Hundreds of personal injury lawsuits have surfaced throughout the country regarding a Johnson & Johnson vaginal mesh implant that is used to repair pelvic organ prolapsevery. In the lawsuits, women who received vaginal mesh implants claim that the product is defective and caused them serious injuries.
In fact, the hammock-like device is very similar to another product that was pulled from the market after being deemed unsafe more than 10 years ago.
Concern over the Johnson & Johnson product was announced by the U.S. Food and Drug Administration in 2008 and again on July 13, 2011. The FDA warned that patients going through pelvic organ prolapse repair with a surgical mesh could be more at risk of mesh complications than women who went through alternate surgical treatment.
What’s more is that these lawsuits stand to expose a flaw within the FDA’s “fast track” approval process for medical devices. Currently, the FDA has a policy known as the 510(k) process, which allows products to be deemed safe by merely showing that a similar product, or “predicate,” has already been reviewed and approved by the FDA.
From there, a third similar device can be approved based on the second device, and so on. The problem is that if one of the devices is recalled or deemed unsafe, it does not necessarily mean that the other products that were granted clearance based on that “dangerous” product will be reviewed.
According to a report by Bloomberg News, this is what happened with the vaginal mesh implants.
In 1996, the FDA approved the first vaginally implanted mesh designed to treat incontinence. It was manufactured by Boston Scientific and called ProteGen.
Johnson & Johnson’s similar device, called Gynecare TVT, was approved under the 510(k) system two years later. Human testing was not required because the Boston Scientific device had already been approved. Two additional products that were considered “substantially equivalent” to the first two were also approved.
Eventually, Boston Scientific’s vaginal mesh implants were pulled from the market after it was determined that they were unsafe. Hundreds of lawsuits were filed after patients were injured by the device. However, the Johnson & Johnson vaginal mesh implants were not recalled.
Additionally, the FDA reported that around 300,000 women received vaginal mesh implants in the year 2010 alone, so there could be many injuries and subsequent lawsuits to follow.
Source: Bloomberg News, “J&J Mesh Approved by FDA Based on Recalled Device,” Alex Nussbaum and David Voreacos, Oct. 27, 2011.