Medtronic Infuse Bone Graft Lawyers
The product liability lawyers at Saiontz & Kirk, P.A. previously reviewed claims for individuals who experienced problems following neck or back surgery where the Medtronic Infuse bone graft was used off-label, which has been linked to a risk of serious and potentially life-threatening side effects. New cases are no longer being accepted. This page is maintained for informational purposes only.
Medtronic recklessly promoted and encouraged use of their Infuse BMP (Bone Morphogenic Protein) for a number of surgical procedures that have not been properly tested and which may increase the risk of inflammatory reactions, breathing problems, severe nerve damage, sterility in men, cancer and wrongful death.
Financial compensation was pursued through Medtronic Infuse lawsuits as a result of the manufacturers failure to adequately warn consumers and the medical community about the side effects associated with use of the bone graft. New cases are no longer being accepted. This page is maintained for informational purposes only.
MEDTRONIC INFUSE BONE GROWTH SIDE EFFECTS
The Medtronic Infuse is a new type of bone graft, which uses recombinant human Bone Morphogenetic Protein (rhBMP-2) to stimulate bone growth. It was approved by the FDA in 2002 for the limited use during single-level anterior lumbar fusion surgery, as well treatment of tibia fractures and some oral or dental procedures.
During spine surgery, the Medtronic Infuse bone graft consists of an absorbable collagen sponge that is treated with rhBMP-2, and then placed in a small “cage”, known as the LT-CAGE, to keep the two vertebrae in place and provide the frame for the Infuse BMP.
It was developed as an alternative to traditional bone graft procedures, which involve either the use of bone harvested from the hip or another part of the body, or bone extracted from dead bodies.
The Medtronic Infuse BMP bone graft was promoted as a superior alternative, because it helps avoid pain and problems associated with harvesting bone and removes the risk of the cadaver bone being rejected by the body.
Although it was only tested and approved for use during anterior lumbar fusion, involving single level fusion, it has been widely used off-label in other spinal surgery, including cervical fusion, thoracic fusion, posterior lumbar fusion (where the lumbar spine is approached from the back instead of through an incision in the abdomen, as is done during an anterior lumbar fusion), as well as during multi-level fusions.
When used during these unapproved procedures, Medtronic Infuse side effects may cause bone growth in areas where it is not wanted, which may cause:
- Severe Inflammatory Reaction
- Airway Compression or Breathing Problems
- Nerve Impingement Resulting in Severe Back or Neck Pain
- Hospitalization with Treatment in ICU
- Need for a Feeding Tube or Tracheotomy
- Additional Surgery to Remove Excessive Bone from the Spinal Canal
Research has also suggested that use of Medtronic Infuse BMP may increase the risk of cancer, as well as cause some men to become sterile.
MEDTRONIC INFUSE BONE GRAFT CLASS ACTION LAWYERS
Although Medtronic was aware risks associated with off-label use, the company engaged in widespread over-prmotion of the Infuse bone graft, encouraging use during fusion surgery that was never properly studies and was known to cause serious side effects.
According to allegations raised in Medtronic Infuse lawsuits, the manufacturer:
- Failed to adequately study the side effects of Medtronic Infuse Bone Morphogenic Protein
- Concealed their knowledge about the potential Medtronic Infuse risks when used off-label
- Failed to report Medtronic Infuse side effects that occurred when used during back or neck surgery
- Failed to adequately warn about the risk that Medtronic Infuse may result in severe damage to the nerves and spinal cord
The Medtronic Infuse lawyers at Saiontz & Kirk, P.A. previously reviewed cases for individuals throughout the United States who have experienced side effects or complications following surgery. New cases are no longer being accepted. This page is maintained for informational purposes only.