North American Spine Society

View all recommendations from this society

Released October 9, 2013

Don’t use Bone Morphogenetic Protein (rhBMP) for routine anterior cervical spine fusion surgery.

Bone Morphogenic Protein is a compound which stimulates bone formation and healing. Life-threatening complications have been reported in the routine use of recombinant human rhBMP in anterior cervical spine fusion surgery, due to swelling of the soft tissues. This may lead to difficulty swallowing or pressure on the airway.


These items are provided solely for informational purposes and are not intended as a substitute for consultation with a medical professional. Patients with any specific questions about the items on this list or their individual situation should consult their physician. THIS CHOOSING WISELY DOCUMENT DOES NOT REPRESENT A “STANDARD OF CARE,” nor is it intended as a fixed treatment protocol. It is anticipated that there will be patients who will require less or more treatment than the average. It is also acknowledged that in atypical cases, treatment falling outside this recommendation list will sometimes be necessary. This document should not be seen as prescribing the type, frequency or duration of intervention. Treatment should be based on the individual patient’s need and physician’s professional judgment. This document is designed to function as a guide and should not be used as the sole reason for denial of treatment and services. This document is not intended to expand or restrict a health care provider’s scope of practice or to supersede applicable ethical standards or provisions of law, but to encourage discussion of these issues between physician and patient, encourage active patient participation in health care decision-making, and foster greater mutual understanding.

How The List Was Created

The North American Spine Society (NASS) appointed a multidisciplinary task force to identify five areas in which to make recommendations. Based on the scientific evidence, existing clinical practice recommendations and expert opinion, the task force collaboratively identified a draft list of nine recommendations that was subsequently submitted to the NASS Board of Directors for review and ranking. After further refinement, the final list was reviewed and approved by the NASS Board of Directors.

NASS’ disclosure and conflict of interest policy can be found at: www.spine.org/Pages/WhoWeAre/MedicalProfessionalism/DisclosureIndustryRelationships.aspx.

Sources

U.S. Food & Drug Administration. FDA public health notification: life-threatening complications associated with recombinant human bone morphogenetic protein in cervical spine fusion [Internet]. Silver Spring (MD): U.S. Food and Drug Administration; 2008 Jul 1 [updated 2013 Mar 21; cited 2013 Jul 19]. Available from: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062000.htm.

Woo EJ. Recombinant human bone morphogenetic protein 2: adverse events reported to the Manufacturer and User Facility Device Experience database. Spine J. 2012 Oct;12(10):894-9.