J&J Stops Selling Vaginal Mesh Implants
June 5th, 2012 // 12:09 pm @ jmpickett
In an unexpected move, Johnson & Johnson’s Ethicon unit will halt marketing of four vaginal mesh implants that have been the subject of lawsuits filed by approximately 1,000 women who claim the products have caused serious internal injuries. The devices treat incontinence and pelvic organ prolapse in which internal organs slump into the vagina.
The decision involves four Gynecare products – TVT Secur; Prosima Pelvic Floor Repair System, Prolift Pelvic Floor Repair System and the Proflit MTM Pelvic Floor Repair System – and was disclosed in a pair of letters sent late Monday to judges overseeing different batches of lawsuits – a federal judge presiding over multi-district litigation in federal court in West Virginia and a state judge in New Jersey.
“Ethicon has no present intention to commercialize these products in the future, but it has requested that FDA allow it 120 days to cease commercialization. This time period would permit Ethicon to notify its customers, and provide those hospitals and surgeons with sufficient time to select alternative treatment options for their patients,†the J&J unit wrote the judges.
“Ethicon will also discontinue or revise, as appropriate, all marketing materials during this time. Ethicon will continue to report adverse events and provide medical communications for these products, consistent with applicable regulations; however, Ethicon has requested that FDA’s Office of Surveillance and Biometrics place the existing 522 orders requiring additional studies for these products on hold. Ethicon is awaiting written confirmation of that plan†(here is the letter to the judge overseeing the multi-district litigation in federal court and the letter to the New Jersey state court judge). For the moment, the implications for the litigation remain uncertain.
The move comes amid ongoing controversy over J&J and its devices. An estimated 300,000 women have reportedly had the devices implanted and a steady stream of FDA alerts have been issued. “Almost 11 years after nearly dying from implantation of a Gynecare TVT bladder mesh, these are real results. What a victory,†writes Lana Keeton, a mesh recipient and patient advocate, in an e-mail last night after hearing about the Ethicon move. “I am so thankful fewer women will be mutilated by the irresposible use of synthetic surgical mesh as a ‘medical device.’â€
Last year, the FDA issued a statement saying it is unclear whether prolapse implants provide any benefit over traditional surgery (read here here) and noted a large increase in deaths and injuries. The MedWatch alert was made three years after the agency acknowledged a problem in a 2008 report that found complications were serious. Meanwhile, an FDA panel recommended the devices should be classified as high risk.
Earlier this year, the agency asked J&J and other manufacturers to conduct safety and effectiveness studies (see this). And, two months ago, documents emerging from the litigation revealed that the health care giant had been selling the Prolift device for three years before the FDA became aware. J&J maintained it was able to do so because the device was very similar to another product.
J&J has been under withering scrutiny for a large and steady stream of product recalls, including tens of millions of over-the-counter meds, contact lenses, epilepsy drugs and hip replacement devices, among other items. There have also been embarrassing shortages of Tampons and shampoos. And manufacturing gaffes led to an FDA probe and a consent decree; highly publicized congressional hearings; a closed plant and accompanying job losses; managerial changes; eroded consumer confidence; various lawsuits and hundreds of millions of dollars in lost sales.
The decision to halt marketing of the vaginal mesh implants also renews attention on the FDA 501k approval process for devices, which is used to determine if a device is substantially equivalent to another marketed device and, therefore, requires little testing in patients. Last year, the US Government Accountability Office slammed the agency for failing to strengthen its approval and recall procedures, despite a 2009 GAO recommendation that “expeditious steps†should be taken to issue regulations for high-risk devices are approved under the 510K process (see this).
An Ethicon spokesman writes to “stress that this is not a product recall. We continue to have confidence in the safety and efficacy of these products. Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics, and is not related to safety or efficacy.†The phase out will take place over the next three to nine months and complete the process by early next year.
Meanwhile, Ethicon plans to update product labeling for Gynecare Gynemesh PS to restrict the indication for use to the abdominal sacrocolpopexy procedure for the treatment of pelvic organ prolapse, the letter states. The J&J unit has asked the FDA for permission to continue sales until the agency responds to its proposal.
