title: A comprehensive assessment of the risk of bone morphogenetic protein use in spinal fusion surgery and postoperative cancer diagnosis.
abstract: The risk of postoperative cancer following the use of recombinant human bone morphogenetic protein (BMP)-2 in spinal fusion is one potential complication that has received significant interest. Until recently, there has been little clinical evidence to support the assertion of potential cancer induction after BMP use in spinal surgery. This report aims to summarize the findings from clinical data available to date from the Yale University Open Data Access (YODA) project as well as more recently published large database studies regarding the association of BMP use in spinal fusion and the risk of postoperative cancer. A detailed review was based on online databases, primary studies, FDA reports, and bibliographies of key articles for studies that assessed the efficacy and safety of BMP in spinal fusion. In an analysis of the YODA project, one meta-analysis detected a statistically significant increase in cancer occurrence at 24 months but not at 48 months, and the other meta-analysis did not detect a significant increase in postoperative cancer occurrence. Analysis of 3 large health care data sets (Medicare, MarketScan, and PearlDiver) revealed that none were able to detect a significant increase in risk of malignant cancers when BMP was used compared with controls. The potential risk of postoperative cancer formation following the use of BMP in spinal fusion must be interpreted on an individual basis for each patient by the surgeon. There is no conclusive evidence that application of the common formulations of BMP during spinal surgery results in the formation of cancer locally or at a distant site.
authors: Carolina Neurosurgery and Spine Associates, Charlotte, North Carolina;
authors: Kevin S
authors: KS
authors: Cahill
authors: Department of Neurological Surgery, Columbia University Medical Center, New York, New York; and.
authors: Paul C
authors: PC
authors: McCormick
authors: Department of Neurological Surgery and The Miami Project to Cure Paralysis, University of Miami Miller School of Medicine, Miami, Florida.
authors: Allan D
authors: AD
authors: Levi
mesh_terms: D019485:Bone Morphogenetic Proteins / Q000009:adverse effects*; D006801:Humans; D009369:Neoplasms / Q000139:chemically induced*; D018570:Risk Assessment; D013123:Spinal Fusion
chemical_list: D019485:Bone Morphogenetic Proteins
keywords: BMP; BMP = bone morphogenetic protein; IDE = investigational device exemption; OHSU = Oregon Health & Science University; SEER = Surveillance, Epidemiology, and End Results; YODA = Yale University Open Data Access; cancer; oncology; rhBMP = recombinant human BMP; spinal fusion; technique