September 18, 2013 – A new study has identified a potential link between the Medtronic Infuse Bone Graft and the risk of cancer. While researchers have theorized that the graft itself is probably not a carcinogen, the device has been associated with cancer and it may promote the disease. In addition to the cancer risk, the Medtronic Infuse Bone Graft has been linked to ectopic bone growth, respiratory problems, nerve compression, retrograde ejaculations, urinary retention and other complications.
What’s the Problem?
The study, which was published earlier this month in the Journal of Bone & Joint Surgery, determined that patients who were implanted with large doses of the Medtronic Infuse Bone Graft had an increased risk of being diagnosed with cancer. The findings represent the latest in a string of troubling studies which have identified problems with Medtronic’s controversial recombinant bone morphogenetic protein-2 (rhBMP-2).
For the study, researchers examined data on hundreds of patients with degenerative lumbar spinal problems who underwent surgery that included either a high dose of Medtronic rhBMP-2 or an autogenous bone graft (a procedure that involves using a patient’s own bone to complete the graft). The results of the study indicated that the group implanted with rhBMP-2 were almost 7x more likely to develop cancer over the next 2 years. Specifically, those who received the Medtronic Infuse Bone Graft had a new cancer incidence rate of 3.37 per 100 person years, as compared to 0.50 per 100 person years among those who were treated with an autogenous bone graft.
The research follows a study presented last year by the editor of the Spine medical journal, which found a link between the Infuse Bone Graft and cancer. According to that study, patients treated with Medtronic rhBMP-2 were 2.5x more likely to be diagnosed with cancer within 1 year of surgery, and that the risk increased fivefold after 3 years. Forms of cancer associated with the bone graft included breast cancer, pancreatic cancer, and prostate cancer.
Medtronic Falsified Infuse Bone Graft Safety Data: Senate Report
The problems with the Infuse Bone Graft have been amplified by a report issued last year by the U.S. Senate Committee on Finance, which accused Medtronic of editing health journal articles and giving kickbacks to doctors who conducted company-sponsored studies on rhBMP-2. According to the report, Medtronic’s role in editing the articles was not disclosed by the company, and that by law, “Medical journals should ensure industry role contributions be fully disclosed.” The senate began investigating these activities in June 2011, after rumors flew about surgeons being paid by Medtronic to omit complications associated with the Infuse.