Post–FDA hearing: Will open power morcellation of uterine tissue remain an option during hysterectomy and myomectomy?

The use of power morcellation to remove the uterus or uterine tumors during hysterectomy and myomectomy has been in the limelight in 2014—particularly morcellation performed in an “open” fashion (without use of a protective bag). Concerns about the dispersion of tissue throughout the peritoneal cavity—including the risk of disseminating tissue from leiomyosarcoma, a rare but deadly cancer—have drawn statements from the American College of Obstetricians and Gynecologists (ACOG), the AAGL, the US Food and Drug Administration (FDA), and others, cautioning against the use of open power morcellation in women with a known or suspected malignancy.

In July 2014, the FDA convened a two-day hearing of the Obstetrics and Gynecology Devices Panel (one of the panels in its Medical Devices Advisory Committee) to consider whether power morcellation should remain an option and, if so, what restrictions or labeling might be recommended.

In advance of the FDA hearing, OBG Management invited two experts in women’s health to explore the options more deeply and address the future of minimally invasive surgery (MIS): Ray A. Wertheim, MD, Director of the AAGL Center of Excellence Minimally Invasive Gynecology Program at Inova Fair Oaks Hospital in Fairfax, Virginia, and Harry Reich, MD, widely known as the first surgeon to perform laparoscopic hysterectomy, among other achievements. Both Dr. Wertheim and Dr. Reich were members of the AAGL Tissue Extraction Task Force.

In this Q&A, Dr. Wertheim and Dr. Reich discuss:

• options for tissue extraction going forward
• the importance of continuing to offer minimally invasive surgical approaches
• the need to educate surgeons about the safest approaches to tissue extraction.

Both surgeons believe that power morcellation should remain an option for selected cases, although neither performs the technique himself. Both surgeons also believe that minimally invasive approaches to hysterectomy and myomectomy are here to stay and should continue to be used whenever possible.

AAGL convened an impartial expert panel
OBG Management: Dr. Wertheim, could you tell us a little about the AAGL position statement on the use of power morcellation for uterine tissue extraction at hysterectomy or myomectomy, since you were on the task force that researched and wrote it?¹

Dr. Wertheim: AAGL convened its task force to conduct a critical appraisal of the existing evidence related to the practice of uterine extraction in the setting of hysterectomy and myomectomy. Areas in need of further investigation also were identified.

The task force consisted of experts who had no conflicts, were not allowed to discuss or review findings with anyone, and were not reimbursed for their time. Our review is the most complete report to date, more comprehensive than the current reports from the FDA, ACOG, the Society of Gynecologic Oncology (SGO), and the American Urogynecologic Society (AUGS).

Interestingly, AAGL, ACOG, SGO, and AUGS all reached the same conclusion: All existing methods of tissue extraction have benefits and risks that must be balanced.

OBG Management: How did the AAGL Task Force assess the evidence?

Dr. Wertheim: The quality of evidence and strength of recommendations were assessed using US Preventive Services Task Force guidelines. There are very few good data on the issue of power morcellation for uterine tissue extraction, especially in regard to leiomyosarcoma. One needs to be careful making recommendations without good data.

Related article: First large study on risk of cancer spread using power morcellation. Janelle Yates (News for your Practice; August 2014)

At this time, we do not believe there is a single method of tissue extraction that can protect all patients. Therefore, all current methods should remain available. We believe that an understanding of the issues will allow surgeons, hospitals, and patients to make the appropriate informed choices regarding tissue extraction for individual patients undergoing uterine surgery.

How to manage tissue extraction going forward
OBG Management: Regardless of the FDA’s final decision, what should the gynecologic specialty be doing to avoid disseminating uterine tissue in the peritoneal cavity, particularly leiomyosarcoma?

Dr. Wertheim: MIS is a wonderful advancement in women’s health care. All surgical specialties are moving toward MIS. Our challenge is to perform it as safely as possible, given the data and instrumentation available.

In regard to leiomyosarcoma, because we lack the ability to accurately make the diagnosis preoperatively, we’ve identified risk factors that should be taken into consideration. They include advanced age, a history of radiation or tamoxifen use, black race, hereditary leiomyomatosis, renal cell carcinoma syndrome, and survival of childhood retinoblastoma.

At this time, we have specimen-retrieval bags that can be used with power morcellation. However, it takes skill to be able to place a large specimen inside a bag without injuring surrounding organs due to limited visibility.

Education, at the hospital and national level, is in the works
OBG Management: How should we go about educating surgeons about MIS alternatives to open power morcellation?

Dr. Wertheim: In my hospital, we are mentoring surgeons to help them gain the new skills needed. In addition, I plan to give a grand rounds presentation on tissue extraction for hospitals in northern Virginia and also would like to offer a course in the near future. I’m also hoping that we’ll be able to offer courses around the country before the annual AAGL meeting this November.

At the annual AAGL meeting, the subject will be discussed at length, with an emphasis on identifying risk factors and conducting appropriate preoperative testing, with workshops likely to teach the skills needed to perform these surgeries as safely as possible.

