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Infuse® Bone Graft Lawsuits on the Rise

Once considered a groundbreaking means of replacing damaged or diseased bone by stimulating bone growth, the Infuse® Bone Graft – manufactured by Medtronic – is now the target of lawsuits alleging that the device causes life-threatening complications when used for off-label purposes.

The Infuse® Bone Graft was initially approved by the FDA in 2002 for use in limited spinal procedures involving the lower back. Subsequently, the Infuse® Bone Graft was also approved for tibia repairs and for limited dental procedures. Medtronic, however, has allegedly encouraged physicians to use the product in off-label spinal procedures including the cervical spine (upper back, including neck), thoracic fusion, and posterior lumbar fusion, as opposed to the lumbar spine (lower back) for which the product is approved. This off-label use of the Infuse® Bone Graft has been associated with serious and sometimes life-threatening injuries, including infection, breathing problems, bone and nerve injury, sterility, urinary problems, and increased risk of cancer.

In 2008, the FDA issued a public health notification alerting patients to the adverse effects reported from off-label use of the Infuse® Bone Graft. The FDA stated that it had received at least 38 reports of complications resulting from the product’s unapproved use in cervical spine fusions, and encouraged patients and healthcare providers to notify the agency of any additional cases of injury or death. Lawsuits have been filed against Medtronic seeking recovery for patients who have suffered serious and permanent injuries after undergoing a bone graft procedure performed in connection with cervical spine surgeries involving the Infuse® Bone Graft.


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