3/6/2023 0 Comments Infuse bone![]() ![]() The study was the first in Yale’s Open Data Access (YODA) project headed by professor Harlan Krumholz. After growing controversy surrounding the genetically engineered bone morphogenetic protein (BMP-2), Medtronic CEO Omar Ishrak authorized a $2.5 million grant to have independent researchers from Yale University study the product. Medtronic said, "Looking ahead, the Company expects continued scientific and clinical research scrutiny focused on the safety and efficacy of Infuse in real-world, clinical experience.A new study from researchers at Yale University suggests that Medtronic’s INFUSE Bone Graft provides little benefit to traditional spinal fusion treatment and can increase complications.Īccording to Medtronic, more than 1 million people received INFUSE, which grows bone and has uses in spine surgery and facial reconstructive surgery. In its securities filing, Medtronic said that at the end of its fiscal third quarter of 2014 about 700 lawsuits involving about 1,000 people had been filed over Infuse in state and federal courts. The product also can cause the growth of unwanted bone. In 2013, two independent reports found that Infuse offered little benefit over conventional spine surgery and may be linked to serious harms including cancer and a complication that can cause sterility in men. Over the course of 15 years, Medtronic paid $210 million to a group of 13 doctors and two corporations linked to doctors, including more than $34 million to University of Wisconsin orthopedic surgeon Thomas Zdeblick, who co-authored a series of papers about the product. The finance committee concluded that Medtronic executives secretly had drafted some of those favorable journal articles. Senate Committee on Finance of Infuse that was started in part because of Milwaukee Journal Sentinel stories. ![]() In addition to the Spine Journal review, there was a damning investigation in 2012 by the U.S. He said it started shortly after the product got on the market in 2002 when doctors who would receive millions of dollars in royalties from Medtronic for other spine products began touting Infuse in medical journal articles they co-authored.Ĭarragee, editor in chief of the Spine Journal, which published its own critical review of BMP-2 in 2011, said the lawsuits represent "a whole lot of people" who got a product that never really showed that it was more beneficial than methods used in traditional spinal fusion surgery. "This is a snowballing effect," said Eugene Carragee, head of spine surgery at Stanford University. The patient lawsuits, which were detailed in a recent securities filing by the company, are the latest development in a decade-long saga of a product that has been the center of investigations, both scientific and legal, and has been linked to conflicts of interest among doctors who wrote favorable articles about it while at the same time taking in millions of dollars in royalties from the company. "Medtronic stands behind Infuse bone graft and will vigorously defend it in court," she said. Some court rulings have led to dismissals and others have limited claims, she said. In a statement, company spokeswoman Cindy Resman said Tuesday that the cases are in early procedural stages and none had resulted in a finding of liability against Medtronic. He said he suspected that many of the lawsuits involved patients who experienced excess bone growth that occurred after an off-label surgery.Īt its height, the product generated sales of $800 million a year, though sales have declined substantially since 2011. "When you start using a product 85% off label, there are going to be problems," said Dan Spengler, a Vanderbilt University orthopedic surgeon. As much as 85% of BMP-2 use has been off-label. Infuse, also known as BMP-2, is a biological agent that stimulates bone growth and has been implanted in the spines of more than 1 million people, most of whom got it in unapproved ways, or so-called off-label use. ![]() "My cynical view is that companies view this as the cost of doing business," he said. ![]() With Infuse, some of the cases may be attorneys drumming up business, but some represent patients who were harmed, Deyo said. That litigation involved products such as the pain drug Vioxx, the diabetes drug Avandia, and Johnson and Johnson's failed artificial hip. Richard Deyo, a professor of family medicine at Oregon Health & Science University who has done research on Infuse, said the lawsuits reminded him of other touted medical products that came on the market only to be later found to be harmful to patients. In addition, several states are looking into sales and marketing practices involving Infuse, which is used in spine surgery. Medtronic said about 1,000 people have sued the company over its controversial bone-growth product, Infuse, and many more lawsuits may be coming. ![]()
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