Why a return to reliance on laparotomy would be unwise
OBG Management: Given all the concerns expressed recently about open power morcellation, do you think some surgeons will revert to abdominal hysterectomy rather than rely on MIS? Would such a move be safer than power morcellation?

Dr. Wertheim: That would be a disaster for women. Very reliable data have shown that MIS is safer than open surgery, with much quicker recovery. Almost all of my patients are discharged within 3 hours after surgery, and most no longer require pain medications other than nonsteroidal anti-inflammatory drugs by postoperative day 2. They’re usually back to work within 2 weeks.

We have worked long and hard to develop skills and instrumentation required to perform MIS safely—but nothing replaces good judgment. In some cases, laparotomy or conversion to a laparotomy may be indicated.

New instrumentation is needed and is being developed. In the meantime, my personal bias is to rule out risk factors for malignancy and continue to morcellate with a scalpel, preferably inside a bag. After all, we know that with open power morcellation, fragments and cells are usually left behind regardless of inspection and irrigation. These fragments may cause leiomyomatosis, endometriosis, bowel obstruction, sepsis, and possible dissemination of tumor fragments. Moreover, morcellation into small fragments complicates the pathologist’s ability to give an accurate report. The use of open power morcellation also subjects the patient to a risk of damage to surrounding organs—usually due to the surgeon’s inexperience.

As I have said before, our challenge is to perform these surgeries using the safest techniques possible, given the current data and instrumentation.

OBG Management: Dr. Reich, you have a unique perspective on this issue, because you pioneered laparoscopic hysterectomy. How has uterine tissue extraction evolved since then? Do you think open power morcellation should remain an option?

Dr. Reich: Uterine tissue extraction has not evolved. The terms “laparoscopic hysterectomy” and “total laparoscopic hysterectomy” imply vaginal extraction using a scalpel, not abdominal extraction using a morcellator. Unfortunately there is no substitute for hard work using a #10 blade on a long handle and special vaginal retraction tools.

In 1983, I made a decision to stop performing laparotomy for all gynecologic procedures, including hysterectomy, myomectomy, urology, oncology, abscesses, extensive adhesions, and rectovaginal endometriosis. I was an accomplished vaginal surgeon at that time, as well as a one-handed laparoscopic surgeon, operating while looking through the scope with one eye.

Interest in a laparoscopic approach to hysterectomy began with my presentations about laparoscopic hysterectomy in January 1988. At that time I had over 10 years of experience doing what is now called laparoscopic-assisted vaginal hysterectomy.

I wrote extensively about specimen removal using a scalpel before electronic power morcellators were available. Since then, I have asked those using power morcellators to stop calling their operation a laparoscopic hysterectomy, as it has more in common with an abdominal-extraction hysterectomy.

I have never advocated removing the uterus using power morcellators, and I still believe that most specimens can be removed vaginally without the spray of pieces of the specimen around the peritoneal cavity that occurs with power morcellation. This goes for hysterectomy involving a large uterus, myomectomy through a culdotomy incision, and removal of the uterine fundus after supracervical hysterectomy. (It is irresponsible to use expensive power morcellation to remove small supracervical hysterectomy specimens.) It is time to get back to learning and teaching vaginal morcellation, although I readily admit it is time consuming.

Nevertheless, I believe power morcellation should remain an option. Recent laparoscopic fellowship trainees know only this technique, which is still better than a return to mutilation by laparotomy.

Gynecology is a frustrating profession—30 years of MIS as a sideshow. General surgery has rapidly adopted a laparoscopic approach to most operations, after gynecologists taught them. Today most ­gynecologists do not do advanced laparoscopic surgery and would love to get back to open incision laparotomy for their operations. We cannot go back.

OBG Management: Dr. Wertheim and Dr. Reich, do your personal views of the morcellation issue differ at all from the official views of professional societies?

Dr. Wertheim: Yes. However, before I share them, I’d like to emphasize that the views I’m about to express are mine and mine only, not those of the AAGL or its task force.

The issue of uterine extraction is a highly emotional and political issue, about which there are few good data.

Abundant Level 1 data strongly support a vaginal or laparoscopic approach for benign hysterectomy when possible. ACOG and AAGL have issued position papers supporting these approaches for benign hysterectomies. Gynecologic surgeons and other surgical specialists have embraced MIS because it is safer, offers faster recovery, produces less postoperative pain, and has fewer complications than open surgery. However, AAGL has maintained for several years that morcellation is contraindicated in cases where uterine malignancy is either known or suspected.

The dilemma with open power morcellation is that even with our best diagnostic tools, the rare uterine sarcoma cannot always be definitively ruled out preoperatively. Endometrial cancer usually can be diagnosed before surgery. However, rare subtypes such as sarcomas are more difficult to reliably diagnose preoperatively, and risk factors for uterine sarcomas are not nearly as well understood as those for endometrial cancer.

