FDA Panel Examines MoM Hip Devices

Katherine Sale and Mary Ann Porucznik

In nearly 23 hours of testimony and deliberations over 2 days in June, the U.S. Food and Drug Administration’s (FDA) Orthopaedic and Rehabilitative Devices Panel (ORDP) considered expert scientific and clinical opinion on the risks and benefits of metal-on-metal (MoM) hip replacement and resurfacing devices. The Panel’s goal was “to better characterize any potential and real safety risks and generate scientifically based recommendations for the clinical and patient communities on how to best communicate and mitigate them.”

William L. Rohr Jr., MD, an orthopaedic surgeon in private practice in northern California, served as temporary chair of the ORDP. Included on the Panel were orthopaedic surgeons, researchers, patients, and industry representatives. Also present were representatives from the FDA as well as from regulatory bodies and professional societies from outside the United States.

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