Sex-Specific Data in Clinical Studies

FDA issues final guidance document

Laura M. Bruse Gehrig, MD

Over the years, clinical research has shown that certain medical devices elicit different responses in females compared to males. For example, according to study data on metal-on-metal (MoM) implants and resurfacing presented at the June 2012 meeting of the U.S. Food and Drug Administration’s (FDA) Orthopaedic and Rehabilitation Devices Advisory Panel, women have higher revision rates after MoM total hip arthroplasty and hip resurfacing than men. (See “Men, Women, and MoM.”) The reasons include a wide array of intrinsic and extrinsic factors, including genetics, hormonal differences, diet, and environmental factors, as well as the natural history of a device based on the activity level.

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