Commentary

The words “disaster preparedness” have been used so many times in the past several years that their mere mention now makes some people’s eyes glaze over. But as much as the drums have been beaten for preparing for natural and manmade calamities, the far more common health care disasters that affect people on a daily basis still go largely unaddressed. Among them is the cycle of over-crowding, ambulance diversions, and admission delays that compromise care in the majority of emergency departments in this country.

Since the fall of 2001, every talk I’ve given about disasters has included a picture of the September 10, 2001, cover of U.S. News & World Report that proclaimed: “Crisis in the ER—Turnaways and Huge Delays Are a Sure-fire Recipe for Disaster.” This striking background for 9/11 was also noted by the Institute of Medicine in its 2006 report, “Hospital-Based Emergency Care: At the Breaking Point.”

If the goal of preparing for an un-anticipated major disaster is to save as many people as possible and minimize the harm to those who survive, why aren’t we willing to devote the same degree of attention and re-sources to our daily disasters? When added together, over the course of a year, these disasters affect more lives and result in more harm to more people than most single mass-casualty events. Is it rational to devote so many resources that hopefully will never be needed while at the same time ignoring what actually happens day after day?

For at least 10 months prior to 9/11, there was a nationwide shortage of tetanus diphtheria (Td) toxoid. Then, late in the afternoon of September 11, our hospital’s apothecary-in-chief called to ask me how many doses of the Td vaccine we would like delivered to the ED. The federal disaster “push packs” had arrived in the New York City area and the supplies they contained (including 50,000 doses of Td) were being distributed to hospitals dealing with the aftermath of the terrorist attack.

Were they important and necessary for a mass-casualty disaster? Absolutely. But no less important for treating the tens of thousands of contaminated wound exposures that people sustained in the months leading up to 9/11.

During disaster drills at our hospital, I make it a practice to “disappear” in order to let the lead attending physician gain the experience of running the ED portion of the exercise. If I were in the ED, participants from every department would inevitably come up to me to ask what was needed, and it would be delivered immediately. This is what happens during actual disasters—what needs to happen happens. Patients in the ED are instantly transferred upstairs to beds that seemingly didn’t exist moments before. House officers, attending physicians, and consultants from all other departments appear in the ED, ready to assist for as long as necessary, often before their presence is even requested.

But why are there no state and federal officials asking during our daily disasters what else is needed in order to quickly care for everyone waiting to be seen? And where are the resources needed to expand the nation’s EDs to accommodate all who seek care there? Why is one type of disaster less important than the other? This seeming oversight is perhaps best expressed in the words of the late comedian George Carlin: “I’m not concerned about all hell breaking loose, but that a part of hell will break loose. It will be much harder to detect.”

Our article on Ebola this month was expanded in response to the diagnosis of the first case in the United States. “Update: Current Management of HIV/AIDs in the Emergency Department” by Sarah Battistich, MD, originally scheduled for this issue will appear instead in the November issue.

The words “disaster preparedness” have been used so many times in the past several years that their mere mention now makes some people’s eyes glaze over. But as much as the drums have been beaten for preparing for natural and manmade calamities, the far more common health care disasters that affect people on a daily basis still go largely unaddressed. Among them is the cycle of over-crowding, ambulance diversions, and admission delays that compromise care in the majority of emergency departments in this country.

Since the fall of 2001, every talk I’ve given about disasters has included a picture of the September 10, 2001, cover of U.S. News & World Report that proclaimed: “Crisis in the ER—Turnaways and Huge Delays Are a Sure-fire Recipe for Disaster.” This striking background for 9/11 was also noted by the Institute of Medicine in its 2006 report, “Hospital-Based Emergency Care: At the Breaking Point.”

If the goal of preparing for an un-anticipated major disaster is to save as many people as possible and minimize the harm to those who survive, why aren’t we willing to devote the same degree of attention and re-sources to our daily disasters? When added together, over the course of a year, these disasters affect more lives and result in more harm to more people than most single mass-casualty events. Is it rational to devote so many resources that hopefully will never be needed while at the same time ignoring what actually happens day after day?

For at least 10 months prior to 9/11, there was a nationwide shortage of tetanus diphtheria (Td) toxoid. Then, late in the afternoon of September 11, our hospital’s apothecary-in-chief called to ask me how many doses of the Td vaccine we would like delivered to the ED. The federal disaster “push packs” had arrived in the New York City area and the supplies they contained (including 50,000 doses of Td) were being distributed to hospitals dealing with the aftermath of the terrorist attack.

Were they important and necessary for a mass-casualty disaster? Absolutely. But no less important for treating the tens of thousands of contaminated wound exposures that people sustained in the months leading up to 9/11.

During disaster drills at our hospital, I make it a practice to “disappear” in order to let the lead attending physician gain the experience of running the ED portion of the exercise. If I were in the ED, participants from every department would inevitably come up to me to ask what was needed, and it would be delivered immediately. This is what happens during actual disasters—what needs to happen happens. Patients in the ED are instantly transferred upstairs to beds that seemingly didn’t exist moments before. House officers, attending physicians, and consultants from all other departments appear in the ED, ready to assist for as long as necessary, often before their presence is even requested.

But why are there no state and federal officials asking during our daily disasters what else is needed in order to quickly care for everyone waiting to be seen? And where are the resources needed to expand the nation’s EDs to accommodate all who seek care there? Why is one type of disaster less important than the other? This seeming oversight is perhaps best expressed in the words of the late comedian George Carlin: “I’m not concerned about all hell breaking loose, but that a part of hell will break loose. It will be much harder to detect.”

Our article on Ebola this month was expanded in response to the diagnosis of the first case in the United States. “Update: Current Management of HIV/AIDs in the Emergency Department” by Sarah Battistich, MD, originally scheduled for this issue will appear instead in the November issue.

