Medtronic INFUSE® Bone Graft/LT-CAGE®
Off-Label Use of Medtronic INFUSE® Bone Graft/LT-CAGE®
The Medtronic INFUSE® Bone Graft and the LT-CAGE® Lumbar Tapered Fusion Devices are manufactured by Medtronic and are used together in a procedure to treat degenerative disc disease. The INFUSE® Bone Graft is made up of a genetically engineered protein that occurs naturally. The protein is created in a laboratory and reproduced using recombinant DNA technology, resulting in the recombinant human protein known as rh BMP-2. When the protein is combined with a collagen sponge, it is marketed by Medtronic Sofamar Danek under the trade name INFUSE® Bone Graft.
Until now, spinal fusion surgery was a two-step process requiring two surgeries. The first procedure was a painful process whereby the surgeon harvested bone from the patient's hip – a surgery that could cause pain for years afterwards. The second step involved implanting the bone into the spine. Instead of harvesting real bone, surgeons implant INFUSE® Bone Graft, thus avoiding the painful harvesting procedure. The INFUSE® Bone Graft is labeled for use with the LT-CAGE® Lumbar Tapered Fusion Device, a thimble-like device made out of titanium that keeps the INFUSE® Bone Graft at the fusion site, stabilizes the spine during the fusion process and maintains the proper height between the vertebrae.
INFUSE® Bone Graft/LT-CAGE® Lawsuits in Columbia
The U.S. Food & Drug Administration has approved the INFUSE® Bone Graft for treating degenerative disc disease, fractures in the tibia and two dental bone grafting procedures: localized alveolar ridge augmentation and sinus augmentation. It has not been approved for other uses, especially in the neck area. Improper insertion, using the device for off-label use, or leaks can cause serious adverse side effects including:
- Difficulty breathing or speaking
- Difficulty swallowing
- Compression of the airway
- Respiratory depression
- Nerve damage
Do you have grounds for a lawsuit?
If you experienced serious adverse side effects after receiving the INFUSE® Bone Graft surgical procedure, you may be entitled to compensation. A Columbia defective products attorney from The Sumner Law Group can evaluate your case and determine whether or not you are eligible for compensation.