Surgeons were recently warned by the FDA of life-threatening complications associated with using Medtronic's "Infuse Bone Graft" in surgeries on the cervical spine.
According to the FDA, over the past 4 years, 38 reports have been received of side effects associated with the Infuse Bone Grafts. Some patients had side effects which included difficulty swallowing, breathing, and speaking. While others suffered more serious complications, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.
Although the FDA's alert was specific to neck surgeries, a review of FDA records and other medical documentation indicates complications as a result of other off-label uses, including unwanted bone growths near nerves or in areas outside the specific fusion site.
Cellino & Barnes is evaluating cases of people who may have suffered as a result of receiving an Infuse Bone Graft.
Read more - Wall Street Journal Blog posted by Jacob Goldstein.
Spine Surgeons Paid by Medtronic Touted Unapproved Use of Bone Graft
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