When a patient is suffering from a degenerative disease that causes damage to the spine, a medical professional may make a recommendation for the patient to undergo a spinal fusion. To perform this type of back surgery, the affected bone is replaced with new bone, often via a bone graft. While the surgery can be effective at reducing patient pain and restoring mobility, it can also be dangerous. Specifically, the use of Medtronic’s INFUSE synthetic bone grafts are linked to patient harm.
Lawsuits for Improper Use in the Cervical Region of the Spine
Napoli Shkolnik, PLLC is currently reviewing cases for patients who have suffered serious side effects caused by Infuse Bone Grafts. The Infuse Bone Graft, manufactured and marketed by Medtronic, was approved by the Food and Drug Administration (FDA) for the treatment of degenerative disc disease in the lumbar region of the spine, which is the lower back. The specific procedure it is approved for is called Anterior Lumbar Interbody Fusion (ALIF), a type of fusion surgery that is used in a small percentage of patients to provide relief from the pain and discomfort caused by lumbar degenerative disc disease. In spite of the fact that Infuse was approved for a specific purpose, there have been instances where Medtronic may have promoted or surgeons may have used the system for other purposes, namely in the cervical region of the spine, located at the neck.
The injuries caused by improper use of the Infuse Bone Graft can be particularly painful and lead to a significantly diminished quality of life. Our pharmaceutical litigation attorneys are committed to helping patients recover financial compensation for medical treatment, pain, suffering, lost earnings and other damages caused by such complications and side effects as:
- Bone spur growth in the neck and/or spine
- Difficulty swallowing (dysphagia)
- Extreme swelling in the neck area
- Severe neck pain
- Difficulty breathing
- Trouble speaking
If you would like to learn more about your legal options, please to not hesitate to call our office for a free case review. We have also included some useful information about lumbar degenerative disc disease and the Infuse Bone Graft system to help you get a better understanding of this important matter.
About Lumbar Degenerative Disc Disease
Aging and injuries can cause a serious and painful condition called lumbar degenerative disc disease. With lumbar degenerative disc disease, the discs that act as cushions between the vertebrae in the lower spine are weakened, leading to small tears in the disc wall. These tears then heal, creating scar tissue that is not actually as strong as the disc wall originally was. The disc wall may continue to tear and scar, weakening the disc wall and eventually causing damage to the center of the disc. Water in the spinal discs keep them as effective shock absorbers, but damaged discs lose their water content. They may collapse, causing the vertebrae to move closer together. The unnatural position of the vertebrae, untreated, will lead to bone spurs which may grow into the spinal canal and pinch the spinal cord, leading to spinal stenosis.
Some of the symptoms of lumbar degenerative disc disease include lower back pain, which may come and go and will typically be worse when sitting down. A patient may also experience pain, numbness or tingling in the legs.
One of the treatment options for advanced and particularly painful stages of lumbar degenerative disc disease is spinal fusion surgery, where the affected vertebrae are fused together, eliminating the motion that was causing pain and discomfort.
Medtronic Bone Graft for Lumbar Degenerative Disc Disease
In some spinal fusion surgeries to treat lumbar degenerative disc disease, bone will be taken from the patient’s hip. This requires a separate surgery that presents its own risks and pain. Medtronic created the Infuse Bone Graft system to eliminate the need for the additional surgery to harvest bone from the hip. It is used with the LT-Cage Device, which is a small, hollow metal cylinder. Two LT-Cage Devices are placed between the vertebrae, side by side, replacing the damaged disc. They are filled with the Infuse Bone Graft, which is made up of a protein and a collagen sponge. The protein, recombinant human Bone Morphogenetic Protein-2, is a genetically-engineered version of a natural protein found in the body. It is meant to simulate the growth of bone. The protein solution soaks the sponge, which is meant to eventually be absorbed by the body over time.
Used properly by a licensed surgeon in ALIF procedures, the Infuse Bone Graft system can present a number of benefits for patients. Used in the cervical region, however, the results can be catastrophic.
Talk to an Attorney About Your Options
If you underwent spinal fusion surgery and the Medtronic Infuse Bone Graft system was used, and you are now experience complications, it is important to seek medical attention. In addition to talking to your doctor, we recommend that you consult with an attorney who can advise you on your legal options. If the Infuse Bone Graft and LT-Cage Device were used in the cervical region, it is possible that Medtronic and/or your surgeon may be held legally responsible. An attorney can determine how to move forward with a lawsuit to seek compensation – contact Napoli Shkolnik, PLLC today.