FDA Considers “High-Risk” Vaginal Mesh Classification

April 30, 2014 — The FDA has proposed re-classifying vaginal mesh as a “high risk” medical device (class III) instead of “moderate” risk (class II), which would require pre-market approval. Nearly 50,000 vaginal mesh lawsuits are now pending in federal court.

The proposed changes only affect devices used to treat pelvic organ prolapse, but not stress urinary incontinence. Manufacturers would no longer be allowed to put new vaginal mesh products on the market through the 510(k) process, which allows similar devices to be approved without independent safety data. Instead, “high-risk” medical devices can only be cleared with safety data.

According to William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health:

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products. If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.”

FDA action began in July 2011, when the agency warned that serious complications were “not rare.” Two months later, an advisory panel recommended re-classifying the devices as “high-risk.” In January 2012, the FDA ordered manufacturers to conduct post-market surveillance studies to address concerns about safety and effectiveness of vaginal mesh.

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