Infuse Linked to Cancer
BY LAUREN UZDIENSKI, NOVEMBER 7, 2011
Eugene Carragee, who devoted the entire June issue of his Spine journal to concerns about Infuse, has now identified a link between cancer and the graft material. He presented his data at NASS last week.
Reviewing the dosages of BMP in both Infuse and Amplify, the higher-dose product that was rejected by the FDA due to cancer concerns, Dr. Carragee found that Infuse patients had 2.5 times greater risk of developing cancer one year after the product was used and a five times greater risk after three years. The results were dose-dependent, with patients receiving Amplify the most likely to develop cancer. It was also noted that some surgeons used more Infuse than recommended by the labeling, with some doses approaching the levels of BMP seen in Amplify. Dr. Carragee stressed that Infuse was likely cancer-promoting rather than cancer-causing. He also plans to submit his results for publication.
In the meantime, Medtronic has turned to Yale University to counter the claims that previously-published Infuse data downplayed or omitted certain dangerous side effects of the material. The company is funding a $2.5 million review of all available Infuse data, both published and previously unpublished. As a Medtronic spokesperson told the New York Times in response to Dr. Carragee's latest results, "the results from the independent reviews being managed by Yale will address the safety and effectiveness" of Infuse.
