Specifically, the senators want to know how the Army handled these procedures—i.e., were the patients told that they were receiving devices for uses that were not cleared by FDA? And how do Army protocols ensure proper review of medical tests involving this population? The surgeons, who were paid by Medtronic, implanted and wrote about the company's Hydrosorb Mesh. Although Hydrosorb is FDA approved, it was only approved for non-weight-bearing applications and not for spinal procedures. Six years later, the product still hasn't been approved for such use, which prompts safety concerns, Baucus says.
“Safety must come first, especially for America’s men and women in uniform, and putting soldiers’ health at risk is an unacceptable price to pay for medical advancements. This case raises serious questions about whether men and women in uniform always receive the best care—questions that need answers,” Baucus said in a statement.
The commander of the Walter Reed Healthcare System says a response to the senators is forthcoming (by January 14). Large companies and their paid surgeon-consultants are continuously under scrutiny, but the inquiry shows that even practices from years past are not exempt. —Lawrence Lloyd