Power morcellation debate: Crunching the data

ORLANDO – Independent of the objective data, the top hits for a Google search of power morcellation are advertisements from lawyers seeking malpractice clients, observed one of four experts participating in a debate at the annual scientific meeting of the Society of Gynecologic Surgeons.

In this opening salvo for the con position, Dr. Eric R. Sokol, an ob.gyn. and urogynecologist at Stanford (Calif.) University, acknowledged, “I am going to appeal a little bit more to your emotions to start.”

The emotional appeal may have resonated. Despite compelling data provided by those providing the pro position, a loose poll at the meeting suggested that only a handful of gynecologic surgeons in the audience still consider power morcellation a viable routine tool for the removal of fibroids.

Use of power morcellation of fibroids has been challenged on the basis of evidence that it is capable of spreading cancerous tissue if used in a woman with unsuspected uterine sarcoma. After convening a panel of experts, the Food and Drug Administration issued a safety communication April 17, 2014 that officially “discourages” use of this device for uterine fibroids.

However, not all experts accept the position that this device should be discouraged in all patients, including one of those who addressed the FDA panel and provided the pro position in the SGS debate. Dr. Jubilee Brown, an ob.gyn. in the department of gynecologic oncology and reproductive medicine at the University of Texas M.D. Anderson Cancer Center, Houston, outlined how a benefit-to-risk analysis still favors power morcellation in at least some individuals.

“We should improve but not abandon power morcellation,” Dr. Brown said. “Power morcellation with appropriate informed consent should remain available to appropriately screened, low-risk women.”

Dr. Brown based this position largely on two decision analyses that show minimally invasive laparoscopic hysterectomy with power morcellation of fibroids is safer than an open abdominal approach, which is the most commonly used alternative. One analysis by Dr. Matthew T. Siedhoff and his associates has been recently published (Am. J. Obstet. Gynecol. 2015 [doi:10.1016/j.ajog.2015.03.006]) while the other, for which Dr. Brown is an author, is in press.

The bottom line for both was that minimally invasive hysterectomy with power morcellation would produce a lower mortality rate than abdominal laparotomy when considering all the risks for both. Specifically, the open, abdominal approach is associated with more fatal surgery-related complications, compensating for the greater but rare risk of cancer-related deaths associated with power morcellation.

To establish true benefit-to-risk equations, Dr. Brown argued that it is essential to rely on objective data. The risks posed by power morcellation for spreading cancer have “been sensationalized in the media” without fully considering how rare these cancers are. In her reading of the published data, 1 case occurs in every 452 patients to 6,400 patients.

“No one is going to argue that this [power morcellation] is a no-risk procedure,“ Dr. Brown observed, but she maintained it is important to consider this risk in context, which includes the complications associated with alternative approaches.

As a participant on the con side, Dr. Sokol rebutted with some data of his own, including a worst-case estimate that suggests the case rate of uterine sarcomas among candidates for hysterectomy may be as high as 1 in 352. However, he suggested that arguing about case rates may not be the critical issue. Rather, other risks of power morcellation deserve consideration.

“We frame this debate about the risk of sarcoma, but I think there are a lot of other issues surrounding morcellation that are important, including the risk of spreading benign disease,” Dr. Sokol maintained at the meeting jointly sponsored by the American College of Surgeons.

Citing a published analysis of a large insurance database with 36,470 women who underwent morcellation (JAMA 2014;312:1253-5), Dr. Sokol noted that the proportion of patients with pathology climbs markedly when it includes those with findings in addition to sarcoma. Specifically, while the case rate of uterine cancer was 2.7 per 1,000 patients, there were an additional 0.7 cases of gynecologic cancers of other types, 1.1 cases of uterine neoplasms with uncertain malignant potential, and 10 cases of endometrial hyperplasia.

“The prevalence of malignancy was 0.34%, but the prevalence of neoplastic conditions was 1.5%, and that is a pretty significant number,” he observed.

Beyond these data, Dr. Sokol focused on conceptual risks. As an example, he proposed that most clinicians would hesitate to employ a morcellator on tissue that appeared infected, and he suggested that this hesitation should apply in tissue with an unknown risk of neoplastic transformation.

“Cancer can spread much like an infection,” he maintained. “Why would you treat uterine fibroids or other masses that could be cancerous differently [than you would an infection]?”

