MDP’s Take on FDA Decision to Halt Pelvic Mesh

Today the FDA released an announcement that orders manufacturers Boston Scientific and Coloplast to stop selling surgical mesh intended for transvaginal repair of pelvic organ prolapse (POP). Everyone at Medical Device Problems applauds this decision, but we feel it was not made soon enough. These mesh devices were on the market for over 20 years, leaving tens of thousands of women to live with permanent disabilities and disfigurement. We also think the announcement, while a step in the right direction, does not go far enough; it does not address other mesh devices that are causing similar life-altering injuries.

Further, let us not forget that these devices were once approved through the FDA’s 510k pathway. Today’s announcement serves to highlight the structural defects in the 510k approval process and serves as a warning for all other medical devices approved through this same pathway. While this is one great small step for one harmful medical device, thousands of devices that might not meet the basic litmus test of “reasonable safety & effectiveness” remain on the market; hernia mesh, breast implants, hip implants, etc. continue to impact lives daily. Therefore, Medical Device Problems will continue to advocate for a better system of regulations, scrutiny, and testing. Humans should not be unwitting experiments used by medical device manufacturers.

We know the actions taken by the FDA today would not have transpired without the tireless voices of those women who refused to remain silent victims of the devastation mesh for pelvic organ prolapse caused them and their families. We commend you all for your ceaseless dedication to getting this device pulled from the market, which will spare other women from suffering your same fate. For those with other types of implantable mesh, we will continue to fight with you!