The FDA has ordered manufacturers of the implantable surgical meshes used in pelvic prolapse and urinary incontinence repair surgeries to conduct new studies of the products. The move, announced yesterday, is a response to reports that 6 patients in whom the mesh was used died and thousands more suffered serious complications between 2008 and 2010.
In all, 33 transvaginal mesh manufacturers, including Boston Scientific, C. R. Bard, Ethicon and W. L. Gore & Associates, will have to conduct surveillance studies involving hundreds of patients to assess the risks and benefits of these products. Once the studies have begun, the FDA expects manufacturers to follow patients for about 3 years to determine the frequency and severity of complications.
FDA officials said in September that serious complications associated with inserting the mesh vaginally to repair prolapse are "not rare'' and that it is not clear whether this technique "is more effective than traditional non-mesh repair.''
From 2008 to 2010, the FDA received 1,503 adverse event reports associated with mesh used for prolapse repair, including reports of 3 deaths due to surgical complications. It also received 1,371 adverse event reports for mesh slings used to treat urinary incontinence, which also included 3 deaths, during this time.
The FDA stressed that yesterday's order didn't cover all uses of surgical mesh to treat incontinence and that the safety of such devices when surgically implanted through the abdomen was well established.
Dan O'Connor
