The Medtronic Infuse Bone Graft, used by surgeons to help stimulate bone growth after back surgery, is a spongelike framework soaked in bone morphogenetic protein (BMP). When implanted between vertebrae, the BMP stimulates bones to grow. The Food and Drug Administration (FDA) approved the device for use in the lower spine in 2002.
While the FDA only approved the device for use in the lower spine, evidence points to Medtronic having conducted illegal off-label marketing for use in upper spine (cervical) surgeries.
Congressional scrutiny for illegal marketing
When used in the upper spine, the Medtronic Infuse Bone Graft may cause massive tissue swelling in the neck and throat, leading to suffocation, nerve damage, chronic pain and even death. An overwhelming majority of people implanted with the Medtronic Infuse Bone Graft suffer overgrown bones, which can lead to severe nerve damage and other side effects.
Medtronic is currently under Congressional investigation of its illegal off-label promotion. While physicians are permitted to use medical devices for off-label purposes, the manufacturers of these devices are prohibited from engaging in off-label promotion.
Severe, life-threatening side effects reported
The FDA has issued an alert regarding the complications from the off-label use of Infuse in the upper spine. These complications include:
- Angioedema (swelling of the neck and throat, which can cause fatal suffocation)
- Chronic pain that radiates into the arms and legs
- Male sterility
- Nerve damage
- Respiratory depression
Protect your rights. Get compensated for your injuries.
If you or a loved one received a Medtronic Infuse Bone Graft and suffered serious side effects or death, you may be entitled to compensation! Complete the Quick Intake form at the top of this page or call our legal intake center at 1 (800) 438-6453 to receive your FREE case evaluation.