New studies suggest a popular spinal bone-graft device has no clinical advantages over traditional bone grafting methods for reducing chronic lower back pain. Perhaps as important, the way these studies came about suggests a better approach to conducting postmarketing surveillance of medical devices and drugs.
The device in question is the Infuse Bone Graft, manufactured by Medtronic. It uses recombinant human bone morphogenetic protein 2 (rhBMP-2), a genetically engineered protein with bone growth–stimulating properties, as a bone graft substitute. The rhBMP-2 device was approved in 2002 by the US Food and Drug Administration (FDA) for anterior lumbar interbody fusion surgery to reduce chronic low back pain. Earlier studies found rhBMP-2 to be superior to other grafting therapies, and the device was soon generating almost $1 billion in annual revenues for Medtronic.
Mitka M. Open Access to Data Closes the Book on Efficacy of Popular Bone-Graft Device. JAMA. 2013;310(4):359-360. doi:10.1001/jama.2013.8485