FDA and Vaginal Mesh Infographic

An October article in Bloomberg addressed the FDA’s 510(k) pre-market clearance process as it has pertained to vaginal mesh over the years. This process only requires that medium-risk devices be “substantially equivalent” to devices that are currently on the market, after which no further testing or investigation is implemented.

The reporters found that a number of vaginal meshes had been cleared for sale as substantially equivalent to a device that was later recalled.

The reporters found that a number of vaginal meshes had been cleared for sale as substantially equivalent to a device that was later recalled, Boston Scientific’s ProteGen. Once ProteGen was recalled, however, the other meshes that cited it as a precedent remained on the market with no apparent investigation by the FDA.

Furthermore, this recalled device was first cleared based on its similarity to products that were not vaginal meshes. Class Action.org has put together an infographic illustrating a portion of vaginal mesh’s history with the FDA’s 510(k) clearance process.

Click on the thumbnail below to see the full version: