Spine specialists repudiate Medtronic spinal fusion product; doctors who cashed in.
Medtronic earns something over 900 million dollars per year selling Infuse, a bone growth product used by surgeons performing spinal fusions. The product is used in about one-quarter of the 432,000 spinal fusions performed in the U.S. annually (a number that has increased substantially as surgeons have created regional corporate entities to buy and sell to hospitals the products they use during fusion surgeries). It is used as a replacement for bone grafting material.
The Spine Journal devoted an entire edition to repudiating the research cited by Medtronic and the ethics of the company and its supporting surgeons. The editors of The New England Journal of Medicine and the Journal of the American Medical Association told the New York Times that this situation was unprecedented. Dr. Christopher Bono, editor of The Spinal Journal told the paper that the "spinal care field is currently at a precarious intersection of professionalism, morality and public safety."
According to the special edition of the journal, Infuse presents a much higher risk of complications (male sterility, infection, bone loss and unwanted bone growth), including dangerous complications, than was published by Medtronic. Use of Infuse in the cervical spine was never approved, due to dangerous complications that were identified originally and not understated.
In addition, the research conducted supporting the use of Infuse was the product of surgical consultants who earned--on median---between 12 and 16 million dollars from Medtronic. One surgeon, Thomas a. Zdeblick of the University of Wisconsin, was reported to have claimed that he had no direct financial interest in the product, even though he has received more than 20 million dollars in royalty payments from Medtronic. Zdeblick's colleagues were quoted in the paper describing his position as "hardly credible" and a "fascinating denial...[of an] enormous conflict of interest."