FDA Reclassifies Transvaginal Mesh as “High Risk”

The FDA’s decision to fast-track transvaginal mesh products has backfired as thousands of women allege injuries from mesh erosion and infection. The FDA approved transvaginal mesh products without conducting human trials because there were similar products already on the market and the FDA deemed them as being “low to moderate” risk.

When the FDA fast-tracked the vaginal mesh products, they hit the market and ran. But, now, thousands of women are filing lawsuits against the medical device companies that make the products, claiming that they suffered injuries and feel like guinea pigs for the dangerous products.

To date, more than 50,000 transvaginal mesh lawsuits have been filed on behalf of women who claim injuries such as severe pain, organ perforation, perforation of the uterus, urinary problems and erosion through the vagina.

Because of the thousands of lawsuits filed, the FDA has deemed these products as high risk and is now requiring manufacturers to conduct clinical trials before marketing new vaginal mesh products. The agency is also requiring companies that already have transvaginal mesh products on the market to conduct safety evaluations of their products if they wish to keep their products on the market.

Critics argue that these new requirements are a little too late. The FDA rejected the consumer advocacy group Public Citizen’s urge to ban these products completely from the market. The group asked the FDA to recall transvaginal mesh products and disallow all marketing efforts in a 2011 petition. Although the FDA rejected the request, it did state that it will be addressing safety issues involving the products.

For more information about filing a transvaginal mesh lawsuit, contact The Law Office of Melinda J. Helbock A.P.C.

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