Product Liability

When NOT to Use Medtronic Infuse

Medtronic INFUSEĀ® is an implantable bone graft for treating degenerative disk disease, certain dental or facial bone conditions, and long bone fractures.1 The bone graft contains recombinant human bone morphogenetic protein (rhBMP-2), which is genetically engineered to promote bone growth in the lower spine.2

Who should not receive INFUSE Bone Grafts

The bone grafts should not be used in:

  • Children (anyone under 18 years of age)
  • Pregnant women
  • Patients who are sensitive to any component in the bone graft (including rhBMP and bovine type 1 collagen)

Smoking, diabetes, and osteoporosis can also limit the effectiveness of the spine graft.3

Off-label uses and risks of Medtronic INFUSE

Despite clear guidance from the Food and Drug Administration (FDA) about where in the body the INFUSE Bone Graft can be used, 85 percent of surgeries using INFUSE Bone Grafts are for off-label uses.4 The FDA issued a warning in 2008 about bone grafting complications in the neck, or cervical spine:

  • Restricted and compressed airways
  • Unexpected bone growth
  • Nerve damage
  • Difficulty swallowing and talking

The only approved use of the bone graft in the spine is in the lower back, or lumbar region.3 4

Medtronic INFUSE lawsuits

A litigation group was formed to handle lawsuits against Medtronic in September 2012. The company reportedly supported off-label uses, which is not allowed under U.S. law. Some lawsuits also claim that the bone graft can cause cancer.4

If you were treated with the Medtronic INFUSE Bone Graft for a condition not approved by the FDA or had unexpected risks associated with your surgery, a personal injury attorney can review your case and determine if you have cause for compensation.

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