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Medtronic Infuse Bone Graft Product Increases Cancer Risk, Study Shows

Sep 17, 2013

A Stanford University study published in the September 4, 2013, Journal of Bone & Joint Surgery finds that Medtronic’s Infuse bone graft product is linked to an increased risk of cancer.

Medtronic’s Infuse bone graft device uses the genetically engineered protein rhBMP-2 to help re-grow bone in the spine after spinal fusion surgery, but the Stanford researchers found that Infuse increased the patient’s risk of new cancer.

The study used data from patients with degenerative lower spine conditions who underwent spinal fusion with either a high-dose of rhBMP-2 (40 mg.) or a traditional bone graft, using bone harvested from the patient’s own body. The bone-graft group was the control group. The risk of new cancers in each group was evaluated two and five years after surgery. At two years, with 86 percent follow-up, there were 15 new cancers in 11 patients in the rhBMP-2 group, compared with two new cancers in two patients in the control group. At five years post-surgery, there was a 37 percent loss of follow-up, but again a significantly larger occurrence of cancer was seen in the rhBMP-2 group.

The Stanford study results appeared just three months after findings from two independent studies of Infuse overseen by Yale University appeared in Annals of Internal Medicine. Those studies revealed that Infuse could result in number of harmful, if not fatal, side effects, including retrograde ejaculation, pain, and extraneous bone growth. The Yale-overseen studies also revealed that cancer was among the potential side effects of Infuse, while noting little difference in the effectiveness of Infuse over a traditional bone graft.

The Yale studies came in the wake of controversy over Medtronic’s sponsorship of research that was found to overstate Infuse’s effectiveness and understate the risks and complications. In 2011 Medtronic agreed to independent reviews of Infuse research, and the company released its study data to Dr. Harlan Krumholz of Yale and provided $2.5 million to fund two reviews, Reuters reports. In May, research teams in Britain and the U.S. reported that they found no benefit to Infuse over grafted bone harvested from the patient’s own body and Infuse’s side effects included an increased risk of cancer.

In commenting on the Stanford study, Gary Falkowitz, managing attorney at national law firm Parker Waichman LLP, said, “We have yet another study that provides us with compelling detail regarding the increased risk of injury among patients who undergo a Medtronic Infuse spinal fusion.”

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