A recent study conducted by Brigham and Women’s Hospital revealed that a bioengineered protein used during spinal fusion procedures to correct neck pain caused more complications in patients who received the protein when compared with those who did not.
The bioengineered protein mimics natural substances that promote bone growth. The FDA first approved bioengineered proteins in 2002, but only for use in spinal fusions to alleviate back pain. However, surgeons are also free to use the protein to treat cervical (neck) pain. Nonetheless, the FDA issued a warning last year after receiving reports of life-threatening complications such as swelling of the neck and difficulty breathing.
One of the manufacturers of the protein is the maligned Medtronic, who has seen their fair share of lawsuits resulting from defective products. Medtronic’s protein, Infuse, is at the center of a controversy in which Army officials have accused a Medtronic consultant who was a former military doctor of falsifying data in a study about the product.
