The move comes after years of reports of serious injuries linked to the devices, including infections, pain and other complications. It follows a recommendation in September by an F.D.A. advisory panel that the agency require such studies.
The move Wednesday by the agency is similar to one it took last year when it ordered producers of all-metal artificial hips to undertake patient studies. The mesh products and the hips belong to a class of implantable devices that manufacturers do not have to study in patients before they are marketed or closely follow in patients afterward.
Female incontinence is often 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, is also caused by muscle weakening.
In 2008, the F.D.A. 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, said Dr. William Maisel, the chief scientist of the F.D.A. division that oversees medical devices.
Dr. Maisel emphasized that the order Wednesday did not cover all uses of surgical mesh to treat incontinence. He added that the safety of such devices when surgically implanted through the abdomen was “well established.”
The top producers of vaginal mesh include Boston Scientific, 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.
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.
Dr. Maisel said he expects that mesh manufacturers, once studies are started, will follow patients for about three years to determine the frequency and severity of complications.
Over the last year, the F.D.A. has increasingly used its authority to order manufacturers to conduct emergency studies. But the effectiveness of that procedure in preventing patient injuries is questionable because by the time the agency acts, a device has been on the market for years and been implanted in hundreds of thousands of patients.
Also, while the F.D.A. in May ordered makers of all-metal hips to conduct postmarket studies of their risks, the agency and company officials are still discussing study designs, Dr. Maisel said.
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source: New York Times (Meier, 1/4)
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