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The Medtronic Infuse is a synthetic bone morphogenetic protein that is injected into the spine during surgery and is supposed to help regrow damaged bone. It once was projected to be agreat advancement in medicine. More recently, however, medical research suggests it can cause a number of serious side effects, including severe pain, growth of cancerouscells, degeneration of bone tissue and unwanted bone in the spinal canal.
I’m Attorney JoAnn Spinks Coleman and I’m here to speak to you regarding the issues with the Medtronic Infuse.
The U.S. Food and Drug Administration only approved the product for use in lower back surgery using an anterior lumbar inter body fusion, a technique wherethe surgeon operates on the spine through the abdomen.The FDA specifically warns against the use of INFUSE in the cervical spine, citing reports of “life-threatening complications.”
Unfortunately there have been numerous cases where the FDA instructions were ignored.
April Cabana, a California woman, is one example of off-label use. 34 year old Cabana alleged that her life altering injuries were caused by Medtronic’s promotion of off-labeluse, in other words it was used in a way that was not approved by the FDA. In her lawsuit, she claimed she suffered debilitating and permanent injuries to her spine caused byMedtronic’s Infuse Bone Graft and another device. She is now permanently disabled.
Anyone who has suffered complications from Infuse should seek legal advice immediately. There is help available for those who suffer from product misuse. Don’t hesitate to get the help you deserve.
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