Unsafe Products Often the Basis for Approval of Vaginal Mesh, Dangerous Medical Devices
In a new report announced by Congressman Edward Markey, it is suggested that a number of medical devices (including transvaginal mesh) have gained FDA approval as a “substantial equivalent” to other products with known safety issues.
Markey’s goal in releasing the report and holding a subsequent press conference is to support a bill that would allow the FDA to place more stringent regulations on medical device manufacturers. The bill aims to require manufacturers to address safety issues with previous versions of devices before gaining approval of a new version.
The report calls into question a loophole in the FDA’s 510(k) approval process, which allows manufacturers to gain approval for devices that are “substantially equivalent” to already approved devices, even when these approved devices present a known safety risk.
Markey’s report mentioned recent concerns about a number of potentially dangerous medical devices such as vaginal mesh products that were approved under the process in question. Thousands of women have suffered pain and injury as a result of poorly designed vaginal mesh that was approved based on previously approved mesh that was subsequently recalled amid safety concerns.
“Already, thousands of patients have been harmed — in some cases grievously and irrevocably — by medical devices that were modeled after recalled devices,” the report states. “Among the most prominent example is that of vaginal mesh implants, used to correct incontinence and weak pelvic organs.”
After so many women were harmed by dangerous vaginal mesh, the FDA issued warnings against the devices and stated that they saw no medical evidence that proved vaginal mesh provides any benefits over other treatments for pelvic organ prolapse and stress urinary incontinence.
In the bill Markey proposes, the Safety of Untested and New Devices Act (SOUND), manufacturers of medical devices would be required to prove that new devices eliminated known safety problems in older versions. Right now, as long as the “substantially equivalent” standard is met, the FDA is required to approve devices.
Vaginal mesh is not the only medical device that was approved based on unsafe previous models. In August 2010, the FDA issued a recall for the DePuy ASR hip replacement system, which was approved based on its similarity to the DePuy Pinnacle hip. The Pinnacle hip has been the subject of numerous complaints, and the ASR was recalled as a result of safety concerns.
Another case where the 510(k) process introduced a dangerous medical device into the market involved the Bard G2 IVC filter, which was based on the Bard Recovery IVC filter. Both devices have since been linked to an unacceptably high rate of failure.
Contact a Medical Device Lawyer
If you have suffered injury after using a potentially defective medical device, you can learn about your right to sue for compensation in a free legal consultation with a personal injury lawyer. Contact an experienced product liability attorney today for more information.