Medtronic's Infuse Product is Bad to the Bone
You may remember the 2007 Medtronic recall of its heart defibrillator leads due to reports of at least five patient deaths. Now Medtronic makes the news again with its Infuse Bone Graft. Shirley Nisbet, a California woman died after neck surgery, allegedly due to the use of Infuse, which is only FDA approved for spine surgery requiring a frontal approach to the lower backbone, called the lumbar spine.
Products used other than specified and approved by the FDA are known as "off-label." What's interesting here is that although doctors can use FDA approved products how they see fit, manufacturers are not allowed to promote off-label use of these products. In the case of Shirley Nisbet, the Medtronic sales rep was apparently present before and during the surgery, and encouraged Ms. Nisbet's surgeon to use the product. What's also interesting is that although identified in the lawsuit, the surgeon is not a defendant. The lawsuit holds Medtronic solely responsible for Ms. Nisbet's death.
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