Medtronic Inc. is the world’s largest provider of medical equipment, and in 2002, the FDA approved Medtronic’s use of the Infuse Bone Graft system in anterior lumbar fusion surgery only. Prior to Infuse, individuals undergoing spinal surgery would first need surgery to take bone from the hip to be used to stabilize the spinal column. Infuse uses a genetically engineered protein to promote bone growth. As a result, surgeons can eliminate bone graft surgery.
Infuse has been linked to numerous serious side effects, including various types of cancer and male infertility. In 2008, the FDA issued a warning that off-label use was not safe, yet evidence suggests Medtronic encouraged surgeons to use Infuse for a variety of procedures. Off-label Infuse usage has led to numerous health problems, including swelling in the neck, uncontrolled bone growth in the spine, nerve injuries, and other severe problems.
In 2011, Congress took interest in Medtronic’s activities after it discovered the company paid $20 million to physicians who conducted studies on Infuse and stated the product produced no negative side effects, despite evidence to the contrary. Congress released a report in 2012 indicating that Medtronic promoted the off-label use of Infuse without disclosing associated risks. In June 2013, the results of two independent reviews concluded that Infuse is no more effective than a bone graft, while carrying increased risks of cancer.
Claims against Medtronic are pending in various venues across the country.