The Medtronic InFuse Bone Graft was approved by the Food & Drug Administration (FDA) as a bone growth product to be utilized in anterior lumbar fusion surgeries. InFuse contains a protein which is designed to stimulate bone growth in patients who suffer from conditions like degenerative disc disease.
However, Medtronic has been the subject of numerous lawsuits and investigations into whether it promoted the device for non-FDA approved uses (“off-label” uses).
In addition to lumbar fusion surgeries, the InFuse Bone Graft has been extensively used in cervical spinal fusion procedures as well. InFuse has not been approved by the FDA for use in this type of surgery. When the InFuse Bone Graft is used in an “off-label” manner it has the potential to cause serious and even deadly injuries or complications.
Complications from the Off-Label Use of InFuse
On July 1, 2008, the FDA issued a public health warning about reports of life-threatening complications associated with the off-label use of the Infuse Bone Graft in surgeries on the neck or cervical area of the spine. These complications, which can be life threatening, include:
- Swelling of the neck and/or throat tissue;
- Difficulty swallowing, breathing and speaking;
- Compression of the Airway;
- Respiratory Depression;
- Nerve damage;
- Retrograde injection resulting in impotence;
- Insertion of Feeding Tubes; and
- Improper bone growth (bone growth in non-targeted areas).
The InFuse Bone Graft may also increase cancer risks among those patients who receive it. The bone growth protein (rhBMP-2) used in the InFuse Graft was also used in a prior bone growth device that was denied approval by the FDA because of concerns that it increased a patient’s risk of cancer. Therefore, because of the rhBMP-2 protein individuals who received Infuse, especially in off-label procedures, may be at higher risk for stomach, thyroid, breast, skin (melanoma), ovarian, lung, leukemia, prostate, laryngeal, lymphoma, and pancreatic cancers.
Do I Have an Infuse Bone Graft Lawsuit?
Several patients who had the InFuse Graft implanted in an off-label procedure have filed suit against Medtronic alleging the implant caused them serious injury. The Doyle APC law firm is currently reviewing claims for individuals injured by the off-label implantation of an InFuse Bone Graft. If you believe you or someone you know has been injured as a result of the off-label implantation of the InFuse Bone Graft in the neck or cervical area, please fill out our confidential form.