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Public Citizen Petitions FDA for Synthetic Surgical Mesh Recall and Ban

By on August 30, 2011

Synthetic and non-absorbable surgical meshes used in female pelvic surgery to correct pelvic organ prolapse (POP) offers no measurable benefits and may present an unnecessary risk to patients, so the consumer advocacy group Public Citizen has petitioned U.S. Food and Drug Administration (FDA) to have the mesh products recalled and banned. Also, Public Citizen wants the mesh to be considered a Class III medical device, which represents the highest risk, so that it must undergo stringent premarket testing before it is approved for use. At the present time, surgical synthetic mesh, which is prolene, a petroleum product, is allowed into the market after the filing of 510 (k) paperwork, which approves it for marketing, not safety. It does not have to undergo any clinical studies or premarket testing for safety, unbelievable for something that is permanently implanted in the body.

The Public Citizen petition follows a July 13th FDA Safety Notification alerting the public that complications are “not rare” and can include vaginal mesh erosion, pain, incontinence, infection among other problems. In a two year period, the FDA noted there were more than 1,500 reports of complications. Another complicating factor is that it takes often repeat surgeries to remove mesh once it has been placed in the body and in some cases it can never be removed. Co-petitioners include a professor of obstetrics and gynecology at Washington University in St. Louis and a urologic surgeon at the Mayo Clinic in Rochester, Minn. Read the rest »

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