You are probably wondering why a dangerous product such as the Medtronic Infuse bone graft was granted approval by the FDA. The truth is, the Medtronic Infuse device has been quite useful to patients suffering lower spinal degeneration. The bone graft contains recombinant human Bone Morphogenetic Protein 2 (rhBMP-2), a protein that stimulates bone growth and aids lumbar fusion.
The problems started occurring when the device was used contrary to the purpose it was designed for, also known as off-label use.
A brief history of the complications of the Medtronic Infuse bone graft:
- The FDA approved Medtronic Infuse for a type of spinal surgery called anterior approach lumbar fusion. A short time later, the FDA also approved Medtronic Infuse for two different types of dental surgery.
- Medtronic allegedly promoted off-label uses of the Infuse device, an illegal practice.
- Physicians began to use Medtronic Infuse in other spinal surgical procedures, including cervical (neck) spine, lateral spine and posterior spine procedures.
- Approximately 85.2% of Medtronic Infuse sales came from off-label uses of the product, leading to an investigation of the issue by the U.S. Department of Justice and an inquiry by the U.S. Senate.
- Patients began to suffer serious, sometimes life-threatening side effects of off-label use.
- Medtronic’s shareholders sued the company for $85M as a result of promoting off-label uses of the device.
If you have suffered ill effects due to this implant, our Kentucky Medtronic Infuse attorneys can advise you on your legal options. Call our offices today at (800) 634-8767 for a FREE one-on-one consultation on your case.