Surgical Techniques

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

OBG Manag. 2014 August;26(8):22,24-26,28
By
Ray A. Wertheim, MD
harry Reich, MD
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A recent FDA hearing on the use of this technology has cast a cloud over its future. Here, two members of the AAGL Tissue Extraction Task Force discuss the evidence and emphasize the importance of preserving minimally invasive options in women’s health.
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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.

AAGL recommendations on the use of power morcellation

In its position statement, the AAGL Tissue Extraction Task Force made the following main points, recommending that surgeons:

  • avoid morcellation in the setting of known malignant or premalignant conditions
  • consider morcellation only for patients who have undergone appropriate evaluation of the myometrium, cervix, and endometrium, and who have reassuring findings
  • use an alternative to morcellation when preoperative evaluation leads to increased suspicion of malignancy. Laparotomy should be one of the alternatives considered.
  • consider alternatives to morcellation for postmenopausal women because of the risk of malignancy, including undetectable malignancy, which is increased in this population
  • discuss, in a patient-centered manner as part of the informed consent process, the specific risks of encountering an undetected malignancy and the likelihood of worsening the patient’s prognosis when open power morcellation is used
  • allow the patient’s active involvement in the decision about whether or not to use power morcellation
  • ensure that you have the skill and experience needed to morcellate within a specimen retrieval pouch if that is the option chosen. These pouches need further investigation of safety and outcomes in a controlled manner.

Further research also is needed to determine how best to diagnose sarcomas preoperatively, the task force noted.

The full report is available on the AAGL Web site.1

—Ray A. Wertheim, MD

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