Researchers Reassess Safety Of Metal-On-Metal Hip Implants; Withdraw Support
New York, NY November 11, 2011
Bernstein Liebhard LLP reports on an October 19, 2011 study released by the California Technology Assessment Forum (“CTAF”), which found that metal-on-metal hip resurfacing is not as safe and effective as a traditional hip replacement.* In 2010, the CTAF conducted a similar review, however, this latest assessment reverses the position previously held by the CTAF. As a basis for abandoning earlier views, researchers used recent findings by foreign orthopedic registries and studies about metal poisoning in hip replacement recipients for support. The lawyers at Bernstein Liebhard LLP, who are representing clients that have been injured by metal-on-metal hip implants, are pleased that the medical community continues to address the safety of metal-on-metal hip implants. Given the number of individuals who received these devices, the Firm’s attorneys believe that ongoing review is paramount in order to protect public health.
CTAF Concerned About Hip Replacement Failure
The CTAF study noted two main types of adverse events associated with metal-on-metal hip implants: early hip replacement failure and elevated levels of metal ions in the bloodstream. In addition to noting that the long-term health effects of metallic ions, which shed from the devices is unclear, the report ultimately concluded that “There is clearly no evidence that the potential benefits outweigh the potential risks.”
The CTAF listed five criteria for determining the safety of metal-on-metal hip implants: (1) the technology must have final approval from the appropriate government regulatory bodies; (2) the scientific evidence must permit conclusions regarding the effectiveness of the technology regarding health outcomes; (3) the technology must improve net health outcomes; (4) the technology must be as beneficial as any established alternatives; and (5) the improvement must be attainable outside of the investigational setting. Metal-on-metal hip implants only pass muster for the first two criteria. Therefore the CTAF concluded, “[I]t is incumbent upon the hip resurfacing community to prove the efficacy and safety of [metal-on-metal] hip resurfacing in randomized clinical trials, rather than subjecting young patients to significant potential harm over their lifetimes.”
DePuy Hip Replacement Recall
Although the CTAF study analyzed several hip implant devices, it discussed the circumstances of the August 2010 DePuy hip replacement recall. Moreover, the CTAF noted that in light of the artificial hip recall, on May 6, 2011, the U.S. Food and Drug Administration ordered medical device manufacturers to conduct post-market surveillance studies of patients who received metal-on-metal hip implants.
Since Johnson & Johnson issued its ASR hip recall in August 2010, Bernstein Liebhard LLP has provided a wealth of consumer information concerning both the Pinnacle and ASR hip systems on its website, www.consumerinjurylawyers.com. If you or a loved one received a DePuy ASR or Pinnacle implant during hip surgery and have experienced hip replacement pain or had to undergo revision surgery, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries.
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country for the past nine consecutive years. Only two firms in the country have been selected for the Hot List nine years in a row.
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