What Is A Medtronic Infuse Bone Graft?
The Infuse Bone Graft is medical device used during spinal fusion surgeries to promote bone growth. The device is manufactured by Medtronic and consists of a bio-engineered protein that is surgically implanted between the vertebrae.
The Medtronic system was granted limited approval by the U.S. Food and Drug Administration (FDA) in 2002 to be used only during surgery on the lower spine.
How the Infuse Bone Graft Works
The purpose of the Infuse graft is to stimulate new bone growth in the spine. It was developed as an alternative to traditional bone graft procedures, which use actual bone harvested from the patient’s own hip, another part of the body, or bone taken from cadavers.
The Medtronic Infuse system has three separate components including a synthetic liquid protein to grow bone tissue, a sponge for holding the protein and delivering it into the body and a small LT-Cage that is inserted in the spine.
What Medtronic Complications Can Occur?
Medtronic allegedly promoted the use of their bone protein in unapproved, or “off-label”, settings including the cervical spine, or upper back. When the Infuse Bone Graft is used in off-label surgeries, severe side effects can occur.
Medtronic Infuse Complications Include:
- Excessive bone growth
- Retrograde ejaculation
- Back and leg pain
- Swelling in neck and throat
- Airway compression
- Male sterility
FDA Medtronic Warnings
In July 2008, the FDA issued a Medtronic Infuse warning after receiving multiple reports of life-threatening complications caused by the bone protein. Medtronic allegedly promoted the use of the bone protein in unapproved settings including the upper back and neck regions.
The manufacturers also allegedly failed to warn patients and doctors about the severity of Infuse Bone Graft complications when used in the lower back.
Medtronic Sued by Shareholders
Medtronic was sued by its own shareholders for making misleading claims about Infuse Bone Grafts in a lawsuit settled in 2012. U.S. Senate concluded that Medtronic had manipulated research studies and secretly paid doctors to write favorable articles about their bone protein devices.
Free Consultation with a Qualified Infuse Bone Graft Attorney
If you or a loved one experienced complications after receiving a Medtronic Infuse Bone Graft during surgery, you may be eligible to file a lawsuit. For a free legal evaluation, contact the bone graft lawyers at Hissey Kientz, LLP by calling toll-free at 8-555-HELPYOU, or by filling out the free case evaluation form located on this page.
For more information:
- FDA Approval
- FDA Notice
- North American Spine Society
- Milwaukee Journal-Sentinel
- United States Senate Committee on Finance
- Medical News Today