Wright Medical filed a citizen’s petition citing flaws in the clinical data supporting Smith & Nephew’s application to the FDA for its metal-on-metal hip implant.
New York, NY (PRWEB) August 07, 2012
One of the early metal-on-metal hip implants on the market was approved despite a petition suggesting flaws in safety data, Bernstein Liebhard LLP reports. The approval of other metal hip implants followed, including the recalled DePuy ASR, the DePuy Pinnacle metal hip implant, and the Stryker Rejuvenate and ABG II metal hip implants. Wright Medical Technology Inc., an orthopedic device manufacturer, tried to stop the U.S. Food and Drug Administration (“FDA”) from approving the Smith & Nephew Birmingham metal-on-metal hip implant in 2006.* Wright Medical filed a citizen’s petition citing flaws in the clinical data supporting Smith & Nephew’s application to the FDA for its metal-on-metal hip implant. For example, Wright Medical criticized Smith & Nephew for only including cases from a single surgeon—the inventor of the metal-on-metal hip implant. Despite the petition, the FDA approved the Smith & Nephew metal hip implant--the first of many models of metal-on-metal hip implants that would later undergo intense scrutiny and criticism due to high incidences of complications and revision surgery.
Studies Find Major Flaws with Metal-On-Metal Hip Implants
The Smith & Nephew metal hip replacement was marketed to younger and more active patients, and was supposed to last a life time. Instead, according to a British Medical Journal report, the implants had seven year failure rates of 11.8 to 13.6 percent-compared with rates from 3.3 to 4.9 percent for implants made from other materials. In March 2012, The Lancet medical journal analyzed British data on the devices and announced that all metal-on-metal hips should be banned. In the U.S., the FDA received nearly 17,000 adverse event reports about metal hip implants from 2000-2011. In June 2012, the FDA gathered an expert advisory panel on metal-on-metal hip implants, in which certain doctors stated their aversion to metal-on-metal hip replacements. Orthopaedic surgeon Dr. Yates said during the panel discussion, “I am not recommending metal-on-metal [total hip replacement] to any current patients of any sort right now.” Another surgeon, Dr. Rohr, stated that “I do not use metal-on-metal, and I can see no reason to do so.”**
Recipients Of Defective Metal-On-Metal Hips File Lawsuits
Bernstein Liebhard LLP, a nationwide law firm representing clients who have been injured by defective metal-on-metal hip implants, is currently offering case reviews to individuals allegedly injured by metal hip replacements, including:
- DePuy ASR hips
- DePuy Pinnacle metal-on-metal implants
- Wright Conserve hips
The Firm is also investigating and filing cases on behalf of individuals allegedly injured by the recalled Stryker Rejuvenate and ABG II hip stems. Those who experienced complications from a metal-on-metal hip may be entitled to compensation including medical expenses, lost wages, and pain and suffering. Since the dangers associated with metal-on-metal hip implants were first identified, Bernstein Liebhard LLP has followed developments and provided a wealth of information on metal hip implants on its website http://www.consumerinjurylawyers.com/Metal-On-Metal-Hip-Implants-Dangers. Call our lawyers today for a free case review: 1.877.779.1414.
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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Felecia L. Stern, Esq.
Bernstein Liebhard LLP