What is a Medtronic Infuse Bone Graft?
The Infuse bone grafting system is made and sold by Medtronic Inc. and designed for spinal fusions and treatment of degenerative disc disease.
The Infuse Bone Graft consists of a liquid, genetically-engineered protein (rhBMP-2) that stimulates bone growth, a sponge-like substance made of cow collagen and an LT-Cage, which is a small metal cylinder. The sponge is soaked in the liquid protein and placed in the LT-Cage, which is then surgically implanted between the vertebrae of the spine.
Has Infuse Bone Graft been approved by the FDA?
Yes, but only for spine surgery on the lower back. The U.S. Food and Drug Administration (FDA) approved the Infuse Bone Graft in 2002 for spinal fusions in the lumbar region of the back when done through the patient’s abdomen. The bone graft was also approved for use in tibia fractures and some mouth surgeries.
Has Infuse been used in ways that are not approved?
Yes. Infuse is often used in cervical fusions, surgeries to the upper spine and neck, as well as in surgeries done through the patient’s back or side. None of these uses have been approved by the FDA.
Medtronic allegedly promoted the use of their bone protein in these “off-label” settings. An “off-label” use is one that has not been approved or deemed as safe and effective by the FDA.
Was the Infuse Bone Graft tested before it was put on the market?
Medtronic never fully disclosed the dangers revealed by early clinical Infuse Bone Graft trials, prompting a U.S. Senate committee to investigate the manner in which Infuse had been tested and marketed. The committee concluded that Medtronic distorted the facts about the safety of the Infuse Bone Graft and violated the trust of its patients.
What are some of the possible side effects of the Infuse Bone Graft?
By 2008, close to 300 reports of Infuse patient injuries has been reported to the FDA. Medtronic Infuse Bone Grafts have been linked to serious complications including:
- Excessive bone growth, ectopic bone and bone spurs
- Bone deterioration
- Male sterility
- Retrograde ejaculation
- Back and leg pain
- Swelling or the neck and throat
- Extreme dysphagia
- Compression of the airway (sometimes requiring a tracheotomy or other emergency procedure)
What can I do if I have been injured because of an Infuse graft?
People across the country who have been injured by off-label use of Infuse Bone Grafts are filing lawsuits against Medtronic to help pay for their medical expenses, lost earnings, pain and suffering, and more.
If you or a loved one experienced complications after receiving a bone graft surgery, call Hissey Kientz, LLP today at 8-555-HELPYOU or use our online contact form to schedule a free consultation with an experienced Infuse Bone Graft lawyer.
For more information:
- FDA Approval
- FDA Notice
- North American Spine Society
- Milwaukee Journal-Sentinel
- United States Senate Committee on Finance
- Medical News Today