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FDA Panel Backs Plans For Premarket Studies Of Organ-Prolapse Mesh Devices

By Jennifer Corbett Dooren Of DOW JONES NEWSWIRES WASHINGTON -(Dow Jones)- A federal advisory panel Thursday called for more clinical studies and tougher regulation of certain surgical mesh products used to treat pelvic organ prolapse, an often painful condition that affects thousands of women. The Food and Drug Administration panel backed plans by the agency to require premarket approval studies for new mesh products when used in a specific type of procedure to repair organ prolapse. The mesh products, which are made by several companies including C.R. Bard Inc. (BCR), Boston Scientific Corp. (BSX) and Johnson & Johnson (JNJ), are currently reviewed under an FDA device clearance process that doesn't require preclinical tests in patients. FDA officials said existing products will be allowed to stay on the market. The panel also agreed with FDA plans to seek post-market studies of existing products. The FDA is proposing that mesh products that are inserted through the vagina be moved to the highest-risk, Class III FDA category of medical devices. This requires companies to conduct clinical trials in people and then submit an application seeking FDA approval, similar to the mechanism required for drugs. The advisory panel didn't take a formal vote on whether to reclassify the devices but a majority of the panel of non-FDA medical experts said they supported FDA's proposal. The FDA isn't required to follow its panel's advice but usually does. The companies have asked FDA to keep the products as Class II, but said they agreed with the need to conduct post-market clinical studies and design training programs for surgeons who use the devices. The devices are currently reviewed under the so-called 510(k) process which allows companies to obtain FDA clearance for devices without conducting clinical trials if they can show a product is "substantially equivalent" to an existing device. The 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. FDA staff said the number of reported mesh-related side effects has increased in recent years, which "calls into question the safety of these devices." Many side effects were caused by the mesh protruding out of the vaginal tissue, which in turn caused pain, infection and bleeding, FDA said. Agency staff said the mesh wasn't better than traditional surgery that doesn't use mesh. Traditional surgery uses a woman's own tissue to support the organs. In the 1970s, surgical mesh, which was being used to repair abdominal hernias, started to be inserted through the abdomen to treat prolapse and incontinence before doctors later started inserting the mesh through the vagina. In the past decade products designed specifically for transvaginal procedures have entered the market through the 510(k) clearance process. FDA said there were about 75,000 transvaginal procedures that used surgical mesh. From 2008 to 2010, the FDA received 1,503 adverse event reports associated with mesh used for POP repair, which was five times as many as the agency received from 2005 to 2007. AdvaMed, a Washington trade group representing medical-device makers, said that complication rates have improved as newer and better mesh products have been developed. The group said serious side effects were less than 2% of reported side effects. -By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com (Shirley S. Wang contributed to this article.)

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