As we previously discussed, several members of Congress are working to close a loophole in the U.S. Food and Drug Administration’s approval process. Currently, the 501(k) process requires the FDA to approve medical devices if a manufacturer can show that the device is similar to one that has already been approved for sale.
Now, a new revelation regarding New Jersey-based Johnson & Johnson may further motivate lawmakers to change the 501(k) process. It was recently learned that Johnson & Johnson placed a controversial medical product on the market despite the fact that the device did not have FDA approval. In fact, Johnson did not even applied for approval for its initial vaginal mesh product, apparently determining on its own that the product was similar to a previously approved device, and therefore eligible for approval and sale.
According to FDA documents, the agency first learned of the Gynecare Prolift in 2007 when Johnson & Johnson sought approval of a related vaginal mesh product under the 501(k) process. The only problem was that the Prolift, which Johnson had been selling since 2005, had never been formally approved by the FDA.
Johnson claims that it could sell the Prolift without approval because it was similar to a previously approved device. According to an FDA spokesperson, however, “FDA disagreed with this assertion.” Johnson subsequently began to distribute the Prolife “without appropriate” FDA clearance.
Currently, more than 500 women have filed personal injury lawsuits against Johnson & Johnson regarding its faulty vaginal mesh products. This revelation certainly will not alleviate the pressure against the company.
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Source: Bloomberg, “J&J Marketed Vaginal Mesh Implant Without U.S. Approval,” David Voreacos and Alex Nussbaum, Mar. 21, 2012