The FDA continues to gather all available information, including the clinical information discussed during the June 2012 Orthopedic and Rehabilitation Devices Advisory Panel Meeting, about currently marketed metal-on-metal (MoM) hip implants. The FDA is committed to providing reliable safety recommendations to patients and health care providers about the utilization of these devices. The Agency’s activities include:
- Working with the manufacturers of MoM hip implants to evaluate the devices in a Magnetic Resonance Imaging (MRI) environment and to develop device specific labeling for MR Conditions, which would help ensure safe scanning of patients with MoM hip implants.
- Supporting the development of metal artifact reduction technologies to improve image quality around metal implants.
- Encouraging metal ion test labs to participate in a trace element proficiency testing program (e.g. New York State Department of Health, Wadsworth Center) to ensure consistency and reliability in metal ion test results.
- Continuing to review published literature, Medical Device Reports (adverse event reports) submitted to the FDA, post-approval study reports and data from several orthopaedic device registries from within and outside the U.S. to better understand possible adverse events associated with metal debris from MoM hip implants.
- Launching the International Consortium of Orthopaedic Registries (ICOR) an international collaborative effort that aims to address differences in orthopaedic registries around the world and allow for collaboration to harmonize and utilize the data available from these registries.
- Requesting and reviewing device retrieval analyses from the manufacturers of the hip systems distributed in the U.S. This will help us understand how and why certain metal-on-metal implants fail over time.
- Pursuing collaborations with multiple partners domestically and internationally to fully understand the postmarket performance of metal-on-metal hip implants and to document the occurrence of and signs and symptoms associated with specific adverse events.
1. On Jan. 17, 2013, the FDA issued a Safety Communication to provide updated safety information and recommendations to patients and health care providers.
2. On Jan. 17, 2013 the FDA issued a proposed order requiring manufacturers of MoM total hip replacement systems to submit premarket approval (PMA) applications. MoM total hip replacement systems were marketed in the U.S. prior to 1976 legislation that gave the agency premarket authority over medical devices. As “preamendment devices,” they were designated as Class III (higher risk) devices but were regulated under the 510(k) premarket notification program.
3. On June 27-28, 2012 the FDA convened the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee to seek expert scientific and clinical opinion on the benefits and risks of MoM hip implants including:
- Failure rates and modes;
- Metal ion testing;
- Imaging methods;
- Local and systemic complications;
- Patient risk factors; and
- Considerations for follow-up after surgery.
Panel members discussed the follow-up of symptomatic and asymptomatic patients with metal-on-metal total hip replacement systems and resurfacing hip systems, the most appropriate patient populations that may be considered candidates for metal-on-metal hip implants, and important labeling considerations. The FDA considers all information discussed during this meeting.
4. On May 6, 2011, the FDA instructed manufacturers of MoM total hip replacement systems to conduct postmarket surveillance study of these devices. Five manufacturers currently market metal-on-metal hip implants in the U.S. and all five have approved postmarket surveillance study plans. Data from these studies will provide patients and healthcare providers with additional information about the safety profiles of the implants, including the effect of metal ion concentrations in the bloodstream.
The FDA derives its authority to order postmarket surveillance studies from Section 522 of the Federal Food, Drug and Cosmetic Act.