Medtronic Infuse Bone Substitute Used Off-Label 17% of Time

Researchers from the Cleveland Clinic have suggested that more than 1 in 6 surgeries in which the Medtronic Infuse bone substitute is implanted involve off-label use, for which the bone graft is not approved and which has been associated with an increased risk of serious and potentially life-threatening complications.

The Medtronic Infuse bone graft is a liquid spinal implant that uses a bone morphogenetic protein (BMP) to stimulate bone growth that replaces damaged disks by filling inter-vertebral gaps.

The Infuse bone substitute is only approved for use in the lumber spine and for certain dental procedures. However, it is widely used off-label in the cervical spine, or neck, which Medtronic has not determined to be a safe or effective use.

In July 2008, the FDA issued a warning to healthcare providers highlighting a number of serious and life-threatening complications associated with use of BMP bone grafts in the cervical spine.

The close proximity of the cervical spine to the airway, could result in difficulty speaking, trouble swallowing and respiratory distress if swelling of the neck compresses the airway and nerves after an Infuse implant.

The Infuse bone substitute problems typically occur within 2 to 14 days after surgery, and for some patients the complications have resulted in tracheotomies, insertion of feeding tubes and additional surgery to drain implant sites.

At the North American Spine Society’s 23rd annual meeting, researchers from the Cleveland Clinic presented data that quantifies the on and off-label use of the bone graft substitute, finding that 17.3% of all Medtronic Infuse bone substitute use was off-label.

Medtronic Inc. currently faces an investigation from the U.S. Department of Justice into their marketing and promotion of the Infuse bone substitute for uses that were not approved by the FDA and a Medtronic class action lawsuit has been filed by investors alleging that the company failed to disclose the extent to which their sales of the bone graft are tied to off-label use.