Hip resurfacing: a complex challenge for device regulation

Metal-on-metal hip failure is the most widespread medical device failure of the past decade,

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and has highlighted weaknesses in regulation, evaluation, and policy.

The UK’s Medicines and Healthcare products Regulatory Agency recently issued an updated alert and recommendations about managing patients with metal-on-metal hip implants,

and in June, 2012, the US Food and Drug Administration (FDA) held a meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee to discuss the evidence. Although stemmed or conventional metal-on-metal hip replacement was discussed extensively at the meeting, hip resurfacing—a more bone-preserving procedure using a metal-on-metal device—was not as thoroughly scrutinised. Furthermore, only results of hip resurfacing in the hands of very experienced surgeons were highlighted.