According to The New York Times, The Food and Drug Administration issued an order on January 4, 2012 requiring the makers of implantable transvaginal surgical mesh used to treat urinary incontinence in women to study its risks.
According to an FDA update, in letters mailed to Johnson & Johnson , C.R. Bard Inc. and 31 other makers, they are asking manufacturers to collect and review all existing data on the safety and efficacy of the devices, and the agency mandated 88 postmarket surveillance studies between the 33 companies.
The move comes after several years of reports of serious injuries linked to the devices. In September 2011, a group of FDA advisors backed a proposal by agency staff to reclassify transvaginal mesh used for POP repair as a Class III (high risk) medical device. Currently, the devices are classified as moderate risk (Class II), making them eligible for the 510(k) approval process, which does not require human trials before a device is brought to market. The majority of advisors on the FDA panel also agreed that the agency should require the manufacturers of transvaginal mesh devices currently on the market to conduct postmarketing studies to assess their safety and effectiveness in POP repair.
Female urinary incontinence is often caused by two conditions. One is called pelvic organ prolapse (POP), 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. One way to treat the incontinence is with the transvaginal mesh. However, this treatment is not for everyone and may come with some complications.
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.
Complications reported to the agency have included mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. The FDA said in a July 2011 safety communication that its review had not seen any evidence that POP repair with transvaginal mesh offered additional benefits compared to other treatment methods.
Dr. Maisel emphasized that the new order 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 FDA isn’t likely to enforce a recall, Maisel told Bloomberg. “There’s strong support in the clinical community that mesh serves a role for certain patients,” Maisel said. “Our goal is not to completely remove these products from the market.”
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.
The FDA is also still considering the reclassification of these devices. Hopefully a decision will be made later this year.
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