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J&J's vaginal mesh implant saga takes new turn as litigation looms

A reasonable reader might sense a disconnect in a Johnson &Johnson (J&J) spokesperson's comment that, "We continue to have confidence in the safety and efficacy of these products" and the company's decision to stop selling multiple models of vaginal mesh implants after being sued by hundreds of women.

The worldwide halt applies to four products made by J&J's Ethicon unit, namely the Gynecare Prolift, the Prolift+M, the TVT Secur and the Prosima surgical meshes.

Those products have undoubtedly induced nightmares in JJ executives in recent years. More importantly, their use has resulted in users' painful injuries and an extensive amount of medical malpractice and product liability litigation now facing the company.

The Gynecare Prolift has been under a regulatory cloud for several years. Johnson & Johnson -- the largest health-care products and medical device maker in the world -- first introduced the product in 2005 as an "innovative and effective surgical option" for treating incontinence and shoring up weakened pelvic muscles. The Prolift and other mesh implants are threaded into place through vaginal incisions.

The FDA initially jumped on J&J owing to the agency's delayed knowledge of the product. Regulators say that they weren't even aware of the Prolift until 2007. The FDA disagreed with J&J's claim that it didn't need approval for the product because it was substantially similar to an already approved product.

The focus now, though, is centrally on the wave of litigation facing J&J. Most commentators believe that the company's decision to stop selling its mesh implants has everything to do with the lawsuits and very little -- if anything -- to do with its claims that discontinuance relates to a declining market and other available treatment options.

Source: Bloomberg Businessweek, "J&J tells judge it will stop sales of vaginal implants," Alex Nussbaum and Jef Feeley, June 5, 2012

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