Gynecare Prolift Mesh Sold by J&J Without FDA Approval
Posted by Shezad Malik MD JDMarch 21, 2012 7:36 PM
According to a report by Bloomberg News, Johnson & Johnson sold their Gynecare Prolift mesh for several years before obtaining FDA approval. Johnson & Johnson has been subjected to 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.
Johnson & Johnson sold the Gynecare Prolift mesh without approval, and claimed that it was substantially similar to the Gynecare Gynemesh, which was already on the market.
The Ethicon Gynecare Prolift mesh is one of a number of surgical mesh products manufactured by Johnson & Johnson, that are the subject product liability lawsuits nationwide.
Thousand of Lawsuits
Thousands of women are filing lawsuits, claiming that 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. Furthermore they claim, rushing the products to the market through the FDA’s controversial fast-track approval system, known as the 510 (k) process, 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.
FDA 510 (k) Process
Johnson & Johnson reportedly failed to obtain 510(k) approval before marketing the Gynecare Prolift mesh.
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.
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