ON THE WAY OUT? The FDA wants stronger warnings for morcellators, at the very least.

FIBROID SURGERY FDA Still Mulling Morcellation

The FDA isn’t banning power morcellators. Not yet, anyway. An agency panel charged with weighing the pros and cons of the devices when used in minimally invasive hysterectomies and myomectomies is recommending a stronger warning label and steps to make sure patients are made aware of associated risks. But as the panel closed its 2-day hearing last month, it didn’t rule out the possibility that morcellators will ultimately be banned altogether.

The issue came to the fore in 2013 after Amy Reed, MD, PhD, an anesthesiologist at Beth Israel Deaconess Medical Center in Boston, Mass., had a leiomyosarcoma upstaged to stage IV cancer as a result of morcellation. She and her husband, Hooman Noorchashm, MD, PhD, of Harvard Medical School, have led the push for a ban. The FDA responded in April, issuing an advisory discouraging the use of laparoscopic power morcellation for women with uterine fibroids and encouraging physicians to discuss alternative treatment options with these patients. But if power morcellation was considered the best option, patients should be informed that their fibroids “may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis,” the FDA advisory said.

But morcellation proponents argue that banning the devices would do more harm than good, arguing that the percentage of women with undetected sarcomas is extremely small, that the prognosis for those women is already bleak, and that a resultant large increase in the number of open procedures would dramatically worsen outcomes for the vast majority of women who don’t have cancer (see “Are Morcellators Safe for Hysterectomies?”).

— Jim Burger