Two US Senators want to know if soldiers implanted with a Medtronic Inc. device called Hydrosorb Mesh were told they were receiving it for uses not approved by the US Food & Drug Administration (FDA). According to New York Times report, Hydrosorb Mesh contains M<"http://www.yourlawyer.com/topics/overview/Medtronic_Infuse_Bone_Graft">edtronic’s Infuse a bone-growth material.
Hydrosorb was approved for nonweight-bearing purposes but not for spines, the Times said. 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 was meant to determine if Hydrosorb was possibly preferable to similar titanium mesh. According to the Times, the study concluded that Hydrosorb might be â€œideally suitedâ€ to spinal use. But six years after the study, the FDA has not approved Hydrosorb for this use.
Medtronic has also made payments for consultancy or other services to the three doctors involved in the study â€” Timothy R. Kuklo, Michael K. Rosner and David W. Polly Jr., all then with Walter Reed, the Times said.
According to the Times, Walter Reed investigators have concluded the doctors violated Army rules by failing to seek or receive permission to conduct research or publish the article. Now, Senators Max Baucus (D-MT) and Charles Grassley (R-IA) have written to the commanding general of Walter Reed Army Medical Center with questions about the study, as well as the safety of Hydrosorb.
“Safety must come first, especially for Americaâ€™s men and women in uniform, and putting soldiersâ€™ 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 â€” questions that need answers,” Senator Baucus said in a statement, according to the Times.
In addition to asking whether or not those patients who received Hydrosorb were told it was for an unapproved use, Baucus and Grassley also asked how Army protocols could ensure proper review of medical tests involving soldiers and veterans.
One of the doctors involved in the questionable Hydrosorb study – Dr. Timothy Kuklo – may be familiar to readers of this blog. In 2008, the Army determined that Kuklo had fabricated signatures of co-authors of another journal article that dealt with Medtronic’s Infuse product. As weâ€™ve reported previously, the Army’s investigation also determined that study cited higher numbers of patients and injuries than Walter Reed officials could account for, and that Kuklo did not obtain the Armyâ€™s required permission to conduct the study.
That study was published in the Journal of Bone & Joint Surgery in August 2008, but later retracted.