Infuse® Bone Graft Injuries
Reports of Medtronic Infuse® Bone Graft injuries have been stacking up from patients who received this bone graft for "off-label" uses — that is, for purposes not specifically approved by the FDA. The Infuse® Bone Graft was approved for one specific surgery, for fusing spinal vertebrae together by a specific technique (anterior approach lumbar fusion), with the vertebrae involved being between the L5 and S1 vertebrae. All other instances in which an Infuse® Bone Graft has been implanted are off-label uses.
Infuse® Bone Graft Neck Injuries
According to reports, it appears that Medtronic, the maker of the Infuse® Bone Graft, encouraged physicians and surgeons across the U.S. to use the device in several off-label ways, including as a graft:
- implanted by other surgical approaches and techniques
- for other vertebrae
- in neck surgery/cervical spine surgery
In recent times, approx. 100,000 patients have received an Infuse® Bone Graft each year, and many have been for off-label uses. When a doctor uses a medical device or drug for an off-label purpose, he or she is supposed to tell the patient (1) that the use is off-label/non-FDA-approved, and (2) about the risk of complications linked to such an off-label use.
Injuries Following Cervical Spine Surgery
The following injuries have been linked to the use of Infuse® Bone Grafts for cervical spine surgery:
- swelling of the neck and throat
- difficulty breathing
- dysphagia (difficulty swallowing)
- respiratory depression
- uncontrolled bone growth
- cyst formation
Other injuries have been reported by patients following non-FDA-approved/off-label uses.
Contact a Lawyer If You've Been Injured
Medtronic, the largest manufacturer of medical devices in the U.S., has been sued again and again for matters such as those surrounding the Infuse® Bone Graft. Every product liability lawyer in the U.S. is acutely aware of Medtronic Infuse® side effects. If you are suffering from an off-label use of an Infuse Bone Graft, you can get answers to all of your legal questions when you contact an Infuse® Bone Graft attorney who represents individuals who have been injured by a medical device or drug. Schedule a free consultation in your area today.