Questions about spine fusion product prompt a new process for reviewing data.

摘要

A CONVERGENCE OF PEER-reviewed research, press scrutiny, federal investigations, and serendipity may lead to a clearer understanding of the safety and efficacy of a spinal fusion product manufactured by Medtronic, Inc. At issue is Infuse Bone Graft, a product containing recombinant bone mor-phogenetic protein-2 (BMP-2), a synthetic bone growth factor that was approved in 2002 by the US Food and Drug Administration (FDA) for single-level anterior interbody lumbar fusion. The product has become widely adopted in spine surgery; by 2007, it was used in more than 50% of primary anterior lumbar spine fusions. Since then, the product's use has expanded further, as positive efficacy and safety results for other indications (posterolateral lumbar fusion, posterior lumbar interbody fusion, and anterior cervical discec-tomy and fusion) from industry-sponsored trials have been published in the peer-reviewed literature.