Medtronic Inc. is one of the world’s leading medical technology firms, and has been successful in bettering the lives of millions. However one of their most popular products, the Infuse bone graft, has been at the center of controversy due to the company’s alleged fraudulent marketing and for the injuries the Infuse may have caused.

The Infuse bone graft was approved in 2002 to be used as an alternative surgical method for people with degenerative disc disease. As of now, the Infuse is only approved to be used in certain lower lumbar procedures, and is not recommended to be used in any cervical spinal procedures. When used correctly, the Infuse will minimize the risk of injury to the patient’s spine, back muscles, and nerves. It also is advertised to be less invasive and require less hospital time.

According to Drugwatch.com, the Infuse bone graft is made up of a synthetic bone morphogenetic protein (rhBMP-2) and cow collagen sponge material. The Infuse comes in a powder form and is then mixed with sterilized water, to create the solution that will be implanted in the patient’s spine. The solution is then applied to the collagen sponge, which is then placed inside a pair of LT-Cages (metallic devices that resemble thimbles). The LT-Cages are then implanted between the damaged vertebrae. Ideally, this implant would stabilize the patient’s spine, and holds the sponge in place until new bone can form. Over time, the sponge gradually releases the rhBMP-2, when it then dissolves.

Despite the amount of benefits the Infuse could bring to the patient, many doctors are currently wary of recommending the Infuse because of the severe side effects it allegedly causes, along with the well-publicized legal action Medtronic is facing.

Overview of Medtronic Infuse Bone Graft Allegations

Due to the misleading marketing campaign by Medtronic, patients and physicians were under the impression that the Infuse was safe to use for cervical spinal procedures, when it was only safe to use for specific lumbar procedures. This misrepresentation has led to numerous patients complaining of device failure, debilitating pain, and ectopic bone growth.

In a recent 2014 case, Medtronic settled approximately 950 Infuse bone graft lawsuits for $22 million. This amounted to less than $25,000 per plaintiff. Despite losing this Infuse lawsuit, Medtronic reportedly still refused to acknowledge or accept any responsibility for the side effects the plaintiffs suffered. In fact, the company stated that it “continues to stand behind Infuse Bone Graft, which has been utilized in more than one million patients since it was approved more than ten years ago, and will vigorously defend the product and company actions in the remaining cases.”

Initially hailed is as one of the greatest innovations in bone surgery, the Infuse bone graft is now known for complications like infection, male sterility, bone and nerve damage, urinary problems, possible cancer risk implant failure, and need for revision surgery.

In addition to the charges Medtronic is facing for Infuse, the company is also facing mass legal action for the false advertising they allegedly used to sell the Infuse bone graft. The company had to pay $85 million in 2012 to settle a lawsuit filed by its shareholders because Medtronic allegedly concealed as much as 82.5 percent of Infuse sales that were garnered from its off-label sales pitch.

In that same year, the Senate Finance Committee found that Medtronic actually ghost-wrote several parts of medical studies that featured the Infuse bone graft, and had paid physicians millions to promote the product. The committee said it was particularly concerning that Medtronic encouraged doctors to either overlook or not put any emphasis on the side effects of Infuse bone graft.