In the update, the FDA is now asking the device manufacturers to include a black box warning and contraindications, to warn both providers and patients of possible health risks with the procedure.
Today, the FDA 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 warns 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 2 contraindications. The IIE guidance allows the FDA to issue its recommendations expeditiously to help address a significant public health issue.
Link to the press release: http://1.usa.gov/1xMyNSQ