No Vaginal Mesh Recall from FDA Yet

August 6, 2012 — Vaginal mesh has not been officially recalled by the U.S. Food and Drug Administration (FDA), although it is possible that there will be a vaginal mesh recall in the future. For now, the FDA is working on increasing public awareness about the risk of serious side effects. The agency has published two safety warnings (one in 2008, and a follow-up in 2011) to warn that serious complications are “not rare” — they received nearly 4,000 injury reports.

Vaginal mesh has caused thousands of injuries, yet there is no evidence that it is more effective than traditional surgical methods of treating Stress Urinary Incontinence (SUI) or Pelvic Organ Prolapse (POP). This is why many people, lawyers, and consumer advocacy groups are calling for a vaginal mesh recall.

One year ago, the consumer advocacy group Public Citizen sent a petition to the FDA. They asked the agency to ban marketing of vaginal mesh devices, re-classify vaginal mesh as a Class III “high-risk” medical device, ask current manufacturers to voluntarily recall vaginal mesh, and ask any future manufacturers of new devices to conduct well-controlled safety studies.

One vaginal mesh product has been recalled — unfortunately, many devices that are still on the market and being implanted in women were based on this recalled device. Boston Scientific Corp.’s ProteGen vaginal mesh was the first vaginal mesh. It was approved in 1996 for the treatment of Stress Urinary Incontinence (SUI).

Soon after the ProteGen was approved, other medical device companies created similar products and submitted approval applications under the FDA’s 510(k) approval system. This system allows new devices to avoid conducting safety studies so long as they prove that their device is “substantially equivalent” to an existing device. Johnson & Johnson’s Gynecare TVT was the first vaginal mesh approved with a 510(k) application, and it was quickly followed by several other companies.

Unfortunately, the ProteGen had serious safety issues. Boston Scientific received more than 100 reports of the device eroding into tissue, pelvic pain during intercourse, nerve damage, and more. They decided to voluntarily recall the ProteGen in 1999.

After Boston Scientific recalled their vaginal mesh, the FDA continued to approve new devices which based their 510(k) application on the ProteGen. The FDA continued to allow devices that were “similar” to the ProteGen to remain on the market, where they continued to be implanted in women. Other manufacturers did not issue a vaginal mesh recall, nor did they conduct additional safety studies.

The FDA has recently asked dozens of vaginal mesh manufacturers to conduct more thorough safety studies. A few months after the FDA made this request, two of the biggest manufacturers of vaginal mesh decided to stop selling their products — C.R. Bard discontinued the Avaulta vaginal mesh, and Johnson & Johnson discontinued all four of its vaginal mesh products. These products were never officially recalled.

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