The Infuse Bone Graft system is a medical device designed for spinal repair. The device consists of a metal support cage with a matrix of bioengineered proteins that encourage bone growth and  is designed to repair degenerative disc disorder. It works by separating the vertebrate to their pre-degenerative state with the support cage. The protein matrix encourages the patient’s bone to grow around the weakened tissue, fusing the vertebrae.

The bioengineered proteins are one of the key differences between the Infuse Bone Graft system and other forms of spinal fusion surgery. The matrix is a bioengineered substance, designed to be mixed with tissue from the patient’s body. Theoretically, this means that the body would be more likely to accept the new tissue, since the bioengineered tissue has components from the patient’s own body.

Infuse Bone Graft Lawsuits

The Infuse Bone Graft system has been involved in several legal controversies. First, some individuals have filed Infuse Bone Graft lawsuits over complications reportedly linked to the medical device. A $40 million settlement with the Department of Justice has complicated some individual lawsuits. The settlement was over allegations that the makers of the Infuse Bone Graft, Medtronic Inc., concealed safety data from the FDA during the device’s development and approval.

Many of the Infuse Bone Graft lawsuits allege that the manufacturers actively promoted the spine surgery device for off-label uses. When a medical device is approved by the FDA, it is only approved for the purpose that companies have tested it for. Many of the Infuse Bone Graft lawsuits allege that Medtronic aggressively promoted usages that were not approved.

The Medtronic Infuse lawsuits allege that this would void any immunity granted by the Justice Department’s settlement. As many as 80 percent of the Infuse Grafts were implanted in spinal surgery patients for uses not listed on the label. Since more than 100,000 people received this bone graft a year, this could translate to tens of thousands of lawsuits.

Alleged Infuse Bone Graft Complications

The Infuse Bone Graft allegedly can cause a variety of injuries — particularly when used in off-label spinal surgery. This includes bone and nerve injuries, particularly to the lower body. Alleged Infuse Bone Graft complications include cancer, nerve pain in the lower body, paralysis, and cyst formation. The graft allegedly can also cause systemic illnesses — those going beyond the area of the lower back. This could include infertility, cancer, and swelling of the neck and throat.

Legal Action

An investigation has been launched to explore the possibility of an Infuse Bone Graft class action lawsuit against Medtronic. The class action lawsuit could allege that Medtronic was aware of the risks associated with their device, but marketed it anyway, and even promoted it for off-label uses.