Effectiveness and Harms of Recombinant Human Bone Morphogenetic Protein-2 in Spine Fusion

Annals of Internal Medicine

A systematic review and meta-analysis of complications associated with rhBMP-2 was recently published in the Annals of Internal Medicine. Given the historical under-reporting of complications associated with the use of rhBMP-2, neurosurgeons are encouraged to examine the data presented in this study for consideration of potential complications associated with its use. Observational studies have reported serious complications associated with recombinant human bone morphogenetic protein-2 (rhBMP-2) in cervical and lumbar spine fusions. Before 2009, trials sponsored by Medtronic reported beneficial effects with no or few adverse events. Underreporting may have misrepresented the potential adverse effects of rhBMP-2. Thirteen RCTs and 31 cohort studies were included in this review. For both lumbar and cervical fusions, rhBMP-2 and iliac crest bone graft (ICBG) had similar results for fusion. For anterior lumbar interbody fusion, rhBMP-2 was associated with non-significantly increased risk for retrograde ejaculation and urogenital problems. For anterior cervical spine fusion, rhBMP-2 was associated with increased risk for wound complications and dysphagia.

The authors assert more research is needed to identify patients in which the use of rhBMP-2 may be beneficial. The authors conclude that on the basis of the currently available evidence, it is difficult to identify clear indications for rhBMP-2 in spinal fusion.

John H. Shin, MD
Boston, MA