Medtronic Faces Senate Scrutiny

Senators Max Baucus and Charles Grassley are asking the commanding general of Walter Reed Army Hospital probing questions about its doctors’ use of an experimental medical device. The medical device, Hydrosorb Mesh, has not received FDA approval for use in spinal surgeries. While surgeons may use drugs and/or medical devices in ways not approved by the FDA, the two Senators believe the Army should have received permission before conducting a study that included spinal surgery.
According to a NY Times article, The Army doctors had implanted Hydrosorb Mesh in spinal fusion procedures for 35 patients in an 18-month period, according to a study published in the journal Neurosurgical Focus in 2004. The study covered 22 patients, including 15 active duty soldiers, to determine whether the bio-absorbable Hydrosorb was possibly preferable to similar titanium mesh. The study concluded, in glowing terms, that Hydrosorb might be “ideally suited” to spinal use. Medtronic has also made payments for consultancy or other services to the three doctors — Timothy R. Kuklo, Michael K. Rosner and David W. Polly Jr., all then with Walter Reed.”
The fact that the three doctors have been remunerated by Medtronic and that after six years Hydrosorb has yet to receive FDA approval has caused concern about safety issues and conflict of interest questions.