Bone growth biologics were used in about 25 percent of all U.S. spinal fusion surgeries in 2006, caused more frequent complications and cost more, according to a study in the Journal of the American Medical Assn.
That’s bad news for Medtronic and Stryker Biotech, which make the BMPs examined in the study of more than 328,000 patients undergoing spinal fusion procedures from 2002 to 2006.
It showed that BMP usage increased from 0.69 percent of all fusions in 2002 to 24.89 percent in 2006 and cost between 11 percent and 41 percent more than spinal fusions performed without it.
And there were more than 2 percent more postoperative complications in anterior cervical fusions in 2006 with the proteins than without. The complications included in wound-related problems, dysphagia (difficulty swallowing) and hoarseness. Complication rates for other fusion procedures were same whether BMP was used or not.
The study also showed:
• Increased BMP use in women (56.26 percent vs. 53.35 percent without);
• Increased BMP use in Medicare patients (29.62 percent vs. 27.16 percent without);
• And decreased use in non-white patients (8.69 percent vs. 10.23 percent without.
Though the news is worse for Medtronic, whose Infuse is the only fully approved product on the market, it’s yet another setback for Stryker’s OP-1 putty.
The product, available under a humanitarian use exemption in the U.S., was denied wider approval by the Food & Drug Administration in April.
And a trio of former sales reps pleaded guilty to charges they promoted off-label combinations of the putty and another of Stryker’s bone-healing products.