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Surg Neurol Int. 2013 Jul 9;4(Suppl 5):S343-52. doi: 10.4103/2152-7806.114813. Print 2013.

Complications due to the use of BMP/INFUSE in spine surgery: The evidence continues to mount.

Author information

1
Chief of Neurosurgical Spine and Education, Department of Neurosurgery, Winthrop University Hospital, Mineola, NY, 11501, USA, and Long Island Neurosurgical Assoc. P.C., 410 Lakeville Rd, New Hyde Park, New York, 11042, USA.

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.

KEYWORDS:

Adverse events; BMP/INFUSE; fusions; morbidity; spinal surgery; “off-label”

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