U.S. Food and Drug Administration Reviewing the Safety of Metal-on-Metal Hip Replacements
(March 14, 2011, New York, NY) The U.S. Food and Drug Administration (FDA) has decided to review the safety of metal-on-metal hip replacement devices after receiving hundreds of complaints that prompted the worldwide recall of hip replacement devices manufactured by DePuy Orthopaedics. DePuy, a division of Johnson & Johnson, recalled its ASR XL Acetabular System and ASR Hip Resurfacing System metal-on-metal hip replacement devices in August, 2010, due to failure in a staggering number of recipients. The average life span of a hip replacement device is 15-20 years, but the DePuy devices were exhibiting failure rates approximately five years after implantation. Patients began experiencing pain, swelling and elevated levels of metal in the blood as the device components become compromised. To date, there have been thousands of lawsuits filed against DePuy, with more to come as the number of affected individuals continues to grow.
The FDA recently created a Web site to address safety issues of metal-on-metal hip replacement devices. It claims it is “actively working in several areas to further assess the safety and effectiveness of metal-on-metal hip implants.” The FDA will be taking a closer look at issues such as risk-benefit profiles, patient selection criteria, and revision rates associated with metal-on-metal hip systems in the United States. These are just a few of the issues the FDA is promising to take a look at.
The Rottenstein Law Group applauds the FDA for its proactive approach, but the root cause of the DePuy hip recall may likely be the FDA 510(k) approval process, used to bring hip replacement devices to market. This process allows companies to claim their products are “substantially equivalent” to existing ones already available, forgoing rigorous testing and clinical trials. The DePuy hip implants were actually grandfathered into the current system based on examples of similar products that are almost 40 years old, and bear no resemblance to modern day metal-on-metal hip replacement devices. The Rottenstein Law Group has set up its own Web site to address the concerns of patients who feel they may have been injured by a defective hip replacement device. Hip replacement lawyers are working hard to advocate for patients seeking representation in this matter.
About the Rottenstein Law Group
The Rottenstein Law Group is a New York-based law firm that represents clients in mass tort actions. The firm was founded by Rochelle Rottenstein, a lawyer with over two decades of experience in compassionate representation of clients in consumer product injury, mass tort, and class action law suits. For more information, please visit their Web site, or call (888) 9-ROT-LAW.
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