FDA: Pelvic Mesh Riskier Than Thought

A product commonly used in surgery to treat pelvic collapse and other women’s health problems causes far more complications than previously thought and is likely exposing patients to unnecessary risks, according to U.S. health officials.

The Food and Drug Administration said Wednesday that women who have a surgical mesh implanted to support their reproductive organs are at greater risk of pain, bleeding and infection than women who have traditional surgery with stitches.

“The added benefit of using the mesh is not evident, but there certainly appears to be an added risk,” said Dr. William Maisel, FDA’s chief scientist and deputy director of the center for devices.

More than a half-million women undergo surgery for so-called pelvic prolapse and incontinence each year, though not all procedures involve mesh. About 75,000 women had prolapse surgery with mesh inserted through the vagina last year, and more than 200,000 women had the procedure for incontinence. A less common procedure inserts the mesh through the abdomen, and the FDA said there are significantly fewer complications with that technique.

Between 2008 and 2010 the agency received more than 1,500 reports of complications from women undergoing vaginal prolapse surgery with mesh, up 500 percent from the prior three years. There were fewer complications among incontinence patients.

Wednesday’s warning applies only to mesh for prolapse. The agency is also reviewing the use for incontinence, though side effects have not been as frequent. Doctors who perform the procedures say incontinence surgery uses less mesh, possibly resulting in fewer complications. […]

Dr. Diana Zuckerman said the agency should have required the studies it is now contemplating before mesh products were approved.

“If they had been required to go through the more rigorous approval process, similar to that for prescription drugs, it would have been obvious years ago that surgical mesh has more risks than benefits in many types of surgery,” said Zuckerman, who directs the National Research Center for Women & Families.

Read the rest of the original article here.