But there are many reported side effects of Infuse Bone Graft, some of which are listed by claimants in the Medtronic lawsuits as being willfully covered up by the company. Medtronic claims that Infuse has been used in over 1 million bone graft surgeries worldwide. However, some of the allegations against Medtronic, including those backed up by a Senate report, claimed that the company manipulated studies of Infuse, deliberately coerced patients into opting for Infuse ahead of alternatives, and covered up information regarding Infuse complications. Medtronic’s Infuse Bone Graft aimed to solve this less-ideal situation by eliminating the need for harvesting natural bone, with the company claiming its Infuse system encouraged natural bone growth through its “revolutionary” Infuse system. While it’s not ideal to take bone from one part of the body to use in another (it’s often harvested from the hip), sometimes it is deemed necessary, the best option among less sound ones. Essentially, bone grafts are a type of bone transplant. Bone grafts can be used throughout the body, for example in bone-based dental procedures, when repairing broken leg and hip bones, and in complicated procedures involving the neck and spine. In 2017, the company tried to draw a line in the sand, setting aside $300 million to resolve pending and future Infuse improper use lawsuits.īone graft surgery is a procedure where bone is taken from one part of the body and used to repair the bones in another. As a result, the company paid out millions in compensation. In short, Medtronic faced multiple allegations of improper use of Infuse Bone Graft. In a sense, Medtronic was accused of going rogue, persuading doctors, some of whom had undisclosed financial relationships with Medtronic, to perform these off-label procedures. In this case, it refers to the off-label use of the specialized procedure and equipment used for Infuse Bone Graft for spine surgeries. The key aspect of the Medtronic bone graft lawsuits centered around the term “off label.” Normally, off-label refers to a drug that has been approved by the FDA for one type of treatment but has been used in another. The company faced multiple allegations, ranging from cases filed from former Infuse patients who suffered injuries after the bone graft procedure to lawsuits from stockholders who took issue with Medtronic’s business practices. Over 10,000 people filed Infuse Bone Graft lawsuits against Medtronic from the late 2000s onwards. In 2022, a statement on the company’s website admits there can be serious complications with its product, listing several dangerous side effects and risks of Infuse Bone Graft. Medtronic calls Infuse “revolutionary,” but there are serious concerns over patient outcomes. It has been used in various types of bone surgeries over the last 20 years (over 1 million surgeries, according to Medtronic), but it is most noted for its use in complicated surgeries on the spine. Infuse uses special protein (Bone Morphogenetic Protein-2, rhBMP-2) and a sponge-like substance made from collagen to act as “scaffolding” for the remodeling and natural formation of new bone. However, in 2002 Medtronic, an Irish-American medical devices company, launched a new type of system, Infuse Bone Graft (often shortened to Infuse). The treatment often requires the harvesting of bone from the hip to repair bones elsewhere, often in the spine. Furthermore, there were accusations that Medtronic manipulated studies on the safety of Infuse Bone Graft.īone grafting is a type of surgical treatment to repair damaged or diseased bones. Medtronic disputes this interpretation of FDA regulation, claiming there is scope within the rules to use off-label products. The underlying allegation of the Medtronic bone graft lawsuits is that the company’s product, Infuse Bone Graft, was used “off label”, meaning it was unapproved for use in that particular type of procedure by the FDA, and this unregulated product caused injury to many bone graft patients. In total, Medtronic said they put aside $300 million to settle claims for the Infuse Bone Graft lawsuits. As a result, Medtronic agreed to pay millions of dollars to settle a large number of lawsuits from various claimants, including individual plaintiffs, Medtronic shareholders, several states, and the U.S Department of Justice. The plaintiffs claim that Infuse Bone Graft, a synthetic protein treatment used to repair diseased or damaged bones, caused severe side effects, serious injury, and even death in some cases. Since the late 2000s, the medical device company Medtronic plc has been hit with 1000s of lawsuits from people who claim the company’s Infuse Bone Graft system caused serious injury.
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