Studies Find Medtronic Product No Better Than Bone Graft, Carries Cancer Risk

The Infuse Bone Graft, which is manufactured by Medtronic, is used during back surgery to stimulate bone growth and to replace damaged spinal discs in the lumbar spine. The Infuse Bone Graft is an alternative to harvesting a bone graft from the patient’s hip. Although it is not approved for other uses, the Infuse Bone Graft has been used off-label for procedures on the cervical spine.

However, since its introduction, there have been some concerns about the use of the Infuse Bone Graft:

  • Off-label use of the Infuse Bone Graft in the cervical spine has been linked to some serious complications between two and 14 days after the surgery, including:
    • Difficulty speaking, swallowing or breathing
    • Nerve damage
    • Airway compression
    • Respiratory depression
    • Need for respiratory support, insertion of feeding tubes, anti-inflammatory medications, tracheotomies, and additional surgery
    • Death
  • Two independent studies published in the Annals of Internal Medicine found that the Infuse Bone Graft does not work any better than a bone graft and carries certain side effects, including the increased risk of cancer. The studies acknowledge that the Infuse Bone Graft is less invasive than a bone graft, which can require an additional surgery, but there are concerns about the cancer risk and other side effects.

The use of the Infuse Bone Graft can present some serious complications. If your doctor used the Infuse Bone Graft and you are now experiencing side effects, speak to an Indiana law firm that handles pharmaceutical litigation.