A comprehensive review of the safety profile of bone morphogenetic protein in spine surgery.

David Benglis, Michael Y. Wang, Allan D Levi

Research output: Contribution to journalArticle

169 Citations (Scopus)

Abstract

WE REVIEW OUR current understanding of the development and potential clinical applications of bone morphogenetic protein (BMP) in spine surgery. We also review the evidence for adverse events associated with the use of BMP and suggest potential reasons for these events and means of complication avoidance. Bone morphogenetic protein 2 (rhBMP-2) is approved by the Food and Drug Administration for anterior lumbar interbody fusion; rhBMP-7, on the other hand, is approved for long bone defects and has received a humanitarian device exemption for revision posterolateral lumbar operations and recalcitrant long bone unions. Nevertheless, "off-label" use in various spinal procedures has been reported and is increasing in frequency. Specific guidelines for rhBMP-2 and rhBMP-7 use are lacking because of the limited availability of randomized controlled clinical trials and its diverse use in many spinal applications. Mechanisms of delivery, carrier type, graft position, surgical location, and variations in BMP concentration may differ from one surgery to the next. Adverse events linked to either rhBMP-2 or rhBMP-7 use include ectopic bone formation, bone resorption or remodeling at the graft site, hematoma, neck swelling, and painful seroma. Other potential theoretical concerns include carcinogenicity and teratogenic effects. In this review, we provide the reader with a historical perspective on BMP, current and past research to support its use in spinal procedures, and a critical analysis of the complications reported thus far.

Original languageEnglish
JournalNeurosurgery
Volume62
Issue number5 Suppl 2
StatePublished - May 1 2008

Fingerprint

Bone Morphogenetic Proteins
Spine
Safety
Bone and Bones
Compassionate Use Trials
Off-Label Use
Transplants
Seroma
Bone Morphogenetic Protein 2
Bone Remodeling
United States Food and Drug Administration
Bone Resorption
Osteogenesis
Hematoma
Neck
Randomized Controlled Trials
Guidelines
Research

ASJC Scopus subject areas

  • Clinical Neurology
  • Surgery

Cite this

A comprehensive review of the safety profile of bone morphogenetic protein in spine surgery. / Benglis, David; Wang, Michael Y.; Levi, Allan D.

In: Neurosurgery, Vol. 62, No. 5 Suppl 2, 01.05.2008.

Research output: Contribution to journalArticle

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