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Symptoms Of Infuse Bone Graft Complications

The FDA issued a safety alert regarding the complications from the off-label use of Infuse in the neck, or cervical area of the spine. These complications, which can be life threatening, include:

  • Swelling of the neck
  • Difficulty swallowing, breathing and speaking
  • Compression of the Airway
  • Respiratory Depression
  • Wheel Chair or other means of assistance needed after operation
  • Nerve damage
  • Additional Surgeries
  • Death

Several patients that were recipients of the Medtronic Infuse Bone Graft in off-label procedures required emergency treatment, including tracheotomies and the insertion of feeding tubes.

Numerous publications, including the Wall Street Journal, have reported use of the Medtronic Infuse Bone Graft has been associated with major injuries and damages. Bone growth can become rapid and uncontrolled. This bone graph has also been associated with many types of cancer. Off-label use can also result in severe neck swelling, difficulty breath, swallowing and speaking because of airway compression. The bone growth may cause nerve injuries or severe pain in the extremities. Some patients have reported infertility as a result of the implant.