The Medtronic Infuse bone graft system has reportedly caused several adverse side effects in thousands of patients who have undergone spinal fusion surgery. The source of the problem allegedly stems from Medtronic’s practice of encouraging doctors to perform off-label use of Infuse. Medtronic Infuse bone graft complications have caused thousands of Infuse lawsuits to be filed against the manufacturer, which may result in enormous settlements or rewards for plaintiffs.

The Medtronic Infuse bone graft was approved by the U.S. Food and Drug Administration (FDA) to aid in bone growth during certain surgeries and bone graft procedures. Traditionally, bone grafts (bone removed from cadavers or other parts of the body and inserted into the needed spot) have been used to grow bone in the human body for decades. However, the Infuse bone graft contains a synthetic protein that promotes bone growth without additional bone being surgically inserted into the body. This protein, rhBMP-2, was only approved for use in the lumbar spine in 2002 and later approved for other surgeries, excluding surgery in the cervical spine.

However, many patients have undergone spinal fusion surgery using Infuse in the cervical spine and allegedly were not adequately warned that this was an off-label procedure that could lead to serious bone graft complications.

Infuse Bone Graft System Dangers

The FDA issued a specific warning in 2008, stating the Medtronic Infuse bone graft was not approved for use in the cervical spine, as “anatomical proximity of the cervical spine to airway structures in the body had contributed to the seriousness of the events reported and the need for emergency medical intervention.”

In 2011, researchers suggested that Medtronic’s original research on the Medtronic Infuse bone graft was inaccurate. Medtronic allegedly failed to adequately report (and therefore warn against) Infuse bone graft complications. Up to 50 percent of patients who underwent spinal fusion surgery with the Infuse bone graft system experienced some kind of complications. Furthermore, Medtronic allegedly used many of their own employees for the study. While this type of research method is not illegal, this did not create confidence in the Medtronic’s research findings. 

One 2013 report published in National Institutes for Health found that the Medtronic Infuse caused fibrosis in a patient which led to additional, serious complications. 

Medtronic Infuse Bone Graft complications may include difficulty breathing, speaking and swallowing; chronic pain requiring daily medication to manage; excessive bone growth; nerve damage; male sterility and other uro-genital injuries; and death.

Medtronic Infuse Bone Graft Lawsuits

Thousands of individuals who have experienced severe Infuse bone graft complications have filed a Medtronic Infuse bone graft lawsuit or have joined a class action lawsuit against the company. Allegations in Infuse bone graft lawsuits include failure to warn, intentional concealment of Medtronic Infuse complications, and others. Medtronic investors have also filed a Medtronic Infuse bone graft lawsuit against the company.