FDA Orders Studies of Surgical Mesh

The U.S. Food and Drug Administration (FDA) wants additional information on the risk of implantable surgical mesh—specifically, mesh used to treat urinary incontinence in women.

The agency ordered companies to initiate studies. The most recent move is similar to one it took last year when it ordered producers of all-metal artificial hips to undertake patient studies. The directive comes after years of reports of serious injuries linked to the devices, including infections, pain and other complications. In September, an FDA advisory panel recommended that the agency require such studies.

While the FDA has not moved to have the devices withdrawn from the market, it notified companies in letters that they have 30 days to submit plans for clinical studies that will monitor patients for three years after surgery to determine the rate of complications as well as the clinical benefits. Companies that do not comply could face financial penalties.

Female incontinence often is caused by two conditions. One is called pelvic organ prolapse, in which muscles that support organs like the bladder weaken, allowing them to descend and press against the vaginal wall. The other, stress urinary incontinence, also is caused by muscle weakening.

In 2008, the FDA issued a warning that the use of vaginal mesh was associated with complications but said at the time that such problems were rare. However, from 2008 to 2010 there was a fivefold increase in adverse event reports related to the use of vaginal mesh to treat pelvic organ prolapse, according to William Maisel, M.D., chief scientist for the FDA’s Center for Devices and Radiological Health. Maisel emphasized that the order did not cover all uses of surgical mesh to treat incontinence, telling the Boston Globe that the safety of such devices when surgically implanted through the abdomen was well established.

Among the more than 30 manufacturers of vaginal mesh are Boston Scientific, Covidien, C. R. Bard, Ethicon and W. L. Gore & Associates.

In 2010, about 185,000 women underwent procedures in which mesh was implanted vaginally to treat urinary incontinence, according to FDA figures. From 2008 to 2010, the agency received 1,503 adverse event reports associated with mesh used for prolapse repair, including reports of three deaths due to surgical complications. It also received 1,371 adverse event reports for mesh slings used to treat urinary incontinence from 2008 to 2010, which also included three deaths from the procedure.

That same year, researchers reported in a medical journal that about 15 percent of the women treated with vaginal mesh experienced potential complications. The study, which appeared in the journal Obstetrics and Gynecology, also concluded that mesh did not provide greater benefits than the traditional surgical treatment in which a patient’s own ligaments are used to strengthen the vaginal wall.