The words “disaster preparedness” have been used so many times in the past several years that their mere mention now makes some people’s eyes glaze over. But as much as the drums have been beaten for preparing for natural and manmade calamities, the far more common health care disasters that affect people on a daily basis still go largely unaddressed. Among them is the cycle of over-crowding, ambulance diversions, and admission delays that compromise care in the majority of emergency departments in this country.

Since the fall of 2001, every talk I’ve given about disasters has included a picture of the September 10, 2001, cover of U.S. News & World Report that proclaimed: “Crisis in the ER—Turnaways and Huge Delays Are a Sure-fire Recipe for Disaster.” This striking background for 9/11 was also noted by the Institute of Medicine in its 2006 report, “Hospital-Based Emergency Care: At the Breaking Point.”

If the goal of preparing for an un-anticipated major disaster is to save as many people as possible and minimize the harm to those who survive, why aren’t we willing to devote the same degree of attention and re-sources to our daily disasters? When added together, over the course of a year, these disasters affect more lives and result in more harm to more people than most single mass-casualty events. Is it rational to devote so many resources that hopefully will never be needed while at the same time ignoring what actually happens day after day?

For at least 10 months prior to 9/11, there was a nationwide shortage of tetanus diphtheria (Td) toxoid. Then, late in the afternoon of September 11, our hospital’s apothecary-in-chief called to ask me how many doses of the Td vaccine we would like delivered to the ED. The federal disaster “push packs” had arrived in the New York City area and the supplies they contained (including 50,000 doses of Td) were being distributed to hospitals dealing with the aftermath of the terrorist attack.

Were they important and necessary for a mass-casualty disaster? Absolutely. But no less important for treating the tens of thousands of contaminated wound exposures that people sustained in the months leading up to 9/11.

During disaster drills at our hospital, I make it a practice to “disappear” in order to let the lead attending physician gain the experience of running the ED portion of the exercise. If I were in the ED, participants from every department would inevitably come up to me to ask what was needed, and it would be delivered immediately. This is what happens during actual disasters—what needs to happen happens. Patients in the ED are instantly transferred upstairs to beds that seemingly didn’t exist moments before. House officers, attending physicians, and consultants from all other departments appear in the ED, ready to assist for as long as necessary, often before their presence is even requested.

But why are there no state and federal officials asking during our daily disasters what else is needed in order to quickly care for everyone waiting to be seen? And where are the resources needed to expand the nation’s EDs to accommodate all who seek care there? Why is one type of disaster less important than the other? This seeming oversight is perhaps best expressed in the words of the late comedian George Carlin: “I’m not concerned about all hell breaking loose, but that a part of hell will break loose. It will be much harder to detect.”

Our article on Ebola this month was expanded in response to the diagnosis of the first case in the United States. “Update: Current Management of HIV/AIDs in the Emergency Department” by Sarah Battistich, MD, originally scheduled for this issue will appear instead in the November issue.

A quarter century ago, the North American Menopause Society (NAMS) started a revolution in the care of women at menopause and beyond, giving menopause care the focus it deserves in clinical practice and putting the standards of care for midlife and older women on solid scientific ground.

The care of midlife women has changed dramatically over the past 25 years, with a greatly expanded array of treatment options, accompanied by extensive research. After the publication of the Women’s Health Initiative and with every significant publication and advancement in the field, NAMS has been available to help clinicians and women make the best possible evidence-based care decisions.

As the Society marks its 25th anniversary, NAMS continues this tradition by publishing the first comprehensive set of evidence-based recommendations for the care of midlife women in the Society’s journal (Menopause 2014;21:1038-62). This valuable resource is now freely available to clinicians and women on the NAMS website. The North American Menopause Society Recommendations for Clinical Care of Midlife Women will help health care providers and women navigate the controversy regarding hormone therapy and other treatments to incorporate the latest scientifically sound findings into care. These key points and recommendations on more than 50 topics cover the management of everything related to midlife women’s health, from hot flashes, genitourinary syndrome of menopause, and osteoporosis to depression, cardiovascular disease, and thyroid dysfunction.

For each topic, the key points and recommendations were written by an expert in the field. Contributors were drawn from a broad range of specialties, including gynecology, internal medicine, medical and reproductive endocrinology, cardiology, neurology, psychiatry, psychology, dermatology, and oncology.

Graded for level of evidence, each topic was carefully reviewed for accuracy and relevance, edited, and approved by an editorial panel of experts in midlife women’s health. The 2013-2014 NAMS Board of Trustees provided final review and approval of the key points and clinical recommendations.

The mission of NAMS is to promote the health and quality of life of all women during midlife and beyond. To further this goal, we offer a succinct and evidence-based guide to all who wish to understand and manage women’s health at this critical stage of life.

Dr. Jan L. Shifren is the president of NAMS and director of the Massachusetts General Midlife Women’s Health Center in Boston, and Dr. Margery L.S .Gass is the executive director of NAMS. Dr. Shifren also is an editorial advisory board member for Ob.Gyn. News. Dr. Shifren and Dr. Gass said they had no relevant financial disclosures.

A quarter century ago, the North American Menopause Society (NAMS) started a revolution in the care of women at menopause and beyond, giving menopause care the focus it deserves in clinical practice and putting the standards of care for midlife and older women on solid scientific ground.

The care of midlife women has changed dramatically over the past 25 years, with a greatly expanded array of treatment options, accompanied by extensive research. After the publication of the Women’s Health Initiative and with every significant publication and advancement in the field, NAMS has been available to help clinicians and women make the best possible evidence-based care decisions.

