Infuse Study Halted by Medtronic Who Allegedly Failed to Disclose Data to FDA

Infuse is a Medtronic bone graft product that has been facing controversy after the company allegedly failed to disclose research data that showed less than favorable results. The Minneapolis Star Tribune published a report about Medtronic conducting a retrospective chart review (RCR) of Infuse in 2008. In a study meant to promote Infuse, highlighting its benefits as well as possible new uses, researchers evaluated 3,647 patients who received the Infuse bone graft. Although there were some positive results from this study, there were over 1,000 documented complaints.

According to the Star Tribune, the biotech “pioneering bone fusion device” Infuse, had government approval for one specific type of back surgery. Medtronic hoped that the data provided in the 2008 study might pave the way for new uses and a much wider use of Infuse in the multibillion-dollar spinal surgery field.

Federal law requires reporting any product related injuries to the U.S. Food and Drug Administration (FDA) within 30 days of learning of any problems or issues. Medtronic employees shut down the study in the spring of 2008 without disclosing any pertinent information to the government, the Star Tribune reports. At the time the study was shut down by Medtronic, “the FDA’s database of post-approval problems with medical devices contained just 261 reports about Infuse – a quarter of the number of complications the company had gathered.”

The fact that the study remained undisclosed for so long raises questions. Minnesota Senator Al Franken said, “We need to get to the bottom of what happened, both with Medtronic and the FDA,” he said. “The public deserves answers.”