United States Needs to Adopt Early Warning System for Defective Hip Replacement Devices
(March 21, 2011, New York, NY) The United States is one of the few advanced countries in the world that does not utilize an early warning system to protect its citizens from defective medical devices and harmful pharmaceutical products. The August, 2010 recall of defective ASR hip replacement devices from DePuy Orthopaedics should have been a wake-up call to the U.S. Food and Drug Administration (FDA) to institute an artificial joint registry to protect the well being of American hip replacement recipients.
DePuy Orthpaedics obtained “510(k)” FDA approval for its ASR XL Acetabular and ASR Hip Resurfacing Systems based on the claim that the devices were “substantially similar” to hip replacement devices already on the market. This loophole allowed DePuy to bypass stringent clinical trials, which may have brought any issues to light before the devices were approved for use. Instead, significant differences in the DePuy devices were ignored (specifically their metal-on-metal composition), and proved harmful to thousands of patients who were implanted with the devices. Statistics have shown that the devices failed in approximately one in eight recipients, about five years after implantation. The average life span of a hip replacement device is about fifteen years.
Artificial joint registries in Australia and the United Kingdom were the first to document issues with the DePuy devices. Both countries keep track of, and document any difficulties with joint replacement surgeries, protecting the health and well being of their citizens. Reports of serious side effects being experienced by DePuy hip implant recipients, including total failure of the devices, were recorded as far back as 2005, prompting DePuy to pull the ASR hip implants from certain foreign markets. A full recall was not issued until August, 2010, after over 90,000 people had received the devices, including thousands of patients in the United States. It is difficult to determine exactly how many Americans have been affected by the recalled DePuy devices, since there is no formal joint registry to keep track of procedures, and document symptoms that could indicate potential harm to recipients. A U.S. joint registry would have uncovered issues much earlier, giving patients the opportunity to seek medical attention before their symptoms became unmanageable. Thousands of people have suffered needlessly, and have seen their quality of life diminished by faulty hip replacement devices.
The Rottenstein Law Group has hip replacement lawyers working diligently on behalf of patients affected by the DePuy hip recall. Patients who are experiencing difficulties such as pain, swelling and difficulty walking as a result of a hip replacement surgery should consult their physicians to see if their hip replacement implants are in danger of failing. Once their medical condition has been diagnosed, patients should stay informed of the latest DePuy hip replacement lawsuit developments by consulting the Web site in place to keep the public updated.
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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