The Infuse Bone Graft System was designed to help make an important medical procedure simpler and safer. However, Infuse bone graft lawsuits have alleged that the device may not be as safe as older versions of the surgery.

Spinal fusion is a procedure meant to treat degenerative disc disorder or DDD. In DDD, a person’s spinal discs fail. In a healthy spine, these discs of connective tissue help support, cushion and protect the spine. However, they are nerve-rich and damage to discs can cause serious problems, including pain and even neurological damage.

When a patient suffers from DDD, surgeons may treat it with a type of surgery called spinal fusion. In spinal fusion, surgeons join one or more individual vertebrae (backbones) together. This helps stabilize and protect the spine as a whole, by functionally turning two individual bones into a single bone.

Traditional spinal fusion surgery usually involves harvesting bone tissue from redundant parts of the body and grafting it onto the spine. The living tissue “heals” around the adjacent bones, fusing them together. However, this requires two separate surgeries, one to harvest the bone and another to graft it to the spine.

Infuse consists of two parts. First is a metal cage, and second is a bioengineered gel. The gel is made of a lab-made material which is mixed with tissue from the patient’s own body. This tissue can be harvested from a small sample in the body, in lieu of a bone-harvesting surgery. The metal cage holds the bones together while the gel encourages new bone growth. At the end of the procedure, the cage remains in place to further strengthen the new fused bone.

In the United States, a drug or medical device must be approved by the U.S. Food and Drug Administration (FDA) before it can be sold. The FDA approval process requires the medical device to be thoroughly tested. This testing process is very specific. Not only must the device be tested for safety, but it must also be tested for efficacy. As a part of the FDA’s protocols, a product must be tested for a specific purpose, to treat a specific disease. For example, the Infuse Bone Graft System is only approved for spinal fusion at a specific point in the lower back, though spinal fusions can be performed throughout the spinal column. A company can only market a medical device for FDA-approved purposes.

However, federal law does allow medical professionals to use drugs and medical devices for unapproved purposes. The practice is called “off-label” usage. Doctors may do this for a variety of reasons. Sometimes medical studies happen faster than formal FDA approval, and a physician may make a judgment call. However, medical device companies may not market their products for off-label use.

It has been alleged that Medtronic Inc., the maker of the Infuse bone graft, has actively promoted the device for off-label usage. This complicates other allegations. For example, the Infuse device has been allegedly linked to an increased risk of complications over older-style spinal fusions. The fact that for many of these procedures, the device may have been used “off-label” may complicate such litigation.