New Information About Medtronic’s INFUSE®

When Medtronic first introduced its INFUSE®  Bone Graft system in 2002, the product was touted in over 10 leading scientific journals as a revolutionary approach to bone healing. The active ingredient in the Medtronic Bone Graft system is a recombinant human bone morphogenetic protein called rhBMP-2, which stimulates bone formation and fixation.

The Food and Drug Administration (FDA) initially approved the INFUSE®  Bone Graft system for use in specified lumbar fusion procedures designed to treat certain types of degenerative disk disease. In 2004, the FDA expanded INFUSE® ’s scope of treatment, allowing it to be used for the treatment of certain types of tibia fractures. Orthopedic surgeons commonly use INFUSE® for a number of off-label procedures involving the cervical spine and other parts of the body. In fact, a 2010 study of administrative data in the medical journal Spine found that as much as 85% of INFUSE®  Bone Graft system use is off-label. The treatment is an enormous profit center for Medtronic, which generates annual revenues of more than $700 million from the product.

By 2008, the FDA was warning physicians that the INFUSE®  Bone Graft system appeared to be linked to serious illnesses and injuries. Patients treated with human bone morphogenetic proteins showed a higher incidence of potentially compromising bone spurs at the injection site as well as certain types of neurological damage, infertility, airway compromise, and even cancer. Additionally, the treatment was linked to a number of adverse, post-surgical events like implant displacement, infection, retrograde ejaculation, and other urogenital events.

Furthermore, it turned out that the lead authors on many of the studies lauding the benefits of rhBMP-2 that had appeared in those 10 plus journals were scientists with strong, undisclosed ties to Medtronic. These researchers had received funding from Medtronic that in some cases amounted to tens of millions of dollars.

Now, it appears that the INFUSE®  Bone Graft system may not work any better than a more conventional bone graft when used in the lumbar fusions for which the FDA has approved its use. Research published in a June 2013 issue of the Annals of Internal Medicine, as part of Krumholz’s Yale University Open Data Access project, found that INFUSE®  showed no appreciable benefit over conventional bone grafts, and that indeed, there were a number of potential risks that might actually tip the scales toward not using the treatment. The Yale study was also funded by Medtronic.

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