FDA to Discuss Risks and Benefits of Metal-On-Metal Hip Replacements

(May 14, 2012) Next month, the U.S. Food and Drug Administration (FDA) will be seeking expert scientific and clinical advice on the risks and benefits of metal-on-metal (MoM) hip systems, as well as recommendations on their use from patients and practitioners, as well as how patients implanted with these MoM devices manage them. The FDA will discuss these issues at a two-day expert advisory panel meeting on June 27 and 28.

 

In addition, the experts invited to this advisory panel meeting, who are also members of the FDA’s Center for Devices and Radiological Health (CDRH), will discuss failure rates and modes, metal ion testing, imaging methods, local and systematic complications, patient risk factors, and considerations for follow-up after surgery.

 

Hip replacement surgery simultaneously increases mobility and reduces pain by replacing damaged hip joints in patients who have sufficient and sound bone to support the components of these MoM hip systems. Last May, the FDA issued an order for manufacturers of MoM hip systems to conduct post-market surveillance studies to collect more safety data on these devices, in response to an increase of the failure rate of these hip replacement systems.

 

There are two categories of these systems:

1) metal-on-metal total hip replacement systems consisting of a metal ball (femoral head), a metal femoral system in the thighbone, and a metal cup in the hip bone (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 hip bone (acetabular component).

 

Deputy director of science at the FDA’s CDRH, William Maisel, M.D., M.P.H., said that “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.”

 

Have any of you had hip replacement surgery? Do you think the expert advisory panel is leaving anything out? Does your hip replacement reduce pain and add mobility to your life? We want to hear your feedback. Feel free to comment on this blogpost.

 

Follow us on Twitter, and become a fan of our Facebook page. If you have more questions, you may stop by our website, or contact one of our attorneys at 1-800-246-HURT (4878).

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