A growing body of evidence has shown that metal-on-metal hip replacement devices can shed dangerous amounts of metal debris into patients' blood streams, leading to serious health problems.
New York, New York (PRWEB) March 14, 2012
Parker Waichman LLP is calling on the U.S. Food & Drug Administration (FDA) to take definitive action to address the serious public health threat posed by metal-on-metal hip implants. According to the firm, a growing body of evidence has shown that metal-on-metal hip replacement devices can shed dangerous amounts of metal debris into patients' blood streams, leading to serious health problems, including tissue damage, device failure, additional surgeries, disability, and possibly cancer. In light of these risks, the FDA must act now to mitigate the damage that has already been done by the use of metal-on-metal hip implants.
Parker Waichman LLP is already representing scores of plaintiffs in personal injury lawsuits filed against the makers of all-metal hip implants, including DePuy Orthopaedics's recalled ASR Acetabular Hip Implant System, as well as a metal-on-metal version of the DePuy Pinnacle Acetabular Cup System. Lawsuits involving the ASR hip implant have been consolidated in a multidistrict litigation in the U.S. District Court for the Northern District of Ohio (MDL 2197). Meanwhile, DePuy Pinnacle hip implant lawsuits have been consolidated in a multidistrict litigation in U.S. District Court for the Northern District of Texas (MDL 2244).
The ASR hip implants were recalled from the global market in August 2010. However, the all-metal Pinnacle hip implant and many other metal-on-metal hip replacements remain on the market, despite mounting evidence of their dangers. [depuy.com/asr-hip-replacement-recall
According to a report published last month in 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. That same report also found that the manufacturers of all-metal hip devices were aware of mounting evidence linking them to serious, long-term health consequences, but for years failed to warn the public about these dangers. [bmj.com/content/344/bmj.e1539/rr/571634]
Yesterday, The Lancet published a study conducted by researchers at the University of Bristol which found that recipients of metal-on-metal hip implants were twice as likely to experience early failure of the devices as those who received hip implants made from other materials. The study was the most comprehensive of its kind, and analyzed data from the National Joint Registry of England and Wales covering more than 400,000 hips replacements, including 31,171 all-metal ones, that were implanted between 2003 and 2011. The authors of the report called for an end to the use of metal-on-metal hip implants for total hip replacement. [thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2960353-5/fulltext]
In early February, the U.K.'s Sunday Telegraph reported that preliminary results from another study conduced at the University of Bristol found that 1 in 5 patients fitted with an all-metal hip implant experienced changes to cells in the bladder that could be precursors of cancer. [telegraph.co.uk/health/9061781/Hip-replacement-patients-could-face-increased-risk-of-cancer.html]
In the U.K., the British Hip Society has advised surgeons there not to use large-diameter metal-on-metal hip implants with bearings 36 mm or larger in total hip replacement procedures. Just two weeks ago, the U.K.'s Medical and Health Products Regulatory Agency advised that patients with large diameter metal-on-metal hip joints should have annual blood tests and possibly MRI scans for the lifespan of the joint. [mhra.gov.uk/NewsCentre/Pressreleases/CON143784, britishhipsociety.com/MoM%20Update.htm]
According to the British Medical Journal, most of the metal-on-metal hip implant devices currently on the market were approved through the FDA's 510(k) clearance protocols, which do not require human studies if a device is shown to be similar to another already on the market. Last May, with evidence of their dangers growing, the agency directed 21 makers of all-metal hip implants, including DePuy Orthopaedics, to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metal debris. While that action was commendable, the attorneys at Parker Waichman believe the evidence that has accumulated against the use of metal-on-metal hip implants since then indicates that nothing short of a ban on the use of all-metal hip implants will protect the public from the dangers posed by these devices. [fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/default.htm
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. 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).
Contact: Parker Waichman LLP
Herbert Waichman, Partner