What is Medtronic Off-Label Use?

By: Shannon Blanchard, Esq.

Despite the FDA issued warning in 2008 about the risks involved when the product is not used for its approved purposes, surgeons across the country continue to use the device for cervical spine procedures. Since FDA did not approve the medical device for use for this purpose, several patients are victims who have sustained serious personal injuries as a result. The FDA is the government agency who is responsible for approving drugs and devices that are safe for consumer use.