Reuters: Regulatory News: J&J to stop selling controversial vaginal implants

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J&J to stop selling controversial vaginal implants Jun 5th 2012, 17:52 By Anna Yukhananov and Ransdell Pierson WASHINGTON/NEW YORK, June 5 | Tue Jun 5, 2012 1:52pm EDT WASHINGTON/NEW YORK, June 5 (Reuters) - Johnson & Johnson said it would stop selling vaginal mesh implants after a raft of lawsuits about the devices causing complications such as infection. The diversified healthcare agency and numerous other device makers have been sued in recent years by patients who allege organ damage and other injuries from such devices, many of which are used to support weakened vaginal muscles. There are over a thousand lawsuits pending against Ethicon Inc, the J&J unit that makes the devices. J&J spokesman Matthew Johnson said on Tuesday that the company has asked the U.S. Food and Drug Administration for permission to discontinue the sales of four such products within the next 120 days, after giving hospitals and surgeons time to select alternative options. Judge Carol Higbee of New Jersey Superior Court in Atlantic City and federal Judge Joseph Goodwin of the U.S. District Court for the Southern District of West Virginia are overseeing product liability litigation involving the J&J devices and others, including those sold by Boston Scientific Corp and C R Bard Inc. In a letter on Monday, the Ethicon division notified Higbee and Goodwin that it had asked the FDA for permission to discontinue sales of the devices and asked the agency to suspend requirements for additional studies on its Gynecare brand of products. The FDA earlier this year asked vaginal mesh makers for further safety studies. "Ethicon has no present intention to commercialize these products in the future," the company said in the letter, adding it will continue to report adverse events connected to them. The surgical mesh, made of synthetic or biological material, is commonly implanted in women to repair weakened or damaged tissue and provide support in cases of pelvic organ prolapse (POP). The condition happens when tissue that holds the pelvic organs in place become weak or stretched and bulges into the vagina. There are different types of such prolapse, including vaginal prolapse, usually after menopause, childbirth or a hysterectomy. The mesh is also used to help patients with a severe overactive bladder known as stress urinary incontinence. About 75,000 women received mesh repairs for pelvic organ prolapse in 2010 and about 200,000 received transvaginal repairs for stress urinary incontinence, according to the FDA. FURTHER SAFETY TESTS The FDA sent letters in January to 35 manufacturers of surgical mesh implants, ordering new safety studies. The agency also said it might reclassify the devices in a higher-risk category that would require manufacturers to conduct clinical trials in people before receiving approval for sale. Many of the devices are now cleared under a special process known as 510(k) that allows companies to sell the mesh if they can prove it is similar to products already on the market. The FDA said it received more than 1,500 reports of complications related to the mesh from 2008 to 2010, including cases where the it eroded into the vagina or caused bleeding and infection. The rate of problems was five times the rate reported from 2005 to 2007. J&J said it plans to stop sales of the products in all global markets over the next 3 to 9 months on a region-by-region basis. The devices include its Gynecare Prolift Pelvic Floor Repair System, its Gynecare TVT Secur System and its Gynecare Prosima Pelvic Floor Repair System. "This is not a recall; it's a global discontinuation," Johnson said. He said J&J was ending sales of the products largely due to negative overall publicity about vaginal mesh devices, not because of lawsuits against the company. J&J said it will continue to sell a related product called Gynecare Gynemesh PS for pelvic organ prolapse, as well as other vaginal devices, including for incontinence. Jeffrey Grand, a lawyer at Bernstein Liebhard in New York that represents some women suing the mesh makers, said J&J's decision could be an attempt to prevent more lawsuits against its devices and suggests they might be unsafe. "I think the timing of everything is going to make it very hard for them to convince the jury that they don't believe safety isn't tied to their decision (to discontinue)," he said. "(And) from our perspective, this is a fantastic development ... We're happy (the surgical mesh devices) won't be on the market and hurting more women." Link this Share this Digg this Email Reprints

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