Infuse Bone Graft, Other BMP Protein Products Linked to Complications in Neck Spine SurgeryJul 1, 2009 | Parker Waichman LLP
BMP protein, a bone growth agent used in products like Medtronic Inc.'s Infuse Bone Graft, may be responsible for serious complications when used to treat neck pain, and may not be cost effective, according to a new study. The study, conducted by researchers at Brigham and Women's Hospital in Boston, found that when used in the neck region of the spine, some complications from BMP products like Infuse could be life-threatening.
BMP products have become very popular since they were first introduced. According to the Associated Press, some small studies have shown that these products allow better healing of the bone and fewer repeat surgeries to fix failed spinal fusions. The product also makes it unnecessary to surgically harvest the patient's own bone from the shin or hip for a graft.
However, last year, the Food & Drug Administration had warned that off-label use of these products - specifically when used in cervical spine (neck) fusion surgeries - had been linked to serious, and sometimes serious complications. According to the Associated Press, BMP can make bone grow in unwanted places if it's incorrectly used, and there are no official guidelines for its use.
This latest BMP study, which appears in the Journal of the American Medical Association, focused on Infuse and on another bone-growth product from Stryker Corp. It looked at records of more than 325,000 spinal fusions from 2002 to 2006. They found that 7% more patients experience a complication before leaving the hospital when they received a BMP product front of the neck region of the spine. That's a 50% higher rate compared to when the product wasn't used. When BMP products where used in other areas of the spine, however, there were no more complications compared with other spinal fusion treatments.
The study also raised questions about the cost of products like Infuse Bone Graft. Fusion surgeries of the neck cost around $46,000 when the products were used, compared to $31,000 when they are not. According to The Wall Street Journal, use of the products "was associated with higher total hospital charges for all categories of fusions.”