FDA Tightens Guidance on Morcellation for Fibroids

November 25, 2014

With this new FDA guidance, the group of women for whom laparoscopic power morcellation remains an appropriate treatment option is quite narrowed.

Yesterday, the FDA again warned against the use of laparoscopic power morcellation to remove the uterus or fibroids in most women. In the agency's efforts to help reduce the risk of spreading an unknown cancer, the FDA issued an Immediately in Effect (IIE) guidance that recommends all manufacturers of laparoscopic power morcellators include a boxed warning and two contraindications.

“The FDA’s primary concern is the safety and well-being of patients and taking these steps will help the agency’s safety recommendations to be implemented as quickly as possible,” said William Maisel, MD, MPH, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “Updating the device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed.”

The intention of the boxed warning is to notify providers and patients alike of the following:

- Uterine tissue may contain an unknown, undiagnosed cancer.

- Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in perimenopausal and postmenopausal patients, or in candidates for en bloc tissue removal through the vagina or a mini-laparotomy incision. (These groups of women represent the majority of women with fibroids who undergo hysterectomy and myomectomy.)

- Laparoscopic power morcellators are contraindicated in gynecological surgery in which the tissue to be morcellated is known or suspected to be cancerous.

The IIE guidance applies to currently marketed and new laparoscopic power morcellators for general and specific gynecological indications. The FDA made these recommendations based on currently available data that estimates the risk of an unsuspected uterine sarcoma is approximately 1 in 350 women undergoing a hysterectomy or myomectomy.

There does remain a small group of women for whom laparoscopic power morcellation remains an appropriate therapeutic option. These are certain younger women who are interested in maintaining their fertility or who simply wish to keep their uterus intact. First, however, they must be informed of the risks associated with this procedure.

“The FDA strongly encourages doctors to inform their patients of the risk of spreading unsuspected cancer from the use of these devices in fibroid surgery and discuss the benefits and risks associated with all treatment options,” said Maisel.

In addition to the updated safety communication and IIE guidance, the FDA is considering other ways to further help reduce the risk of unsuspected cancer spread by laparoscopic power morcellation, such as encouraging innovative ways to better detect uterine cancer and contain potentially cancerous tissue. The agency says they will continue to review adverse event reports, peer-reviewed scientific literature, and information from patients, health care professionals, gynecologic and surgical professional societies, and medical device manufacturers. If necessary, the FDA says it may take further action in the future.