FDA MoM Panel Convenes this Week
The Orthopedic and Rehabilitation Devices Panel of the Food and Drug Administration’s (FDA) Medical Devices Advisory Committee will meet this week (June 27 and 28, 2012) to discuss the safety of metal-on-metal hip implants.
Details of the FDA Panel Meeting
According to the FDA web site, the two-day meeting will cover reports of complications, adverse events, and revision surgeries associated with the all-metal hips. The committee will also seek expert scientific and clinical opinion on the risks and the benefits based on the data available.
Though current data shows MoM hip implants are highly successful, recent scientific publication raised serious concerns about the failure rates. FDA intends to make background material available to the public no later than 2 business days before the meeting.
Concerns About Metal on Metal Hip Implants
Information below provided by the FDA.
- Metal-on-metal hip (MoM) replacement systems may pose unique risks in addition to the general risks of all hip implant systems.
- Because the metal ball and the metal cup slide against each other during walking or running, some tiny metal particles may wear off of the device and enter into the space around the implant.
- Some of the metal ions from the metal implant or from the metal particles may even get into the bloodstream.
- In addition to these reactions to metal near the joint and implant, there are some case reports in the literature of a small number of patients in which high levels of metal ions in the bloodstream may have caused other types of symptoms or illnesses elsewhere in the body, including effects on the heart, nervous system, and thyroid gland.
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