Anxiety is likely on the rise this week among the more than 30,000 British patients who have metal-on-metal hip replacements. That's because the U.K. regulators have launched an investigation as to how safe the implants actually are.
Britain's Sunday Telegraph writes about the details, including the stark finding that failure rates for the metal-on-metal full hip replacement could be even higher than the estimated 17% national figure.
Concerns about metal-on-metal implants aren't new. Safety worries date at least back to 2010, when Johnson & Johnson ($JNJ) issued an extensive and costly global recall of implants made by its DePuy subsidiary because of high failure rates, and problems such as metal fragments breaking off into the body. Many patients in the U.K. had received the DePuy hips. Doctors have been anxious that the device breakdown could cause inflammation, harm muscle and bone and potentially poison the nervous system, heart and lungs, the Sunday Telegraph article explains.
The paper says it determined that more than 30,000 patients in Britain have received the implants and many may not have even been notified that their health might be at risk. In light of those concerns, the Medicines and Healthcare products Regulatory Agency, which evaluates the safety of these and other devices, already had advised patients with metal-on-metal implants to be checked annually, especially if they had any health problems that could be related to metal pieces in the body. But regulators are now considering additional data and plan to issue tougher recommendations based on heightened concerns about "systemic toxicity" due to contamination from implant-related metal pieces, the Sunday Telegraph notes.
MHRA regulators cautioned, however, that most of the implants are "at low risk" of causing serious health problems. And a DePuy spokesperson told the paper that his company was actively trying to communicate with affected patients and give them "information and support."
European regulators have been criticized for months for not doing enough to ensure the safety of medical devices before they're approved for commercial use. The U.S. Food and Drug Administration has also followed the metal-on-metal hip replacement closely. In May, FDA officials asked 20 device makers including Stryker ($SYK), Zimmer ($ZMH) and J&J to investigate whether their hip implants raise the level of metal in patients' blood to dangerous levels.