A study published in JAMA reviewed use of BMPs in spinal fusion surgeries, and outcomes included higher complication rates for off-label use in cervical fusions and increased charges for all procedures.
Researchers at Brigham and Women's Hospital in Boston conducted a retrospective cohort study of 328,468 patients who underwent fusion procedures from 2002 to 2006. The cohort was assembled from the Nationwide Inpatient Sample database, which represents a 20% sample of U.S. community hospitals.
Among the results, the study's authors found that BMPs (either Medtronic's Infuse or Stryker's OP-1) were used in approximately 25% of fusion cases in 2006, up from less than 1% in 2002, when Infuse first went on the market. Patterns of use also appeared correlated with demographic information, including increased use in women and Medicare patients and decreased use in nonwhite patients.
The study also provided confirmation of previous reports of higher complication rates in cervical fusion cases. Multivariate analysis of 2006 data showed that BMP correlated with a 7% complication rate, compared to less than 5% in patients who did not receive BMP. Complications cited included wound healing, and dysphagia or hoarseness. Reports of these and additional complications, including respiratory distress and one death, resulted in the FDA issuing a warning about off-label use of the product. Such use appears to have declined since these concerns surfaced last year.
The study also showed that use of BMPs was associated with additional hospital charges, and that charges increased most with BMP use in cervical fusions.
