June 27, 2012 – In a recently discovered letter, the FDA directed Johnson & Johnson to stop selling their Gynecare Prolift vaginal mesh implant.
The letter, written in 2007, warned J&J to take the product off the market as it had not been approved and safety concerns needed to be addressed. J&J continued to sell the product for 9 months unregulated. The FDA did not sanction the company for its deliberate disregard of the order. It appears that the agency lacks the necessary power and resources to enforce the proper safety measures, allowing companies to put patients at risk.
This is very disconcerting for the thousands of women out there who have been injured by the mesh products. J&J has agreed to stop selling four of its vaginal meshes, including Prolift, but is not conducting a recall and says the decision has nothing to do with safety concerns, citing changing market conditions instead.
The Nations Law Firm represents women across the country who have been injured by these defective mesh products. See our Transvaginal Mesh page for more information.
Posted by Shelley J. Blas
The Nations Law Firm