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. 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

Nancy E Epstein  1
Affiliations

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

Nancy E Epstein. Surg Neurol Int. .

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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