Bone Fusion Agent May Be Dangerous

A bone growth agent used in thousands of spinal fusion surgeries for neck pain has been linked to complications and higher cost, according to the first nationwide study of the product. Spinal fusion is one option for people with back and neck pain, although some researchers have questioned how well it works.
In a spinal fusion, a surgeon removes the disc between two vertebrae and replaces it with the patient’s own bone, BMP or another product. If successful, new bone grows and fuses the vertebrae into one piece, stabilizing the spine.
Safety questions arose last year about the protein product, BMP, when used in fusion surgeries in the neck region, a use not approved by federal regulators. Doctors are allowed to use products such as this for purposes for which they have not been approved. The lead author of the study which appears in the latest issue of the Journal of the American Medical Association reported that some of these complications are life-threatening because the neck is such a sensitive area.
Smaller studies have shown BMP promotes 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, the powerful protein can make bone grow in unwanted places if it’s incorrectly used. There are no official guidelines for its use.
For the new study, researchers looked at records of more than 325,000 spinal fusions from 2002 to 2006. When BMP was used in the front of the neck region of the spine, there were complications in 7 percent of patients before they left the hospital, a 50 percent higher rate compared to when the product wasn’t used.
Elsewhere in the spine, however, BMP led to no more complications than other spinal fusion treatments.
Surgeons have rapidly adopted BMP since the Food and Drug Administration approved it in 2002 for back surgeries. Doctors used it in 17,623 spinal fusions in 2006, nearly 1 in 4 cases, the researchers found.
Last year, the FDA warned doctors about 38 reports of complications when the treatment was used in the neck region of the spine. For unknown reasons, some patients had swelling after surgery, and that caused problems with breathing and swallowing.