Medtronic Marketed The Infuse Bone Graft For Off-Label Uses. It Had Consequences.

The Medtronic Infuse Bone Graft device was approved by the FDA in 2002 for use in surgery on the lower (lumbar) spine. It was designed to treat people with lumbar degenerative disk disease.

Investigation revealed that Medtronic marketed the device for off-label uses for cervical spinal surgery. The company also paid a doctor to write a fake study that alleged positive results for the use of the device in the cervical spine. Unfortunately, when used in the cervical spine, the Medtronic Infuse Bone Graft device poses risk for serious injuries and death.

If you or a family member has suffered injury from off-label use of this device, you may be able to recover compensation. Just call us at 304-347-5050 or send us your information.

What Are The Serious Consequences Of Off-Label Uses?

The Medtronic Infuse Bone Graft device is only approved for use in the lumbar spine area after spinal surgery. Off-label use for cervical spinal surgeries has been reported to cause injuries such as:

  • Swelling of the neck and throat
  • Respiratory depression and possible suffocation
  • Difficulty speaking
  • Nerve damage
  • Chronic pain
  • Sepsis or other severe infections
  • Breast, prostate or pancreatic cancer
  • Bladder control or incontinence problems
  • Abnormal, uncontrolled bone growth in the back
  • Erectile dysfunction (ED) or sexual dysfunction
  • Paralysis

In the most severe cases, wrongful death may occur.

Contact Our Lawyer If An Off-Label Use Caused You Harm

To schedule a free consultation with a Medtronic Infusion device graft attorney, call James F. Humphreys & Associates, L.C., in Charleston at 304-347-5050, or contact us online.