I do agree with the FDA’s cautionary statement on April 17, which pointedly prohibits power morcellation for women with suspected precancer or known cancer of the gynecologic organs.² However, the AAGL Task Force critically reviewed about 120 articles, including the studies assessed by the FDA. Concerns arose regarding the FDA’s interpretation of the data. Due to a number of deficiencies in these studies, some of the conclusions of the FDA may not be completely accurate. The studies analyzed by the FDA were not stratified by risk factors for sarcoma and were not necessarily performed in a setting of reproductive-aged women with presumed fibroids.

Dr. Reich: Here are my personal views about the sarcoma problem and I am sure they differ from the official views:

• Laparoscopic hysterectomy should always mean vaginal extraction unless a less disfiguring site can be discovered; power morcellation implies minilaparotomy and should be renamed to reflect that fact.
• Power morcellation must be differentiated from vaginal and minilaparotomy scalpel morcellation, especially in the media. Vaginal hysterectomy has entailed vaginal scalpel morcellation with successful outcomes for more than 100 years.
• Remember that most gynecologic cancers are approached using the laparoscope today. This certainly includes cervical and endometrial cancer and some ovarian cancers. (For example, one of my neighbors is a 25-year survivor of laparoscopically treated bilateral ovarian cancer who refused laparotomy!)
• I have removed sarcomas by vaginal morcellation during laparoscopic hysterectomy and laparoscopic myomectomy with no late sequelae. In fact, most cervical cancer surgery is done by laparoscopic surgery today. And even an open laparotomy hysterectomy can spread a sarcoma.
• The current morcellation debate arose when a single case of disseminated leiomyosarcoma became highly publicized. It involved a prominent physician whose leiomyosarcoma was unknown to her initial surgeon, and the malignancy was upstaged after the use of power morcellation during hysterectomy. After this case was covered in the media, other cases began to be reported in the lay press as well, some of which predated the publicized case. The truth is, regrettably, that sarcomas carry poor prognoses even when specimens are removed intact. And we don’t know much about the sarcoma that started this debate. Was it mild or aggressive? How many mitotic figures were there per high-powered field? And what was found macroscopicallyand microscopically at the subsequent laparotomy? We on the AAGL Task Force do not know the answers to these questions, although at least some of these variables are reported in other published cases. And because this case is likely to have a powerful effect on MIS in our country and the rest of the world, it is my opinion that we need to know these details.

What is your preferred surgical approach?
OBG Management: Do you perform open power morcellation in selected patients?

Dr. Wertheim: Even though I have performed morcellation with a scalpel transvaginally or through a mini-laparotomy incision for many years, I have never used open power morcellation because of the risk of leaving behind benign or malignant tissue fragments. Morcellation with a scalpel is easily learned and can be performed as quickly as power morcellation. Morcellation with a scalpel produces much larger pieces than with power morcellation. This probably markedly decreases the loss of fragments. I cannot make a definitive statement regarding cell loss, however. Until we have improved instrumentation and are better able to make a preoperative diagnosis of sarcoma, I’m going to rule out risk factors identified by the AAGL Task Force, do the appropriate work-up, and continue to morcellate with a scalpel, placing the specimen in a bag, if technically possible.

Dr. Reich: As I mentioned, I am a vaginal scalpel morcellator. I tried power morcellation when it first was developed but was never a fan. The same techniques used for vaginal extraction using a coring maneuver can be used abdominally through the umbilicus or a 1- or 2-cm trocar site.

WE WANT TO HEAR FROM YOU! Share your thoughts on this article. Send your Letter to the Editor to: rbarbieri@frontlinemedcom.com 

The use of power morcellation to remove the uterus or uterine tumors during hysterectomy and myomectomy has been in the limelight in 2014—particularly morcellation performed in an “open” fashion (without use of a protective bag). Concerns about the dispersion of tissue throughout the peritoneal cavity—including the risk of disseminating tissue from leiomyosarcoma, a rare but deadly cancer—have drawn statements from the American College of Obstetricians and Gynecologists (ACOG), the AAGL, the US Food and Drug Administration (FDA), and others, cautioning against the use of open power morcellation in women with a known or suspected malignancy.

In July 2014, the FDA convened a two-day hearing of the Obstetrics and Gynecology Devices Panel (one of the panels in its Medical Devices Advisory Committee) to consider whether power morcellation should remain an option and, if so, what restrictions or labeling might be recommended.

In advance of the FDA hearing, OBG Management invited two experts in women’s health to explore the options more deeply and address the future of minimally invasive surgery (MIS): Ray A. Wertheim, MD, Director of the AAGL Center of Excellence Minimally Invasive Gynecology Program at Inova Fair Oaks Hospital in Fairfax, Virginia, and Harry Reich, MD, widely known as the first surgeon to perform laparoscopic hysterectomy, among other achievements. Both Dr. Wertheim and Dr. Reich were members of the AAGL Tissue Extraction Task Force.

In this Q&A, Dr. Wertheim and Dr. Reich discuss:

• options for tissue extraction going forward
• the importance of continuing to offer minimally invasive surgical approaches
• the need to educate surgeons about the safest approaches to tissue extraction.

