Amid evidence that Johnson & Johnson continued to sell a dangerous vaginal mesh implant for nine months after the U.S. Food and Drug Administration ordered it to stop, some observers are questioning whether federal regulatory agencies are currently able protect consumers.
A Bloomberg story quotes University of Michigan business professor Erik Gordon as saying that the issue points out “the industry’s ability to shrug off FDA enforcement. If companies can get away with selling products they aren’t supposed to sell, the FDA is a sheriff packing a water pistol.”
The FDA’s order that Johnson & Johnson stop selling the implant was included in a 2007 letter that was part of a group of documents filed under seal in New Jersey state court, and recently made public in response to a lawyer’s request.
Thousands of patients have filed suit against the company, alleging that the implants malfunctioned and caused them serious injury.
The devices are meant to treat urinary incontinence and a condition called pelvic organ prolapse, which occurs when weakened muscles are no longer capable of supporting internal organs. Neither condition is debilitating or deadly, and both are treatable with safer options.
But the FDA has collected widespread reports of malfunctions, deaths and serious injuries connected with the devices, which tend to erode and cause problems including infections, organ perforation and chronic pain.
Johnson & Johnson began selling its Prolift model in 2005, Bloomberg reports, without filing a new application after determining on its own that it was substantially similar to another device already approved by the FDA.
In August of 2007, the FDA told J&J to halt Gynecare Prolift sales until the agency decided whether the device was “substantially equivalent” to other products on the market, citing the “potential high risk for organ perforation.”
But the company continued to sell it until May 2008, when the FDA cleared the device without ordering sanctions.
If you’ve received a vaginal mesh implant, you should consult with a doctor if you have any ongoing symptoms or health concerns. If you have significant injuries, you should also consult with a mesh lawyer to discuss your legal rights.
See the report here: