Off-Label Use in Orthopaedic Surgery

Benjamin C. Taylor, MD; Jacob J. Triplet, DO; Taleed El-Sabawi, MS, JD


J Am Acad Orthop Surg. 2019;27(17):e767-e774. 

In This Article


With quite a large variety of companies providing spinal instrumentation and products, off-label use of products in spinal surgery remains common.[39,40] Most notable in the spinal realm remains the use of biologics, including the BMP products. In a recent review of BMP usage in the United States, an increasing use of BMP in this cohort with spinal issues was noted, irrespective of its FDA-approved indication for anterior lumbar interbody fusion.[39] Over a 5-year period, a 4.3-fold increase in BMP use (from 23,900 to 103,194 cases) was discovered, with spine fusion accounting for the majority (92.8%). Quite notably, it was concluded that more than 85% of spinal procedures using BMP were off-label.[39] Use of BMP is not without risk because multiple complications have been described in the spinal literature.[40] Such reported adverse events included swelling, fluid collections, osteolysis, pain/radiculopathy, heterotopic bone, pseudarthrosis, surgical site infections and other wound complications, thromboembolic events, respiratory distress, and malignancies.[40]