Product Liability

Medtronic Infuse FAQ

When doctors graft a bone onto another bone, they typically take bone from elsewhere in a person's body and attach it onto the site where part of a bone is missing. The bones then grow together to replace the missing piece. This is different from an allograft, in which bone can be taken from another person.

A Medtronic Infuse bone graft is a product that physicians use to stimulate bone growth when operating on the spine. It is an alternative to transplanting bone from elsewhere in the body. Instead of performing a bone transplant, physicians use Infuse bone grafts to replace the missing bone.

Like with all medical procedures, there are safety concerns regarding bone grafting.

What are the safety concerns related to Medtronic’s Infuse bone graft?

Medtronic Infuse bone graft has been linked to cancer, sterility, and bone dissolution.1 Medtronic’s website lists a wide range of possible complications including2:

  • Allergic reactions
  • Bending, breakage, loosening, and/or migration of the implants
  • Bleeding
  • Bone fracture or failure to fuse
  • Bone formation that is abnormal, excessive, or in the wrong location
  • Bowel, bladder, or gastrointestinal problems
  • Damage to nearby tissue
  • Fetal development issues
  • Infection
  • Pain
  • Neurological problems, including paralysis
  • Changes in posture
  • Breathing problems
  • Scars
  • Sexual problems
  • Side effects due to anesthesia or surgery
  • Damage to the spinal cord or the tissue that covers it
  • Nerve damage
  • Vein problems
  • Death

Are there lawsuits related to Medtronic’s Infuse bone graft?

The U.S. Department of Justice investigated Medtronic’s claims of product effectiveness and safety.3 Medtronic was also sued by its shareholders in connection with this product.4

Why did these lawsuits take place?

Senators claimed the research on Infuse was performed by doctors who had conflicts of interest and were funded by Medtronic.5 Shareholders were concerned that Medtronic had not informed them that most of the product’s uses were off-label and not approved by the U.S. Food and Drug Administration.4

What were the results of the litigation and investigation?

The investigation was closed in May 2012 with no penalties for Medtronic.6 Medtronic paid $85 million to settle the shareholder lawsuit.4

Is Medtronic’s Infuse bone graft still on the market after these lawsuits?

Doctors still use this product regularly. Many of its uses are off-label.

What should I do if I’m experiencing adverse effects from this product?

Consult a lawyer for advice about how to file a lawsuit for compensation from Medtronic or your doctor.

Medtronic Infuse bone grafts may lead to a range of health problems when they are used instead of bone transplants. For more information about what an Infuse bone graft is and how the surgical process works, please see Medtronic's website.

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