Veterans care

Questions raised about medical device testing at Walter Reed Army Medical Center

Posted Dec. 30, 2010, at 12:51 p.m.
Last modified Dec. 30, 2010, at 3:27 p.m.

The testing of a bone-growth medical product on military veterans at Walter Reed Army Medical Center, perhaps without their consent, has raised questions from two U.S. senators.  The New York Times reports that Hydrosorb Mesh, manufactured by Medtronics, was used in spinal fusion procedures in 35 patients at the medical center during an 18-month period. A 2004 report authored by Walter Reed physicians and published in 2004 in the journal Neurosurgical Focus found the material, which is FDA-approved for non-weight-bearing bone applications but not for spinal implants,  might be “ideally suited” for spinal use.  But Hydrosorb Mesh is still not approved for weight-bearing uses, and Sens. Max Baucus of Montana and Charles Grassley of Iowa have asked the Army to investigate the study and whether patients were appropriately informed that they were taking part.  The three doctors have received payments from Medtronics for consultancy or other services.

Read the NYT story here:  http://www.nytimes.com/2010/12/28/business/28device.html

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