New York, New York (PRWEB) March 06, 2012
Parker Waichman LLP has learned that the British Hip Society is now advising that primary total hip replacements with large-diameter metal-on-metal hip implants using bearings of 36 mm or larger should no longer be performed until more evidence is available, except in properly conducted and ethically approved research studies. At its meeting in Manchester, U.K. last week, the British Hip Society also unanimously endorsed guidance issued last month by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) advising 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. [britishhipsociety.com/MoM%20Update.htm; mhra.gov.uk/NewsCentre/Pressreleases/CON143784]
According to a report published by the Sunday Telegraph on March 5, the advice was issued amid growing concerns that metal-on-metal hip implants could be shedding dangerous amounts of metal debris into patients' blood streams, potentially leading to systemic toxicity that could put the nervous system, heart and lungs at risk of being slowly poisoned. The Sunday Telegraph also pointed to preliminary findings from a study conducted by researchers at the University of Bristol which indicated that patients fitted with all-metal hip implants may be at risk of experiencing genetic changes to the cells of the bladder, a possible precursor to cancer, and possibly bladder cancer itself. [telegraph.co.uk/health/healthnews/9121861/Surgeons-urge-ban-on-new-metal-on-metal-hip-joints.html]
Metal-on-metal hip implants have been the subject of growing concerns since the August 2010 worldwide recall of the DePuy Orthopaedics’ ASR Hip Resurfacing System and ASR Acetabular System. The recall was issued after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who had received the devices had to undergo revision surgery within five years of receiving it. Just last week, a report published by the British Medical Journal revealed that metal-on-metal hip implant manufacturers, including DePuy, a division of Johnson & Johnson, 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. 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." The British Medical Journal further asserts that potentially unhealthy levels of metal ions have been recorded in around 20% of patients with a metal-on-metal version of DePuy's Pinnacle hip implant. Yet DePuy Orthopaedics heavily promoted the Pinnacle hip implant system as an alternative to its recalled ASR devices, according to the British Medical Journal. [bmj.com/content/344/bmj.e1410]
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. Last May, the U.S. Food & Drug Administration (FDA) 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. In light of the recent guidance issued by the MHRA and the British Hip Society in the U.K., Parker Waichman LLP believes the FDA must do more to protect the public from the potentially catastrophic health consequences that may be associated with the use of metal-on-metal hip implants. [fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241769.htm]
“The British Hip Society recommendations are just the latest in a long line of recent studies and reports calling into question the safety of all metal-on-metal hip implants, especially those with larger diameter heads,” 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 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).
Contact: Parker Waichman LLP
Herbert Waichman, Partner