From the Popular Press: What Your Patients are Reading:

A lawsuit is blaming the death of a California woman on Medtronic, the maker of a spinal implant that was used off-label in the woman’s neck surgery earlier this year. Infuse Bone Graft encourages bone growth through the use of a man-made human protein, and is approved for use in lower-back surgery and some oral and dental procedures. However, Infuse is also used by surgeons off-label, sometimes with harmful results. The US FDA has warned that using Infuse for neck surgery can lead to trouble breathing, swallowing, and talking. The family of Shirley Nisbet, the woman who died of respiratory failure shortly after her surgery, is claiming that a Medtronic representative encouraged her surgeon to use Infuse in the surgery despite warnings from the FDA just a month prior that such off-label use is dangerous. Medtronic counters that they do not promote off-label use, but sent a representative to be on hand during the surgery in case complications arose. Although doctors are allowed to use medical devices how they see fit, the makers of such devices are prohibited from promoting the device to be used in ways not approved by the FDA. Medtronic is currently under investigation for possible promotion of off-label uses of their product.

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