J&J Vaginal Mesh Product Sold for 3 Years Without U.S. Approval
On March 21, 2012, Bloomberg reported the news that Johnson & Johnson’s Ethicon unit sold a particular vaginal mesh product called “Gynecare Prolift” for 3 years before it obtained proper FDA approval in 2008. The Gynecare Prolift device was introduced in 2005 as a “innovative and effective surgical option” to repair weakened pelvic muscles, yet J&J had not filed any documents with the FDA for formal approval in humans. According to an FDA spokesperson, J&J believed it could market the Gynecare Prolift device without approval since it was so similar to a device already on the market. The FDA learned about the Gynecare Prolift device in 2007 and required J&J to submit a 510(k) application to obtain approval. Under the FDA's very controversial 510(k) approval process, companies are allowed to introduce a product without requiring new studies demonstrating their safety or effectiveness if the product is "substantially equivalent" to a product already on the market.