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After a two yearlong investigation, the U.S. The Unites States Senate has also gotten involved. This investigation also came less than a decade after Medtronic agreed to pay close to $10 million dollars in a whistleblower suit that alleged kickbacks and gifts were given to doctors who actively used other Medtronic products as well. Although the investigation was eventually closed without action, it exposed several immoral and unethical practices committed by Medtronic.
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Justice Department investigation after reports surfaced that up to 80% of surgeries using Medtronic Infuse were off label. The FDA warning along with the complaints from consumers led to an official U.S.
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The FDA announced that swelling of the neck and throat was the most common issue, which often required emergency surgery and other treatment. FDA Warns Consumers About RiskĪfter receiving over 280 reports of severe complications, the FDA warned that Infuse bone graft and other similar products had caused serious complications when used off-label in spine surgeries. Other patients had to undergo revisionary surgery to remove additional growths from the Infuse bone graft product. In a few reported cases, death has even followed Medtronic Infuse bone graft surgery after symptoms went untreated. However, more serious Medtronic Infuse side effects have been reported which include: Difficult swallowing, breathing, and speaking are the three most common side effects as well as swelling in the neck and throat. The FDA has received hundreds of complaints that allege Medtronic Infuse bone grafts caused serious complications that can be life threatening when untreated. Medtronic Infuse Bone Graft Complications Several individual lawsuits, as well as larger class actions suits, have been filed against Medtronic after patients reported serious and potential life threatening complications. Patients who have suffered complications from Medtronic Infuse problems after undergoing surgery may be able to seek compensation for their injuries.