Posted by: NadrichandCohen on Apr 26, 2012
The U.S. Food and Drug Administration has announced that it's developing a new system that will help to identify defective and/or malfunctioning medical devices. The move comes in response to several high-profile reports of patients being injured by defective medical devices, including all-metal hip implants and vaginal mesh.
Under the new system, devices would be assigned a unique identification number similar to a bar code. That number would then be used to scan databases of records from hospitals and insurance companies. The system would effectively allow the FDA get an accurate estimate of medical device failure rates and determine which patients may be at risk for a device malfunction.
Unlike some other countries, including the U.K. and Australia, the U.S. currently does not have a national registry system in place to track medical devices. It was joint registries in these countries that first revealed problems with all-metal hip implants manufactured by DePuy Orthopedics, a subsidiary of Johnson & Johnson. In August 2010, DePuy issued a recall of approximately 93,000 ASR metal hip implants based on data from the two joint registries, which indicated that the devices were failing at a rate of 12 to 13 percent.
The move to identify defective or malfunctioning medical devices is yet another step the FDA is taking in order to protect consumers from potentially harmful products. Legislation is currently pending which would grant the FDA broader power to approve or reject medical devices submitted for approval through the 510(k) rule. This rule allows medical device manufacturers to seek approval for a device without additional clinical trials if the device is substantially similar to a product already on the market, regardless of whether the predicate device has any known safety issues.
It was under the 510(k) rule that the DePuy ASR hips were first approved as well as numerous vaginal mesh implants which have since been linked to serious complications. Both the DePuy ASR hips and several vaginal mesh products have triggered numerous lawsuits filed on behalf of patients who were injured by one of these devices.
If you or a loved one was injured by a defective metal hip or vaginal mesh implant, you may be entitled to monetary compensation for your medical bills, lost wages and pain and suffering. Contacting an experienced vaginal mesh attorney or DePuy hip lawyer is the first step in protecting your rights.