FDA Reviewed Safety of Metal-on-Metal Hip Implants Including Biomet

By: LawInfo

On June 27-2, 2012, an FDA advisory panel of 18 experts inquired into metal-on-metal hip replacements.  This panel examined the safety of metal-on-metal hip implants.

Metal-on-metal hip replacement: Recent Regulatory Trends:

 

  • December 2009: Australia’s Therapeutic Goods Administration (TGA) withdrew Depuy ASR hip systems from the Australian market after data of higher-than-anticipated revision rates.
  • April 2010: the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a Medical Device Alert regarding revision surgery.
  • August 2010: Worldwide recall of the DePuy Orthopaedics’ ASR Hip Resurfacing System and ASR Acetabular System.
  • February 2011: FDA posted a public health communication on its website regarding Metal-on-metal hip systems.  This contained a summary of the safety issues with the devices.
  • May 2011: FDA issued orders for post market surveillance studies to each manufacturer of Metal-on-metal hip replacement systems requiring them to submit a study protocol addressing safety issues related to these devices.
  • June 2012: FDA reviewed recent data. Report revealed that metal-on-metal hip replacement systems are likelier to fail than other hip implant devices.

Statistics reported from the FDA:

 

  • 2000 to 2011: There were 16,800 adverse reports associated with metal-on-metal hip replacement devices.
  • 2000 to 2011: More than 14,000 of the 16,800 adverse reports involved revision surgery to remove a failing metal-on-metal hip implant.
  • 2011: 12,137 metal-on-metal hip implant complaints were made to the FDA.

Recommendations from the Experts on the FDA Advisory Panel:

 

  • All patients with metal-on-metal hip implants who are experiencing pain and other symptoms should get regular blood testing for cobalt and chromium levels.  
  • All patients with metal-on-metal hip implants should undergo annual X-rays to monitor their implants, regardless of symptoms.
  • The FDA is urged to provide the public with more information, including additional warning notices on their labels.