Both surgeons believe that power morcellation should remain an option for selected cases, although neither performs the technique himself. Both surgeons also believe that minimally invasive approaches to hysterectomy and myomectomy are here to stay and should continue to be used whenever possible.

AAGL convened an impartial expert panel
OBG Management: Dr. Wertheim, could you tell us a little about the AAGL position statement on the use of power morcellation for uterine tissue extraction at hysterectomy or myomectomy, since you were on the task force that researched and wrote it?¹

Dr. Wertheim: AAGL convened its task force to conduct a critical appraisal of the existing evidence related to the practice of uterine extraction in the setting of hysterectomy and myomectomy. Areas in need of further investigation also were identified.

The task force consisted of experts who had no conflicts, were not allowed to discuss or review findings with anyone, and were not reimbursed for their time. Our review is the most complete report to date, more comprehensive than the current reports from the FDA, ACOG, the Society of Gynecologic Oncology (SGO), and the American Urogynecologic Society (AUGS).

Interestingly, AAGL, ACOG, SGO, and AUGS all reached the same conclusion: All existing methods of tissue extraction have benefits and risks that must be balanced.

OBG Management: How did the AAGL Task Force assess the evidence?

Dr. Wertheim: The quality of evidence and strength of recommendations were assessed using US Preventive Services Task Force guidelines. There are very few good data on the issue of power morcellation for uterine tissue extraction, especially in regard to leiomyosarcoma. One needs to be careful making recommendations without good data.

Related article: First large study on risk of cancer spread using power morcellation. Janelle Yates (News for your Practice; August 2014)

At this time, we do not believe there is a single method of tissue extraction that can protect all patients. Therefore, all current methods should remain available. We believe that an understanding of the issues will allow surgeons, hospitals, and patients to make the appropriate informed choices regarding tissue extraction for individual patients undergoing uterine surgery.

How to manage tissue extraction going forward
OBG Management: Regardless of the FDA’s final decision, what should the gynecologic specialty be doing to avoid disseminating uterine tissue in the peritoneal cavity, particularly leiomyosarcoma?

Dr. Wertheim: MIS is a wonderful advancement in women’s health care. All surgical specialties are moving toward MIS. Our challenge is to perform it as safely as possible, given the data and instrumentation available.

In regard to leiomyosarcoma, because we lack the ability to accurately make the diagnosis preoperatively, we’ve identified risk factors that should be taken into consideration. They include advanced age, a history of radiation or tamoxifen use, black race, hereditary leiomyomatosis, renal cell carcinoma syndrome, and survival of childhood retinoblastoma.

At this time, we have specimen-retrieval bags that can be used with power morcellation. However, it takes skill to be able to place a large specimen inside a bag without injuring surrounding organs due to limited visibility.

Education, at the hospital and national level, is in the works
OBG Management: How should we go about educating surgeons about MIS alternatives to open power morcellation?

Dr. Wertheim: In my hospital, we are mentoring surgeons to help them gain the new skills needed. In addition, I plan to give a grand rounds presentation on tissue extraction for hospitals in northern Virginia and also would like to offer a course in the near future. I’m also hoping that we’ll be able to offer courses around the country before the annual AAGL meeting this November.

At the annual AAGL meeting, the subject will be discussed at length, with an emphasis on identifying risk factors and conducting appropriate preoperative testing, with workshops likely to teach the skills needed to perform these surgeries as safely as possible.

Why a return to reliance on laparotomy would be unwise
OBG Management: Given all the concerns expressed recently about open power morcellation, do you think some surgeons will revert to abdominal hysterectomy rather than rely on MIS? Would such a move be safer than power morcellation?

Dr. Wertheim: That would be a disaster for women. Very reliable data have shown that MIS is safer than open surgery, with much quicker recovery. Almost all of my patients are discharged within 3 hours after surgery, and most no longer require pain medications other than nonsteroidal anti-inflammatory drugs by postoperative day 2. They’re usually back to work within 2 weeks.

We have worked long and hard to develop skills and instrumentation required to perform MIS safely—but nothing replaces good judgment. In some cases, laparotomy or conversion to a laparotomy may be indicated.

New instrumentation is needed and is being developed. In the meantime, my personal bias is to rule out risk factors for malignancy and continue to morcellate with a scalpel, preferably inside a bag. After all, we know that with open power morcellation, fragments and cells are usually left behind regardless of inspection and irrigation. These fragments may cause leiomyomatosis, endometriosis, bowel obstruction, sepsis, and possible dissemination of tumor fragments. Moreover, morcellation into small fragments complicates the pathologist’s ability to give an accurate report. The use of open power morcellation also subjects the patient to a risk of damage to surrounding organs—usually due to the surgeon’s inexperience.

As I have said before, our challenge is to perform these surgeries using the safest techniques possible, given the current data and instrumentation.

OBG Management: Dr. Reich, you have a unique perspective on this issue, because you pioneered laparoscopic hysterectomy. How has uterine tissue extraction evolved since then? Do you think open power morcellation should remain an option?

