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In the (ProDisc) study results submitted to the F.D.A., moreover, an unusually large number of patients were not included, and some of those patients have said they fared poorly. As a result, some patients and doctors critical of the research say the study may have cast the Prodisc in an overly flattering light.
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The Prodisc, used on thousands of patients, has been shown to benefit many people with back pain, they say. It is unclear, however, whether the disk’s maker fulfilled its legal obligation to inform the Food and Drug Administration of the researchers’ financial interests before it used the study’s results to approve Prodisc in August 2006.
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http://www.irbforum.org/forum/read/2/162/162
I know my surgeon is listed there. What's more ironic I even questioned him about this 3-months post-op. All he had to say was that it was nonesense. Yet look at me now, I was not even a candidate.
I have a feeling the reason Maverick hasn't been approved yet might be because of this process.
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1/2006 DDD L5/S1
Prodisc St. Mary's 12/2006 not diagnosed properly pre-op and now have DDD L4/L5, facet calcification L5-S1/L4-L5, mild scoliosis and left knee pain. DDD: C3 through C6
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