One answer might be to reduce the risk of morcellated tissue from being disseminated in the peritoneal cavity, according to Dr. Andrew Sokol, an ob.gyn. and urologist at Georgetown University, Washington. The brother of Dr. Eric Sokol and serving on the pro side of the debate, Dr. Sokol suggested that containment bag attachments are being developed for power morcellator devices, and these appear to preserve the benefits while mitigating the risks.

Citing some early data from controlled studies indicating that surgical outcomes using containment bags are similar to those without a bag, Dr. Sokol suggested that containment bags might be the way to improve rather than abandon power morcellation.

Despite the potential risk of rupture and the need for more data, “these bags have the potential to maintain the advantages of minimally invasive surgery,” said Dr. Sokol, although he acknowledged that no containment bags have been approved by the FDA.

The final panelist in the debate rejected both minimally invasive surgery with power morcellation and open abdominal hysterectomies as a first choice in most women. Rather, Dr. Carl Zimmerman, professor of obstetrics and gynecology at Vanderbilt University Medical Center, Nashville, Tenn., maintained hysterectomies should most often be performed vaginally and morcellation of the fibroid should be performed extracorporeally.

“I was unable to find a single report of spread of malignant tumor” when morcellation of the fibroid was performed outside the body after a vaginal hysterectomy, Dr. Zimmerman reported. He expressed dismay that employing vaginal surgery has not been much discussed in any of the statements guiding clinicians to alternatives for power morcellation.

One reason vaginal hysterectomy is being overlooked, according to Dr. Zimmerman, is a decline in training for this technique. He believes that surgeons should either learn to perform vaginal hysterectomies or be prepared to refer patients to those experienced with this procedure.

“What do we need to do as surgeons? We need to have a working knowledge of all the surgical approaches to a given problem, and then we are ethically obligated to help our patients to chose the correct one in terms of safety, cost, and recovery,” Dr. Zimmerman said. For many women with fibroids, he believes the correct choice would be a vaginal hysterectomy that avoids both morcellation in the peritoneal space and the disadvantages of an open approach.

The debate was initially framed by a case. In the description, a 44-year-old woman with menorrhagia and fibroids had multiple features suggesting a low risk of uterine sarcoma, including a recent biopsy of the endometrium that proved benign. In this case, Dr. Brown described minimally invasive surgery with power morcellation as an “excellent option,” while Dr. Eric Sokol maintained the FDA advisory remained applicable.

However, for the minority of surgeons in the audience who sided with Dr. Brown, one issue may be reimbursement. Ten days after the SGS debate, a survey conducted by and published in the Wall Street Journal (April 3, 2015) found that insurance companies covering more than 90 million Americans have established or are considering restrictions on reimbursement for power morcellation. Increasingly, the choice is being taken out of the hands of both surgeons and patients.

Dr. Jubilee Brown, Dr. Andrew Sokol, Dr. Eric Sokol, and Dr. Carl Zimmerman reported no relevant financial disclosures.

ORLANDO – Independent of the objective data, the top hits for a Google search of power morcellation are advertisements from lawyers seeking malpractice clients, observed one of four experts participating in a debate at the annual scientific meeting of the Society of Gynecologic Surgeons.

In this opening salvo for the con position, Dr. Eric R. Sokol, an ob.gyn. and urogynecologist at Stanford (Calif.) University, acknowledged, “I am going to appeal a little bit more to your emotions to start.”

The emotional appeal may have resonated. Despite compelling data provided by those providing the pro position, a loose poll at the meeting suggested that only a handful of gynecologic surgeons in the audience still consider power morcellation a viable routine tool for the removal of fibroids.

Use of power morcellation of fibroids has been challenged on the basis of evidence that it is capable of spreading cancerous tissue if used in a woman with unsuspected uterine sarcoma. After convening a panel of experts, the Food and Drug Administration issued a safety communication April 17, 2014 that officially “discourages” use of this device for uterine fibroids.

However, not all experts accept the position that this device should be discouraged in all patients, including one of those who addressed the FDA panel and provided the pro position in the SGS debate. Dr. Jubilee Brown, an ob.gyn. in the department of gynecologic oncology and reproductive medicine at the University of Texas M.D. Anderson Cancer Center, Houston, outlined how a benefit-to-risk analysis still favors power morcellation in at least some individuals.

“We should improve but not abandon power morcellation,” Dr. Brown said. “Power morcellation with appropriate informed consent should remain available to appropriately screened, low-risk women.”

Dr. Brown based this position largely on two decision analyses that show minimally invasive laparoscopic hysterectomy with power morcellation of fibroids is safer than an open abdominal approach, which is the most commonly used alternative. One analysis by Dr. Matthew T. Siedhoff and his associates has been recently published (Am. J. Obstet. Gynecol. 2015 [doi:10.1016/j.ajog.2015.03.006]) while the other, for which Dr. Brown is an author, is in press.

The bottom line for both was that minimally invasive hysterectomy with power morcellation would produce a lower mortality rate than abdominal laparotomy when considering all the risks for both. Specifically, the open, abdominal approach is associated with more fatal surgery-related complications, compensating for the greater but rare risk of cancer-related deaths associated with power morcellation.

To establish true benefit-to-risk equations, Dr. Brown argued that it is essential to rely on objective data. The risks posed by power morcellation for spreading cancer have “been sensationalized in the media” without fully considering how rare these cancers are. In her reading of the published data, 1 case occurs in every 452 patients to 6,400 patients.

“No one is going to argue that this [power morcellation] is a no-risk procedure,“ Dr. Brown observed, but she maintained it is important to consider this risk in context, which includes the complications associated with alternative approaches.

As a participant on the con side, Dr. Sokol rebutted with some data of his own, including a worst-case estimate that suggests the case rate of uterine sarcomas among candidates for hysterectomy may be as high as 1 in 352. However, he suggested that arguing about case rates may not be the critical issue. Rather, other risks of power morcellation deserve consideration.

“We frame this debate about the risk of sarcoma, but I think there are a lot of other issues surrounding morcellation that are important, including the risk of spreading benign disease,” Dr. Sokol maintained at the meeting jointly sponsored by the American College of Surgeons.

Citing a published analysis of a large insurance database with 36,470 women who underwent morcellation (JAMA 2014;312:1253-5), Dr. Sokol noted that the proportion of patients with pathology climbs markedly when it includes those with findings in addition to sarcoma. Specifically, while the case rate of uterine cancer was 2.7 per 1,000 patients, there were an additional 0.7 cases of gynecologic cancers of other types, 1.1 cases of uterine neoplasms with uncertain malignant potential, and 10 cases of endometrial hyperplasia.

“The prevalence of malignancy was 0.34%, but the prevalence of neoplastic conditions was 1.5%, and that is a pretty significant number,” he observed.

Beyond these data, Dr. Sokol focused on conceptual risks. As an example, he proposed that most clinicians would hesitate to employ a morcellator on tissue that appeared infected, and he suggested that this hesitation should apply in tissue with an unknown risk of neoplastic transformation.

“Cancer can spread much like an infection,” he maintained. “Why would you treat uterine fibroids or other masses that could be cancerous differently [than you would an infection]?”

One answer might be to reduce the risk of morcellated tissue from being disseminated in the peritoneal cavity, according to Dr. Andrew Sokol, an ob.gyn. and urologist at Georgetown University, Washington. The brother of Dr. Eric Sokol and serving on the pro side of the debate, Dr. Sokol suggested that containment bag attachments are being developed for power morcellator devices, and these appear to preserve the benefits while mitigating the risks.

Citing some early data from controlled studies indicating that surgical outcomes using containment bags are similar to those without a bag, Dr. Sokol suggested that containment bags might be the way to improve rather than abandon power morcellation.

Despite the potential risk of rupture and the need for more data, “these bags have the potential to maintain the advantages of minimally invasive surgery,” said Dr. Sokol, although he acknowledged that no containment bags have been approved by the FDA.

The final panelist in the debate rejected both minimally invasive surgery with power morcellation and open abdominal hysterectomies as a first choice in most women. Rather, Dr. Carl Zimmerman, professor of obstetrics and gynecology at Vanderbilt University Medical Center, Nashville, Tenn., maintained hysterectomies should most often be performed vaginally and morcellation of the fibroid should be performed extracorporeally.

“I was unable to find a single report of spread of malignant tumor” when morcellation of the fibroid was performed outside the body after a vaginal hysterectomy, Dr. Zimmerman reported. He expressed dismay that employing vaginal surgery has not been much discussed in any of the statements guiding clinicians to alternatives for power morcellation.

