The FDA 510(k) Clearance Process and Transvaginal Mesh

An investigative report in Bloomberg concerning the FDA's 510(k) clearance process (previously vetted by the Institute of Medicine and reported on by the New York Times) took a close look at transvaginal mesh. The article revealed that many vaginal meshes were cleared for the market based solely on their similarity (known as "substantial equivalency") to other products of their kind.

One of the earliest products was recalled by the manufacturer, yet other devices were cleared based on their equivalency to it. Furthermore, the initial, recalled product (Boston Scientific's ProteGen) was cleared based on its similarity to devices that were never designed as vaginal meshes to begin with. Using the Bloomberg article as a starting point and incoporating original research from the FDA's database, ClassAction.org traced this process and adapted the results into the infographic below.


FDA Vaginal Mesh Infographic

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