Complications can require the need for respiratory support, insertion of feeding tubes, anti-inflammatory medications, tracheotomies and additional surgeries. Complications with Medtronic Infuse Bone Graft Cervical Spine UseĪs noted by the FDA, most Medtronic Infuse complications begin two to fourteen days after surgery. If you or a loved one have received a Medtronic Infuse Bone Graft for an off-label use and have suffered illness or injury because of it, you may be eligible to file a claim. This had led to numerous lawsuits across the country and has landed Medtronic in serious legal trouble. It was not, however, approved for use in cervical spine treatment.Īccording to Complaints, Medtronic allegedly encouraged physicians to use the Infuse product off-label in the cervical spine, subsequently boosting sales and causing a number of serious medical complications.
Medtronic’s product was also approved for treatment of degenerative disc disease and open fractures on the tibia, as well as treatment of localized alveolar ridge augmentation and in sinus augmentation. ZKB’s ‘Did You Know’? Medtronic said that the number of Infuse lawsuits could reach 2,600 cases going forward.In 2002, the FDA approved Medtronic’s Infuse Bone Graft for use in the lumbar spine and for some oral and dental procedures. Zoll, Kranz & Borgess, LLC – Defective Medical Drug and Device Lawyers
INFUSE LAWSUITS FREE
If you have questions about a potentially defective medical device or have suffered injuries as a result of Infuse, talk with our spinal device lawyers for a free initial review of your case. Our attorneys represent victims who have been injured by defective drugs and medical devices. Additionally, the company said that it would set aside additional funds for about 750 cases filed by other injured patients, as well as any future litigation.Ĭan I File a Lawsuit If I Am Injured By Infuse? Medtronic said it would pay out $22 million to resolve the claims of about 950 injured people. Most of the lawsuits state that Medtronic, through payments to the spine surgeons, illegally promoted Infuse for uses that were not approved by the FDA, in addition to the injury claims. This led to allegations that Medtronic employees were “involved in drafting and editing favorable articles about Infuse while the company paid millions to the surgeons whose names lent weight to the studies.” Senate Committee on Finance over Medtronic’s marketing.
Eventually, the research was published in the Milwaukee Journal Sentinel, which led to a review by the U.S. The news outlet also reported that it has been implanted in more than 1 million people.Īfter its release, researchers began to link the product to complications.
Food and Drug Administration (FDA) approval, with annual sales of about $800 million. The product was very successful following its 2002 U.S. The Journal reported that the Infuse device includes the biologic drug BMP-2, which serves as an “alternative to conventional spinal fusion, which normally would require harvesting a small amount of bone from the patient’s hip.” According to the Wall Street Journal, Medtronic said that it would pay $22 million to settle current claims over its controversial spine surgery product Infuse, and is setting aside $140 million for other expected lawsuits.
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