One reason vaginal hysterectomy is being overlooked, according to Dr. Zimmerman, is a decline in training for this technique. He believes that surgeons should either learn to perform vaginal hysterectomies or be prepared to refer patients to those experienced with this procedure.

“What do we need to do as surgeons? We need to have a working knowledge of all the surgical approaches to a given problem, and then we are ethically obligated to help our patients to chose the correct one in terms of safety, cost, and recovery,” Dr. Zimmerman said. For many women with fibroids, he believes the correct choice would be a vaginal hysterectomy that avoids both morcellation in the peritoneal space and the disadvantages of an open approach.

The debate was initially framed by a case. In the description, a 44-year-old woman with menorrhagia and fibroids had multiple features suggesting a low risk of uterine sarcoma, including a recent biopsy of the endometrium that proved benign. In this case, Dr. Brown described minimally invasive surgery with power morcellation as an “excellent option,” while Dr. Eric Sokol maintained the FDA advisory remained applicable.

However, for the minority of surgeons in the audience who sided with Dr. Brown, one issue may be reimbursement. Ten days after the SGS debate, a survey conducted by and published in the Wall Street Journal (April 3, 2015) found that insurance companies covering more than 90 million Americans have established or are considering restrictions on reimbursement for power morcellation. Increasingly, the choice is being taken out of the hands of both surgeons and patients.

Dr. Jubilee Brown, Dr. Andrew Sokol, Dr. Eric Sokol, and Dr. Carl Zimmerman reported no relevant financial disclosures.

ORLANDO – Independent of the objective data, the top hits for a Google search of power morcellation are advertisements from lawyers seeking malpractice clients, observed one of four experts participating in a debate at the annual scientific meeting of the Society of Gynecologic Surgeons.

In this opening salvo for the con position, Dr. Eric R. Sokol, an ob.gyn. and urogynecologist at Stanford (Calif.) University, acknowledged, “I am going to appeal a little bit more to your emotions to start.”

The emotional appeal may have resonated. Despite compelling data provided by those providing the pro position, a loose poll at the meeting suggested that only a handful of gynecologic surgeons in the audience still consider power morcellation a viable routine tool for the removal of fibroids.

Use of power morcellation of fibroids has been challenged on the basis of evidence that it is capable of spreading cancerous tissue if used in a woman with unsuspected uterine sarcoma. After convening a panel of experts, the Food and Drug Administration issued a safety communication April 17, 2014 that officially “discourages” use of this device for uterine fibroids.

However, not all experts accept the position that this device should be discouraged in all patients, including one of those who addressed the FDA panel and provided the pro position in the SGS debate. Dr. Jubilee Brown, an ob.gyn. in the department of gynecologic oncology and reproductive medicine at the University of Texas M.D. Anderson Cancer Center, Houston, outlined how a benefit-to-risk analysis still favors power morcellation in at least some individuals.

“We should improve but not abandon power morcellation,” Dr. Brown said. “Power morcellation with appropriate informed consent should remain available to appropriately screened, low-risk women.”

Dr. Brown based this position largely on two decision analyses that show minimally invasive laparoscopic hysterectomy with power morcellation of fibroids is safer than an open abdominal approach, which is the most commonly used alternative. One analysis by Dr. Matthew T. Siedhoff and his associates has been recently published (Am. J. Obstet. Gynecol. 2015 [doi:10.1016/j.ajog.2015.03.006]) while the other, for which Dr. Brown is an author, is in press.

The bottom line for both was that minimally invasive hysterectomy with power morcellation would produce a lower mortality rate than abdominal laparotomy when considering all the risks for both. Specifically, the open, abdominal approach is associated with more fatal surgery-related complications, compensating for the greater but rare risk of cancer-related deaths associated with power morcellation.

To establish true benefit-to-risk equations, Dr. Brown argued that it is essential to rely on objective data. The risks posed by power morcellation for spreading cancer have “been sensationalized in the media” without fully considering how rare these cancers are. In her reading of the published data, 1 case occurs in every 452 patients to 6,400 patients.

“No one is going to argue that this [power morcellation] is a no-risk procedure,“ Dr. Brown observed, but she maintained it is important to consider this risk in context, which includes the complications associated with alternative approaches.

As a participant on the con side, Dr. Sokol rebutted with some data of his own, including a worst-case estimate that suggests the case rate of uterine sarcomas among candidates for hysterectomy may be as high as 1 in 352. However, he suggested that arguing about case rates may not be the critical issue. Rather, other risks of power morcellation deserve consideration.

