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The Medtronic company has been in some hot water lately. A recently published article in the Minneapolis Star Tribune failed to report adverse events attributed to the use of their Infuse Bone Graft device to the FDA. Now, a United States senator is questioning the company and the Food and Drug Administration about the events.
U.S. Senator Al Franken recently asked Medtronic Inc for more detailed information about the adverse events reported by patients after being implanted with their device.
In the article for the Minneapolis Star Tribune, the author claimed that the company studied the outcomes of some 3,600 patients who received the bone graft. The study returned more than 1,000 adverse events.
Manufacturers of medical devices and medications are required to report adverse events to the FDA within 30 days. The article alleges that Medtronic hid the results of the study and did not release them until 5 years later.
Officials for Medtronic told the Star Tribune that the report had been misfiled internally. They additionally stated that it was reported to the FDA once it was discovered.
Franken, who is a senator from Minneapolis, has asked Medtronics to produce information about what they reported to the FDA and when. He also inquired as to how staff are trained to report adverse events.
In response to the article published in the Star Tribune, Medtronic stated that they concluded that the adverse events seen in the report were consistent with already known outcomes.
Franken also involved the FDA. He asked FDA commissioner Dr. Robert Califf to provide more data on the types of injuries captured in the previously unsubmitted data.
Franken was also curious as to whether the injuries were attributed to approved uses versus non-approved uses of the Infuse bone graft.
If you have experienced complications or injury due to the use of an Infuse bone graft, you may be entitled to compensation. Contact the law offices of John Foy & Associates. The “Strong Arm” attorneys will work to get you the compensation you deserve. Contact us today.
