A recent FDA investigation of Medtronic’s Infuse Bone Graft discovered that the product may cause cancer infection, ectopic bone growth, cyst formation, difficulty breathing, nerve damage, and death when the product is used in the neck and cervical spine. Infuse is not FDA-approved for use in the neck and cervical spine, but Medtronic illegally spent millions of dollars to encourage these dangerous off-label uses and to cover up study results showing the severe injuries caused by Infuse.
Infuse Bone Graft is a liquid form of recombinant bone morphogenic protein that is housed in a small cage-like structure that is implanted in the spine where it facilitates bone growth to fill gaps between vertebrae and replace damaged disks. Infuse is FDA-approved for use only in the lumbar spine and has been proven to be extremely dangerous when it is used in other parts of the body, specifically the neck and cervical spine. When Infuse is used in the neck or cervical spine, it tends to promote unintended bone growth that leads to significant problems such as swelling of the neck, tightening of the airways, and difficulty swallowing, breathing, and speaking.
Despite knowledge of the risks associated with off-label uses of Infuse, Medtronic paid doctors to cover up and discredit unfavorable study results. Medtronic is now under investigation by the FDA for its illegal promotion of Infuse as safe and effective when used in the neck and cervical spine.
If you or someone you know has suffered serious side effects or injuries following use of Infuse Bone Graft in the neck or cervical spine, you may be entitled to legal compensation. To learn more about your legal rights, please contact one of our experienced Infuse Bone Graft attorneys
at (215) 972-1376 (x 2) for a free and confidential consultation.