Dr. Reich: Uterine tissue extraction has not evolved. The terms “laparoscopic hysterectomy” and “total laparoscopic hysterectomy” imply vaginal extraction using a scalpel, not abdominal extraction using a morcellator. Unfortunately there is no substitute for hard work using a #10 blade on a long handle and special vaginal retraction tools.

In 1983, I made a decision to stop performing laparotomy for all gynecologic procedures, including hysterectomy, myomectomy, urology, oncology, abscesses, extensive adhesions, and rectovaginal endometriosis. I was an accomplished vaginal surgeon at that time, as well as a one-handed laparoscopic surgeon, operating while looking through the scope with one eye.

Interest in a laparoscopic approach to hysterectomy began with my presentations about laparoscopic hysterectomy in January 1988. At that time I had over 10 years of experience doing what is now called laparoscopic-assisted vaginal hysterectomy.

I wrote extensively about specimen removal using a scalpel before electronic power morcellators were available. Since then, I have asked those using power morcellators to stop calling their operation a laparoscopic hysterectomy, as it has more in common with an abdominal-extraction hysterectomy.

I have never advocated removing the uterus using power morcellators, and I still believe that most specimens can be removed vaginally without the spray of pieces of the specimen around the peritoneal cavity that occurs with power morcellation. This goes for hysterectomy involving a large uterus, myomectomy through a culdotomy incision, and removal of the uterine fundus after supracervical hysterectomy. (It is irresponsible to use expensive power morcellation to remove small supracervical hysterectomy specimens.) It is time to get back to learning and teaching vaginal morcellation, although I readily admit it is time consuming.

Nevertheless, I believe power morcellation should remain an option. Recent laparoscopic fellowship trainees know only this technique, which is still better than a return to mutilation by laparotomy.

Gynecology is a frustrating profession—30 years of MIS as a sideshow. General surgery has rapidly adopted a laparoscopic approach to most operations, after gynecologists taught them. Today most ­gynecologists do not do advanced laparoscopic surgery and would love to get back to open incision laparotomy for their operations. We cannot go back.

OBG Management: Dr. Wertheim and Dr. Reich, do your personal views of the morcellation issue differ at all from the official views of professional societies?

Dr. Wertheim: Yes. However, before I share them, I’d like to emphasize that the views I’m about to express are mine and mine only, not those of the AAGL or its task force.

The issue of uterine extraction is a highly emotional and political issue, about which there are few good data.

Abundant Level 1 data strongly support a vaginal or laparoscopic approach for benign hysterectomy when possible. ACOG and AAGL have issued position papers supporting these approaches for benign hysterectomies. Gynecologic surgeons and other surgical specialists have embraced MIS because it is safer, offers faster recovery, produces less postoperative pain, and has fewer complications than open surgery. However, AAGL has maintained for several years that morcellation is contraindicated in cases where uterine malignancy is either known or suspected.

The dilemma with open power morcellation is that even with our best diagnostic tools, the rare uterine sarcoma cannot always be definitively ruled out preoperatively. Endometrial cancer usually can be diagnosed before surgery. However, rare subtypes such as sarcomas are more difficult to reliably diagnose preoperatively, and risk factors for uterine sarcomas are not nearly as well understood as those for endometrial cancer.

I do agree with the FDA’s cautionary statement on April 17, which pointedly prohibits power morcellation for women with suspected precancer or known cancer of the gynecologic organs.² However, the AAGL Task Force critically reviewed about 120 articles, including the studies assessed by the FDA. Concerns arose regarding the FDA’s interpretation of the data. Due to a number of deficiencies in these studies, some of the conclusions of the FDA may not be completely accurate. The studies analyzed by the FDA were not stratified by risk factors for sarcoma and were not necessarily performed in a setting of reproductive-aged women with presumed fibroids.

Dr. Reich: Here are my personal views about the sarcoma problem and I am sure they differ from the official views:

• Laparoscopic hysterectomy should always mean vaginal extraction unless a less disfiguring site can be discovered; power morcellation implies minilaparotomy and should be renamed to reflect that fact.
• Power morcellation must be differentiated from vaginal and minilaparotomy scalpel morcellation, especially in the media. Vaginal hysterectomy has entailed vaginal scalpel morcellation with successful outcomes for more than 100 years.
• Remember that most gynecologic cancers are approached using the laparoscope today. This certainly includes cervical and endometrial cancer and some ovarian cancers. (For example, one of my neighbors is a 25-year survivor of laparoscopically treated bilateral ovarian cancer who refused laparotomy!)
• I have removed sarcomas by vaginal morcellation during laparoscopic hysterectomy and laparoscopic myomectomy with no late sequelae. In fact, most cervical cancer surgery is done by laparoscopic surgery today. And even an open laparotomy hysterectomy can spread a sarcoma.
• The current morcellation debate arose when a single case of disseminated leiomyosarcoma became highly publicized. It involved a prominent physician whose leiomyosarcoma was unknown to her initial surgeon, and the malignancy was upstaged after the use of power morcellation during hysterectomy. After this case was covered in the media, other cases began to be reported in the lay press as well, some of which predated the publicized case. The truth is, regrettably, that sarcomas carry poor prognoses even when specimens are removed intact. And we don’t know much about the sarcoma that started this debate. Was it mild or aggressive? How many mitotic figures were there per high-powered field? And what was found macroscopicallyand microscopically at the subsequent laparotomy? We on the AAGL Task Force do not know the answers to these questions, although at least some of these variables are reported in other published cases. And because this case is likely to have a powerful effect on MIS in our country and the rest of the world, it is my opinion that we need to know these details.

