New York, NY (PRWEB) March 05, 2012
Parker Waichman LLP, a national law firm representing plaintiffs in lawsuits involving defective medical devices, is warning the public of the serious, long-term health risks associated with exposure to dangerously high levels of toxic metals ions shed by failing metal-on-metal hip implants. According to a new report published in the British Medical Journal, hip implant manufacturers were aware of mounting evidence linking metal-on-metal hip replacement devices to serious, long-term health consequences, but for years failed to warn the public about these dangers.
Metal-on-metal hip implants have been the subject of growing concerns since the August 2010 worldwide recall of the DePuy ASR Hip Resurfacing System and the DePuy ASR Acetabular System. Now, an investigative report published in the British Medical Journal has asserted that hundreds of thousands of people globally were exposed to toxic metal ions from failing all-metal hip implants, despite the risks being known and documented for decades. Manufacturers remained silent in the face of mounting evidence of risk.
According to the article, it was known as early as 1975 that cobalt and chromium ions could cause local tissue damage. The report shows how such reactions from all metal hip implants can destroy muscle and bone, leaving some patients with long-term disability. According to the British Medical Journal, studies have also shown that metal ions can leak into the bloodstream, and spread to the lymph nodes, spleen, liver and kidneys. Additional research has raised red flags about the carcinogenic potential of metal-on-metal hips. [bmj.com/content/344/bmj.e1410]
Years before the DePuy ASR hip implant recall, evidence was apparently already mounting about high metal concentrations in patients with all-metal devices. For example, the report cites an internal DePuy memo from 2005 that expressed concern about the potential for patient harm, including one study that "suggested a threefold risk of lymphoma and leukemia 10 years after joint replacement." Yet publically, DePuy continued to aggressively market the devices, and worked to downplay concerns about their safety.
The British Medical Journal also points out that many metal-on-metal hip implants did not have to pass any clinical trials before they were put into patients. In the U.S., most of these devices were eligible for the FDA's 510(k) clearance protocols, which do not require human studies if a devices is shown to be similar to another already on the market. Many manufacturers changed the design of their metal hips over the last decade in an attempt to prevent dislocation and increase movement. None of these design changes were subject to new clinical trials or post-marketing studies to detect any long-term problems. According to the report, experts believe that these modifications are likely responsible for the release of high levels of toxic metals into the body.
Finally, the report makes it clear that DePuy Orthopaedic's recalled ASR Hip Implants are far from the only all-metal hip implant devices to have compromised the health of so many patients. For instance, potentially unhealthy levels of metal ions have been recorded in around 20% of patients with other metal-on-metal, including an all-metal version of DePuy's Pinnacle hip implant. According to the article, not only has the all-metal Pinnacle device been allowed to remain on the market, but DePuy promoted it as “an alternative for the majority of patients” when the ASR implants were recalled globally.
According to the British Medical Journal, metal-on-metal hip replacement devices have been implanted in 60,000 patients in England and Wales since 2003. In the U.S. the figure is closer to a million and likely to increase, as device makers continue to promote all-metal implants to doctors. Parker Waichman LLP believes that the revelations in the report make it clear that metal-on-metal hip implants present a clear threat to public health and should be treated as such by regulators.
“This shocking report confirms what we have suspected for some time, namely that although problems occur to varying degrees manufacturer by manufacturer, the entire class of metal-on-metal hip implants place patients at an unreasonable risk of failure and/or new disease," states Daniel Burke, attorney at Parker Waichman LLP.
Parker Waichman LLP continues to offer free legal consultations to victims of metal-on-metal hip implant injuries, including DePuy Orthopaedics' ASR Hip Implant and the metal-on-metal version of the Pinnacle hip replacement device. If you or a loved experienced premature failure of your implant or other health problems associated with metal-on-metal hip replacement devices, please contact their office by visiting the firm's defective hip implant page at http://www.yourlawyer.com.
Specific information regarding the DePuy ASR hip implant recall or the DePuy Pinnacle hip implant can also be accessed at the firm's website. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
For more information regarding defective hip implant lawsuits and Parker Waichman LLP, please visit: http://www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Herbert Waichman, Partner