Johnson & Johnson subsidiary Ethicon will stop selling four of its surgical mesh products: the Prolift, the Prolift+ M, TVT Secur, and Prosima systems.
Ethicon announced its plans to stop selling these four products in a letter to U.S. District Judge Joseph R. Goodwin that the company filed yesterday in the U.S. District Court for the Southern District of West Virginia, where Judge Goodwin is presiding over the pre-trial proceedings of a multi-district litigation (MDL No. 2327) consolidating hundreds of cases against Ethicon for surgical mesh injuries. The letter reportedly states that “Ethicon has asked the FDA for 120 days to end sales so it can ‘notify its customers and provide those hospitals and surgeons with sufficient time to select alternative treatment options for their patients. The letter reportedly also stated that “Ethicon will also discontinue or revise, as appropriate, all marketing materials during this time.”
According to a June 5, 2012, Bloomberg News article, Ethicon also said that it has asked the FDA to let the company continue selling a fifth product, the Gyencare Gynemesh, with a change to the product’s labeling that would limit Gynemesh’s use to repair surgeries that implant mesh through a woman’s abdomen, as opposed to through a woman’s vagina (i.e., transvaginally). In announcements questioning the safety of using surgical mesh to treat a common female condition known as pelvic organ prolapse (POP), the FDA has singled out transvaginal repair as being particularly problematic.
As a law firm that is representing many of the claimants in the surgical mesh MDLs against Ethicon and other mesh manufacturers, the Rottenstein Law Group is encouraged by Ethicon’s voluntary recall of four of its surgical mesh products that have been used for the transvaginal repair of POP.