Medtronic is back in the news this week as new data suggests that one of their products, when used in high doses during spinal fusion procedures, may actually increase a patient’s risk for developing cancer.
The information, which was presented during a recent national meeting of spinal surgeons, was given to the FDA by Medtronic when the company sought approval to sell a high-strength version of an already existing bone growth product known as Infuse. However, based on the results of the study, the FDA subsequently rejected Medtronic’s high-dose product, which was called Amplify, due to concerns over the increased cancer risks.
The study’s data regarding the higher-dose formulation (Amplify) also revealed potential implications for patients who have previously received Infuse, as both products contain the same active ingredient. In response to the controversy surrounding the wide-spread use of Infuse, Medtronic issued a $2.5 million grant to Yale University for the purpose of conducting an independent review of all data associated with the efficacy and safety of Infuse.
