The Infuse Bone Graft
Manufactured by Medtronic, Inc., this product was originally approved for the use in lumbar spine procedures. However, in recently filed whistleblower and separate individual injury lawsuits, the company has been accused of marketing the product for use in the cervical spine (neck) procedures, which is an "off-label" use and not approved by the FDA.
The Medtronic Infuse Bone Graft contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body. According to Medtronic's website, the Infuse Bone Graft provides a scaffolding where new bone can grow. It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia. The U.S. Food & Drug Administration (FDA) has also approved it for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation.
The FDA has not approved this device for any other procedure. Using it on the neck area, or operating from the back side, is considered off-label. Other procedures with the device put patients at significant risk of injury. The artificial protein contained in Infuse Bone Graft can inflame nearby tissue. If the material isn't inserted properly, or if it leaks, it can cause bone growth in areas outside the surgical site.
Congress is investigating the possible payment to Orthopaedic Surgeons to hide serious side effects of the Medtronic Infuse Bone Graft. In addition, a recently released report stated that during clinial trials, Medtronic was aware of problems with the Infuse Bone Graft device
Despite the dangers, the off-label use of this graft is quite common. In fact, at least three-quarters of the roughly 200 "adverse events" reported to the FDA involve off-label uses of the product. In November 2008, the U.S. Department of Justice began an investigation to determine if Medtronic illegally promoted off-label use of Infuse bone Graft.