Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 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

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”.

PubMed Disclaimer

References

    1. Arts MP, Kols NI, Onderwater SM, Peul WC. Clinical outcome of instrumented fusion for the treatment of failed back surgery syndrome: A case series of 100 patients. Acta Neurochir (Wien) 2012;154:1213–7. - PMC - PubMed
    1. Carragee EJ, Hurwitz EL, Weiner BK. A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: Emerging safety concerns and lessons learned. Spine J. 2011;11:471–91. - PubMed
    1. Carragee EJ, Mitsunaga KA, Hurwitz EL, Scuderi GJ. Retrograde ejaculation after anterior lumbar interbody fusion using rhBMP-2: A cohort controlled study. Spine J. 2011;11:511–6. - PubMed
    1. Chrastil J, Patel AA. Complications associated with posterior and transforaminal lumbar interbody fusion. J Am Acad Orthop Surg. 2012;20:283–91. - PubMed
    1. Comer GC, Smith MW, Hurwitz EL, Mitsunaga KA, Kessler R, Carragee EJ. Retrograde ejaculation after anterior lumbar interbody fusion with and without bone morphogenetic protein-2 augmentation: A 10-year cohort controlled study. Spine J. 2012;12:881–90. - PubMed