11,000 Consumers Sign FDA Comment Letter Asking for New Metal Hip Regulations, May Prevent Injuries Named in Hip Replacement Lawsuits
Consumers Union is urging the U.S. Food and Drug Administration (FDA) to try and prevent the kind of injuries associated with hip replacement lawsuits by implementing a new regulation for metal-on-metal hips requiring all manufacturers to submit new and pre-existing designs to the agency for premarket approval, MarketWatch.com reports.
According to the article published April 18th, 2013 by the Wall Street Journal affiliate, Consumers Union sent a comment letter to the FDA signed by 11,000 consumers asking the agency to institute a new rule that would require all metal-on-metal hips to undergo rigorous clinical testing to prove their safety and effectiveness. Critical safety information for products already on the market must also be provided to the FDA within 90 days.
Although a change in the approval process for this class of devices would not erase the thousands of DePuy Pinnacle hip lawsuits, Stryker hip lawsuits and DePuy ASR hip recall – related claims that have already been filed, the FDA’s action may prevent future patients from experiencing the dangerous complications associated with metal-on-metal hip failure.
Right now, metal hip devices may still be eligible to receive approval via the FDA’s 510(k) process, which allows a product to enter the market if the manufacturer can prove it to be equivalent to one that has already been approved. The Stryker Rejuvenate, DePuy ASR metal-on-metal hip, and a version of the DePuy Pinnacle hip replacement that includes a metal Ultamet liner, and several other metal hip implants received FDA approval through this program.
“Thousands of patients have been seriously injured by faulty metal on metal hip implants and other medical devices that were never properly tested before being cleared for sale,” said the Director of Consumers Union’s Safe Patient Project.
“It’s time to stop experimenting on patients and require more rigorous safety testing of all high risk implants to prevent flawed medical devices from reaching the market.”
Injuries Named in Hip Replacement Lawsuits
The following side effects have been named in adverse event reports and lawsuits associated with metal-on-metal hip devices:
- pain and/or swelling at the local joint site;
- immobility; and
- inflammation of the surrounding tissue.
These complications, which indicate early hip failure, often require revision surgery to correct. It is estimated that between 2000 and 2011, nearly 17,000 adverse events about metal-on-metal hips were reported to the FDA.
How to File a Hip Replacement Lawsuit
If you experienced pain, swelling, loosening of the implant, symptoms associated with metallosis (metal ion poisoning) or another injury stemming from your hip replacement device, you may be eligible to file a claim against the manufacturer. Contact an attorney at Bernstein Liebhard LLP to learn more about hip replacement lawsuits at (877) 779-1414.