FDA seeks expert and patient comments on metal-on-metal hip replacement systems

The U.S. Food and Drug Administration (FDA) is concerned about the safety of metal-on-metal (MoM) hip systems and has put out a call for expert scientific and clinical advice.

The FDA will discuss potential patient and practitioner recommendations on the use of MoM hip systems and the management of patients implanted with such devices during a two-day expert advisory panel meeting on June 27-28, 2012. The meeting will be open to the public.

Hip replacement surgery is intended to provide increased 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. 

There are two categories of MoM replacement systems:

  1. Total hip replacement systems consisting of a metal ball (femoral head), a metal femoral stem in the thighbone and a metal cup in the hip bone.

  2. Hip resurfacing systems consisting of a trimmed femoral head capped with a metal covering and a metal cup in the hip bone.

In May 2011, 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 said it is currently considering whether to make MoM hip systems subject to more rigorous testing and premarket review requirements.

A recent study noting an increased failure rate related to those systems that utilize large-diameter femoral heads has added to the agency’s existing concerns over the safety of MoM hip systems, according to an FDA statement.

“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 healthcare providers,” said William Maisel, MD, MPH, 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.

Click here for more information on the upcoming meeting.

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