Regulatory News In Brief
This article was originally published in The Gray Sheet
FDA advisors will meet in June to discuss the safety and effectiveness of metal-on-metal hip implants. More regulatory news.
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The firm is discontinuing sales of an optional metal liner for one of its hip systems due to higher-than-expected revision rates.
Devices were linked to a notably higher five-year revision rate compared to metal-on-polyethylene or ceramic-on-ceramic hips in an analysis of more than 400,000 implants. Recalled J&J/DePuy ASR devices were not included in the analysis.
Regulatory developments from around the world.