Medtronic’s Infuse Studies Failed to Report Serious Risks, Surgeons Say
Studies of Medtronic Inc. (MDT)’s Infuse, used to spur bone growth after spinal surgery, failed to disclose serious and potentially life-threatening side effects, leading to excess use of the product, researchers said.
None of the 13 trials involving 780 patients, funded by Minneapolis-based Medtronic, reported any adverse events from the product, according to a review led by Eugene Carragee, chief of spinal surgery at Stanford School of Medicine in Palo Alto, California. Data provided to U.S. regulators and other publications showed up to 50 percent of patients suffered side effects, including infection, pain, cyst formation and cancer, the reviewers said.
Infuse attracted greater scrutiny after it gained marketing approval in 2002 when patients began reporting unanticipated side effects, said Carragee, who published a report last month showing the device can lead to infertility in men. The U.S. Senate Finance Committee last week asked Medtronic to detail payments to doctors who conducted research on the bone product.
“We don’t think it should be pulled from the market, but people need to have a realistic idea of what the risks are,” Carragee said in a telephone interview. “Patients and families should have a discussion with their doctors that’s not based on the idea that there are no complications.”
Two reviews, two studies and an editorial appear in a special issue of The Spine Journal today devoted to Infuse.
“While the Spine Journal articles raise questions about researchers’ conclusions in their published peer-reviewed literature, the articles do not raise questions about the data Medtronic submitted to the FDA in the approval process or the information available to physicians today through the instructions for use brochure attached to each product sold,” Omar Ishrak, Medtronic’s chairman and chief executive officer, said in a statement. “Based on that data, we strongly believe that the safety profile reported to the FDA and summarized in the product label support the safe use” of Infuse.
To contact the reporter on this story: Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
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