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Off- Label Use of Proteins in Neck Surgery Poses 50 % Increase of Complications

A bone growth protein, when used in spinal fusion surgeries for neck pain, has been linked to serious complications. 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.

A study recently published in The Journal of the American Medical Association confirms previous concerns about the use of the protein in neck surgeries. Medtronic and Stryker sell these bioengineered proteins, which are not federally approved for neck procedures. Minneapolis-based Medtronic sells Infuse, and Kalamazoo, Mich.-based Stryker sells OP-1 Putty.

These bioengineered proteins, which mimic natural substances that promote bone growth, were first approved in 2002 by the Food and Drug Administration but only for use in spinal fusions to alleviate lower back pain. Since 2002, doctors used BMP in 17,623 spinal fusions in 2006, nearly 1 in 4 cases.

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.

The study found that patients who had received the bioengineered proteins during spinal fusions for lower or middle back pain did not have increased complications when compared with those who did not get the product. But complications rates while patients were still in the hospital were 50 percent higher for cervical fusions procedures, researchers reported.

Last year alone the FDA received 38 reports of complications when the treatment was used in the neck region of the spine. Patients suffered complication such as swelling after surgery, which caused problems with breathing and swallowing. These reports prompted the FDA to issue an alert to health care providers of the complications.

Both companies are under investigation by both federal and state entities for off-label promotion. While doctors can independently choose to use a product for non-FDA approved purposes, companies may promote their products only for federally approved uses.

Medtronic added a label warning about neck complications in 2005. Stryker stated its product should only be used for approved purposes.

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