It has recently been reported that Johnson & Johnson (J & J) continued to market and sell its Gynecare ProLift transvaginal mesh product for months after the FDA ordered it to stop marketing the device. In a letter dated August 24, 2007, the FDA told J & J, the world’s biggest seller of health care products, to halt sales of the product until the agency decided whether the device was “substantially equivalent” to other products on the market. J & J continued to market the product for nine months until the product was finally cleared by the FDA. The FDA has not imposed any sanction upon J & J for disregarding its order. J & J currently faces more than 600 lawsuits by women who have reported that J & J’s vaginal mesh products caused them serious injuries.
In 1996, the FDA cleared the first mesh product for use transvaginally to treat stress urinary incontinence, and in 2001 the agency cleared the first surgical mesh device for treatment of pelvic prolapse. Pelvic organ prolapse and stress urinary incontinence frequently occur in women after childbirth (resulting in organs that prolapse and push against the vagina toward the outside). These devices were generally cleared by the FDA’s 510(k) process, which allows approval without substantive studies if a product is “substantially equivalent” to others already on the market.
In 2008, the FDA issued a public health notification on serious complications associated with surgical mesh placed transvaginally to treat pelvic organ prolapse and stress urinary incontinence. In July 2011, after nearly 4,000 adverse events associated with the transvaginal mesh were reported, the FDA warned of a rise in “serious complications” associated with surgical mesh for transvaginal repair. The FDA also stated that “it is not clear” that transvaginal mesh repair for pelvic organ prolapse is more effective than traditional non-mesh repair, and may expose patients to greater risk. In January, 2012, the FDA ordered J & J and other manufacturers of vaginal mesh products to study organ damage and other injuries claimed to be caused by the products.
J & J’s Ethicon unit recently stated that it intends to stop selling four vaginal mesh implant products: the ProLift, ProLift+, TVT Secur and Prosima surgical meshes. In a letter filed by J & J counsel with a federal judge overseeing mesh litigation, J & J said it has sought approval from the FDA to “stop commercializing” these four vaginal mesh implant systems.
If you would like more information about transvaginal mesh, or would like to discuss your potential claim, please email Marianne C. LeBlanc at firstname.lastname@example.org or call 617-542-1000.