Medical Devices

Metal-on-Metal Hip Implants: The FDA's Activities

In January 2013, the FDA published a proposed order to allow for notice and comment regarding the FDA’s recommendation to change the requirements for all MoM total hip implants from premarket notification, to premarket approval, the most stringent regulatory category of the FDA’s oversight for medical devices. A final order was published in February 2016 and the requirement for premarket approvals was effective in May 2016. Since that time, all manufacturers of MoM total hip implants are required to stop marketing their devices and submit premarket approvals that must be approved before the devices can be marketed. Premarket approval is based on a determination by the FDA that the application contains sufficient valid scientific evidence to reasonably assure that the device is safe and effective for its intended use, and requires manufacturers to apply for the FDA’s approval before making changes to the device, its labeling or manufacturing, and imposes certain other annual reporting requirements.

To date, there are no FDA-approved MoM total hip systems. There are two FDA-approved MoM hip resurfacing devices available.

The FDA's other activities include:

  • Working with standards development organizations to develop standards to address issues arising from the use of MoM devices.
  • Supported the development of technologies to improve image quality around metal implants; this is important because the metal in the devices can prevent doctors from monitoring bone and soft tissue around the implant for signs of problems.
  • Encouraged metal ion test labs to participate in a trace element proficiency testing program (for example, New York State Department of Health, Wadsworth Center) to ensure consistency and reliability in metal ion test results.
  • Continuing to review published medical 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.
  • Launched 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.
  • Requested 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 MoM implants fail over time.
  • Pursued collaborations with multiple partners, domestically and internationally, to fully understand the postmarket performance of MoM hip implants and to document the occurrence of and signs and symptoms associated with specific adverse events.
  • Issued a Safety Communication to provide updated safety information and recommendations to patients and health care providers.
  • Issued a proposed order requiring manufacturers of MoM total hip replacement systems to submit premarket approval (PMA) applications.
  • 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. Panel members discussed:
    • Failure rates and modes;
    • Metal ion testing;
    • Imaging methods;
    • Local and systemic complications;
    • Patient risk factors;
    • Labeling considerations; and
    • Considerations for follow-up after surgery.
  • Instructed manufacturers of MoM total hip replacement systems to conduct a postmarket surveillance study of these devices.
    • Data from these studies will provide patients and health care providers with additional information about the safety profiles of the implants, including the effect of metal ion concentrations in the bloodstream.
       

 

Page Last Updated: 11/16/2018
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