Veteranclaims’s Blog

December 28, 2010

Senators Call for Investigation into Use of Hydrosorb in Spinal Fusion Procedures at Walter Reed Medical Center

Full Article at: 2 Senators Raise Questions on Use of Medtronic Device
By DUFF WILSON
Published: December 27, 2010

Two senators are raising new questions about an experimental use of a Medtronic device in spinal surgery on veterans and soldiers at the Walter Reed Army Medical Center from 2002 to 2004.

Senators Max Baucus, Democrat of Montana and chairman of the Senate Finance Committee, and Charles E. Grassley of Iowa, the committee’s ranking Republican, wrote the commanding general of Walter Reed on Dec. 17 to ask about safeguards in a study by three Army surgeons. Senator Grassley’s office provided the letter to The New York Times.

The senators asked what the Army was doing to investigate certain back surgeries at Walter Reed and whether patients had been told they were receiving devices for uses not cleared by the Food and Drug Administration. They also asked how Army protocols could ensure proper review of medical tests involving soldiers and veterans. The surgeons, who have received money from Medtronic, had implanted and written about a Medtronic device called Hydrosorb Mesh, which contained a bone-growth material called Infuse.

Hydrosorb was approved by the Food and Drug Administration for nonweight-bearing purposes but not for spines, the senators wrote. Doctors are free to use F.D.A.-approved medical devices for any purpose they see fit, but in this case, Army officials said the surgeons should have sought permission for the study.

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.

Six years after the implants, however, Hydrosorb has still not been approved for that use. The senators expressed safety concerns.

Mr. Baucus said in a statement, “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.”

Col. Norvell V. Coots, commander of the Walter Reed Healthcare System, said last week that he would respond to the senators by Jan. 14 with assurances of improved controls over research and publication.”

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