Metal-on-Metal Hip Replacements Now Undergoing Comprehensive Review by FDA
(February 28, 2011, New York, NY) Subsequent to the massive DePuy Orthopaedics hip replacement device recall in August 2010, the U.S. Food and Drug Administration (FDA) has decided to re-evaluate the use of metal-on-metal hip replacement devices. This news comes after hundreds of recipients of DePuy’s recalled devices, the ASR XL Acetabular System and the ASR Hip Resurfacing System, have filed lawsuits against the company due to catastrophic occurrences of failure approximately 5 years after implantation. Normally, a hip replacement device is designed to have a 15-20 year life span, but approximately 12-13 percent of patients who received either DePuy device began experiencing side effects such as chronic pain, swelling, and elevated levels of metal in the bloodstream. The Rottenstein Law Group has learned that the FDA has established an internal Web site, stating that the “FDA is actively working in several areas to further assess the safety and effectiveness of metal-on-metal hip implants.”
When devices such as hip implants are brought to the FDA for approval, a company can claim that its new product is similar to existing products already in use. This makes a product a candidates for the 510(k) approval process, which does not involve extensive testing or clinical trials. This approval “loophole” has likely contributed to the pain and suffering of recipients of the DePuy devices, since the filing of hundreds of lawsuits has proved that the devices were problematic for many patients. Many have endured incredible pain and suffering, and will likely have to undergo revision surgeries to correct the problem. The American Academy of Orthopaedic Surgeons approves of the FDA’s efforts, claiming in a statement, “We believe that a significant majority of metal-on-metal hip replacement implants have successfully relieved pain and improved function without any problems for the patients who have received them but there have been some concerning exceptions.” Those exceptions have proven to be recipients of DePuy’s defective hip replacement devices.
The Rottenstein Law Group has been retained as counsel for many of the DePuy plaintiffs. The firm’s hip replacement lawyers are currently advocating for damages due to pain and suffering, lost wages, and travel expenses not covered by insurance policies. The firm has established a Web site that specifically addresses the concerns of hip replacement patients; the site also keeps the public informed of the latest developments in the ongoing litigation.
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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