Infuse® Bone Graft Information
The Medtronic Infuse® Bone Graft was approved by the U.S. Food and Drug Administration (FDA) in 2002 for a number of very specific surgeries. This medical device is in the news because it has been used for non-FDA-approved surgeries, such as in the neck and cervical spine, with sometimes disastrous results. Many patients don't know that they received an Infuse® Bone Graft until they start having terrible symptoms.
For more information about Infuse® Bone Graft side effects, contact us today.
What Is an Infuse® Bone Graft Used For?
The FDA okayed the Infuse® Bone Graft for use in the lumbar spine and for some dental procedures. It stimulates bone growth and can be used to replace a damaged spinal disc. According to Medtronic, the device eliminates the need for additional surgery.
Unfortunately, however, the Infuse® Bone Graft has been associated with serious injuries, including:
- uncontrolled bone growth
- the formation of cysts
- swelling of the throat and neck
- respiratory depression
- difficulty swallowing (dysphagia)
- breathing difficulties
In some patients, these symptoms have been life-threatening or fatal. In others, permanent injuries developed. A great deal of attention is being focused on the issue of whether Medtronic Infuse® Bone Graft has been marketed improperly.
Medtronic Infuse® Bone Graft
Medtronic has been accused of misrepresenting the risks of using Infuse® Bone Grafts, especially in off-label uses — the promotion of which is illegal. Off-label uses of Infuse® Bone Grafts include:
- for neck or cervical spine repair
- spinal surgery using a lateral approach (through the patient's side)
- surgery using a posterior approach (through the patient's back)
The Infuse® Bone Graft is only approved for use in anterior-approach lumbar fusion surgery at the L5-to-S1 level of the vertebrae.
Contact an Infuse® Bone Graft Lawyer
Medical device manufacturers such as Medtronic have a responsibility to American consumers. When their products cause harm, they can and should be held accountable, especially if they knowingly withhold information about the risks associated with their products.
If you or someone you love has received a bone graft procedure and has since experienced complications such as trouble breathing or swallowing, you may be eligible to seek compensation from Medtronic. To learn more, contact us to schedule a free case review today.