As the Society marks its 25th anniversary, NAMS continues this tradition by publishing the first comprehensive set of evidence-based recommendations for the care of midlife women in the Society’s journal (Menopause 2014;21:1038-62). This valuable resource is now freely available to clinicians and women on the NAMS website. The North American Menopause Society Recommendations for Clinical Care of Midlife Women will help health care providers and women navigate the controversy regarding hormone therapy and other treatments to incorporate the latest scientifically sound findings into care. These key points and recommendations on more than 50 topics cover the management of everything related to midlife women’s health, from hot flashes, genitourinary syndrome of menopause, and osteoporosis to depression, cardiovascular disease, and thyroid dysfunction.

For each topic, the key points and recommendations were written by an expert in the field. Contributors were drawn from a broad range of specialties, including gynecology, internal medicine, medical and reproductive endocrinology, cardiology, neurology, psychiatry, psychology, dermatology, and oncology.

Graded for level of evidence, each topic was carefully reviewed for accuracy and relevance, edited, and approved by an editorial panel of experts in midlife women’s health. The 2013-2014 NAMS Board of Trustees provided final review and approval of the key points and clinical recommendations.

The mission of NAMS is to promote the health and quality of life of all women during midlife and beyond. To further this goal, we offer a succinct and evidence-based guide to all who wish to understand and manage women’s health at this critical stage of life.

Dr. Jan L. Shifren is the president of NAMS and director of the Massachusetts General Midlife Women’s Health Center in Boston, and Dr. Margery L.S .Gass is the executive director of NAMS. Dr. Shifren also is an editorial advisory board member for Ob.Gyn. News. Dr. Shifren and Dr. Gass said they had no relevant financial disclosures.

A quarter century ago, the North American Menopause Society (NAMS) started a revolution in the care of women at menopause and beyond, giving menopause care the focus it deserves in clinical practice and putting the standards of care for midlife and older women on solid scientific ground.

The care of midlife women has changed dramatically over the past 25 years, with a greatly expanded array of treatment options, accompanied by extensive research. After the publication of the Women’s Health Initiative and with every significant publication and advancement in the field, NAMS has been available to help clinicians and women make the best possible evidence-based care decisions.

As the Society marks its 25th anniversary, NAMS continues this tradition by publishing the first comprehensive set of evidence-based recommendations for the care of midlife women in the Society’s journal (Menopause 2014;21:1038-62). This valuable resource is now freely available to clinicians and women on the NAMS website. The North American Menopause Society Recommendations for Clinical Care of Midlife Women will help health care providers and women navigate the controversy regarding hormone therapy and other treatments to incorporate the latest scientifically sound findings into care. These key points and recommendations on more than 50 topics cover the management of everything related to midlife women’s health, from hot flashes, genitourinary syndrome of menopause, and osteoporosis to depression, cardiovascular disease, and thyroid dysfunction.

For each topic, the key points and recommendations were written by an expert in the field. Contributors were drawn from a broad range of specialties, including gynecology, internal medicine, medical and reproductive endocrinology, cardiology, neurology, psychiatry, psychology, dermatology, and oncology.

Graded for level of evidence, each topic was carefully reviewed for accuracy and relevance, edited, and approved by an editorial panel of experts in midlife women’s health. The 2013-2014 NAMS Board of Trustees provided final review and approval of the key points and clinical recommendations.

The mission of NAMS is to promote the health and quality of life of all women during midlife and beyond. To further this goal, we offer a succinct and evidence-based guide to all who wish to understand and manage women’s health at this critical stage of life.

Dr. Jan L. Shifren is the president of NAMS and director of the Massachusetts General Midlife Women’s Health Center in Boston, and Dr. Margery L.S .Gass is the executive director of NAMS. Dr. Shifren also is an editorial advisory board member for Ob.Gyn. News. Dr. Shifren and Dr. Gass said they had no relevant financial disclosures.

How did you pick your field?

Neurology, for me, was a combination of personal likes and dislikes. I found it interesting, but also learned I didn’t enjoy most other branches of medicine.

Like other medical students, I went through a series of rotations, gradually crossing things off my list. Eventually, I found that internal medicine fit my personality best, but I didn’t like having to know something about everything. Neurology was a good fit for the way my mind and temperament work. Now, after 16 years in practice, I have no regrets. I still like the job, in spite of having to deal with insurance companies, excessive paperwork, and hospital administrators.

I’m not an adrenaline junkie, living to run in and save lives at the drop of a hat. Nor am I someone who enjoys procedures. I’m the thinking type, and happy to spend my days sitting behind a desk and trying to look smart. I’d have to say I nailed it, my atypical wardrobe notwithstanding.

Medical fields, like cars and music, are incredibly diverse. There’s something out there for every personality type. And that’s excluding all the subspecialties a field gets further broken down to. (In my world there’s movement disorder docs, epileptologists, and stroke-ologists, to name a few.)

When I was in training, an adviser told me that one’s choice of field is as much success as failure. By becoming a neurologist, I’m admitting that I’ve failed to understand pretty much everything else in medicine. On the opposite side, an internist has conceded failure to understand any given organ system in depth.

Most importantly, you don’t care that you’ve failed the rest. This frees you to focus only on what you enjoy and what interests you, and to not worry about anything else.

Using this argument, the best care is from someone who failed everything else. Or, in a better light, who only does one thing, but does it well. No matter how you play it, it’s what works out best for all involved – especially our patients.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

How did you pick your field?

Neurology, for me, was a combination of personal likes and dislikes. I found it interesting, but also learned I didn’t enjoy most other branches of medicine.

Like other medical students, I went through a series of rotations, gradually crossing things off my list. Eventually, I found that internal medicine fit my personality best, but I didn’t like having to know something about everything. Neurology was a good fit for the way my mind and temperament work. Now, after 16 years in practice, I have no regrets. I still like the job, in spite of having to deal with insurance companies, excessive paperwork, and hospital administrators.

