Over 100,000 patients per year have undergone spinal surgery using the Medtronic Infuse bone graft. However, The Medtronic Infuse bone graft has been linked to serious and catastrophic life altering injuries because of bone graft complications experienced by patients who were given the Medtronic Infuse bone graft off-label. A number of Medtronic lawsuits allege the manufacturer illegally promoted the Medtronic Infuse bone graft product for off-label uses.

What is the Medtronic Infuse Bone Graft?

The Medtronic Infuse bone graft is used during surgery to stimulate bone growth and replace damaged spinal disks. Medtronic marketed and sold their bone graft product as one of the alternatives to harvesting a bone graft from the hip. Infuse has been used off-label in cervical spine (neck) procedures, even though it has not been approved by the U.S. Food and Drug Administration (FDA) for such a surgery.

In 2002, the FDA granted Medtronic approval for its Infuse Bone Graft System, but for limited use in the lumbar spine and for some oral and dental procedures. More specifically, the agency approved the Infuse bone graft to treat degenerative disc disease and open fractures on the tibia. The FDA also approved Medtronic Infuse bone graft for use in sinus augmentation and localized alveolar ridge augmentation.

The Infuse bone graft contains recombinant human bone morphogenetic protein (rhBMP), which stimulates bone growth and bone formation. It is a genetically modified version of a protein that is normally found in someone’s body.

Infuse Bone Graft Complications

The Medtronic Infuse bone graft has been associated with many serious problems, including:

• Sterility
• Excessive bone growth
• Bone resorption (Dissolution of mineral crystals and breakdown of bones)
• Inflammation, specifically inflammation of the airways and neck
• Cancer
• Back and leg pain
• Neurological Problems
• Retrograde ejaculation
• Urinary retention

The FDA notes that most Medtronic Infuse complications occurred between 2 and 14 days following surgery. Complications can also include the need for respiratory support, insertion of feeding tubes, anti-inflammatory medications, tracheotomies, and additional surgery.

Allegations Against Medtronic

Many of these Infuse bone graft side effects were not well known because they were under-reported or completely unreported in clinical studies. In 2011, The Spine Journal examined 13 studies that promoted Medtronic Infuse. These studies allegedly failed to report serious Infuse side effects, even though they were supposed to be peer reviewed. The Spine Journal estimated that adverse events occur at 10 to 50 times the original estimates.

Not surprisingly, the authors of these 13 studies allegedly had significant financial ties to Medtronic. These financial ties have come under increasing scrutiny, and it has become clear that Medtronic may have manipulated the studies.  In 2011, the U.S. Department of Justice began an investigation into Medtronic’s practices of paying for influence from researchers, and positive reviews like the ones in The Spine Journal. A subsequent lawsuit was filed by the DOJ against Medtronic and resulted in a $40 million settlement. Ultimately, it was made clear that Medtronic had paid millions of dollars in incentives to doctors to use the Infuse bone graft.

Additionally, it is believed that Medtronic failed to disclose the proper uses of its Infuse product and even went to far as to improperly train doctors on uses that were not approved by the FDA, allegedly resulting in life-altering injuries for some patients.

Medtronic Bone Graft Lawsuits

Serious problems have been linked to off-label use of the Medtronic Infuse bone graft. Infuse bone graft lawsuits are being filed nationwide for Medtronic’s alleged reckless promotion of their Infuse bone graft in a number of surgical procedures that have not been properly tested and which may increase the risk of inflammatory reactions, breathing problems, severe nerve damage, sterility in men, cancer, and wrongful death.

These Infuse bone graft lawsuits seek financial compensation for bone graft complications suffered by patients as a result of the manufacturers failure to adequately warn consumers and the medical community about the Infuse bone graft side effects associated with use of the Medtronic Infuse bone graft.