Last Month, the United States Senate Finance Committee reported that medical device manufacturer, Medtronic, Inc. paid authors over $200 million to manipulate the data reported in medical studies. Medtronic paid these industry leaders to promote Infuse bone graft for uses not approved by the Food and Drug Administration (FDA) which violates the agency’s regulations.
Infuse Bone Graft is a genetically engineered product that converts stem cells into bone cells. Designed to grow bones, Infuse is made up of three parts: recombinant engineered human bone morphogenetic protein-2 (RhBMP-2), a sponge manufactured from bone Type 1 collagen which is a natural carrier for delivery, and a cage which holds the BMP-soaked sponges that gradually release and reabsorb the protein.
Infuse was approved by the FDA in 2002 for use in dental, oral and spinal surgeries with an anterior (frontal) approach. Infuse was not approved for anterior (back) approach spinal surgeries, because too many patients experienced complications in the 1999 clinical trials.
Some neck surgeries and other types of procedures in which Infuse was used were performed “off-label,” which is the term applied to describe the use of a product for a reason other than its intended purpose. . Some operations were anterior approach spinal surgery.
The FDA permits doctors to use drugs and medical devices off-label as they see fit. However, medical device manufacturers are prohibited from promoting off-label use.