The spine journal : official journal of the North American Spine Society
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Increasingly, reports of frequent and occasionally catastrophic complications associated with use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in spinal fusion surgeries are being published. In the original peer review, industry-sponsored publications describing the use of rhBMP-2 in spinal fusion, adverse events of these types and frequency were either not reported at all or not reported to be associated with rhBMP-2 use. Some authors and investigators have suggested that these discrepancies were related to inadequate peer review and editorial oversight. ⋯ Level I and Level II evidence from original FDA summaries, original published data, and subsequent studies suggest possible study design bias in the original trials, as well as a clear increased risk of complications and adverse events to patients receiving rhBMP-2 in spinal fusion. This risk of adverse events associated with rhBMP-2 is 10 to 50 times the original estimates reported in the industry-sponsored peer-reviewed publications.
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Considerable debate exists regarding the incidence of persistent pain from the iliac crest bone graft (ICBG) harvest site. Different study designs have led to a variety of reported rates. ⋯ The results of this study highlight the difficulty in differentiating pain originating from the graft site versus residual low back pain. The incidence of pain over the iliac crest was similar in patients in which iliac crest was harvested and those in which no graft was harvested.
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The commercially available growth factor recombinant bone morphogenic protein-2 (rhBMP-2) used in spinal fusion has been associated with numerous adverse reactions, including inflammatory reactions in soft tissue, heterotopic bone formation, radiculitis, osteolysis, and cage or graft subsidence. The original Food and Drug Administration Summary of anterior lumbar interbody fusion (ALIF) reported 12 retrograde ejaculation (RE) events (8%) in the rhBMP-2 groups compared with (1.4%) in the control group. It had been debated whether this finding was related to rhBMP-2 use. ⋯ This study confirms previous reports of a higher rate of RE in ALIF procedures using rhBMP-2. This may be an important consideration in subjects concerned with sterility after surgery.
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Recent studies have demonstrated cases of adjacent vertebral body osteolysis when assessing the effect of bone morphogenetic protein (BMP) on fusion rates. However, no study to date has evaluated the course of osteolysis at different periods. ⋯ The rate of osteolysis decreased at 1 year compared with 3 to 6 months, but only 24% of the vertebral bodies with evidence of osteolysis at 3 to 6 months completely resolved by 1 year.