San Diego Personal Injury Attorney
DePuy ASR™ Hip Replacement Implant Recall: Complaints And Possible Links To Cancer
The following information has been obtained from various sources.
Depuy Hip Replacement Implants — Recall Background
The DePuy ASR is a metal-on-metal hip replacement system developed in 2005. The Depuy ASR XL Acetabular Hip System and Depuy ASR Hip Resurfacing System Implants was recalled on August 26, 2010. DePuy Orthopaedics announced the recall of DePuy ASR XL Acetabular Hip System and DePuy ASR Hip Resurfacing System implants, after confirming that they have an unreasonably high failure rate. DePuy recalled 93,000 ASR metal hip implants, after data suggested that about one out of every 8 may fail within five years.
Johnson & Johnson's DePuy Orthopaedics unit was already phasing out the ASR hip implant system when it finally acknowledged in March 2010 that the device was prone to early failure. By March, the US Food & Drug Administration (FDA) had received hundreds of reports describing early failure of the DePuy ASR hip implant system and the company still waited months to issue its recall. The recall was made a year-and-a-half after the first lawsuit over DePuy ASR hip problems was filed.
Approximately 93,000 DePuy ASR hips have been sold, and new data suggests that approximately 15% fail within five years which results in the need for additional hip surgery to replace the defective metal on metal artificial hip.
Soon after the DePuy ASR was introduced in 2005 there were reports of complications and failures. According to the FDA, there were nearly 100 reports of ASR problems in 2007, over 200 in 2008 and over 300 in 2009. The vast majority of these reports (over 90% of those reported in 2009) involved the need for a surgical hip revision after a DePuy ASR hip replacement.
What are the complaints?
The lawsuits over DePuy ASR hip implants involve similar allegations of design defect which usually result in the need for additional surgery to revise or replace the hip implant.
The complaints allege that DePuy failed to adequately test the metal-on-metal hip system and did not immediately issue a recall when it became apparent that the DePuy ASR had a high failure rate.
Health care professionals have increasingly been warning about problems with metal-on-metal hip implants, which can shed metal particles into the body. The particles can damage soft tissue, cause inflammatory reactions and lead to bone loss.
The DePuy ASR hip failures appear to be linked to a defective design of the acetabular cup, which is shallower than acetabular cups made by other companies, making it prone to problems.
According to data from the National Joint Registry of England and Wales 12%-13% of the patients who had received the recalled devices had to undergo revision surgery within five years of receiving it. A hip implant should last around 15 years. The ASR Hip Resurfacing System fails in about 12% of recipients within five years and the ASR XL Acetabular System fails in about 13% of recipients, with the failure rate even higher among women and those with heads smaller than 50mm.
Possible Links to Cancer
The ASR hips recalled by DePuy can potentially release toxic, perhaps cancer-causing, metal shavings into the tissue surrounding the defective artificial hip and be spread throughout the body through the bloodstream.
The ASR XL Acetabular Head System and ASH Hip Resurfacing System were designed for metal-on-metal construction, which permits grinding and allows metal particles to enter the tissue surrounding the hip replacement site. When these metals (Cobalt and Chromium) enter the tissues and are spread to other areas of the body though the blood stream, serious problems can result.
Chromium which is found in the Johnson & Johnson recalled hip systems is a cancer causing agent. When the Cobalt and Chromium ions are released by the metal-on-metal grinding of the artificial hip, the metal contaminates surrounding tissues. As the contaminated tissue deteriorates over time, the metal particles enter the blood stream and are carried to other parts of the body. Prolonged exposure can cause toxicity and may cause cancer.
British Orthopedic Association advised the the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK, that over time metal debris may affect the performance of a hip implant and cause painful complications. Furthermore, the same expert group links metal hip implants, such as DePuy AST to genotoxocity. The local exposure to metal debris causes the chromosomes of bone marrow or white blood cells to breakdown. Genotoxic effects may result in cancer or even inheritable defects, if reproductive cells are affected.
What Should I do if I have a DePuy ASR Hip Resurfacing System implant?
1. Call your doctor and find out if you have a DePuy ASR™ Hip Implant that was recalled.
2. If you have the Depuy ASR™ Hip Implant, Contact Dean Goetz (858-481-8844) and set up a free personal or telephone appointment to discuss your options. You will be able to talk to Attorney Dean Goetz directly. You will not be talking to a Paralegal about your case.
3. Learn More: article by San Diego injury attorney Dean Goetz
Burden of Proof in Depuy ASR™ Hip Implant Recall Cases
If you received an ASR hip implant and you are having hip related problems, you should call Attorney Dean Goetz today. CALL 858-481-8844.
You can speak directly with Attorney Dean Goetz and get answers without any obligation.
Do not contact DePuy Orthopaedics or Johnson & Johnson without first talking to an attorney. It's important that you know what your options are.
Hip Recall - Learn More:
• Depuy ASR™ Recall: Complaints And Possible Links To Cancer
• FAQ's: DePuy Hip Transplant Recall
• Burden of Proof in DePuy Hip Implant Recall Law Cases
• Information and Articles on the DePuy Hip Implant Recall
• Depuy Pinnacle hip replacement device has not been recalled.
• Depuy ASR & Depuy Pinnacle Hip Replacement Lawsuits
Related Informational Links:
Medical News Today: Hip Replacement Recall By Depuy Orthopaedics Is Big News
