Bone Growth Agent Linked to Life-Threatening Neck Complications

Thousands of patients who underwent spinal fusion surgeries to relieve neck pain may be at increased risk of deadly complications due to the use of a controversial bone growth agent, a new study says.

The product, called BMP, is a protein made by Medtronic and Stryker, two leading manufacturers of medical devices. It was approved by the Food and Drug Administration in 2002 for use in back surgeries, but many surgeons have used BMP for fusion surgeries in other areas of the body, including the neck area.

In 2006, the product was used in 17,623 spinal fusion surgeries – about one in every four such procedures, according to researchers from Brigham and Women’s Hospital in Boston. In spinal fusion, a surgeon removes a disc from between two vertebrae and replaces it with the patient’s own bone, BMP, or another product. Over time, new bone grows and fuses the vertebrae into one piece, stabilizing the spine.

Earlier studies have shown that the potent protein in BMP can grow out of control in unwanted areas if it is not used correctly. Also, there are no official guidelines for how the product should be used.

In 2008, the FDA warned doctors about 38 reports of complications when BMP was used in the neck region of the spine. Some patients experienced swelling after surgery and had difficulty breathing and swallowing.

“Some of these complications are life-threatening because the neck is such a sensitive area,” said lead author Dr. Kevin Cahill.

The results of the study are published in this week’s Journal of the American Medical Association.

BMP is a popular product because it helps speed healing of the bone following surgery, requiring fewer repeat procedures to repair failed spinal fusions. By using BMP, surgeons also do not have to harvest bone from elsewhere in the patient’s body for a graft.

But researchers who studied more than 325,000 spinal fusion surgeries from 2002 to 2006 in which the bone growth product was used found an increased rate of complications.

When BMP was used in the front of the neck region of the spine, complications were reported in seven percent of patients before they left the hospital. That is 50 percent higher compared to when the product wasn’t used, researchers said.

Surgeons should “think twice” before using BMP in neck fusion surgeries, the researchers cautioned.

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