Medtronic’s Infuse Bone Graft May Cause Injury in Off-Label Uses

If you or a loved one has been injured due to the implant of Infuse Bone Graft in an off-label use, please CONTACT US for a free consultation.

Medtronic’s Infuse is a man made product that mimics a human protein that promotes bone growth. In 2002, the Food and Drug Administration (FDA) approved Infuse for some oral and dental procedures. Infuse was also approved for spinal fusion procedures, for the correction of curved spines and for strengthening damaged discs. Infuse was only approved for spine injuries in the lower back, and only in procedures that enter this area through the front of the body. The product is restricted to oral and lower back procedures because studies showed a danger of unwanted bone growth when Infuse was used in other parts of the body.

Unfortunately, Infuse has been used for off-label uses. Off-label uses are those not approved by the FDA. Off-label use is not illegal, but may be controversial, as it has been reported by the Wall Street Journal that doctors, paid by Medtronic, have written articles promoting the use of Infuse in off-label procedures. Serious complications have been reported when the product is used for alternate methods. The most popular off-label use is in the neck. The FDA reports use in the neck may lead to swelling of neck and throat tissue, compressing the airway and causing problems with swallowing, breathing and speaking. Some patients have had to undergo tracheotomies and additional surgeries to correct these complications.

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