FDA Warns Against Using Laparoscopic Power Morcellators to Treat Uterine Fibroids
The U.S. Food and Drug Administration (FDA) today announced that it is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids. In an updated safety communication, originally issued in April 2014, the FDA warned against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women.
In an Immediately in Effect (IIE) guidance, the FDA is also recommending that manufacturers of laparoscopic power morcellators include in their product labeling specific safety statements in the form of a boxed warning and two contraindications. The IIE guidance allows the FDA to issue its recommendations expeditiously to help address a significant public health issue.
“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.”
Boxed Warning and Contraindications
The boxed warning informs health-care providers and patients that uterine tissue may contain unsuspected cancer, and that the use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients.
The two contraindications advise of the following:
- Laparoscopic power morcellators are should not be used for removal of uterine tissue containing suspected fibroids in patients who are peri- or postmenopausal, or candidates for en bloc tissue removal through the vagina or mini-laparotomy incision.
- Laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.
The new guidance applies to currently marketed and new laparoscopic power morcellators for general and specific gynecologic indications.
Based on a quantitative analysis of currently available data, the FDA estimated that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma. If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.
The two contraindications help to clarify the narrow population of patients in which laparoscopic power morcellation may be an appropriate therapeutic option.
“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 Dr. Maisel.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
