Medtronic, the makers of the Infuse Bone Graft System, are currently facing more than 1,000 Infuse lawsuits over alleged complications from the medical implant.

The Infuse Bone Graft System is a medical implant designed to improve spinal fusion surgery. Spinal fusion is a medical procedure designed to help patients cope with degenerative disc disorder.

In a healthy human spine, discs of connective tissue separate and cushion the individual vertebrae of the spine. In some people, wear and tear from old age or injuries can damage these discs, leading to pain and nerve damage.

In spinal fusion, two or more adjacent vertebrae are fused together into a single bone. This lends greater support to the bones, and bypasses the damaged disc. However, this procedure requires harvesting bone from elsewhere in the body to graft onto the spine. The Infuse bone graft is designed to cut out this step.

Infuse consists of a metal cage and a bioengineered gel. The metal cage supports the bones of the spine as they grow together, and the gel encourages new bone growth — without harvesting bone from the patient’s body. To discourage rejection, the gel is seeded with tissue from the patient’s body. However, it has been alleged that the Infuse Bone Graft System can cause serious side effects.

Various Infuse bone graft lawsuits — and several research studies — allege that the device can cause bone overgrowth, which can cause spinal damage. Spinal damage can cause pain, numbness, and even paralysis. Additionally, it has been alleged that the device can cause male sterility, swelling of the throat, and even cancer.

The bone graft lawsuits over Infuse have also alleged that Medtronic paid doctors and researchers to drum up positive research for the bone graft system. This includes the allegation that Infuse has paid out over $210 million to a group of 13 doctors and two corporations, all of which were subsequently involved in publishing research papers about Infuse.

These research papers made the assertion that the Infuse bone graft was safe and promoted its use. Some of Medtronic’s beneficiaries even promoted Infuse for off-label use. In 2013, two independent studies found that Infuse at best works about as well as traditional spinal fusion, and may carry a risk of new bone graft complications.

According to federal law, the makers of a drug or medical device must test a device to U.S. Food and Drug Administration standards before promoting its use. Additionally, medical companies must get FDA approval for every use of a device they intend to promote.

Physicians may make a professional judgment call, and use a medical device for other purposes, but companies are forbidden from promoting their devices for off-label use. The Infuse bone graft was only approved for spinal fusion at a very specific point in the spine by the FDA. If Medtronic’s paid articles promoted off-label Infuse surgeries, it could be argued that Medtronic broke this rule, complicating the Infuse lawsuits against them. As many as 85 percent of Infuse bone graft surgeries were off-label.