Did Medtronic Promote Dangerous Off-Label Use of Infuse Bone Graft?
Off-label use of Medtronic’s Infuse Bone Graft has been linked to serious, life-threatening complications in some patients. According to a new report in The Wall Street Journal, there is some evidence that Medtronic may have promoted the off-label use of the Infuse Bone Graft. Promoting the off-label use of a medical device is illegal, although doctors are allowed to use a device anyway they see fit. Infuse Bone Graft contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body. It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia. It is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation. According to Medtronic’s Website, the Infuse Bone Graft provides a scaffolding where new bone can grow. In July, the Food & Drug Administration (FDA) warned that the use of the Infuse Bone Graft had caused serious problems w
