What is Infuse?
The Medtronic Infuse bone graft is a genetically engineered liquid protein that helps the body to grow its own bone. It includes a bioengineered protein manufactured by Wyeth, called bone morphogenetic protein (BMP).
Scope of the Infuse Problem
Medtronic’s Infuse Bone Graft is used in about a quarter of the estimated 432,000 spinal fusions performed in the U.S. annually, according to the New York Times.
The Infuse system involves three steps:
Small collagen sponges are used to absorb in bone morphogenetic protein (known as rhBMP-2), a substance that encourages bone growth. Sponges are then placed in small, hollow metallic cages. The cages are then implanted in the spine between vertebrae to support the spine while new bone grows between the vertebrae.
FDA Approved Infuse only for Anterior Lumbar Surgery
Medtronic’s Infuse Bone Graft system was FDA-approved in 2002 for anterior approach lumbar fusion surgery. Infuse was not, approved for other types of spine surgeries, including lateral or posterior approach lumbar fusion surgeries or for those on the cervical spine.
Medical research has demonstrated that both approved and off-label uses of Infuse Bone Graft system may cause serious and potentially fatal injuries, such as:
Uncontrolled/Ectopic Bone Growth
Airway Swelling and Compression
Questionable Behavior by Medtronic Infuse Manufacturer
Medtronic, maker of Infuse Bone Graft System, should have conducted thorough and competent research into all possible risks of Infuse. But according to the Spine Journal, Medtronic caused the endangerment of patients who received the Infuse system.
The Spine Journal review found that the 13 original Medtronic-funded studies overestimated the usefulness and downplayed the risks of Infuse component rhBMP-2.
The authors of these studies received an estimated $12 million to $16 million each from Medtronic, and their studies frequently revealed absolutely no Infuse complications.
Other studies that weren’t funded by Medtronic have revealed serious and potentially fatal injuries associated with Infuse Bone Graft system.
Medtronic to Pay $85 Million Lawsuit
Medtronic has agreed to settle a shareholder lawsuit for $85 million, regarding accusations that the company made misleading statements about Infuse.
Shareholders claim that Medtronic failed to disclose that 85.2% of Infuse sales depended on off-label uses that are not approved by the FDA.
They allege that Infuse sales began to drop after the U.S. Department of Justice and the U.S. Senate launched investigations into whether Medtronic was illegally promoting off-label uses of Infuse to doctors.