Vaginal Mesh Implant Was Put On Market Without FDA Approval

Johnson & Johnson sold a transvaginal mesh implant for three years before the U.S. Food and Drug Administration (FDA) provided approval.

According to Bloomberg, Johnson & Johnson’s Ethicon unit introduced the Gynecare Prolift device in March of 2005. At the time, the company touted it as an “innovative and effective surgical option” for weakened pelvic muscles. The FDA claims that the first it heard of the product was in 2007 when Johnson & Johnson named it as a predicate for another related product it was seeking approval for.

Johnson & Johnson states that it followed FDA protocol and claims it had the right to market the device without approval because it was so similar to an FDA approved device called Gynecare Gynamesh.

According to an FDA spokeswoman, the agency begs to differ with the corporate giant’s assertion, claiming that distribution began “without appropriate” clearance and that it should have filed a separate 510(K) for this product.

Andrew Sokol, an associate professor of obstetrics/gynecology and urology at the Georgetown University School of Medicine, said that he was “absolutely concerned” by the news and if surgeons had known at the time that Prolift was on the market without FDA approval, they probably wouldn’t have used it.

In July of 2011, the FDA reported a fivefold jump in malfunctions, injuries, or deaths tied to vaginal mesh products. In January of 2012, the FDA ordered manufacturers to further study complications and damage done by those products.

The vaginal mesh lawsuit attorneys at Farah & Farah are appalled at the extent to which Johnson & Johnson was willing go to fast track its potentially dangerous vaginal mesh product. If you have been injured by a vaginal mesh implant and don’t know what to do, call our experienced team at (800) 533-3555 to discuss your next move. We may be able to help you hold negligent parties legally responsible.