In two reviews, two studies and an editorial appearing in a special issue of The Spine Journal today, a group of spinal specialists directly rebuke the research of other spinal surgeons that has supported the widespread use of a Medtronic bone growth product called Infuse. More specifically, the specialists chastise those researchers who received millions of dollars from Medtronic and allegedly failed to report serious complications and side effects that affected patients receiving the Medtronic Infuse bone graft product during clinical trials. Ultimately, the specialists have found the clinical research to be both misleading and biased. Early access to these reports spurred the U.S. Senate Finance Committee to announce last week that it was conducting a formal investigation into whether doctors with financial ties to the Medtronic were aware of but didn't report potentially serious complications including male sterility, infection, bone loss and unwanted bone growth.
The FDA recently announced in late May that 15 infants who had been given the product SimplyThick developed a life-threatening intestinal condition known as necrotizing enterocolitis (NEC), and that two have died. This has led the FDA to warn all parents, caregivers, and health care providers NOT to use SimplyThick to help with swallowing problems in babies who were born prematurely. Nearly all of the 15 infants who developed the condition had been born prematurely (before 37 weeks) but had been released by the hospital with a diet regimen that included SimplyThick to be mixed with their milk or formula in order to thicken it so that the babies would be able to keep their liquids down.