A group of as many as 60 people in Ireland is preparing to file suit against DePuy Orthopaedics over its recalled ASR Hip Implants. According to a report from the Irish Examiner, per million population, surgeons in Ireland fitted more patients with ASR hp implants than any other country worldwide.
Both the ASR Hip Resurfacing System and the ASR Acetabular Hip Implant were recalled worldwide by DePuy, a division of Johnson and Johnson, in August 2010. The recall came 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. At the time of the recall, DePuy had sold more than 93,000 units of the hip replacement devices.
Since then, concerns about the ASR Hip Implant devices and similar hip replacement products have grown. Last year, a British study involving more than 500 patients found failure rates of up to 50% at six years for those who received a DePuy ASR hip implant in a total hip replacement procedure.
Both the ASR Hip Resurfacing System and the ASR Acetabular Hip Implant are metal-on-metal hip implants devices. It is believed such implants can shed dangerous amounts of cobalt and chromium through wear, leading to tissue damage, premature device failure, the need for revision surgery, and even long-term health problems, including heart and nervous system damage. Last week, The Sunday Telegraph reported that researchers at Bristol University in the U.K. found that some recipients of the devices had sustained genetic damage to the cells of the bladder, a possible precursor to cancer, while three developed full blown cancer. That study has yet to be released, as an analysis of its findings is ongoing.
The Telegraph had previously reported that U.K. health regulators were preparing to issue new guidance regarding metal-on-metal hip implants amid concerns that the shedding of metal debris into patients’ blood streams could lead to “systemic toxicity,” and could put the nervous system, heart and lungs at risk of being slowly poisoned. U.K. health regulators first advised in 2010 that chromium or cobalt levels of 7 ppb in metal-on metal hip implant patients should at least trigger imaging studies. If those also indicate abnormalities, then revision should be considered.
Last May, the U.S. Food & Drug Administration (FDA) directed 21 makers of all-metal hip implants, including DePuy, to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metallic debris in patients.
According to a report from the Irish Examiner, 3,282 Irish patients were fitted with the faulty ASR hip implants while they were on the market between 2003 and 2010. As many as 516 have had MRIs, 192 have had revision surgery and 96 more surgeries are scheduled.
According to the Irish Examiner, about a third of all Irish patients fitted with a recalled ASR hip implant underwent surgery at Whitfield Clinic in Waterford where the orthopedic consultant, Tadhg O’Sullivan, served as a design surgeon for DePuy International and helped develop the ASR Hip Resurfacing components and technique.
The chief executive at the clinic told the Examiner that the issues arising from the DePuy recall did “not reflect on the quality of healthcare provided at Whitfield”.