Senate Proposes Bill to Allow Tracking of Hip Implant Devices
Citing the need for increased follow-up measures, the U.S. Senate has proposed a bill which would allow the tracking of potentially defective medical devices, such as hip implants and vaginal mesh implants.
The proposed bill would grant the U.S. Food and Drug Administration the authority to order companies to conduct safety studies after a product as been approved. The measure is intended to safeguard consumers from potentially defective products that would normally be approved under the FDA’s 510(k) system.
Under the current guidelines, companies that manufacture medical devices only have to prove that they are substantially similar to products already on the market in order to gain approval. The 510(k) process was used to approve defective DePuy ASR hip implants that were later recalled in 2010 as well as a number of vaginal mesh devices, which have also proven problematic. In July 2011, the Institute of Medicine recommended that the FDA retire the 510(k) guidelines and introduce new safety standards for approving medical devices.
Numerous lawsuits have already been filed against DePuy Orthopedics, alleging that the devices caused serious pain and other complications, including metal poisoning. In some cases, plaintiffs who received a DePuy ASR hip implant had to undergo additional surgery to correct the injuries caused by the device.
While the Senate argues that the additional oversight is needed to prevent additional injuries to consumers, a device industry lobby group is strongly opposed to the move. The Advanced Medical Technology Association calls the proposed bill unnecessary, claiming that less than .5% of all devices approved by the FDA are subject to a recall.
While it remains unclear what will become of the Senate’s proposed bill, it is more than evident that concerns over the safety of these medical devices are growing. As hip implant manufacturers continue to mount, the FDA may be required to change its practices in order to ensure public safety.
If you or a loved one has suffered injuries or other complications after implantation of a defect hip implant, contact Nadrich & Cohen Accident Injury Lawyers today for a free consultation. Our attorneys specialize in handling defective medical device claims in all 50 states.
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