What is your preferred surgical approach?
OBG Management: Do you perform open power morcellation in selected patients?

Dr. Wertheim: Even though I have performed morcellation with a scalpel transvaginally or through a mini-laparotomy incision for many years, I have never used open power morcellation because of the risk of leaving behind benign or malignant tissue fragments. Morcellation with a scalpel is easily learned and can be performed as quickly as power morcellation. Morcellation with a scalpel produces much larger pieces than with power morcellation. This probably markedly decreases the loss of fragments. I cannot make a definitive statement regarding cell loss, however. Until we have improved instrumentation and are better able to make a preoperative diagnosis of sarcoma, I’m going to rule out risk factors identified by the AAGL Task Force, do the appropriate work-up, and continue to morcellate with a scalpel, placing the specimen in a bag, if technically possible.

Dr. Reich: As I mentioned, I am a vaginal scalpel morcellator. I tried power morcellation when it first was developed but was never a fan. The same techniques used for vaginal extraction using a coring maneuver can be used abdominally through the umbilicus or a 1- or 2-cm trocar site.

WE WANT TO HEAR FROM YOU! Share your thoughts on this article. Send your Letter to the Editor to: rbarbieri@frontlinemedcom.com 

The use of power morcellation to remove the uterus or uterine tumors during hysterectomy and myomectomy has been in the limelight in 2014—particularly morcellation performed in an “open” fashion (without use of a protective bag). Concerns about the dispersion of tissue throughout the peritoneal cavity—including the risk of disseminating tissue from leiomyosarcoma, a rare but deadly cancer—have drawn statements from the American College of Obstetricians and Gynecologists (ACOG), the AAGL, the US Food and Drug Administration (FDA), and others, cautioning against the use of open power morcellation in women with a known or suspected malignancy.

In July 2014, the FDA convened a two-day hearing of the Obstetrics and Gynecology Devices Panel (one of the panels in its Medical Devices Advisory Committee) to consider whether power morcellation should remain an option and, if so, what restrictions or labeling might be recommended.

In advance of the FDA hearing, OBG Management invited two experts in women’s health to explore the options more deeply and address the future of minimally invasive surgery (MIS): Ray A. Wertheim, MD, Director of the AAGL Center of Excellence Minimally Invasive Gynecology Program at Inova Fair Oaks Hospital in Fairfax, Virginia, and Harry Reich, MD, widely known as the first surgeon to perform laparoscopic hysterectomy, among other achievements. Both Dr. Wertheim and Dr. Reich were members of the AAGL Tissue Extraction Task Force.

In this Q&A, Dr. Wertheim and Dr. Reich discuss:

• options for tissue extraction going forward
• the importance of continuing to offer minimally invasive surgical approaches
• the need to educate surgeons about the safest approaches to tissue extraction.

Both surgeons believe that power morcellation should remain an option for selected cases, although neither performs the technique himself. Both surgeons also believe that minimally invasive approaches to hysterectomy and myomectomy are here to stay and should continue to be used whenever possible.

AAGL convened an impartial expert panel
OBG Management: Dr. Wertheim, could you tell us a little about the AAGL position statement on the use of power morcellation for uterine tissue extraction at hysterectomy or myomectomy, since you were on the task force that researched and wrote it?¹

Dr. Wertheim: AAGL convened its task force to conduct a critical appraisal of the existing evidence related to the practice of uterine extraction in the setting of hysterectomy and myomectomy. Areas in need of further investigation also were identified.

The task force consisted of experts who had no conflicts, were not allowed to discuss or review findings with anyone, and were not reimbursed for their time. Our review is the most complete report to date, more comprehensive than the current reports from the FDA, ACOG, the Society of Gynecologic Oncology (SGO), and the American Urogynecologic Society (AUGS).

Interestingly, AAGL, ACOG, SGO, and AUGS all reached the same conclusion: All existing methods of tissue extraction have benefits and risks that must be balanced.

OBG Management: How did the AAGL Task Force assess the evidence?

Dr. Wertheim: The quality of evidence and strength of recommendations were assessed using US Preventive Services Task Force guidelines. There are very few good data on the issue of power morcellation for uterine tissue extraction, especially in regard to leiomyosarcoma. One needs to be careful making recommendations without good data.

Related article: First large study on risk of cancer spread using power morcellation. Janelle Yates (News for your Practice; August 2014)

At this time, we do not believe there is a single method of tissue extraction that can protect all patients. Therefore, all current methods should remain available. We believe that an understanding of the issues will allow surgeons, hospitals, and patients to make the appropriate informed choices regarding tissue extraction for individual patients undergoing uterine surgery.

