What is Failed Back Surgery Syndrome? Linked to Infuse Bone Graft?
In September 2011, the Milwaukee Journal Sentinel profiled Tom Engel of Milwaukee and his experience with failed back surgery syndrome. Engel has undergone two spinal surgeries, one in 2002 and another in 2004, in an effort to manage his excruciating back pain. In his second surgery, the Medtronic Infuse bone graft was implanted into his spine in an off-label (non-FDA approved) use of the product. Today, Engel has what is known as Failed Back Surgery Syndrome (FBSS), and is bedridden and heavily medicated 24 hours, 7 days a week for his pain.
Engel’s experience also puts him at the intersection of two growing medical controversies – dangerous side effects from off-label use of the Infuse bone graft, and the rise of failed back surgery syndrome.
Failed Back Surgery Syndrome Defined
The International Association for the Study of Pain defines FBSS as “lumbar spinal pain of unknown origin, either persisting despite surgical intervention or appearing after surgical intervention.”
The Los Angeles Times notes in, “For back pain sufferers, surgery isn’t always the answer,” spinal surgeries in the United States are performed at double the rate of other developed nations, with no corresponding evidence that Americans are actually suffering from back pain at twice the rate of their extranational counterparts. Further, “there is a long-standing controversy among spinal specialists over how often surgery is the best option — and some say surgeons can be too quick to sharpen their scalpels.”
The St. Petersburg Times reports that about 800,000 Americans have back surgery each year, but “evidence is mounting that for many patients, surgery is no better at relieving pain” than non-surgical treatment options, and that “some patients are even worse off after surgery, leading the profession to coin the term ‘failed back surgery syndrome.’” Dr. Norman Marcus tells the Record Searchlight that “half of all patients who had a spinal fusion or laminectomy surgery say they ended up no better or worse off after the procedures.”
Why is back surgery so popular in the United States? Dr. Steven Richeimer, chief of the division of pain medicine at USC, speculates that the United States’ extraordinarily high rates of spinal surgery may be cultural – he states, “We’re in a little bit of a quick-fix society.”
Medical Device Industry Payments for Research: Example of Medtronic’s Infuse Device
Another possible reason for the rising popularity of spine surgeries is the financial entanglements of doctors with medical device companies. Some doctors who recommend surgery over other treatment options, or who promote the use of specific medical devices used in spine surgery, have received enormous amounts of money from spine device companies. In many case, these doctors failed to disclose their financial ties to the medical device companies.
Certain physicians who published early studies on the Infuse bone graft system manufactured by Medtronic earned millions of dollars in consulting payments from Medtronic. For example, the Milwaukee Journal Sentinel reported that surgeon Thomas Zdeblick received more than $22 million in royalties and other payments from Medtronic since 2002.
The early industry-sponsored studies on BMP-2 (the bone growth protein in Infuse) either failed to disclose or dramatically downplayed the side effects of BMP-2, including ectopic bone growth, unusual inflammatory cysts, osteolysis (or bone resorption) causing cage migration following spine fusion surgeries.
The nonprofit Foundation for Informed Medical Decision Making strives to help patients research treatment options and make fully informed decisions regarding surgery. Another resource for patients is the Association for Medical Ethics, founded by Charles Rosen, M.D., director of the Spine Center at UC Irvine. Dr. Rosen founded the Association for Medical Ethics (AME) in 2006 out of his concern over the rise in surgery rates. The AME calls for transparency from doctors who receive over $50,000 in consulting fees from medical device companies.
Earlier this year, Dr. Rosen sharply criticized the “marketing-disguised-as-research” that can arise from industry-sponsored research. Dr. Rosen cited Medtronic-sponsored research on the Infuse bone graft as an example of the harm that patients can suffer when new medical devices are brought to the market based on research conducted by physicians that are paid by the device manufacturers.