FDA To Propose Tighter Regulations for Metal-on-Metal Hip Implants
The U.S. Food and Drug Administration (FDA) is announcing a proposal this Thursday that will require metal-on-metal hip implant manufacturers to prove their devices—including all-new designs and existing ones already on the market—are safe and effective before they can either continue selling them or gain initial approval, according to the New York Times.
FDA’s Proposal Could Mean New Rules for Metal-on-Metal Hip Implants
If passed, the agency’s new proposal may make metal-on-metal hip implants ineligible for the 510(k) process, which allows a medical device to be sold if the maker can prove it to be substantially equivalent to one that is already on the market, the Jan. 16 article stated. This allows the manufacturer to bypass clinical testing for safety and effectiveness.
This process is a loophole in a federal law for medical devices passed in 1976.
Regulation Changes Announced in Wake of Stryker Hip Recall, DePuy ASR Hip Recall
Members of the medical community will surely not fail to notice that the news of the FDA’s action was announced at the height of controversy, not to mention the highly-publicized ASR hip recall of August 2010, which has surrounded metal-on-metal hip implants lately. Other metal-on-metal hip implants that are currently the subject of scrutiny include:
- Metal-on-metal version of the DePuy Pinnacle Hip Replacement System
- Biomet Magnum M2a Hip Implants
- Wright Profemur hip implants
- Wright Conserve hip implants
The DePuy ASR hip recall was announced in August 2010 after the metal-on-metal hip replacement was suggested to cause patients to suffer from early failure rates, metallosis (metal ion poisoning) and revision surgeries. An estimated 20,000 implants were affected by this recall, which is likely to cause more DePuy ASR hip lawsuits to be filed. The company’s Pinnacle metal-on-metal hip replacement has not yet been recalled.
William H. Maisel who serves as Deputy director for science at the F.D.A. said its action will order companies to produce clinical data for their products since a “large number of patients who received these products and the numbers of adverse events associated with them.”
Between the years 2000 and 2011, the agency received approximately 17,000 adverse event reports from patients who received metal-on-metal hip implants. Many of those complaints were undoubtedly filed over metal-on-metal hip implants that were passed by the 510(k) process.
Considering a Metal-on-Metal Hip Implant Lawsuit? Contact a Lawyer Today.
If you received a metal-on-metal hip implant and suffered side effects, you may be entitled to compensation for any lost wages, medical expenses or pain and suffering you were caused as a result of your injuries. Learn more about how to file a metal-on-metal hip implant lawsuit by contacting a lawyer at Bernstein Liebhard LLP at (877) 779-1414.