The U.S. Food and Drug Administration on Monday announced that new “boxed warning” labels will be added to devices called laparoscopic power morcellators, which are used to grind up uterine fibroid growths.
The warning labels follow a recommendation issued in July by an FDA advisory panel that stated there’s no way to guarantee surgical morcellation wouldn’t increase the risk of spreading cancer to other parts of a woman’s body.
The new warning will let surgeons and patients know that “uterine tissue may contain unsuspected cancer [and] the use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients,” the FDA said in a news release.
Two other warnings will state that the morcellators should not be used in patients who are in or around menopause or in most patients who would need to undergo hysterectomy due to fibroids. The morcellators are also not to be used “in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous,” the FDA added.
“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,” Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in the agency’s news release.
“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,” he added.
In April, the FDA stopped short of banning the power morcellation devices from the market, but the agency is urging physicians and patients to weigh the risks involved with the devices prior to their use.
Women who already have undergone power morcellation don’t need to undergo a cancer screening, because some of the tissue removed during the procedure would have been sent for pathologic analysis, Maisel said. If cancer had been detected, they would have been informed, he added.