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Surgeons, Medtronic Under Investigation Over Infuse Complications

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Washington, DCFurther to concerns about financial conflict of interest stemming from reports of physicians with financial ties to the medical device company, Medtronic, a senate committee has been established to investigate whether or not those physicians were aware of the serious complications associated with Medtronic's spinal device, Medtronic Infuse, and if so, why they failed to disclose those adverse events in journal papers.

Infuse, a bone morphogenetic protein-2, is used in spinal fusion surgery. It works by stimulating growth of the bone, thereby eliminating the need to harvest bone from the patient to create a fusion between two vertebrae. It has proven to be very popular. However, Infuse carries an FDA warning on the label because it is associated with ectopic bone formation; retrograde ejaculation, which causes male sterility; and cervical complications including swelling in the throat or neck.

According to a report in the more than 500,000 patients have received an Infuse implant, which converts to several hundred million dollars a year of revenue to Medtronic.

This isn't the first time Medtronic has been investigated. Earlier, it was the subject of an investigation for off-label marketing of Infuse, by the U.S. Department of Justice.


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I am a Victim of a Surgery told to Me. A Cut and Hinge. I thoight it was a Small Incision in my Neck. Called Cervical Laminoplasty. I feel was Experimental. It was No where mention on Website. No brochures. Coersed Me with Tricky Optioms. Scare Me to Choose. I awoken with 21 Muscles Cut and Re attached. 14 inch Cut in the back of my Neck. 12 Screws with Some of them went through the Bone. Pressing Upon my Spinal Cord. I can Never again Sleep on a Pillow. Both Arms go Immediately Numb and Electrical Every Nite and Each time i Lay back onto these Screws. My Head began to swim sorta Dizzy like. My job had given me a PTP from there MPN. He kept telling Me that i had No Work Comp Case. I told him I did. I had Proof on a New MRI.i thought he was sending me to a Neurosurgeon for Surgery. Found out it was a IME exam. Still with Proof. He called Me one Morning and told Me that he do not need to see me again. I had Severe Withdrawals at Home. No Doctor all of a Sudden. He want give Me Records. Been seeing him for Seven Years. He said on a Dr Note that i am Permanently Total Disabled due to my Severe Myelopathy. I Relocated here to SC. Not One Surgeon will Help Me Here. They tell Me to go back to California and get a Doctor. My Body Nerves keep Jumping over Body.


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