By Jennifer Corbett Dooren Of DOW JONES NEWSWIRES WASHINGTON -(Dow Jones)- The Food and Drug Administration is ordering manufacturers of surgical mesh to conduct new studies of the products when used to treat two conditions affecting millions of women, pelvic organ prolapse and stress urinary incontinence amid concerns about the products' safety. The move is the first step toward tighter regulation of the mesh when inserted through the vagina to repair pelvic organs, a less invasive procedure than traditional surgery. Surgical mesh was initially developed to repair hernias in the 1950s but doctors later adapted the mesh for other uses. The mesh products, which are made by several companies including C.R. Bard Inc., (BCR) Boston Scientific Corp. (BSX) and a unit of Johnson & Johnson (JNJ), are reviewed under an FDA device-clearance process that doesn't require preclinical tests in patients. In a letter mailed to companies this week, FDA said it's "concerned with the potential safety risks" of the devices and ordered studies that would follow women receiving the mesh for at least three years to look at side-effects as well as to compare safety and effectiveness to other procedures. Pelvic organ prolapse, an often painful condition, affects 30% to 50% of women at some point in their lives, occurs when the tissues that hold the pelvic organs in place become stretched or weakened, often from childbirth. Stress urinary incontinence is a leakage of urine caused by an activity like exercise, coughing or lifting that puts pressure on the bladder. The FDA has received hundreds of reports of serious complications involving the mesh for pelvic organ prolapse in recent years and some companies are facing lawsuits. In a safety communication issued in July, the agency said transvaginal mesh pelvic organ prolapse procedures "poses risks" and suggested other procedures, such as surgery through the abdomen was more effective. Many side effects were caused by the mesh protruding out of the vaginal tissue, which in turn caused pain, infection and bleeding. The agency has also proposed requiring some mesh products to undergo a premarket approval process that would require tests in patients before a device is approved, but hasn't yet made a final decision. But in ordering studies of mesh products already on the market, FDA suggested companies design the studies in such a way that they could satisfy requirements for premarket approval applications for products that would be used in transvaginal pelvic organ prolapse procedures. The FDA has said it doesn't think mesh products for stress urinary incontinence need to be reclassified from their current regulatory status to undergo premarket approval testing. In an interview Wednesday, William Maisel, the deputy director of FDA's device division, said "it's important for patients to understand not every urogynecologic procedure with mesh is affected." Still there was an estimated 75,000 transvaginal mesh procedures involving pelvic organs, FDA said along with thousands of others for stress urinary incontinence. The FDA is in the process of sending letters to 33 manufacturers of surgical mesh for pelvic organ prolapse and seven companies who make so-called "mini-slings" for stress urinary incontinence. The companies have said they would cooperate with additional postmarket studies of mesh products but have argued they shouldn't have to undergo a premarket approval process. Under current law companies only need to show the mesh is "substantially equivalent" to an existing mesh product rather conduct preclinical tests in patients. The FDA's so-called 510(k) clearance system is meant to allow companies to keep updating existing devices without going through a lengthy review process with each change. However, the risks and benefits of some 510(k)-approved products have been questioned. In July, the Institute of Medicine, an independent group that advises the government on health policy, issued a report recommending an overhaul of the FDA's medical-device process to require more oversight. The consumer group Public Citizen has called for existing pelvic-organ-prolapse mesh products to be recalled. -By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com
