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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 three years before obtaining proper FDA approval in 2008. Introduced to the market in 2005, the Gynecare Prolift was promoted as an "innovative and effective surgical option" to repair weakened pelvic muscles in women although J&J had not filed any documents with the FDA for formal approval of the medical device. 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. Apparently, the FDA did not learn about the Gynecare Prolift device until 2007. At that time, it required J&J to submit a 510(k) application in order to obtain approval. The 510(k) approval process has been at the root of much controversy when it comes to safety and efficacy of medical products.
Under this particular approval process, manufacturing companies are allowed to introduce a product to the market without the necessity of conducting any studies demonstrating their safety or efficacy if the product is considered "substantially equivalent" to another product already on the market. On March 13, 2012, according to a Reuters news report, the President of Consumer Reports sent an e-mail blast to one million people documenting his concerns about this clearance process. Unfortunately, most patients undergoing surgery do not know what tests have or have not been performed on the products being implanted into their bodies. As to pelvic mesh products, they were approved based upon the fact that they were considered substantially equivalent to other mesh products on the market. The previously approved mesh products were to be utilized in a region of the body which is not considered as dynamic as the female pelvic region and were implanted through an abdominal incision. Also, many of the predicate products which formed the basis of the 510(k) approval process for the pelvic mesh products have been the subject of litigation and have even been recalled.
Manufacturers want to continue using the streamlined 510(k) approval process in order to get their products on the market. Consumer advocates want the process dismantled and want more testing for medical devices which are considered to carry a higher risk. As patients and consumers we must be hyper-vigilant about our health and consider becoming activists ourselves. This issue is being addressed by Congress via the SOUND Devices Act (H.R. 3847). Thousands of medical devices are placed into the market every year through the 510(k) process and they are "FDA approved". However, most patients and consumers do not understand that FDA approval does not mean that that a particular device has been tested in humans for safety and efficacy.