Medtronic Infuse® Bone Graft
The Medtronic Infuse® bone graft system is used in neck and spinal surgeries to help promote bone growth. Specifically approved by the U.S. Food and Drug Administration (FDA) in 2002 for use in anterior lumbar fusion surgery on adults (excluding pregnant women), the product has also been widely used for off-label purposes. The Infuse bone graft system has been used to treat more than 500,000 patients and has been used by more than 2,300 surgeons.
What should I do if I’ve been affected?
If you or someone you care about after undergoing surgery in which the Infuse bone graft system was used suffered serious health problems, contact our law firm today for a free and confidential case evaluation. We want to help.
What is the Infuse bone graft system?
The Infuse system is a man-made liquid form of bone morphogenetic protein, or BMP. It is surgically implanted between vertebrae soaked in a sponge-like substance enclosed in a metallic cage. Ideally, BMP causes bone growth that fills in the gap between vertebrae to replace damaged disks; however, a number of health problems have been associated with the product.
Is the Infuse bone graft system dangerous?
After receiving a number of reports of serious complications in patients treated with the Infuse bone graft system, the FDA issued a statement, warning that off-label use of Infuse in cervical fusion procedures was unsafe.
What are the health risks?
Health risks of Infuse systems include:
- compression of the airway and/or neurological structures in the neck
- difficulty swallowing (sometimes severe), breathing, or speaking
- infection at surgical site
- irregular bone growth
- nerve pain or nerve damage
- swelling of neck and throat tissue
The FDA reports most complications occurred between two and 14 days after surgery with only a few events occurring prior to the second day.
Infuse® is a registered trademark of Medtronic, Inc.
This law firm is not associated with, sponsored by, or affiliated with the Food and Drug Administration or Medtronic, Inc.