Medtronic’s Infuse Bone Grafts are synthetic proteins that help grow new bone. But new studies find that they may come with an increased risk of cancer, and conclude that there is no clear advantage that the device is better than traditional spinal fusion surgery options.

What is the Infuse Bone Graft?

The Medtronic Infuse Bone Graft is a surgically implanted medical device that contains a genetically engineered protein, known as recombinant human bone morphogenetic protein (rhBMP-2), which is designed to stimulate bone growth.

Although it was only tested and approved for one type of lower back surgery, an anterior lumbar interbody fusion. However, it has allegedly been widely used “off-label” for other types of spine surgery.

Studies Find No Advantage With Infuse Bone Graft

In July 2013, the Annals of Internal Medicine published the results of a two-year analysis of Medtronic Infuse Bone Graft data conducted by Yale University. The analysis concluded that use of the Infuse Bone Graft is no better than traditional operations for spinal surgeries and can include additional risks.

Yale University contracted with Oregon Health & Sciences University in Portland and the University of York in the United Kingdom to analyze Medtronic data from 17 spinal studies using Infuse Bone Grafts on more than 2,000 patients.

Both universities determined that there is not a clear advantage in terms of benefits of the Infuse Bone Graft for lumbar spinal surgery. Researchers believe that previous Medtronic studies praising the effectiveness of the Infuse Bone Graft contain biased results and selective reporting. The analyses also suggests that early published data from Medtronic on the trials underreported side effects and emphasized favorable results.

Infuse Bone Graft Cancer Risks

According to new medical studies, rhBMP-2, the active ingredient in the Medtronic Infuse Bone Graft, may be linked to cancer. Recent research conducted by independent doctors has found higher rates of cancer among patients who received the Infuse Bone Graft than patients who did not.

These findings were presented to the U.S. Food and Drug Administration, or FDA, when Medtronic sought approval for a new product called Amplify that had a higher dose of rhBMP-2 than the Infuse, whereupon the FDA rejected the product for use in the United States.

The high incidence of cancer found in Amplify patients has raised serious concerns regarding the health and safety of Infuse bone graft patients.

A new study published in the Spine Journal, found that many patients who received off-label Infuse treatments have been treated with doses that significantly exceed the recommended amount and often even exceed the levels of rhBMP-2 found in Amplify.

So far, the Infuse has been linked to breast cancer, pancreatic cancer, and prostate cancer.

Medtronic Infuse Lawsuits

A number of patients have filed Infuse Bone Graft lawsuits against Medtronic for the dangerous Infuse Bone Graft side effects that they say were not sufficiently warned about or reported. The Medtronic lawsuits allege that Medtronic had been aware of the dangerous side effects of the Infuse Bone Graft, but that Medtronic paid researchers to downplay the dangers.

If you have developed cancer or suffered other severe bone graft complications after receiving an Infuse implant you may have legal recourse to recover financial compensation for damages.