How to manage tissue extraction going forward
OBG Management: Regardless of the FDA’s final decision, what should the gynecologic specialty be doing to avoid disseminating uterine tissue in the peritoneal cavity, particularly leiomyosarcoma?

Dr. Wertheim: MIS is a wonderful advancement in women’s health care. All surgical specialties are moving toward MIS. Our challenge is to perform it as safely as possible, given the data and instrumentation available.

In regard to leiomyosarcoma, because we lack the ability to accurately make the diagnosis preoperatively, we’ve identified risk factors that should be taken into consideration. They include advanced age, a history of radiation or tamoxifen use, black race, hereditary leiomyomatosis, renal cell carcinoma syndrome, and survival of childhood retinoblastoma.

At this time, we have specimen-retrieval bags that can be used with power morcellation. However, it takes skill to be able to place a large specimen inside a bag without injuring surrounding organs due to limited visibility.

Education, at the hospital and national level, is in the works
OBG Management: How should we go about educating surgeons about MIS alternatives to open power morcellation?

Dr. Wertheim: In my hospital, we are mentoring surgeons to help them gain the new skills needed. In addition, I plan to give a grand rounds presentation on tissue extraction for hospitals in northern Virginia and also would like to offer a course in the near future. I’m also hoping that we’ll be able to offer courses around the country before the annual AAGL meeting this November.

At the annual AAGL meeting, the subject will be discussed at length, with an emphasis on identifying risk factors and conducting appropriate preoperative testing, with workshops likely to teach the skills needed to perform these surgeries as safely as possible.

Why a return to reliance on laparotomy would be unwise
OBG Management: Given all the concerns expressed recently about open power morcellation, do you think some surgeons will revert to abdominal hysterectomy rather than rely on MIS? Would such a move be safer than power morcellation?

Dr. Wertheim: That would be a disaster for women. Very reliable data have shown that MIS is safer than open surgery, with much quicker recovery. Almost all of my patients are discharged within 3 hours after surgery, and most no longer require pain medications other than nonsteroidal anti-inflammatory drugs by postoperative day 2. They’re usually back to work within 2 weeks.

We have worked long and hard to develop skills and instrumentation required to perform MIS safely—but nothing replaces good judgment. In some cases, laparotomy or conversion to a laparotomy may be indicated.

New instrumentation is needed and is being developed. In the meantime, my personal bias is to rule out risk factors for malignancy and continue to morcellate with a scalpel, preferably inside a bag. After all, we know that with open power morcellation, fragments and cells are usually left behind regardless of inspection and irrigation. These fragments may cause leiomyomatosis, endometriosis, bowel obstruction, sepsis, and possible dissemination of tumor fragments. Moreover, morcellation into small fragments complicates the pathologist’s ability to give an accurate report. The use of open power morcellation also subjects the patient to a risk of damage to surrounding organs—usually due to the surgeon’s inexperience.

As I have said before, our challenge is to perform these surgeries using the safest techniques possible, given the current data and instrumentation.

OBG Management: Dr. Reich, you have a unique perspective on this issue, because you pioneered laparoscopic hysterectomy. How has uterine tissue extraction evolved since then? Do you think open power morcellation should remain an option?

Dr. Reich: Uterine tissue extraction has not evolved. The terms “laparoscopic hysterectomy” and “total laparoscopic hysterectomy” imply vaginal extraction using a scalpel, not abdominal extraction using a morcellator. Unfortunately there is no substitute for hard work using a #10 blade on a long handle and special vaginal retraction tools.

In 1983, I made a decision to stop performing laparotomy for all gynecologic procedures, including hysterectomy, myomectomy, urology, oncology, abscesses, extensive adhesions, and rectovaginal endometriosis. I was an accomplished vaginal surgeon at that time, as well as a one-handed laparoscopic surgeon, operating while looking through the scope with one eye.

Interest in a laparoscopic approach to hysterectomy began with my presentations about laparoscopic hysterectomy in January 1988. At that time I had over 10 years of experience doing what is now called laparoscopic-assisted vaginal hysterectomy.

I wrote extensively about specimen removal using a scalpel before electronic power morcellators were available. Since then, I have asked those using power morcellators to stop calling their operation a laparoscopic hysterectomy, as it has more in common with an abdominal-extraction hysterectomy.

I have never advocated removing the uterus using power morcellators, and I still believe that most specimens can be removed vaginally without the spray of pieces of the specimen around the peritoneal cavity that occurs with power morcellation. This goes for hysterectomy involving a large uterus, myomectomy through a culdotomy incision, and removal of the uterine fundus after supracervical hysterectomy. (It is irresponsible to use expensive power morcellation to remove small supracervical hysterectomy specimens.) It is time to get back to learning and teaching vaginal morcellation, although I readily admit it is time consuming.

