FDA Reviewers See Possible Bias in Assessments of Zimmer Spine Product

Zimmer’s FDA application for expanded uses of its Dynesys Spinal System is raising questions that company payments to physicians may have influenced their assessments of the product, according to a report by FDA reviewers.

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The reviewers stated they found “a trend which suggests the possibility of bias from compensation” when payments or stock holdings were analyzed in an FDA review process to determine whether Dynesys, now used for spinal fusion, could also be used for patients with pain from back injuries.

However, the reviewers added that Dynesys was at least as effective as another Zimmer product, the Silhouette Spinal Fixation System, in treating patients with the new indication.

Read the FDA report on Zimmer’s Dynesys Spinal System (pdf).

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