I’m not an adrenaline junkie, living to run in and save lives at the drop of a hat. Nor am I someone who enjoys procedures. I’m the thinking type, and happy to spend my days sitting behind a desk and trying to look smart. I’d have to say I nailed it, my atypical wardrobe notwithstanding.

Medical fields, like cars and music, are incredibly diverse. There’s something out there for every personality type. And that’s excluding all the subspecialties a field gets further broken down to. (In my world there’s movement disorder docs, epileptologists, and stroke-ologists, to name a few.)

When I was in training, an adviser told me that one’s choice of field is as much success as failure. By becoming a neurologist, I’m admitting that I’ve failed to understand pretty much everything else in medicine. On the opposite side, an internist has conceded failure to understand any given organ system in depth.

Most importantly, you don’t care that you’ve failed the rest. This frees you to focus only on what you enjoy and what interests you, and to not worry about anything else.

Using this argument, the best care is from someone who failed everything else. Or, in a better light, who only does one thing, but does it well. No matter how you play it, it’s what works out best for all involved – especially our patients.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

How did you pick your field?

Neurology, for me, was a combination of personal likes and dislikes. I found it interesting, but also learned I didn’t enjoy most other branches of medicine.

Like other medical students, I went through a series of rotations, gradually crossing things off my list. Eventually, I found that internal medicine fit my personality best, but I didn’t like having to know something about everything. Neurology was a good fit for the way my mind and temperament work. Now, after 16 years in practice, I have no regrets. I still like the job, in spite of having to deal with insurance companies, excessive paperwork, and hospital administrators.

I’m not an adrenaline junkie, living to run in and save lives at the drop of a hat. Nor am I someone who enjoys procedures. I’m the thinking type, and happy to spend my days sitting behind a desk and trying to look smart. I’d have to say I nailed it, my atypical wardrobe notwithstanding.

Medical fields, like cars and music, are incredibly diverse. There’s something out there for every personality type. And that’s excluding all the subspecialties a field gets further broken down to. (In my world there’s movement disorder docs, epileptologists, and stroke-ologists, to name a few.)

When I was in training, an adviser told me that one’s choice of field is as much success as failure. By becoming a neurologist, I’m admitting that I’ve failed to understand pretty much everything else in medicine. On the opposite side, an internist has conceded failure to understand any given organ system in depth.

Most importantly, you don’t care that you’ve failed the rest. This frees you to focus only on what you enjoy and what interests you, and to not worry about anything else.

Using this argument, the best care is from someone who failed everything else. Or, in a better light, who only does one thing, but does it well. No matter how you play it, it’s what works out best for all involved – especially our patients.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

I read about Dr. Siedhof’s decision analysis with interest, because I fear that the Food and Drug Administration may have overreached again. Based on a few, small, retrospective studies, the FDA has published a position statement discouraging the use of power morcellation for laparoscopic hysterectomy for fibroids. This has caused an uproar in the ob.gyn. community, particularly with the recent popularity of minimally invasive laparoscopic surgical (MIS) approaches. I realize the FDA has the safety of the American populace at heart, but I think that FDA officials really do not understand the power they hold in such announcements.

Based on this and other similar statements, our legal colleagues turn the full force of the product liability teams on the “problem,” beginning to advertise and sign up class action lawsuit cases. Because the bulk of the legal profession concentrates on only one side of the issue (potential injuries), this in turn results in one-sided media coverage. The public begins to be bombarded with negative opinions, and through repetition, public opinion is typically swayed. Product manufacturers and physician groups circle the wagons as the number of complaints and lawsuits explodes. As the complaint numbers increase, the FDA has no choice but to issue a “boxed warning.” We have seen this pattern repeat itself with silicone breast implants, and, more recently, vaginal mesh. Already we have seen hospitals ban the use of morcellators, and at least one manufacturer has pulled its instruments off the market.

I must emphasize that the FDA safety alert about morcellators is not a boxed warning. Nothing about the position statement suggests that the morcellator itself malfunctions, risks patient injury, or performs in any way other than the way it was designed. The issue is whether women are being counseled that morcellation could lead to the very rare possibility of disseminating a leiomyosarcoma. Seeing that the underlying risk of leiomyosarcoma has not been well established (with the range of incidence being 1/350 to 1/7,400), it is difficult to know how much to emphasize the risks of leiomyosarcoma to each patient, and, thus, the risk of distant spread or up-staging as a result of morcellation during laparoscopic hysterectomy.

I believe Dr. Siedhof’s team used the best published data available, made conservative assumptions, and tried to take into account the 5-year survival and quality-adjusted life-years (QALY) data for those patients who ultimately were determined to have leiomyosarcoma, regardless of hysterectomy route. Their major findings showed very similar results whether the hysterectomy was performed abdominally or laparoscopically with morcellation. If reliable screening tests or predictive factors were available, then those at higher risk could be guided away from MIS and morcellation. But because symptoms and ultrasound findings are nonspecific, and endometrial sampling that is less than 50% effective is establishing the diagnosis, we are back to square one.

While I cautiously applaud Dr. Siedhof’s team for performing much needed research in an area where we desperately need information, I urge my colleagues to temper their reactions to the position statement before changing their practice patterns. Certainly, we can emphasize the possibility of disseminating a rare leiomyosarcoma in 1/1,000 cases, if a power morcellator is used. But we need to balance out the overwhelmingly bad information being propagated by legal professionals and the media with a good dose of common sense.

Patrick J. Woodman, D.O., is associate director of the female pelvic medicine and reconstructive surgery fellowship at Indiana University, Indianapolis.

