Medtronic Inc.’s Infuse Bone Graft, which is used in spine-repair surgery to promote bone growth has been linked to life-threatening complications in dozens of patients.
Many of the complications have occurred during off label uses, when surgeons use it in ways that haven’t been approved by the Food and Drug Administration. The FDA warned surgeons in July that it had received reports of life-threatening complications associated with using the product in surgeries on the cervical spine, around the neck. The agency said it is receiving reports of side effects, mainly swelling of neck and throat tissue, which resulted in compression of the airway and other structures of the neck. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.
Each year, and estimated half-million people undergo spinal fusion procedures to repair and stabilize damaged discs, and to correct conditions like scoliosis, a curvature of the spine.
The FDA’s alert about Infuse was specific to neck surgeries. But a review of FDA records and medical literature shows there have been scores of other cases in which serious complications arose after the product was used in off label situations. Many of these cases involve unwanted bone growths near nerves or in areas outside targeted fusion sites. That can lead to pain, repeat surgeries and, in some cases, emergency intervention.
Do I Have a Medtronic Infuse Bone Graft Lawsuit?
If you or a loved one have been injured by the Medtronic Infuse Bone Graft, you should contact us immediately. You may be entitled to compensation for your injuries and we can help.
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