Side Effects of Medtronic Infuse Bone Grafts
Last Updated on June 27, 2017
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The Medtronic Infuse bone graft is a bioengineered morphogenetic protein (BMP), a liquid bone graft used to encourage bone growth to replace damaged spinal disks. While it has proved effective in many instances, its use has also been accompanied by serious side effects.
Medtronic Bone Graft Issues
Medtronic Infuse bone graft is approved by the FDA for use on the lower lumbar spine. Yet, even under its approved usage, there have been reports of serious side effects, including sterility in males, cancer, infections, and severe pain. Studies that were commissioned to look into these Medtronic side effects may have been skewed in the manufacturer’s favor, as there have been allegations of bribery and a cover-up of the results. According to a study of the clinical trials sponsored by Medtronic, 10% to 50% of the participants experienced these negative side effects, but this was not reported by the researchers in their papers.
Infuse Bone Graft Complications
Furthermore, a reported 17% of Medtronic bone graft procedures were performed off-label on the cervical spine (i.e., the neck region), a use for which they have not been approved. This has led to potentially life-threatening complications including:
- Swelling of the neck and throat
- Difficulty breathing, swallowing, and speaking
- Compression of airways
- Nerve damage
- Cyst formation
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