Johnson & Johnson has announced that it will stop selling certain vaginal mesh products. In letters dated June 4, 2012, Johnson & Johnson advised judges overseeing transvaginal mesh litigations that Johnson & Johnson had informed the FDA that its Ethicon unit would no longer be selling certain vaginal mesh products. The stopping of sales is a result of numerous complaints of mesh erosion leading to serious pain and injuries. These injuries have resulted in hundreds of lawsuits being filed.
Johnson & Johnson has requested the FDA allow it 120 days to cease commercialization, in order to properly notify its customers and to provide time to find an alternate treatment for patients. In addition to stopping sales worldwide, Ethicon will also discontinue or revise all marketing materials. The Ethicon products which will no longer be sold include Gynecare TVT Secure, Gynecare Prosima, Gynecare Prolift, and Gynecare Prolift+M systems.
Surgical mesh has been under severe scrutiny for years. In 2008, the FDA released a warning regarding rare but possible adverse events for mesh products. Due to additional complaints and an increase in complications, an FDA update was released in July 2011. This warning advised that serious complications associated with surgical mesh were not rare and these products should be classified as high risk. With this heightened risk an FDA requirement was sent to all transvaginal device manufactures, which will require manufactures to present study plans to the FDA detailing safety and effectiveness concerns.
With mounting pressure from the FDA and more lawsuits being filed, it is a positive sign that J&J has finally decided to remove these dangerous products from the market. If you or a loved one has experienced problems resulting from a surgical mesh implant, please contact Pogust Braslow & Millrood for a free consultation to make sure that your rights are protected.