FDA Investigates Safety of Metal Hip Replacements
This week, the Food and Drug Administration (FDA) will hold a meeting to evaluate the safety of metal-on-metal hip implants following numerous patient reports of metal toxicity, pain, swelling, and in some cases, early removal of the devices.
During the two-day meeting, the FDA will:
- look at data from both foreign countries and the U.S. to determine which patients are at the highest risk and which implants are most problematic.
- ask a group of experts to recommend a strategy for monitoring patients with the devices, which could consist of blood tests, medical imaging, and laboratory tests.
For the last 10 years, doctors have favored metal-on-metal hip implants because laboratory tests suggested the devices are more resistant to wear and reduce the chances of dislocation. However, recent data showing high premature failure rates has federal regulators worried about the estimated 500,000 patients in the United States who have metal-on-metal hip replacements.
The FDA has already asked several manufacturers of metal-on-metal hip implants, including Johnson & Johnson, and Zimmer Holdings Inc. to conduct long-term, follow-up studies of the over 100 metal hip implants currently on the market.
Typically, hip replacements are supposed to last between 10 to 15 years. However, over six percent of patients with metal-on-metal hip implants needed them replaced after less than five years, compared to just two percent of patients who had ceramic or plastic hip replacements.
For more information about these devices, you can visit our metal-on-metal hip implants page, or check out any of the following new stories:
- New Bill Proposes Increased Monitoring of Medical Devices
- Metal-on-Metal Hip Implants: More Harm than Good?
- Study: Metal-on-Metal Hip Implants Release Toxins
- Many Medical Devices Aren't Tested Before They're Used on Patients