Johnson & Johnson Sold Trans-Vaginal Mesh Three Years before Approval

Johnson & Johnson sold a vaginal mesh implant for three years before U.S. regulators approved the device, according to a March 2012 article from Bloomberg Online News. Johnson & Johnson’s Ethicon unit introduced the Gynecare Prolift device in March 2005.

In Johnson and Johnson’s Annual Report, the device was listed as an “innovative and effective surgical option” for weakened pelvic muscles. The U.S. Food and Drug Administration said it discovered the Prolift in 2007, when Johnson & Johnson sought approval for a related product. The FDA cleared both devices in May 2008.

Johnson & Johnson thought they could sell the Prolift without formal approval because it was quite similar to the Gynecare Gynemesh but the FDA disagreed. The FDA said distribution began “without appropriate clearence”. As a result, Johnson and Johnson’s unauthorized sales might cost it more to resolve lawsuits over the product, according to the report.