A woman filed an Infuse bone graft lawsuit against Medtronic Inc. alleging she was injured by the device, and that the company marketed it to her surgeon for an off-label use of the product.

Arizona plaintiff Deidra King underwent spinal surgery on Jan. 11, 2007. The Infuse bone graft was used an anterior lumbar interbody fusion (ALIF) procedure, which was not one of the approved surgeries for the Infuse, according to the Medtronic lawsuit.

The plaintiff’s surgeons were also not aware of the risks presented at the time of the surgery, including that the fact that the synthesized bone liquid could cause ectopic bone growth around the surgical area, according to the Infuse bone graft lawsuit. Before the plaintiff suffered Infuse side effects, the surgeons believed the product to be effective and safe to use. The injuries allegedly suffered by King include autonomic neuropathy, nerve damage, sterility, bone overgrowth, and other complications, the Infuse lawsuit said.

It was not until late 2011 that the plaintiff’s surgeons learned of the side effects associated with off-label uses of the Infuse bone graft. The surgeon stated that if he had known about these possibilities at the time the plaintiff’s surgery was performed, he would not have used the product for the surgery.

After the plaintiff was informed that her surgery was considered an off-label purpose as specified by the U.S. Food and Drug Administration (FDA), King filed the Infuse lawsuit against Medtronic. King said that she never would have allowed the Infuse bone graft to be used if she had known the injuries she suffered were possible.

The Infuse lawsuit accuses Medtronic of negligence, false advertising, concealing information, and misrepresenting a product.

The Infuse Bone Graft Lawsuit is Deidra King v. Medtronic Inc., Case 2:14-cv-01834-DLR, in the U.S. District Court for the Central District of California.

Overview of Infuse Bone Graft Complications

The Infuse bone graft is used for specific lower spinal surgeries, which are meant to replace or mend damaged spinal discs. The FDA approved the Infuse in 2002, at which point Medtronic’s Infuse became the choice of patients undergoing spinal fusion surgery. The Infuse bone graft is made from a bioengineered liquid meant to allow the surgeon to regulate bone growth, and erase the need to harvest bone from another area.

While successful, many experts believe Medtronic marketed the product for surgeries that the FDA did not approve. Patients have reported suffering numerous injuries, with many having to undergo revision surgeries to correct the Infuse complications. Medtronic is currently facing hundreds of product liability lawsuits regarding alleged Infuse bone graft complications.