Endo/AMS Pays $830 Million Vaginal Mesh Lawsuit SettlementMay 1, 2014 — Endo International has agreed to pay $830 million to resolve a “substantial majority” of the vaginal mesh lawsuits pending in federal court against its American Medical Systems subsidiary. The company expects payments to occur throughout 2016.

According to to Bloomberg, women who qualify would receive an average of $40,000 per case. However, the settlement is designed to allow women to seek additional funds if they had severe injuries or required multiple surgeries to have the devices removed.

The settlement will resolve 20,000 lawsuits involving the Perigee, Apogee, and Elevate vaginal mesh mesh implants. About 5,000 are unresolved. Endo is facing over 16,500 lawsuits centralized in a federal Multi-District Litigation (MDL) in West Virginia. In July 2013, Endo and AMS paid $54.5 million to resolve an undisclosed number of these cases.

The FDA recently proposed tightening safety regulations on vaginal mesh, changing them moderate-risk (Class II) to high-risk (Class III). Until now, manufacturers have gained approval through the 510(k) system, which allows approval of new devices without new safety studies so long as the device is similar to a product already on the market. The FDA has also asked 31 manufacturers, including Endo and AMS, to conduct safety studies.

About 50,000 vaginal mesh lawsuits are pending in state and federal courts around the nation. Women allege that the mesh can erode through the vaginal wall, become infected, cause chronic pain and disfigurement, and make sexual intercourse impossible. Many women have required multiple revision surgeries at great expense, yet still suffer from complications that permanently decrease quality of life.

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