FDA warns gynecologic device has spread cancer

The US Food and Drug Administration Monday warned against a gynecologic device that has spread cancer in women who thought they had harmless fibroids.

In the last year, two-dozen women have reported that their cancer was made worse by the device, called a power morcellator, which turned a treatable condition into a life-threatening disease.

"We believe that in the vast majority of women, the procedure should not be performed," said Dr. William Maisel, deputy director for science and chief scientist of the FDA's Center for Devices and Radiological Health.

The device is used to pulverize fibroids before removing them through a tiny hole in the abdomen. If any growths are cancerous – which is impossible to determine before surgery – the power morcellation spreads cancer cells throughout the abdomen, virtually guaranteeing that the cancer will become more dangerous.

Opposition to the device has been led by a surgeon, Hooman Noorchashm, whose wife, Amy Reed, went in for a routine hysterectomy a year ago and came out with stage 4 cancer. Reed, then a doctor at Beth Israel Medical Center in Boston, is now in remission and getting ready to go back to work at the Hospital of the University of Pennsylvania. The two have six children ages 2 to 13.

Noorchashm, who has repeatedly called for the FDA to institute an outright ban on morcellation, said Monday that he doesn't think the warning goes far enough to protect women like his wife. As long as the device is on the market, women will be vulnerable, he said.

Maisel said the device might still be useful in younger women who are at low risk of cancer and who are concerned that surgery without morcellation could leave scar tissue that would reduce their chance of becoming pregnant.

Use of the device has fallen dramatically since April, when the Johnson & Johnson subsidiary that makes many of the morcellators pulled its products from the market. Most major hospitals, including Brigham and Women's Hospital in Boston, where Reed's procedure was done, have also stopped using power morcellators.

Maisel said that until then, roughly 50,000 women per year had a laparoscopic procedure that might have included power morcellation, and roughly one in every 350 of those who were morcellated saw their cancer spread.

The cancer was generally identified immediately after surgery when the morcellated tissue was analyzed. Maisel said women who weren't informed of spread right after surgery aren't at risk.

The American College of Obstetricians and Gynecologists praised the FDA's decision to stop short of a ban, saying in a statement Monday that "we continue to believe that power morcellation has a role in gynecologic surgery."

Carefully choosing and informing women about the risks of the surgery will provide appropriate protection, Dr. Hal Lawrence, executive vice president and CEO of the group, said in the statement. And many women will continue to choose surgery with power morcellation, he said, because it can be performed with a tiny incision, substantially reducing recovery time.