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Review group disputes FDA’s power morcellator warning


 

FROM OBSTETRICS AND GYNECOLOGY

References

The review group asks that a number of clinical recommendations be considered. For example, the group suggests that caution be exercised prior to recommending morcellation procedures for postmenopausal women because of a higher risk of leiomyosarcoma in that population, and that careful inspection for tissue fragments be undertaken following morcellation, with “copious irrigation of the pelvic and abdominal cavities to minimize the risk of retained tissue.

“Respecting women who have leiomyosarcoma, we conclude that the FDA directive was based on a misleading analysis. Consequently, more accurate estimates regarding the prevalence of leiomyosarcoma among women having surgery for leiomyomas should be issued. Women have a right to self-determination,” they wrote in the commentary.

Dr. Charles E. Miller

Dr. Charles E. Miller

Dr. Charles E. Miller, a clinical associate professor at the University of Illinois, Chicago, and a past president of the AAGL, applauded the work by Dr. Parker and his colleagues in putting together the analysis, but noted that there have been some positive effects of the FDA warning, namely that it challenged physicians and industry to “think outside the box” in creating methods to reduce potential leiomyosarcoma spread.

“I strongly believe that risk can be further decreased at time of morcellation – electronic versus cold knife, via laparoscopy, minilaparotomy, or vaginal if the morcellation is performed in a contained system (i.e. bag),” Dr. Miller said in an interview.

The FDA will likely approve a containment system designed by Dr. Tony Shibley in cooperation with Olympus, according to Dr. Miller. Also, Dr. Miller recently received approval from the FDA to perform an Investigational Device Exemption study on a multiport containment system that his minimally invasive gynecologic surgery team developed in conjunction with Espiner Medical, Ltd.

“It is my opinion, along with many others, that not only can the risk of inadvertent spread of leiomyosarcoma be minimized with contained morcellation, but risk of leiomyomatosis and bowel injury be significantly reduced as well,” he said.

Dr. Hal C. Lawrence, executive vice president and chief executive officer of the American College of Obstetricians and Gynecologists, also weighed in on the morcellation controversy.

“The conclusions of the paper’s authors largely reflect positions that ACOG has reiterated during the ongoing discussion about potential safety concerns with morcellation as well as its value in facilitating minimally invasive gynecologic surgery,” he said in a statement. “Without question, morcellation of an undiagnosed sarcoma can disseminate malignant tissue. However, by allowing some women to avoid the higher morbidity and mortality associated with open abdominal surgery, morcellation can also save lives.”

As a result of the continuing conversation about morcellation, ob.gyns. are “better able to evaluate each individual woman’s risk of an undiagnosed sarcoma, and to counsel her to receive the right approach for her own unique medical needs,” he added.

In a statement, an FDA spokesperson said that the agency’s recommendations have not changed. “We continue to believe that inclusion of a boxed warning and contraindications to the use of power morcellation for uterine fibroid removal in the majority of women is both appropriate and necessary. We welcome the continued scientific dialogue concerning the available evidence about benefits and risks associated with power morcellation and will notify the public if our recommendations change.”

The authors of the commentary and open letter to the FDA, and Dr. Raine-Bennett and her colleagues, all reported having no conflicts of interest.

*This story was updated 12/9/2015

sworcester@frontlinemedcom.com

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