FDA weighs cancer risk of fibroid removal devices

WASHINGTON - Federal health advisers said Friday that there is little to no evidence that a popular technique for removing uterine fibroids can be performed without the risk of spreading an undetected cancer to other parts of the body.

The Food and Drug Administration advisory panel also agreed that women who do undergo the procedure should be asked to give written consent stating they understand the serious risks of power morcellation. It involves a device with a motorized blade that shreds the uterus or fibroids so that tissue can be removed through a small incision in the abdomen.

Power morcellators, first marketed for gynecology in 1995, were developed to reduce the invasiveness of traditional surgery, which requires a larger abdominal incision and results in more bleeding and longer hospital stays. They are now used in tens of thousands of procedures a year.

The FDA convened the two-day meeting after concluding that the risk of accidentally spreading a hidden, rare, notoriously aggressive cancer to other organs is far more common than previously thought - perhaps 1 in 350.

The catalyst for the FDA's scrutiny was cardiothoracic surgeon Hooman Noorchashm and his wife, anesthesiologist Amy Reed. The couple, who were trained in Philadelphia and are moving back from Boston with their six children in August, launched a campaign to ban power morcellators in December.

That was one month after Reed, 40, underwent a hysterectomy with morcellation that spread the undiagnosed cancer, called leiomyosarcoma. She has had extensive surgery and chemotherapy to fight her stage 4 disease.

The couple and their relatives joined other affected families in making impassioned presentations at the meeting.

"There was a very clear shift after the morning session - after the presentations," Noorchasm said afterward. "It made a big difference."

The agency convened the 16-member panel - mostly obstetrician-gynecologists, but also general surgeons, an ethicist, and others - to weigh in on potential methods for minimizing the risk, including using plastic specimen bags to catch bits of shredded tissue. Some surgeons already use the bags, but panelists said that choice is based on "intuition."

"There's no evidence that the bags or any containment devices prevent the outcome we are trying to prevent," Craig Shriver of Walter Reed medical center told the panel. Shriver was the only one to explicitly support a ban on the devices.

"There is at present no safe way to offer morcellation as part of gynecological surgery," he said.

The panel discussed the difficulties of screening women for leiomyosarcoma ahead of time. While there are some common risk factors - based on women's age, race and family history - panelists said they are not reliable. Imaging with ultrasound, MRI or PET is also unreliable, and adds to the cost.

"It doesn't sound like anyone has confidence that those will be able to predict the vast majority of leiomyosarcomas," said panel chair Michael Diamond, an ob-gyn at Georgia Regents University.

The FDA takes the opinions of its panelists into consideration when it makes regulatory decisions on medical devices and other treatments but is not bound by them. The agency has not set a timeline for taking action on power morcellators.

Doctors have long acknowledged the risk of accidentally spreading undetected cancer with the devices, but it was believed to be remote, perhaps 1 in 10,000.

The prevalence continues to be debated, because existing studies are few, small and inconsistent; some include cases of cancer spread by "manual" morcellation with scalpel.

In April, after the FDA found the risk may be as high as 1 in 350, the agency issued a safety advisory "discouraging" it. The primary device maker, Johnson & Johnson, suspended worldwide sales.

Power morcellators were cleared 20 years ago through an abbreviated review process because they were deemed similar to simpler devices long on the market.

Fibroids - benign growths that can cause pain, bleeding, and other problems, mostly among women in their late 30s and 40s - are the reason for an estimated 240,000 of the 400,000 annual hysterectomies in the U.S. At least 40,000 of them involve power morcellation.