Transvaginal Mesh FDA Approvals Were Based on Prior Defective Product
Many of the transvaginal mesh implants that are the subject of current litigation were approved through the FDA 510k approval process, which allows medical devices to be approved without extensive testing based on its similarity to an already approved device. However, it has been discovered that the 510(k) approval for Johnson & Johnson's transvaginal mesh product was based on an older Boston Scientific device that was ultimately pulled from the market.
According to Bloomberg News, the approvals that started with the Boston Scientific transvaginal mesh device point to a key weakness with 510(k) clearances because the system lets manufacturers win clearance for a product by citing its similarity to an already approved device, known in FDA jargon as a “predicate.” However, there’s no system in place to ensure that devices based on defective, recalled products are recalled as well.
Boston Scientific's ProteGen was approved in 1996, and according to Bloomberg, was the first surgical mesh approved to treat SUI. Two years later, Gynecare TVT was approved through the 510(k) process, after Johnson & Johnson claimed it was “substantially equivalent” to the Boston Scientific device. Ultimately, Boston Scientific's ProteGen was pulled from the market, after it was found to be associated with a high number of complications, including discomfort, painful sex, and erosion of vaginal tissue. However, transvaginal mesh manufacturers were still obtaining 510(k) approvals even after ProteGen's recall.
Thousands of women may now be paying the price for the FDA’s lax oversight of transvaginal mesh devices. Consulting an attorney experienced in handling these matters is usually easy. Most lawyers will provide a complimentary initial consultation to evaluate a claim or case and let the person know if they can help. If you or someone you know has questions about transvaginal mesh speak with one of the attorneys at Bahe Cook Cantley & Nefzger PLC by calling (502) 587-2002.