I read about Dr. Siedhof’s decision analysis with interest, because I fear that the Food and Drug Administration may have overreached again. Based on a few, small, retrospective studies, the FDA has published a position statement discouraging the use of power morcellation for laparoscopic hysterectomy for fibroids. This has caused an uproar in the ob.gyn. community, particularly with the recent popularity of minimally invasive laparoscopic surgical (MIS) approaches. I realize the FDA has the safety of the American populace at heart, but I think that FDA officials really do not understand the power they hold in such announcements.

Based on this and other similar statements, our legal colleagues turn the full force of the product liability teams on the “problem,” beginning to advertise and sign up class action lawsuit cases. Because the bulk of the legal profession concentrates on only one side of the issue (potential injuries), this in turn results in one-sided media coverage. The public begins to be bombarded with negative opinions, and through repetition, public opinion is typically swayed. Product manufacturers and physician groups circle the wagons as the number of complaints and lawsuits explodes. As the complaint numbers increase, the FDA has no choice but to issue a “boxed warning.” We have seen this pattern repeat itself with silicone breast implants, and, more recently, vaginal mesh. Already we have seen hospitals ban the use of morcellators, and at least one manufacturer has pulled its instruments off the market.

I must emphasize that the FDA safety alert about morcellators is not a boxed warning. Nothing about the position statement suggests that the morcellator itself malfunctions, risks patient injury, or performs in any way other than the way it was designed. The issue is whether women are being counseled that morcellation could lead to the very rare possibility of disseminating a leiomyosarcoma. Seeing that the underlying risk of leiomyosarcoma has not been well established (with the range of incidence being 1/350 to 1/7,400), it is difficult to know how much to emphasize the risks of leiomyosarcoma to each patient, and, thus, the risk of distant spread or up-staging as a result of morcellation during laparoscopic hysterectomy.

I believe Dr. Siedhof’s team used the best published data available, made conservative assumptions, and tried to take into account the 5-year survival and quality-adjusted life-years (QALY) data for those patients who ultimately were determined to have leiomyosarcoma, regardless of hysterectomy route. Their major findings showed very similar results whether the hysterectomy was performed abdominally or laparoscopically with morcellation. If reliable screening tests or predictive factors were available, then those at higher risk could be guided away from MIS and morcellation. But because symptoms and ultrasound findings are nonspecific, and endometrial sampling that is less than 50% effective is establishing the diagnosis, we are back to square one.

While I cautiously applaud Dr. Siedhof’s team for performing much needed research in an area where we desperately need information, I urge my colleagues to temper their reactions to the position statement before changing their practice patterns. Certainly, we can emphasize the possibility of disseminating a rare leiomyosarcoma in 1/1,000 cases, if a power morcellator is used. But we need to balance out the overwhelmingly bad information being propagated by legal professionals and the media with a good dose of common sense.

Patrick J. Woodman, D.O., is associate director of the female pelvic medicine and reconstructive surgery fellowship at Indiana University, Indianapolis.

I read about Dr. Siedhof’s decision analysis with interest, because I fear that the Food and Drug Administration may have overreached again. Based on a few, small, retrospective studies, the FDA has published a position statement discouraging the use of power morcellation for laparoscopic hysterectomy for fibroids. This has caused an uproar in the ob.gyn. community, particularly with the recent popularity of minimally invasive laparoscopic surgical (MIS) approaches. I realize the FDA has the safety of the American populace at heart, but I think that FDA officials really do not understand the power they hold in such announcements.

Based on this and other similar statements, our legal colleagues turn the full force of the product liability teams on the “problem,” beginning to advertise and sign up class action lawsuit cases. Because the bulk of the legal profession concentrates on only one side of the issue (potential injuries), this in turn results in one-sided media coverage. The public begins to be bombarded with negative opinions, and through repetition, public opinion is typically swayed. Product manufacturers and physician groups circle the wagons as the number of complaints and lawsuits explodes. As the complaint numbers increase, the FDA has no choice but to issue a “boxed warning.” We have seen this pattern repeat itself with silicone breast implants, and, more recently, vaginal mesh. Already we have seen hospitals ban the use of morcellators, and at least one manufacturer has pulled its instruments off the market.

I must emphasize that the FDA safety alert about morcellators is not a boxed warning. Nothing about the position statement suggests that the morcellator itself malfunctions, risks patient injury, or performs in any way other than the way it was designed. The issue is whether women are being counseled that morcellation could lead to the very rare possibility of disseminating a leiomyosarcoma. Seeing that the underlying risk of leiomyosarcoma has not been well established (with the range of incidence being 1/350 to 1/7,400), it is difficult to know how much to emphasize the risks of leiomyosarcoma to each patient, and, thus, the risk of distant spread or up-staging as a result of morcellation during laparoscopic hysterectomy.

I believe Dr. Siedhof’s team used the best published data available, made conservative assumptions, and tried to take into account the 5-year survival and quality-adjusted life-years (QALY) data for those patients who ultimately were determined to have leiomyosarcoma, regardless of hysterectomy route. Their major findings showed very similar results whether the hysterectomy was performed abdominally or laparoscopically with morcellation. If reliable screening tests or predictive factors were available, then those at higher risk could be guided away from MIS and morcellation. But because symptoms and ultrasound findings are nonspecific, and endometrial sampling that is less than 50% effective is establishing the diagnosis, we are back to square one.

While I cautiously applaud Dr. Siedhof’s team for performing much needed research in an area where we desperately need information, I urge my colleagues to temper their reactions to the position statement before changing their practice patterns. Certainly, we can emphasize the possibility of disseminating a rare leiomyosarcoma in 1/1,000 cases, if a power morcellator is used. But we need to balance out the overwhelmingly bad information being propagated by legal professionals and the media with a good dose of common sense.

