DePuy Orthopaedics, a division of Johnson & Johnson, has indicated that its ASR metal-on-metal hip replacement system, has been linked to a high failure rate and the device will be removed from the market.
While the company initially indicated that the DePuy ASR hip cup was being phased out due to low sales numbers, a letter was sent to doctors on March 6 warning about a potential risk of ASR hip replacement problems. Many patients have experienced hip failures soon after the device was implanted, leading to an additional expensive and painful hip replacement surgery.
According to a report by the New York Times, some medical experts have said that a DePuy ASR cup recall should have been issued earlier, claiming that the failures are linked to a design problem that makes them difficult to implant.
DePuy officials say that ASR hip implant failures are most likely to occur in patients of smaller stature, including women and individuals with weak bones. The FDA has received complaints from about 300 recipients since 2008, most of whom had to undergo another round of hip surgery to replace the defective ASR hip implants.
The ASR is a metal-on-metal hip replacement system. 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.
Last year, U.K. researchers studied 660 patients who had received metal hip implants from DePuy Orthopaedics and found that 3.4 percent suffered from adverse reactions to metal debris. Surgeons are warning that one to three percent of all metal on metal hip implant recipients may experience hip implant problems, and possibly need to have the devices replaced, due to metallic debris.
DePuy announced it would phase the devices out by late 2010. However, the hip implants have already been put into thousands of people’s bodies worldwide. DePuy said the withdrawal was not caused by the problems, saying that the failure rate was new information.
All of the major orthopedic medical device companies manufacture their own version of “metal on metal” hip implants, and several have said that the metallic debris problem does not pose a significant risk. However, an increasing number of orthopaedic surgeons and experts disagree. In a recent editorial in the Journal of Arthroplasty, the medical journal warned doctors to avoid the use of the metal hip implants, and said they should only be used “with great caution.”
As a result of the increased reports of problems, product liability lawyers are investigating and reviewing potential DePuy ASR metal hip replacement lawsuits for individuals who received the device and experienced complications, including hip replacement failure or other hip problems.