Bone growth agent linked to problems in neck surgeries

“Some of these complications are life-threatening because the neck is such a sensitive area,” said lead author Dr. Kevin Cahill of Harvard-affiliated Brigham and Women's Hospital in Boston. The study appears in Wednesday's Journal of the American Medical Association.

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.

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.

“It's a new product and use is taking off right now,” Cahill said.

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.

BMP is produced by two companies, Minneapolis-based Medtronic and Kalamazoo, Michigan-based Stryker.

Medtronic spokeswoman Marybeth Thorsgaard said that company added a label warning about neck complications in 2005. She said the company has a study under way that may help address how the product could be safely used in the neck region.

In an e-mailed statement, Stryker said doctors should use its BMP product only for approved uses, which do not include spinal fusions in the neck.

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 shock-absorbing disc between two vertebrae and replaces it with the patient's own bone, BMP or another product. Ideally, new bone grows and fuses the vertebrae into one piece, stabilizing the spine.

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