European Regulators to Review Metal Hip Replacements

European health regulators will be conducting a review of 40,000 metal-on-metal hip replacements over fears that the devices could cause non-cancerous tumors and tissue damage. An official with the Medicines and Healthcare Products Regulatory Agency (MHRA) told the Sunday Times that the review likely means that some recipient of metal hip implants will need to have them replaced.

Recently, concerns over one such device, the ASR artificial hip implant, prompted DePuy Orthopedics to warn that the implant appears to have a high early failure rate in some patients. According to a letter to doctors, patients of small stature, a group that typically includes women and patients with weak bones, faced the highest risk.

As we reported last month, the warning from DePuy followed more than two years of reports that the device was failing in patients only a few years after implant, requiring costly and painful replacement operations. According to records from the U.S. Food & Drug Administration (FDA), since the beginning of 2008, the agency has received about 300 complaints on the ASR involving patients in the U.S.

Just months before DePuy issued the ASR hip implant warning, the company had announced that it was phasing out the device because of declining sales. The firm maintains that safety concerns did not play a role in its decision.

European regulators are concerned that in a small number of cases, debris from the such metal implants can cause non-cancerous tumors, severe swelling and sinew damage. Officials from MHRA said anyone considered at risk will be given tests to establish whether there are high levels of metal compounds in the blood.

Those potentially affected include patients who have had full hip replacements involving metal-on-metal implants or had resurfacing operations. Patients impacted by these recommendations will be contacted by their doctors, MHRA said.

According to the Sunday Times, last year a study by the Nuffield Orthopaedic Centre, Oxford, England found that of 1,200 patients who had undergone metal-on-metal hip resurfacing, 4% required a further operation because they developed “pseudotumors”. Women under 40 were the most at risk, with 13% suffering this reaction.