FDA Discusses Risks & Benefits of Metal-on-Metal Hip Systems

(April 17, 2012) – The FDA will discuss the risks and benefits of metal-on-metal hip replacements, and expert, as well as patient recommendations, are being sought.

 

The U.S. Food and Drug Administration announced that it is seeking expert scientific and clinical advice regarding the risks and benefits of metal-on-metal (MoM) hip systems, as well as potential patient and practitioner recommendations on the use of MoM hip systems and the management of patients implanted with these devices. The FDA will discuss these issues at a two-day expert advisory panel meeting on June 27-28, 2012.

 

There are two categories:

  1. Metal-on-metal total hip replacement systems consisting of a metal ball (femoral head), a metal femoral stem in the thighbone, and a metal cup in the hipbone (acetabular component).
  2. Metal-on-metal hip resurfacing systems consisting of a trimmed femoral head capped with a metal covering and a metal cup in the hipbone (acetabular component).

 

Hip replacement surgery is intended to provide improved patient mobility and reduce pain by replacing the damaged hip joint in patients where there is evidence of sufficient sound bone to seat and support the components.

 

Last May (almost one year ago), the agency issued an order for manufacturers of MoM hip systems to conduct post-market surveillance studies to collect more safety data on these devices, including data related to metal ion concentrations in the bloodstream.

 

The FDA is currently considering whether to make MoM hip systems subject to more rigorous testing and premarket review requirements.

 

A recent study, which noted an increase in failure rates related to those systems utilizing large diameter femoral heads has added to the agency’s existing concerns regarding the safety of MoM hip systems.

 

“We are asking outside scientific and medical experts to discuss recent information on these devices so that the agency can continue to make reliable safety recommendations to patients and their health care providers,” said William Maisel, M.D.,M.P.H., deputy director of science at FDA’s Center for Devices and Radiological Health (CDRH).

 

Experts on CDRH’s Orthopedic Devices Panel will discuss:

–       Failure rates and modes

–       Metal ion testing

–       Imaging methods

–       Local and systemic complications

–       Patient risk factors; and

–       Considerations for follow-up after surgery

 

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