Lawsuits spur J&J to stop sales of vaginal mesh implants
06 Jun 2012
Johnson & Johnson's Ethicon division has pulled out from the markets four types of mesh implants used to treat urinary incontinence, after it was taken to court by two large groups of women who claim that the devices caused infections and bleeding.
J&J informed the court that it has asked the US Food and Drug Administration's (FDA) permission to stop selling four of its vaginal mesh implant systems, Gynecare TVT Secur, Prosima, Prolift and Prolift+M, within the next four months.
The New Brunswick, New Jersey-based health care major said in a statement that it is not stopping the sales of these safe devices because of litigation, but due to commercial viability.
"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," it said in a statement.
The announcement comes after years of controversy over the implants, which are implanted in women to repair weakened or damaged tissue caused by muscle weakening and a condition called pelvic organ prolapse, in which the vagina becomes weak or stretches and bulges.
Vaginal prolapse usually occurs after menopause, childbirth or a hysterectomy and around 75,000 women in the US had prolapse surgery done with mesh inserted through the vagina.
The litigants allege that the Ethicon meshes that were threaded into place through vaginal incisions, had eroded and shrunk over time, causing pain and injuries.
Currently, Ethicon and J&J are defending hundreds of lawsuits in both state and federal courts filed by individuals.
Bernstein Liebhard, a law firm representing clients in the suit said that by J&J pulling out of these devices from the market, ''confirms what plaintiffs have alleged from the start of this litigation - that any purported benefits of the mesh kits are not worth the significant safety risks to patients. These are poorly designed products that are very dangerous and should never have been placed on the market."
In January, the FDA ordered J&J and five other companies to undertake studies to track the complication rates with their products over time.
There are 35 manufacturers selling such devices in the US, including C R Bard Inc, American Medical Systems, Covidien Plc and Boston Scientific.
J&J has asked the FDA for 120 days to end the sale of these products so it could notify customers and provide hospitals and surgeons with sufficient time to select alternative treatment options.
In its last quarterly filing with regulators, J&J said that it has set aside money to pay for litigation costs associated with the mesh, but it did not specify an amount.
