FDA will weigh safety of surgical morcellators
Public comments are due this week on whether devices known as power morcellators should continue to be used in minimally invasive hysterectomies and surgical removal of uterine fibroids. The Food and Drug Administration will review the comments and decide whether to take regulatory action.
While the devices have been around for decades, there are new questions about whether their use increases the risk of spreading undiagnosed and unsuspected cancer in patients. It’s unclear what percentage of patients are at risk. Estimates range from 1 in 350 to 1 in 7,400. “It’s difficult for the FDA to make a definite recommendation with incomplete data,” said Dr. Jubilee Brown, a gynecological oncologist at the University of Texas MD Anderson Cancer Center.
Morcellators cut fibroid or uterine tissue into smaller pieces to allow removal of the tissue during surgery. Complaints by two physicians, one of whom underwent morcellation and saw her cancer spread, helped drive the current debate.
In a comment posted online, the Society for Gynecologic Oncology said it does not support restrictions on power morcellation because the tool has enabled women to receive minimally invasive procedures rather than open procedures. “Banning morcellation may cause more harm to more women,” the society said.
Johnson & Johnson, which is estimated to have about two-thirds of the power morcellator market in the U.S., said July 31 that it would withdraw its morcellation devices globally. A handful of smaller manufacturers have not said whether they will recall the devices.