FDA Reclassifies Mesh as “High Risk Device”

Earlier today, January 4, 2016, the FDA issued two final orders that can only be interpreted as a response to cries for help from woman injured by transvaginally placed polypropelene mesh products. Today, the agency has reclassified mesh products designed and marketed for transvaginal treatment of pelvic organ prolapse (POP) as “High Risk Devices.”

Additionally, the FDA will require the manufacturers of these medical devices to undertake its rigorous Premarket Approval (PMA) procedure. The PMA process will require manufacturers of transvaginally placed POP mesh to prove their products are both safe and effective for use in the public.

For women who have had their lives dramatically altered after a POP repair procedure involving transvaginally placed mesh, the announcement should provide encouragement their voices are being heard and others will hopefully not have to suffer their pain in the future. The PMA process is typically required for new medical device products, unless a device manufacturer can prove that a proposed product satisfies the much less stringent 501(k) approval process. Device manufacturers received the less stringent 501(k) approval for transvaginally placed mesh for POP repair, but the FDA’s actions today show it has reconsidered its previous decision in light of mounting evidence that these products should not be used for transvaginal POP repair. All manufacturers of transvaginally placed mesh for POP repair must now submit a PMA within 30 months. Sometime thereafter the FDA will issue its decision regarding whether the products should be removed from the market. Even if the products stay on the market, the FDA could require stricter warning labels, attorneys have been calling for removal of these products from the market after the FDA issued warnings in 2008 and 2011.

Once again, device manufacturers are showing that unless compelled to action by the FDA, they will not respond to the plight of their consumers.