“We frame this debate about the risk of sarcoma, but I think there are a lot of other issues surrounding morcellation that are important, including the risk of spreading benign disease,” Dr. Sokol maintained at the meeting jointly sponsored by the American College of Surgeons.

Citing a published analysis of a large insurance database with 36,470 women who underwent morcellation (JAMA 2014;312:1253-5), Dr. Sokol noted that the proportion of patients with pathology climbs markedly when it includes those with findings in addition to sarcoma. Specifically, while the case rate of uterine cancer was 2.7 per 1,000 patients, there were an additional 0.7 cases of gynecologic cancers of other types, 1.1 cases of uterine neoplasms with uncertain malignant potential, and 10 cases of endometrial hyperplasia.

“The prevalence of malignancy was 0.34%, but the prevalence of neoplastic conditions was 1.5%, and that is a pretty significant number,” he observed.

Beyond these data, Dr. Sokol focused on conceptual risks. As an example, he proposed that most clinicians would hesitate to employ a morcellator on tissue that appeared infected, and he suggested that this hesitation should apply in tissue with an unknown risk of neoplastic transformation.

“Cancer can spread much like an infection,” he maintained. “Why would you treat uterine fibroids or other masses that could be cancerous differently [than you would an infection]?”

One answer might be to reduce the risk of morcellated tissue from being disseminated in the peritoneal cavity, according to Dr. Andrew Sokol, an ob.gyn. and urologist at Georgetown University, Washington. The brother of Dr. Eric Sokol and serving on the pro side of the debate, Dr. Sokol suggested that containment bag attachments are being developed for power morcellator devices, and these appear to preserve the benefits while mitigating the risks.

Citing some early data from controlled studies indicating that surgical outcomes using containment bags are similar to those without a bag, Dr. Sokol suggested that containment bags might be the way to improve rather than abandon power morcellation.

Despite the potential risk of rupture and the need for more data, “these bags have the potential to maintain the advantages of minimally invasive surgery,” said Dr. Sokol, although he acknowledged that no containment bags have been approved by the FDA.

The final panelist in the debate rejected both minimally invasive surgery with power morcellation and open abdominal hysterectomies as a first choice in most women. Rather, Dr. Carl Zimmerman, professor of obstetrics and gynecology at Vanderbilt University Medical Center, Nashville, Tenn., maintained hysterectomies should most often be performed vaginally and morcellation of the fibroid should be performed extracorporeally.

“I was unable to find a single report of spread of malignant tumor” when morcellation of the fibroid was performed outside the body after a vaginal hysterectomy, Dr. Zimmerman reported. He expressed dismay that employing vaginal surgery has not been much discussed in any of the statements guiding clinicians to alternatives for power morcellation.

One reason vaginal hysterectomy is being overlooked, according to Dr. Zimmerman, is a decline in training for this technique. He believes that surgeons should either learn to perform vaginal hysterectomies or be prepared to refer patients to those experienced with this procedure.

“What do we need to do as surgeons? We need to have a working knowledge of all the surgical approaches to a given problem, and then we are ethically obligated to help our patients to chose the correct one in terms of safety, cost, and recovery,” Dr. Zimmerman said. For many women with fibroids, he believes the correct choice would be a vaginal hysterectomy that avoids both morcellation in the peritoneal space and the disadvantages of an open approach.

The debate was initially framed by a case. In the description, a 44-year-old woman with menorrhagia and fibroids had multiple features suggesting a low risk of uterine sarcoma, including a recent biopsy of the endometrium that proved benign. In this case, Dr. Brown described minimally invasive surgery with power morcellation as an “excellent option,” while Dr. Eric Sokol maintained the FDA advisory remained applicable.

However, for the minority of surgeons in the audience who sided with Dr. Brown, one issue may be reimbursement. Ten days after the SGS debate, a survey conducted by and published in the Wall Street Journal (April 3, 2015) found that insurance companies covering more than 90 million Americans have established or are considering restrictions on reimbursement for power morcellation. Increasingly, the choice is being taken out of the hands of both surgeons and patients.

Dr. Jubilee Brown, Dr. Andrew Sokol, Dr. Eric Sokol, and Dr. Carl Zimmerman reported no relevant financial disclosures.