Infuse bone graft trial#

Incidentally, one of the co-author on Dr. Polly’s lawyer characterized the study as a “historical review of surgeries” and a ‘look-back inquiry.”

Infuse bone graft trial#

Polly told the Star Tribune that patients in the study where “properly informed of alternative treatments, as well as the risks and benefits of the surgery.” The attorney also asserted that they “were not part of any clinical trial or ‘experiment,’ as erroneously assumed by the person who wrote the letter.” Dr. He also asks if an Institutional Review Board - an independent ethics board that oversees clinical studies - was engaged at Walter Reed “to oversee and approve this experiment on the men and women of the armed forces.” According to the Star Tribune, the Army Surgeon General, who has acknowledged receiving the letter, has not yet issued a formal reply.Īn attorney for Dr. Specifically, he asked if they knew the products used in their surgeries were not approved by the FDA. Rosen asks if the patients in the Walter Reed study were given informed consent before spine surgery. In his letter to the Army Surgeon General, Dr. According to the Star Tribune report, 14 of the patients in the Walter Reed study had multiple-level fusions, two of which involved fusing five spinal levels. When the study was conducted, Infuse had only been approved for single-level fusion surgeries in the lower back using a different type of supportive cage than Hydrosorb. Different type of supportive cage than Hydrosorb Polly was involved in 10 of the cases cited in the article, though at the time of the study, he was not a paid consultant for Medtronic. The results of the study were subsequently published in a 2004 edition of the medical journal Neurosurgical Focus, the Star Tribune said. Following his May 2006 testimony, Polly and his colleagues at the University of Minnesota received a $466,644 Department of Defense grant for a two-year study involving Infuse Bone Graft.Īccording to the Minneapolis Star Tribune, the Walter Reed study involved 35 patients with back problems who were treated with Infuse packed into a bioabsorbable implant called Hydrosorb, which was distributed by Medtronic, and inserted between the vertebrae. Paul Business Journal, Polly never told the panel that he was a Medtronic consultant, and was billing the company $6,000 for his appearance. Polly had resigned from the board of the American Academy of Orthopaedic Surgeons after he was criticized for not disclosing his financial relationship with Medtronic when he testified before a Senate committee in 2006 urging more funding for research into combat-related injuries.Īccording to Minneapolis-St. The Walter Reed Infuse study detailed by the Star Tribune was conducted by Dr. However, medical firms are barred from promoting off-label uses. Doctors are allowed to used approved medical devices in this way – a practice known as off-label use. Rosen involved its use in procedures that at the time were not approved by the FDA. RosenĪccording to the Star Tribune, the Infuse study questioned by Dr. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries. Patients reported difficulty swallowing, breathing and speaking. In July 2008, the Food & Drug Administration (FDA) warned that the use of Infuse Bone Graft and similar products had caused serious problems when they were used off-label in cervical spine (neck) surgeries. It is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation. It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia.

Infuse Bone Graft, which is manufactured by Medtronic., contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body. Army Surgeon General expressing concerns about the way the Medtronic Infuse study was conducted. Charles Rosen, president of the Association for Medical Ethics, has written a letter to the U.S. According to a report in the Minneapolis Star Tribune, Dr. Infuse Bone Graft Contains Recombinant human Bone Morphogenetic Protein. Another study of Medtronic Inc.’s Infuse Bone Graft product that involved soldiers at Walter Reed Army Medical Center is coming under fire. Pennsylvania Sexual Abuse Lawsuit Lawyers.Clergy Sexual Abuse Lawyers | Priest Abuse Attorneys.

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