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FDA Orders End to U.S. Sales of Pelvic Mesh

The final two medical device companies selling faulty surgical mesh meant to repair pelvic organ prolapse were ordered by the Food and Drug Administration on Tuesday to cease the products’ sale and distribution in the United States, The New York Times reports. The FDA issued the mandate against Boston Scientific and Coloplast in the wake of an extensive legal battle over the defective vaginal mesh. The synthetic implant is used in millions of women and is purported to strengthen atrophied pelvic muscles to prevent organs from dropping into the vaginal area. According to the FDA, more than 10,000 women with vaginal mesh have reported serious injury. As of last year, nearly 80 deaths had been linked to the use of the product. “In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair pelvic organ prolapse,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, told the Times. “We couldn’t assure women that these devices were safe and effective long term.”