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Data Questions Dominate Metal-On-Metal Panel; New Monitoring Recommended

FDA advisory panel examines science behind controversial metal-on-metal hips, recommends new monitoring, possible label changes.

FDA panelists expressed frequent puzzlement in the face of a deluge of data on metal-on-metal hip devices during a meeting last month, leaving some questions unanswered on what FDA’s next steps should be for the controversial products.

Significant discussion at the June 27-28 meeting of the agency’s Orthopaedic and Rehabilitation Devices Panel centered on the need for more data to explain potential causes of elevated revision rates and to explore the possible

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