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.
In addition, the FDA issued a proposed new rule that would require filing of a premarket approval (PMA) application or a notice of completion of a product development protocol (PDP) for both cemented and uncemented MoM hip implants. Because MoM hip replacement systems were marketed in the United States prior to the 1976 legislation that gave the agency premarket authority over medical devices, they were designated as Class III (higher risk) devices, but were regulated under the 510(k) premarket notification program. (See “Who Sets the Standards,” for an explanation of the various approval methods and a definition of device classes.)
The rule was published in the Federal Register on Jan. 18, which also opened a 90-day comment period. The AAOS Biological Implants and Biomedical Engineering Committees are reviewing the rule and will determine if submitting a comment is warranted.