Patrick J. Woodman, D.O., is associate director of the female pelvic medicine and reconstructive surgery fellowship at Indiana University, Indianapolis.

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

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

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

David G. Bryan, MD
Monroe, Louisiana

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

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

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

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

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

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

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

Enas Ramih, MD, MPH; Jennifer Doyle, MSN, WHNP; Tiffany Kenny, MSN;
Michele McCarroll, PhD; Vivian von Gruenigen, MD
Summa Health System Akron City Hospital
Women’s Health Services
Akron, Ohio

References

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

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

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

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

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

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

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

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

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

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

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

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

Michael Swor, MD
Sarasota, Florida

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

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

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

References

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

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

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

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

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

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

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

David G. Bryan, MD
Monroe, Louisiana

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

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

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

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

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

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

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

Enas Ramih, MD, MPH; Jennifer Doyle, MSN, WHNP; Tiffany Kenny, MSN;
Michele McCarroll, PhD; Vivian von Gruenigen, MD
Summa Health System Akron City Hospital
Women’s Health Services
Akron, Ohio

References

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

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

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

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

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

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

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

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

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

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

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

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

Michael Swor, MD
Sarasota, Florida

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

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

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

References

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

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

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

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

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

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

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

David G. Bryan, MD
Monroe, Louisiana

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

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

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

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

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

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

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

Enas Ramih, MD, MPH; Jennifer Doyle, MSN, WHNP; Tiffany Kenny, MSN;
Michele McCarroll, PhD; Vivian von Gruenigen, MD
Summa Health System Akron City Hospital
Women’s Health Services
Akron, Ohio

References

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

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

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

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

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

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

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

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

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

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

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

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

Michael Swor, MD
Sarasota, Florida

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

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

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

References

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

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

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

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

Numerous studies on the reproductive safety of selective serotonin reuptake inhibitors (SSRIs) have been published, particularly over the last decade. With the different methodologies used and often disparate results, the extensive data now available in the medical literature can be overwhelming for clinicians and researchers to sort through. Many of the most recently published studies derive from analyses using large administrative databases, from sources such as Medicare, Medicaid, or large HMO databases. Less common are prospective cohort studies, where patients with or without a history of exposure to SSRIs are followed across pregnancy in real time.

Studies over the past 5-10 years have consistently suggested that the risk of major congenital malformations associated with fetal exposure to SSRIs is nonexistent or modest. A major criticism of this literature has been that much of the data are derived from claims databases, which do not adequately account for the potential confounding effect of major depression – so-called “confounding by indication.”

While the consensus is that fetal exposure to SSRIs is not associated with a significant overall risk for major congenital malformations, questions have lingered about whether antidepressant exposure during pregnancy increases risk for cardiac defects. This had been a particular concern with respect to paroxetine, which in 2006 was changed from a pregnancy category C to D because of a purported increase in risk of heart defects associated with first-trimester exposure to this medication.

This issue was addressed again in a large population cohort study published this past June, using Medicaid data from 2000-2007. The study, in which I participated, involved a collaboration of investigators representing epidemiology, teratology, and reproductive psychiatry (N. Engl. J. Med. 2014;370:2397-2407). The study compared the risk of major cardiac defects in babies with and without exposure to antidepressants during the first trimester, providing a risk estimate unadjusted for depression, and an analysis that adjusted for the potential effect of depression and other potential confounders using propensity score adjustment methodology. (Propensity scores are an analytic tool that makes it possible to match groups with the exception of the variable being scrutinized, to minimize confounding.)

Results indicated that the increased risk identified in the unadjusted analysis is attenuated when factoring in depression: Compared with those not exposed to SSRIs, the unadjusted relative risk of any cardiac defect associated with SSRI exposure was 1.25. But with the fully adjusted analysis, the relative risk approached the null, at 1.06, and is not significant. The results are noteworthy because of the large sample size and the effort to control for relevant confounding factors, relevant to many other previously published studies evaluating risk of fetal SSRI exposure.

One would imagine that the increasing number of studies such as this one would be helpful to clinicians. But it can be very challenging for clinicians and even clinical researchers to navigate the growing literature and to attempt to parse out the methodologic strengths and limitations of the various analyses put forth. What makes interpretation of these growing data even more complicated is that reviews of this topic frequently are selective, and reflect what the author chooses to highlight, with resulting conclusions about safety that may be incomplete. The issue is relevant with respect to the medical literature and even the more general media.

An example is the recent publication of an article in the New York Times about whether antidepressants are safe during pregnancy. The article elicited volley after volley of diverse replies, expressing both outrage at the selective reference of studies associating antidepressants with increased fetal risk, as well as criticism of potential cavalier prescribing and use of antidepressants during pregnancy, with their risks still not absolutely quantified. The New York Times public editor also weighed in with a response, writing in a column that “readers – many of them doctors – wrote to complain that the article was inappropriately alarmist, and that the idea behind it was dangerous for pregnant women suffering from depression.”

As my colleagues and I wrote in a response to the article in a blog, whatever the reason for the brevity, a “cursory presentation of the complexity of decisions made around antidepressant use during pregnancy” can potentially be harmful to patients, and at best “is just incomplete; at its worst, it is irresponsible.”

Perhaps of even greater concern than the selective discussion of studies was the implication in the article that the decision to take antidepressants during pregnancy is similar to the decision to give up wine, caffeine, and ripened cheese across such an important time. The decision is certainly not that simple. After more than 2 decades and thousands of consults with women contemplating the decision of whether to take an SSRI during pregnancy or not, I remain impressed with the bind faced by patients with major depression who are trying to make this decision with their doctors and partners, applying their own private calculus to the question of whether to use antidepressants during pregnancy.

