FDA Issues Updated Guidance on Power Morcellators, Recommends Boxed WarningNov 26, 2014
The U.S. Food and Drug Administration (FDA) has updated safety information concerning the risk of spreading cancer through the use of power morcellation. The agency is recommending a new boxed warning and contraindications, according to an Updated Safety Communication issued on November 24, 2014. The notification is an update on a communication issued in April, when the FDA discouraged use of morcellators due to the risk of spreading undetected cancer, specifically uterine sarcomas.
Power morcellators break up tissues into smaller pieces to be removed through small incisions during minimally invasive, or laparoscopic, surgeries. Data suggests that 1 in 350 undergoing hysterectomy (removal of the uterus) or myomectomy (removal of fibroids) has a hidden uterine cancer that can be spread through the use of power morcellators.
“If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s long-term survival.” the notification stated. “Limiting the patients for whom laparoscopic morcellators are indicated, the strong warning on the risk of spreading unsuspected cancer, and the recommendation that doctors share this information directly with their patients, are part of FDA guidance to manufacturers of morcellators. The guidance strongly urges these manufacturers to include this new information in their product labels.”
“We believe that in the vast majority of women, the procedure should not be performed,” said Dr. William Maisel of the FDA's Center for Devices and Radiological Health, according to NBC.
There are two new contraindications, the notification said. The FDA says that women who are peri- or post-menopausal or are candidates for en bloc tissue removal should not undergo procedures with a power morcellators. The tools should also not be used in gynecologic procedures where there is known or suspected cancerous tissue.
Women are advised to ask their doctors about all the options available to treat their condition. After a hysterectomy or myomectomy, tissues are usually tested for cancer. If women had a normal test result, they should go to routine follow-up.
An Immediately In Effect (IIE) guidance is being issued, and the FDA is asking manufacturers to update their product labeling to include a boxed warning and the two new contraindications. Although this information is referred to as a recommendation, FDA spokeswoman Jennifer Rodriguez said “Our experience is that manufacturers follow F.D.A. guidance. The F.D.A. has asked manufacturers of currently marketed devices to submit their revised labeling to the agency within 120 days after issuance of the guidance.” according to the New York Times.
Dr. Hooman Noorchashm, whose wife was diagnosed with stage 4 cancer after undergoing a uterine procedure with a power morcellator, is unsatisfied with the recent FDA actions and stated that his wife's cancer “would still have been morcellated under the new guidelines.”