Proposed new rule would require PMA for MoM implants
As this issue of AAOS Now went to press, the U.S. Food and Drug Administration (FDA) had issued a new safety communication for orthopaedic surgeons, other healthcare providers, and patients with or considering a metal-on-metal (MoM) hip implant. The new document is based, in part, on the results of the June 2012 meeting of the Orthopaedic and Rehabilitation Devices Advisory Panel. (See “FDA Panel Examines MoM Hip Devices,” AAOS Now, September 2012.)
The new communication goes into greater depth than previous statements in its recommendations to orthopaedic surgeons who are treating patients who received MoM hip implants. It calls for periodic follow-up, but says that additional imaging or metal ion assessment is not required for asymptomatic patients with well-functioning implants. It lists categories of patients who should be followed more closely because they may be at risk for increased device wear and/or adverse local tissue reaction.