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Bone Graft – Medtronic FDA Warnings

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 by eliminating the second surgery that is typically required to remove bone from a patient’s hip for transplantation to the spine for repair.

The U.S. Food and Drug Administration (FDA) originally approved Infuse Bone Graft in 2002 for the purpose of anteriorly fusing together the vertebrae in the lower spine, as well as for open tibial shaft fractures and two minor dental procedures. 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 adequately warn patients about the potential risks of doing so.

 

FDA Warning

In a Public Health Notification issued on July 1, 2008, the FDA warned 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. 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.” The Agency’s warning summarized the adverse events and health risks associated with the off-label use of Infuse Bone Graft, which included neck and throat swelling leading to airway compression, swallowing and breathing difficulties, as well as problems with speech.

 

Manufacturer Misconduct

Concerns abound regarding the off-label use of Infuse Bone Graft. The Wall Street Journal has run several reports over the past few years regarding payouts from Medtronic to various surgeons who have promoted the off-label use of Infuse Bone Graft in various studies, including one surgeon who allegedly fabricated a study that favorably portrayed Infuse Bone Graft despite data suggesting otherwise. This surgeon, Dr. Timothy R. Kuklo, received approximately $800,000 from Medtronic over the course of eight years for travel, consulting, training and speaking engagements. The Journal also reported on concerns held by the FDA regarding the off-label use of Infuse Bone Graft even before the product received initial approval. Transcripts from an FDA advisory committee meeting indicate that Dr. Scott Boden, who was presenting clinical trial data to the committee on behalf of Medtronic, diverted the conversation when the issue of off-label use arose. Dr. Boden had received in excess of $100,000 from Medtronic at the time of that meeting and continued to be paid through 2006.

 

Currently, the U.S. Senate Finance Committee is conducting an investigation to determine if surgeons who received large payouts from Medtronic for their consulting work and other obligations failed to disclose complications associated with the off-label use of Infuse Bone Graft. The U.S. Justice Department is also investigating whether Medtronic illegally marketed and promoted Infuse Bone Graft for off-label uses.

Additionally, The Spine Journal recently devoted an entire issue (June 2011) to the Infuse Bone Graft controversy. In the issue, authors criticized early research by physicians with financial ties to Medtronic as “biased and corrupted.” The issue notes that none of the 13 original trials funded by Medtronic disclosed adverse events associated with the use of Infuse Bone Graft, despite existing data provided to U.S. regulators and other publications that suggested up to half of all patients who received Infuse Bone Graft suffered adverse events.

As noted in the FDA’s 2008 notification, serious risks are associated with the off-label use of Infuse Bone Graft for cervical spinal fusion, including life-threatening breathing problems and difficulties with swallowing and speech.