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Spinal Surgery with Infuse Bone Graft

The Infuse Bone Graft, manufactured by Medtronic, is a biologically-engineered protein (known as rhBMP-2) that is used to promote bone growth and replace damaged spinal discs. It is used in conjunction with a metallic cage implant (LT-Cage Device) that works to stabilize the spine as the new bone grows. Infuse Bone Graft is designed to reduce the pain and complications that are associated with treating degenerative disc disease (DDD) by eliminating the second surgery that is typically required to remove bone from a patient’s hip for transplantation to the spine for repair.

Approved Uses

DDD occurs when a spinal disc deteriorates to the point of causing back pain, a diagnosis that must be confirmed by history and x-rays. Spinal fusion is a surgical method used to treat DDD and involves removing the damaged disc and replacing it with bone graft that will fuse – or join – the two adjacent vertebrae together in order to stabilize the spine. Infuse Bone Graft is used in over 100,000 U.S. spinal fusion surgeries each year.

Infuse Bone Graft is currently approved by the U.S. Food and Drug Administration (FDA) for use in anterior spinal fusion of the lumbar spine, as well as for the repair of open tibial shaft fractures and two minor dental procedures. When used for label-approved indications, Infuse Bone Graft should not be used under the following circumstances:

  •  Women who are pregnant or who suspect pregnancy
  • Individuals with infections near the area of the surgical incision
  • Individuals who have had a tumor removed from the area of the implantation site
  • Individuals who currently have tumors in or near the area of the implantation site
  • Individuals whose bones have not stopped growing
  • Individuals who are sensitive to titanium, titanium alloy, bovine (cow) Type I collagen or rhBMP-2.

Off-label Uses

The FDA originally approved Infuse Bone Graft in 2002 but as with many drugs and devices, off-label use of Infuse Bone Graft was permitted once the device received FDA approval. The practice of using a drug or device off-label is permitted if physicians believe it will benefit their patients and if they fully advise their patients of the risks associated with the off-label use. In July of 2008, the U.S. Food and Drug Administration issued a warning to healthcare providers about reported life-threatening complications associated with the off-label use of Infuse Bone Graft for cervical (neck) spinal fusions. This warning was issued in response to 38 reports of complications received by the FDA between 2004 and 2008. These complications include neck and throat swelling leading to airway compression, swallowing and breathing difficulties, as well as problems with speech. In the warning, the FDA noted that “the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use.”

 Recent Regulatory Scrutiny

Recently, the manufacturer of Infuse Bone Graft – Medtronic – has come under increasing scrutiny for its alleged marketing and promotion of off-label uses for the device, as well as for evidence of financial ties to physicians and researchers who may have concealed potentially life-threatening complications associated with off-label uses. In June 2011, the U.S. Senate Finance Committee announced an investigation to probe whether surgeons who received substantial financial compensation from Medtronic failed to report serious complications associated with the product during clinical trials – complications that reportedly included neck swelling, abnormal bone growth and sterility in male patients. Shortly thereafter, in August 2011, Medtronic announced that an independent review of the Infuse Bone Graft will be conducted by Yale University. The review will examine patient data and all adverse event reports to the FDA at a cost of $2.5 million to the manufacturer.