Gynecare Prolift Vaginal Mesh Sold by J&J for 3yrs Without FDA Approval

According to a recent report, Johnson & Johnson sold their Gynecare Prolift mesh for several years before obtaining FDA approval, and the manufacturer now faces a number of product liability lawsuits brought by women who suffered complications allegedly caused by design defects with the vaginal surgical mesh.

Johnson & Johnson’s Ethicon unit began selling the Prolift mesh in March 2005, but it was not approved by the FDA until May 2008, three years later.

The FDA did not know that the device was on the market until 2007, when the manufacturer asked for approval for a related device, which are both used to treat pelvic organ prolapse and female stress urinary incontinence.

According to a recent report by Bloomberg News, Johnson & Johnson believed it was allowed to sell the Gynecare Prolift mesh without approval because it was substantially similar to the Gynecare Gynemesh, which was already on the market. However, the FDA has taken issue with this assertion.

Between the release date of the Prolift mesh and the FDA actually approving it for sale, there were 123 adverse event reports associated with the product, including reports of death and serious injury, according to Bloomberg. The fact that doctors and patients were reporting problems with a medical device that the FDA had not approved without raising alarm bells raises questions about the agency’s oversight over approved medical devices.

The Ethicon Gynecare Prolift mesh is now one of a number of surgical mesh products manufactured by Johnson & Johnson, as well as other companies, that are the subject product liability lawsuits nationwide. Hundreds of women are presenting claims that allege they suffered painful and debilitating complications after the vaginal mesh was implanted, such as pelvic pain, infection and erosion of the mesh through the vagina.

All vaginal mesh lawsuits involve similar allegations that the manufacturers failed to adequately research and test their products, rushing the products to the market through the FDA’s controversial fast-track approval system, which allows the agency to approve medical devices without rigorous pre-market testing when they feature a substantially similar design to other previously approved products.

Johnson & Johnson reportedly failed to even obtain 510(k) approval before marketing the Gynecare Prolift mesh.

Public awareness about the risk of the vaginal mesh problems increased last year, after the FDA issued warnings about an increasing number of adverse event reports associated with the products.  In July 2011, the FDA issued transvaginal mesh warning, indicating that they have been unable to find any evidence that transvaginal mesh kits used for repair of pelvic organ prolapse provide any benefit over other available means of treatment.