Infuse Bone Graft
The Infuse Bone Graft, manufactured by Medtronic, is a biologically-engineered protein (known as rhBMP-2) that is used to promote bone growth and replace damaged spinal discs. It is used in conjunction with a metallic cage implant (LT-Cage Device) that works to stabilize the spine as the new bone grows. Infuse Bone Graft is designed to reduce the pain and complications that are associated with treating degenerative disc disease by eliminating the second surgery that is typically required to remove bone from a patient’s hip for transplantation to the spine for repair.
The U.S. Food and Drug Administration (FDA) originally approved Infuse Bone Graft in 2002 for the purpose of anteriorly fusing together the vertebrae in the lower spine, as well as for open tibial shaft fractures and two minor dental procedures. As with many drugs and devices, off-label use of Infuse Bone Graft was permitted once the device received FDA approval. The practice of using a drug or device off-label is permitted if physicians believe it will benefit their patients and if they adequately warn patients about the potential risks of doing so.
In a Public Health Notification issued on July 1, 2008, the FDA warned healthcare providers about reported life-threatening complications associated with the off-label use of Infuse Bone Graft for cervical (neck) spinal fusions. This warning was issued in response to 38 reports of complications received by the FDA between 2004 and 2008. In the warning, the FDA noted that “the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use.” The Agency’s warning summarized the adverse events and health risks associated with the off-label use of Infuse Bone Graft, which included neck and throat swelling leading to airway compression, swallowing and breathing difficulties, as well as problems with speech.
No further warnings have been issued by the FDA, however Medtronic is currently under investigation by the U.S. Department of Justice and the U.S. Senate Finance Committee for allegations of off-label marketing and failure to disclose life-threatening side effects associated with the off-label use of Infuse Bone Graft.