A new article published in The Spine Journal examines recombinant human bone morphogenetic protein-2 use in the U.S. before and after the publication issued a warning about the fusion adjunct in 2011.
The researchers gathered data from the National Inpatient Sample for spinal fusion patients from 2002 to 2013. There were 4.16 million patients who underwent spinal fusion in the NIS database over the study period. The researchers found:
1. After The Spine Journal issued a warning about rhBMP-2, there was a greater decrease in its use than after the FDA advisory for all fusion procedures in 2008.
2. The number of lumbosacral spine surgeries had a larger decline after The Spine Journal's warning when compared with the FDA warning. Anterior and posterior lumbosacral fusions followed suit.
3. The only procedure that declined after the FDA advisory at a greater rate than The Spine Journal's warning was anterior cervical fusion.
4. The study authors concluded, "Warning sanctioned through spine literature may have a greater influence on practice of the spine surgery community as compared to advisories issued by the FDA."
5. The study authors called for more comprehensive guidelines for rhBMP-2 use.