FDA Panel to Discuss Laparoscopic Power Morcellator RisksJune 9, 2014 — An advisory panel to the U.S. Food and Drug Administration (FDA) has scheduled a meeting next month to evaluate the cancer risks of laparoscopic power morcellators.

According to the advisory committee calendar, the Obstetrics and Gynecology Devices panel will meet July 10-11:

“The committee will discuss the safety of laparoscopic power morcellator devices as it pertains to their potential to disseminate and upstage a confined, but undetected (occult) uterine malignancy during laparoscopic hysterectomy or myomectomy.”

In April, the FDA warned that power morcellators should not be used in hysterectomies because they can potentially spread undiagnosed uterine cancer or leiomyosarcoma (LMS). Shortly after this announcement, Johnson & Johnson discontinued sales of the devices.

The FDA is currently seeking expert advice and opinions on the risks and benefits of laparoscopic power morcellators and containment bags. These recommendations could lead to new requirements on the appropriate use, premarket testing, labeling, and other risk-management techniques. The FDA may also choose to re-classify the devices as a Class II or Class III.

The panel plans to discuss the use of containment bags as a risk-mitigation device. Several hospitals now encourage surgeons to perform morcellation inside a containment bag. Other hospitals have banned the procedure altogether. Transvaginal application of a bag is challenging because the bags were not designed for this purpose. Only one is FDA-approved for uterine fibroids.

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