Commentary

Commentary: Musings on morcellation


 

References

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.

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