![]() ![]() ![]() ![]() The potential for ectopic, heterotopic or undesirable exuberant bone formation with Infuse has always been included in the IFU, Medtronic spokesman Eric Epperson said via e-mail. For example, it was included in the fine print on the product label, and it was the subject of a 2004 Dear Doctor letter that said an investigation into occasional complaints was ongoing. The company also says it did work with the FDA to notify doctors about risks from using the novel biotech product near airways and cervical nerves in patients necks. Your analysis, which solely analyzes adverse event reports in order to reach conclusions about problems associated with the device, is fundamentally incomplete, flawed and inappropriate, the company said last week in a written response to the Star Tribunes findings. Medtronic also pointed out that Carragee, while generally an Infuse critic, wrote in 2012 that the product should not be banned in neck surgery because there are special cases in which using Infuse could be less risky than doing the procedure without it. But they said that the project didnt turn up any problems that werent known from other reports and that the study had an unconventional design that limited the datas value. Medtronic officials have acknowledged that they should have given the data to the FDA much sooner. These are serious complications that should spread throughout the community, Carragee said. Nerve damage, excessive bone growth and breathing trouble can all be life-threatening, especially when the complications are overlapping, as they are in many of the cases in the database. Eugene Carragee, a Stanford spine surgeon and journal editor who has been critical of Medtronic, said he was shocked by what he saw especially in the neck surgeries, which have been shown to be riskier than other uses of Infuse.Īsked to review the data for the Star Tribune, Carragee said the frequency and gravity of the problems turned up in Medtronics in-house study of real-world data should have immediately set off alarms. ![]()
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