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FDA Panel Has Questions About Spine Implant
An FDA panel says there are some lingering questions about whether an implant is safe and effective in the treatment of a painful spinal condition.
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GAITHERSBURG, Md. (November 4, 2009)--Federal health officials say there are some lingering questions about whether an implant from Zimmer Holdings Inc. is safe and effective for treating a painful spinal condition.
The U.S. Food and Drug Administration's panel of outside experts says Zimmer studies have not clearly shown which patients would benefit from its titanium Dynesys implant.
The panel also has concerns about wear and tear on the device over time.
Panel chair Dr. John Kelly of the University of Pennsylvania said, "I think panel generally believes this is reasonably safe, however the long-term safety remains to be seen."
The FDA is not required to follow the group's advice, although it often does.
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