In 2002, the FDA granted Medtronic Inc. approval for its Infuse Bone Graft, a man-made bone growth product for limited use in the lumbar spine region.
Alleged Promotion of Off-Label Use
Despite this limited scope of approval, Medtronic, Inc. allegedly promoted off-label uses of the Infuse® Bone Graft, including surgeries in the cervical spine, the thoracic spine, and also lateral and posterior approach of the lumbar spine.
Off-Label Use Linked to Injuries
- Severe swelling of the neck or throat
- Excess bone growth in the spine
- Chronic and severe pain in the legs or arms (inflammatory reaction)
- Male infertility
- Pancreatic, prostate, or breast cancer
- Nerve damage
Peterson & Associates, P.C. fights hard to make sure medical device companies take responsibility for the pain and suffering they cause. Get immediate legal assistance by calling us.