Medtronic- Too Little, Too Late for Infuse
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
Too little too late for medical technology company Medtronic, as they fork over $2.5 million dollars to hire Yale University researchers to review their highly controversial spine surgery product Infuse - this time without hiding unfavorable results with hush money.
Concern was raised after independent doctors brought attention to the serious complications that occur with Infuse. Medical journal articles that were published over ten years ago did not report any of these complications because Medtronic paid millions of dollars in royalties and other payments to the doctors writing the articles. The Yale University reviewers will be provided with patient data from all Infuse clinical trials as well as FDA reported adverse reactions, starting from when the product came on to the market in 2002. A Yale professor of internal medicine promises that Medtronic will have no oversight or influence to the process, and that the company will be required to surrender all information and data.
Complications After Using Infuse
The product under heat, Infuse, is a bone morphogenetic protein-2, which encourages new bone growth through intense stimulation. Infuse, which brings in $700 million dollars a year, is in high demand because it eliminates the need to harvest some of the patient's bone necessary for spinal fusion surgery. So far, reports acknowledge that Infuse works for a small portion of patients, but there is no accurate assessment of safety in almost 90% of people using the product. Complications from using Infuse include cancer, serious infection, radiating pain, and retrograde ejaculation, which causes sterility in men. Because surgeons were never made aware of these complications, due to omissions in reports that Medtronic-sponsored doctors publicized, they implanted the product at the risk of their patients. The editor of Spine Journal expressed his concern that at this point, the Yale reviews may be irrelevant. They can research and review, but they cannot fix the flaws that reside in the original examination.