Infuse Bone Graft Linked to Life-threatening Complications in Dozens of Patients

The Wall Street Journal is reporting that Medtronic`s `Infuse Bone Graft` has been linked to life-threatening complications in dozens of patients. 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 received 38 reports over four years of side effects, mainly swelling of neck and throat tissue, which resulted in compression of the airway and other structures in 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, according to reports filed with the FDA.

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