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J&J’s Gynecare Prolift marketed for 3 years without FDA approval

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A new report published by Newsinferno recently revealed that Johnson & Johnson marketed their Gynecare Prolift device for three years before the FDA approved its use. Johnson & Johnson introduced the vaginal mesh product into the market in 2005 without applying for FDA clearance. The product continued to be marketed, undetected by the FDA, until 2007 when Johnson & Johnson cited Gynecare Prolift as the predicate in the 510(k) application for a similar product, the Prolift + M. Neither mesh product was officially approved for market by the FDA until 2008.

Those involved with the mass tort cases against Johnson & Johnson believe that the unapproved marketing of the Gynecare Prolift device may increase the cost for Johnson & Johnson to resolve the lawsuits currently filed against them.