Nevertheless, I believe power morcellation should remain an option. Recent laparoscopic fellowship trainees know only this technique, which is still better than a return to mutilation by laparotomy.

Gynecology is a frustrating profession—30 years of MIS as a sideshow. General surgery has rapidly adopted a laparoscopic approach to most operations, after gynecologists taught them. Today most ­gynecologists do not do advanced laparoscopic surgery and would love to get back to open incision laparotomy for their operations. We cannot go back.

OBG Management: Dr. Wertheim and Dr. Reich, do your personal views of the morcellation issue differ at all from the official views of professional societies?

Dr. Wertheim: Yes. However, before I share them, I’d like to emphasize that the views I’m about to express are mine and mine only, not those of the AAGL or its task force.

The issue of uterine extraction is a highly emotional and political issue, about which there are few good data.

Abundant Level 1 data strongly support a vaginal or laparoscopic approach for benign hysterectomy when possible. ACOG and AAGL have issued position papers supporting these approaches for benign hysterectomies. Gynecologic surgeons and other surgical specialists have embraced MIS because it is safer, offers faster recovery, produces less postoperative pain, and has fewer complications than open surgery. However, AAGL has maintained for several years that morcellation is contraindicated in cases where uterine malignancy is either known or suspected.

The dilemma with open power morcellation is that even with our best diagnostic tools, the rare uterine sarcoma cannot always be definitively ruled out preoperatively. Endometrial cancer usually can be diagnosed before surgery. However, rare subtypes such as sarcomas are more difficult to reliably diagnose preoperatively, and risk factors for uterine sarcomas are not nearly as well understood as those for endometrial cancer.

I do agree with the FDA’s cautionary statement on April 17, which pointedly prohibits power morcellation for women with suspected precancer or known cancer of the gynecologic organs.² However, the AAGL Task Force critically reviewed about 120 articles, including the studies assessed by the FDA. Concerns arose regarding the FDA’s interpretation of the data. Due to a number of deficiencies in these studies, some of the conclusions of the FDA may not be completely accurate. The studies analyzed by the FDA were not stratified by risk factors for sarcoma and were not necessarily performed in a setting of reproductive-aged women with presumed fibroids.

Dr. Reich: Here are my personal views about the sarcoma problem and I am sure they differ from the official views:

• Laparoscopic hysterectomy should always mean vaginal extraction unless a less disfiguring site can be discovered; power morcellation implies minilaparotomy and should be renamed to reflect that fact.
• Power morcellation must be differentiated from vaginal and minilaparotomy scalpel morcellation, especially in the media. Vaginal hysterectomy has entailed vaginal scalpel morcellation with successful outcomes for more than 100 years.
• Remember that most gynecologic cancers are approached using the laparoscope today. This certainly includes cervical and endometrial cancer and some ovarian cancers. (For example, one of my neighbors is a 25-year survivor of laparoscopically treated bilateral ovarian cancer who refused laparotomy!)
• I have removed sarcomas by vaginal morcellation during laparoscopic hysterectomy and laparoscopic myomectomy with no late sequelae. In fact, most cervical cancer surgery is done by laparoscopic surgery today. And even an open laparotomy hysterectomy can spread a sarcoma.
• The current morcellation debate arose when a single case of disseminated leiomyosarcoma became highly publicized. It involved a prominent physician whose leiomyosarcoma was unknown to her initial surgeon, and the malignancy was upstaged after the use of power morcellation during hysterectomy. After this case was covered in the media, other cases began to be reported in the lay press as well, some of which predated the publicized case. The truth is, regrettably, that sarcomas carry poor prognoses even when specimens are removed intact. And we don’t know much about the sarcoma that started this debate. Was it mild or aggressive? How many mitotic figures were there per high-powered field? And what was found macroscopicallyand microscopically at the subsequent laparotomy? We on the AAGL Task Force do not know the answers to these questions, although at least some of these variables are reported in other published cases. And because this case is likely to have a powerful effect on MIS in our country and the rest of the world, it is my opinion that we need to know these details.

What is your preferred surgical approach?
OBG Management: Do you perform open power morcellation in selected patients?

Dr. Wertheim: Even though I have performed morcellation with a scalpel transvaginally or through a mini-laparotomy incision for many years, I have never used open power morcellation because of the risk of leaving behind benign or malignant tissue fragments. Morcellation with a scalpel is easily learned and can be performed as quickly as power morcellation. Morcellation with a scalpel produces much larger pieces than with power morcellation. This probably markedly decreases the loss of fragments. I cannot make a definitive statement regarding cell loss, however. Until we have improved instrumentation and are better able to make a preoperative diagnosis of sarcoma, I’m going to rule out risk factors identified by the AAGL Task Force, do the appropriate work-up, and continue to morcellate with a scalpel, placing the specimen in a bag, if technically possible.

Dr. Reich: As I mentioned, I am a vaginal scalpel morcellator. I tried power morcellation when it first was developed but was never a fan. The same techniques used for vaginal extraction using a coring maneuver can be used abdominally through the umbilicus or a 1- or 2-cm trocar site.

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