Many Victims of the DePuy ASR XL Acetabular Hip Implant May Have Metal PoisoningNov 17, 2010 | Parker Waichman LLP
Many people suffering due to DePuy Orthopaedic’s recalled ASR XL Acetabular Hip Replacement System may be victims of metal poisoning. Some recent studies indicate that metal-on-metal hip implants like the ASR XL Acetabular Hip Replacement System can wear in way that allows metallic debris to enter a patients’ body.
One study, conducted by English researchers noted that 3.4 percent of patients from a pool of 660 DePuy metal implant recipients experienced adverse reactions due to metallic particles. A group of 155 patients who received a competitor’s hip devices were also examined and were not found to have experienced similar side effects. The condition – called metallosis – can cause an immune response that can lead to bone destruction, as well as the extensive formation of noncancerous tumors called granulomas.
Late last month, the online American edition of the Journal of Bone and Joint Surgery (JBJS) published a case study regarding two patients who received metal-on-metal total hip replacements and experienced adverse events. After the revision surgeries, the symptoms improved. Both patients were fit, healthy 49-year old males. Their experience reports that cobalt toxicity – arthroprosthetic cobaltism – developed within their bodies after the all-metal devices were implanted. Left untreated, cobaltism can result in tinnitus, vertigo, deafness, blindness, optic nerve atrophy, convulsions, headaches, peripheral neuropathy, cardiomyopathy, and hypothyroidism. The case report states that a larger group study will be required to define the prevalence and spectrum of cobalt poisoning due to hip arthroplasty.
According to a New York Times report published in March 2010, metal-on-metal hip implants like the ASR XL Acetabular Hip Replacement System have been used in about one-third of the approximately 250,000 hip replacements performed annually in this country. However, many of the nation’s leading orthopedic surgeons have reduced or stopped use of these devices because of concerns that they can cause severe tissue and bone damage. According to the Times, studies in recent years indicate that in some cases the devices can quickly begin to wear, generating high volumes of metallic debris that is absorbed into a patient’s body. The limited studies conducted so far on metal-on-metal hip implants estimate that 1 to 3 percent of implant recipients could be affected by such problems.
In August, DePuy issued a worldwide recall of the ASR XL Acetabular System, a hip socket used in traditional hip replacement, and the ASR Hip Resurfacing System, a partial hip replacement that involves placing a metal cap on the ball of the femur. Only the ASR XL Acetabular System was approved for use in the US. 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 recalled devices had to undergo revision surgery within five years of receiving it. A hip implant should last for 15 years or so.
DePuy 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 that time, the US Food & Drug Administration (FDA) had received hundreds of reports describing premature failure of the DePuy ASR hip implant system. Still, it would be months before the DePuy ASR hip implant system was finally recalled.
Help filing claims and other legal assistance for the victims of defective hip implants, including the DePuy ASR XL Acetabular Hip Replacement System is available here.