberg? Ultrasound Obstet Gynecol. 2016;47(1):6–7.
  18. European Centre for Disease Prevention and Control. Rapid risk assessment: Zika virus epidemic in the Americas: potential associations with microcephaly and Guillain-Barré syndrome. December 10, 2015. http://ecdc.europa.eu/en/publications/Publications/zika-virus-americas-association.
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OBG Management - 28(3)
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OBG Management - 28(3)
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Zika virus: Counseling considerations for this emerging perinatal threat
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Zika virus: Counseling considerations for this emerging perinatal threat
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Anushka Chelliah MD, Patrick Duff MD, Zika virus, perinatal threat, pregnancy, pandemic, virus transmission, RNA Flavivirus, Aedes aegypti mosquito, Aedes albopictus mosquito, microcephaly, CDC, reverse transcription-polymerase chain reaction, RT-PCR
Legacy Keywords
Anushka Chelliah MD, Patrick Duff MD, Zika virus, perinatal threat, pregnancy, pandemic, virus transmission, RNA Flavivirus, Aedes aegypti mosquito, Aedes albopictus mosquito, microcephaly, CDC, reverse transcription-polymerase chain reaction, RT-PCR
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  • Management strategies for pregnant patients with Zika virus exposure
  • Fetal surveillance
  • Perinatal counseling on exposure prevention
  • Algorithm for evaluation and management
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