Abstract
Increasingly, adverse events (AE) attributed to utilizing BMP/INFUSE (Bone Morphogenetic Protein, Medtronic, Memphis, TN, USA) “off-label” in spine surgery are being reported. In 2008, the Food and Drug Administration (FDA) issued a warning that in anterior cervical spine surgery, the “off-label” use of BMP/INFUSE contributed to marked dysphagia, hematoma, seroma, swelling, and/or the need for intubation/tracheostomy. Subsequent studies have cited the following AE; heterotopic ossification (HO), osteolysis, infection, arachnoiditis, increased neurological deficits, retrograde ejaculation, and cancer. Furthermore, in 2011, Carragee et al. noted that 13 of the original industry-sponsored BMP/INFUSE spinal surgery studies failed to acknowledge multiple AE. Additionally, in 2012, Comer et al. observed that the frequency of retrograde ejaculation reported for BMP/INFUSE used “on-label” to perform Anterior Lumbar Interbody Fusion/Lumbar Tapered Fusion-Cage Device (ALIF/LT-Cage) was also largely “under-reported.” To summarize, there is mounting evidence in the spinal literature that utilizing BMP/INFUSE in spinal fusions contributes to major perioperative and postoperative morbidity.
Highlights
Major complications, adverse events (AE) and reoperations have increasingly been attributed to the “off-label” use of BMP/INFUSE (Bone Morphogenetic Protein, Medtronic, Memphis, TN, USA) in spine surgery
The mounting recent evidence in the spinal literature acknowledges that utilizing BMP/INFUSE to perform spinal fusions can contribute to major perioperative and postoperative morbidity (AE)
The web site for Food and Drug Administration (FDA) public health notification, stated that Risk with AMPLIFY/ BMP/INFUSE (rhBMP)-2 was FDA approved in the spine for fusion of the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1, and Grade I spondylolisthesis
Summary
Summary: In newer studies, evidence continues to mount regarding the increasing AE attributed to utilizing BMP/INFUSE “off-label” in spinal surgery. Summary: In 2011, the FDA reported that retrograde ejaculation (RE) was observed in 8% of ALIFs (12 cases) performed to address lumbar spondylosis or spondylolisthesis at either the L5-S1 or the L4-L5/L5S1 levels utilizing BMP/INFUSE vs a 1.4% incidence performed without BMP/INFUSE (control patients). Summary: Woo et al reported on the major AEs utilizing BMP/INFUSE (including documentation of the Morphogenetic Protein-2: Adverse Events “off-label” use of rhBMP-2) in spinal surgery based on the FDA database of post marketing reports Summary: Commenting on the article by Maerz et al, Genetic Advances in the Regeneration of the Intervertebral Disc, Epstein noted the in vivo and in vitro complications observed in animal models attributed to Bone Morphogenetic Protein dated back to the mid 2000s They included, at higher doses; “inflammation/inflammatory processes, increased vascularity, fibroblastic proliferation, and catabolism.”. SNI: Spine 2013,Vol 4, Suppl 2 - A Supplement to Surgical Neurology International (Table 1 Continued)
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