What is also ironic is that there is common use of other medications during pregnancy for which there are vastly less available reproductive safety data. These medicines would include, for example, sedative hypnotics or antibiotics; so why the enormous concern about SSRIs? One has to wonder whether the scrutiny about SSRIs is not about using the medication but is related to bias regarding the use of a medicine during pregnancy to treat an illness such as depression, where many people, including clinicians, would discount the devastating effect of depression on women’s lives – as well as the evolving data on the impact of untreated psychiatric illness on fetal well-being, and the well-documented association between psychiatric illness during pregnancy and increased risk for postpartum depression.

Ironically, the availability of more data has not made it easier for the clinician but has brought about a need for greater scrutiny; the conversation about this issue is probably good for the field. Ultimately, decisions about what women choose to do will be made on a case-by-case basis, as individuals make the decision with their doctors and partners using available data in the context of their individual clinical situations, factoring in severity of illness as well as their own individual wishes.

Dr. Cohen is the director of the Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information about reproductive mental health at www.womensmentalhealth.org. He is a consultant to manufacturers of antidepressant medications. He was an author of the NEJM study, which was funded by the U.S. Agency for Healthcare Research and Quality and the National Institutes of Health. To comment, e-mail him at [email protected].

Numerous studies on the reproductive safety of selective serotonin reuptake inhibitors (SSRIs) have been published, particularly over the last decade. With the different methodologies used and often disparate results, the extensive data now available in the medical literature can be overwhelming for clinicians and researchers to sort through. Many of the most recently published studies derive from analyses using large administrative databases, from sources such as Medicare, Medicaid, or large HMO databases. Less common are prospective cohort studies, where patients with or without a history of exposure to SSRIs are followed across pregnancy in real time.

Studies over the past 5-10 years have consistently suggested that the risk of major congenital malformations associated with fetal exposure to SSRIs is nonexistent or modest. A major criticism of this literature has been that much of the data are derived from claims databases, which do not adequately account for the potential confounding effect of major depression – so-called “confounding by indication.”

While the consensus is that fetal exposure to SSRIs is not associated with a significant overall risk for major congenital malformations, questions have lingered about whether antidepressant exposure during pregnancy increases risk for cardiac defects. This had been a particular concern with respect to paroxetine, which in 2006 was changed from a pregnancy category C to D because of a purported increase in risk of heart defects associated with first-trimester exposure to this medication.

This issue was addressed again in a large population cohort study published this past June, using Medicaid data from 2000-2007. The study, in which I participated, involved a collaboration of investigators representing epidemiology, teratology, and reproductive psychiatry (N. Engl. J. Med. 2014;370:2397-2407). The study compared the risk of major cardiac defects in babies with and without exposure to antidepressants during the first trimester, providing a risk estimate unadjusted for depression, and an analysis that adjusted for the potential effect of depression and other potential confounders using propensity score adjustment methodology. (Propensity scores are an analytic tool that makes it possible to match groups with the exception of the variable being scrutinized, to minimize confounding.)

Results indicated that the increased risk identified in the unadjusted analysis is attenuated when factoring in depression: Compared with those not exposed to SSRIs, the unadjusted relative risk of any cardiac defect associated with SSRI exposure was 1.25. But with the fully adjusted analysis, the relative risk approached the null, at 1.06, and is not significant. The results are noteworthy because of the large sample size and the effort to control for relevant confounding factors, relevant to many other previously published studies evaluating risk of fetal SSRI exposure.

One would imagine that the increasing number of studies such as this one would be helpful to clinicians. But it can be very challenging for clinicians and even clinical researchers to navigate the growing literature and to attempt to parse out the methodologic strengths and limitations of the various analyses put forth. What makes interpretation of these growing data even more complicated is that reviews of this topic frequently are selective, and reflect what the author chooses to highlight, with resulting conclusions about safety that may be incomplete. The issue is relevant with respect to the medical literature and even the more general media.

An example is the recent publication of an article in the New York Times about whether antidepressants are safe during pregnancy. The article elicited volley after volley of diverse replies, expressing both outrage at the selective reference of studies associating antidepressants with increased fetal risk, as well as criticism of potential cavalier prescribing and use of antidepressants during pregnancy, with their risks still not absolutely quantified. The New York Times public editor also weighed in with a response, writing in a column that “readers – many of them doctors – wrote to complain that the article was inappropriately alarmist, and that the idea behind it was dangerous for pregnant women suffering from depression.”

As my colleagues and I wrote in a response to the article in a blog, whatever the reason for the brevity, a “cursory presentation of the complexity of decisions made around antidepressant use during pregnancy” can potentially be harmful to patients, and at best “is just incomplete; at its worst, it is irresponsible.”

Perhaps of even greater concern than the selective discussion of studies was the implication in the article that the decision to take antidepressants during pregnancy is similar to the decision to give up wine, caffeine, and ripened cheese across such an important time. The decision is certainly not that simple. After more than 2 decades and thousands of consults with women contemplating the decision of whether to take an SSRI during pregnancy or not, I remain impressed with the bind faced by patients with major depression who are trying to make this decision with their doctors and partners, applying their own private calculus to the question of whether to use antidepressants during pregnancy.

What is also ironic is that there is common use of other medications during pregnancy for which there are vastly less available reproductive safety data. These medicines would include, for example, sedative hypnotics or antibiotics; so why the enormous concern about SSRIs? One has to wonder whether the scrutiny about SSRIs is not about using the medication but is related to bias regarding the use of a medicine during pregnancy to treat an illness such as depression, where many people, including clinicians, would discount the devastating effect of depression on women’s lives – as well as the evolving data on the impact of untreated psychiatric illness on fetal well-being, and the well-documented association between psychiatric illness during pregnancy and increased risk for postpartum depression.

