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FDA Again Urges Caution and Advises Against Using Morcellators for Uterine Fibroids

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Maurie Markman, MD

Hello. I am Dr Maurie Markman from Cancer Treatment Centers of America in Philadelphia, Pennsylvania.

I wanted to briefly highlight the recently updated US Food and Drug Administration (FDA) assessment on the use of laparoscopic power morcellators to treat uterine fibroids. This is clearly a complex and controversial topic, and one that has received a lot of attention in the medical and lay literature.

In December 2017, the FDA reassessed their own evaluation of the risk for the possibility of uterine sarcoma being found in fibroids and affirmed their previous findings. They noted that the risk for uterine sarcoma in women undergoing surgery for presumed fibroids ranged from approximately 1 in 225 to 1 in 580; with leiomyosarcoma specifically, the risk ranged from 1 in 495 to 1 in 1100. The FDA noted that others have reached the conclusion that the risk for sarcomas in uterine fibroids is substantially lower than this.

This reassessment looked at a number of papers in the literature and noted this level of risk, and the FDA has stated that it continues to caution against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for the treatment of fibroids. Clearly, some individuals, after a very appropriate informed consent and discussion about potential medical risks associated with surgery, would elect to have this procedure performed, with the advice of their own surgeons. The FDA’s comments, based upon their data, advise great caution.

Ongoing research in this area is looking for potentially safer ways to perform morcellation so that the risk for any type of spread of material containing sarcoma can be substantially reduced, but that topic remains for the future and future publications. This review by the FDA is important for oncologists, general physicians, obstetricians, and gynecologists. We are seeing women considered for fibroid surgery, and the FDA’s review, which appears to me to be quite thoughtful, needs to be seriously considered.

Thank you for your attention. I encourage you, if you have an interest in the topic, to review the FDA’s updated assessment of the use of laparoscopic power morcellators.

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