Bone morphogenetic protein (BMP) is increasingly used as an alternative to the patient's own bone for spinal fusion surgery. Yet at least 85 percent of these procedures are operations for which BMP use has not been formally approved by the U.S. Food and Drug Administration (FDA), suggests a study in the September 1 issue of Spine. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health, a leading provider of information and business intelligence for students, professionals, and institutions in medicine, nursing, allied health, and pharmacy.
Although BMP is approved for use in stimulating bone growth in one specific type of spinal fusion surgery, it is more often used for non-approved, "off-label" purposes, according to the new study, led by Kevin L. Ong, PhD, of Exponent, Menlo Park, Calif. Dr Ong and coauthors write, "With uncertainty regarding the risks of using BMP in certain off-label applications, further research will be needed to better define the appropriate indications."
Use of BMP for Spine Surgery Is Rising Rapidly…
The researchers used a large U.S. hospital database to analyze trends in the use of BMP for spinal surgery. Bone morphogenetic proteins are growth factors that can induce the formation of new bone. They provide an alternative to using the patient's own bone—typically from the hip bone (iliac crest)—as a source of grafts for spinal fusion procedures.
From 2002 to 2007, BMP was used in approximately 340,000 surgical procedures. During this time, the use of BMPs more than quadrupled—from about 24,000 to 103,000 procedures. More than 90 percent of these operations were spinal fusion procedures. (BMP is also used in some less-common operations, such as surgery for complex fractures.)
The FDA has formally approved BMP for use in only one type of spinal fusion procedure—a lower back operation called anterior lumbar interbody fusion (ALIF). However, ALIF procedures accounted for only about 17 percent of procedures using BMP in the study.