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Latest Research Highlights Medtronic Infuse Cancer Risk

Recent research conducted by a team at Stanford’s School of Medicine found that exposure to large quantities of Medtronic Infuse recombinant bone morphogenetic protein-2 (rhBMP-2) was linked with an increased rate of cancer. The results of the study, which highlight the Medtronic Infuse cancer risk, were published on September 4 in The Journal of Bone & Joint Surgery.

The findings are similar to those of a previous clinical trial that examined the effects of autogenous bone grafts in patients. In a 2011 review in the Spine medical journal, researchers discovered a definitive link between cancer and Medtronic Infuse bone graft surgery when individuals who received the rhBMP-2 protein were shown to have a 2.5 greater likelihood of developing cancer within one year. Furthermore, this cancer risk spiked significantly – nearly five-fold – after three years. 

Studies elicit concern about Medtronic Infuse cancer risk

Though further investigation is necessary to determine cancer risks among patients who have Medtronic Infuse bone graft surgery, researchers believe that rhBMP-2 is not carcinogenic in and of itself, but is a growth factor thought to have in vitro effects on the spread and invasiveness of cancer. The Stanford study concluded that “a high dose of 40 mg of rhBMP-2/CRM in lumbar spinal arthrodesis was associated with an increased risk of new cancer. “

In the study group spinal fusion surgery patients who were given Infuse were almost seven times more inclined to be diagnosed with cancer during the following 24 months. Individuals who received Medtronic Infuse protein had a new cancer occurrence of 3.37 per 100 person- years, versus a 0.50 per 100 person-years cancer diagnosis rate among those who did not receive Infuse.

Pancreatic cancer, prostate cancer and breast cancer are all forms of the disease that can result from implantation of the recombinant human bone morphogenetic protein-2 (rhBMP-2). In another clinical trial conducted by scientists at Duke University, researchers found a significantly higher rate of benign tumors (but not malignancies) among patients who received Infuse bone grafts. That study included just over 4,600 patients and sought to further explore Infuse cancer risks among patients undergoing spinal fusion operations with the product. 

Infuse bone graft problems continue to spark litigation

This is just the latest report of potentially life-threatening Infuse bone graft problems that patients and the medical community must consider. Medtronic critics say the company promoted its bone graft for off-label uses, without properly assessing cancer and other risks. In addition to allegations of illegal and deceptive marketing practices, the manufacturer is being held liable for severe Infuse bone grafting problems such as male sterility, ectopic bone growth, infections, cancer and debilitating complications recipients say they weren’t adequately warned about.

Infuse bone graft lawsuits are being filed in state and federal courts nationwide, as more patients are seeking legal recourse and reparations for medical bills, lost wages and pain and suffering attributed to Medtronic products. Recipients argue that Medtronic failed to sufficiently warn health care providers and patients about risks associated with off-label spinal fusion surgeries, and that the bone grafts were marketed for purposes that were never approved of by the Food and Drug Administration. With Infuse product sales topping $900 million, Medtronic is being accused of placing  priority on company profits rather than public safety.