The nation's largest medical device manufacturer, Medtronic, has funded and released the results of an independent review of its Infuse Bone Graft product. The results of the review confirm that the product may pose more risks than benefits for patients.
The Food and Drug Administration (FDA) approved Infuse in 2002 as an alternative bone graft treatment to repair spinal discs. When the product was first released, Medtronic-sponsored researchers reported that the product was superior to traditionally used bone grafts and posed less risk to patients. However, in 2008, the FDA warned of possible life-threatening injuries if Infuse was used for "off-label" purposes on the upper spine, including uncontrolled bone growth, breathing problems, infection, and paralysis. Concern grew in 2011 when a reputable medical journal published an issue claiming that Infuse's initial reports were biased and made false claims because of close financial ties to Medtronic. Medtronic funded the review of the initial research shortly after the controversy.
The outside research teams reported that Infuse has no advantage over traditional bone grafts, and it may have negative side effects, including a possible added risk of cancer. The teams also reported that Infuse does repair spinal discs more quickly than bone grafts, but this small benefit doesn't outweigh possible risks. Overall, the researchers concluded that there was no significant difference between Infuse and traditional bone grafts in terms of reducing pain or improving spinal function.
Infuse's sales, which are already down over $350 million since the 2011 publication, will most likely drop as a result of the review. By releasing these reports, Medtronic will allow doctors and patients to make a better decision for spinal disc treatment. Medical officials hope that Medtronic's unprecedented release of an unfavorable review will prompt other medical device manufacturers to make clinical data available to the public.
If you, or someone you love, were injured as a result of an unsafe medical product such as the Infuse Bone Graft, you're probably angry and confused. At Edgar Snyder & Associates, we believe medical products should improve your health, not make it worse. That's why we're here to help get you the compensation you deserve for medical bills, lost wages, and your pain and suffering.
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