Ironically, the availability of more data has not made it easier for the clinician but has brought about a need for greater scrutiny; the conversation about this issue is probably good for the field. Ultimately, decisions about what women choose to do will be made on a case-by-case basis, as individuals make the decision with their doctors and partners using available data in the context of their individual clinical situations, factoring in severity of illness as well as their own individual wishes.

Dr. Cohen is the director of the Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information about reproductive mental health at www.womensmentalhealth.org. He is a consultant to manufacturers of antidepressant medications. He was an author of the NEJM study, which was funded by the U.S. Agency for Healthcare Research and Quality and the National Institutes of Health. To comment, e-mail him at [email protected].

Numerous studies on the reproductive safety of selective serotonin reuptake inhibitors (SSRIs) have been published, particularly over the last decade. With the different methodologies used and often disparate results, the extensive data now available in the medical literature can be overwhelming for clinicians and researchers to sort through. Many of the most recently published studies derive from analyses using large administrative databases, from sources such as Medicare, Medicaid, or large HMO databases. Less common are prospective cohort studies, where patients with or without a history of exposure to SSRIs are followed across pregnancy in real time.

Studies over the past 5-10 years have consistently suggested that the risk of major congenital malformations associated with fetal exposure to SSRIs is nonexistent or modest. A major criticism of this literature has been that much of the data are derived from claims databases, which do not adequately account for the potential confounding effect of major depression – so-called “confounding by indication.”

While the consensus is that fetal exposure to SSRIs is not associated with a significant overall risk for major congenital malformations, questions have lingered about whether antidepressant exposure during pregnancy increases risk for cardiac defects. This had been a particular concern with respect to paroxetine, which in 2006 was changed from a pregnancy category C to D because of a purported increase in risk of heart defects associated with first-trimester exposure to this medication.

This issue was addressed again in a large population cohort study published this past June, using Medicaid data from 2000-2007. The study, in which I participated, involved a collaboration of investigators representing epidemiology, teratology, and reproductive psychiatry (N. Engl. J. Med. 2014;370:2397-2407). The study compared the risk of major cardiac defects in babies with and without exposure to antidepressants during the first trimester, providing a risk estimate unadjusted for depression, and an analysis that adjusted for the potential effect of depression and other potential confounders using propensity score adjustment methodology. (Propensity scores are an analytic tool that makes it possible to match groups with the exception of the variable being scrutinized, to minimize confounding.)

Results indicated that the increased risk identified in the unadjusted analysis is attenuated when factoring in depression: Compared with those not exposed to SSRIs, the unadjusted relative risk of any cardiac defect associated with SSRI exposure was 1.25. But with the fully adjusted analysis, the relative risk approached the null, at 1.06, and is not significant. The results are noteworthy because of the large sample size and the effort to control for relevant confounding factors, relevant to many other previously published studies evaluating risk of fetal SSRI exposure.

One would imagine that the increasing number of studies such as this one would be helpful to clinicians. But it can be very challenging for clinicians and even clinical researchers to navigate the growing literature and to attempt to parse out the methodologic strengths and limitations of the various analyses put forth. What makes interpretation of these growing data even more complicated is that reviews of this topic frequently are selective, and reflect what the author chooses to highlight, with resulting conclusions about safety that may be incomplete. The issue is relevant with respect to the medical literature and even the more general media.

An example is the recent publication of an article in the New York Times about whether antidepressants are safe during pregnancy. The article elicited volley after volley of diverse replies, expressing both outrage at the selective reference of studies associating antidepressants with increased fetal risk, as well as criticism of potential cavalier prescribing and use of antidepressants during pregnancy, with their risks still not absolutely quantified. The New York Times public editor also weighed in with a response, writing in a column that “readers – many of them doctors – wrote to complain that the article was inappropriately alarmist, and that the idea behind it was dangerous for pregnant women suffering from depression.”

As my colleagues and I wrote in a response to the article in a blog, whatever the reason for the brevity, a “cursory presentation of the complexity of decisions made around antidepressant use during pregnancy” can potentially be harmful to patients, and at best “is just incomplete; at its worst, it is irresponsible.”

Perhaps of even greater concern than the selective discussion of studies was the implication in the article that the decision to take antidepressants during pregnancy is similar to the decision to give up wine, caffeine, and ripened cheese across such an important time. The decision is certainly not that simple. After more than 2 decades and thousands of consults with women contemplating the decision of whether to take an SSRI during pregnancy or not, I remain impressed with the bind faced by patients with major depression who are trying to make this decision with their doctors and partners, applying their own private calculus to the question of whether to use antidepressants during pregnancy.

What is also ironic is that there is common use of other medications during pregnancy for which there are vastly less available reproductive safety data. These medicines would include, for example, sedative hypnotics or antibiotics; so why the enormous concern about SSRIs? One has to wonder whether the scrutiny about SSRIs is not about using the medication but is related to bias regarding the use of a medicine during pregnancy to treat an illness such as depression, where many people, including clinicians, would discount the devastating effect of depression on women’s lives – as well as the evolving data on the impact of untreated psychiatric illness on fetal well-being, and the well-documented association between psychiatric illness during pregnancy and increased risk for postpartum depression.

Ironically, the availability of more data has not made it easier for the clinician but has brought about a need for greater scrutiny; the conversation about this issue is probably good for the field. Ultimately, decisions about what women choose to do will be made on a case-by-case basis, as individuals make the decision with their doctors and partners using available data in the context of their individual clinical situations, factoring in severity of illness as well as their own individual wishes.

Dr. Cohen is the director of the Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information about reproductive mental health at www.womensmentalhealth.org. He is a consultant to manufacturers of antidepressant medications. He was an author of the NEJM study, which was funded by the U.S. Agency for Healthcare Research and Quality and the National Institutes of Health. To comment, e-mail him at [email protected].