U.S. Senator Al Franken asked federal regulators and Medtronic Inc. for a detailed information about the bone graft injury. Recently, it was reported that Medtronic hid thousands of adverse events linked to the company's bone graft Infuse.
According to CNBC, the Minneapolis Star Tribune reported on Sunday that Medtronic studied the results of 3,600 patients who received Infuse between 2002, when the product was approved, and 2006. The studied outcomes reveal that the doctors unveiled more than 1,000 adverse events caused by the product.
The company should have reported the events to the U.S. Food and Drug Administration within the 30 days of discovering them. But instead Medtronic hid them, the Star Tribune stated.
Reuters claimed that the company's officials told the Star Tribune that the database of the adverse events was internally misfiled. It also added that the data was reported to the FDA after it was rediscovered more than five years later.
Moreover, the company assured that no patients were harmed by the delay. Medtronic's operational headquarters is based in Minneapolis.
With that, Al Franken, a Senator from Minnesota, sought Medtronic to clarify the information it gave to the FDA. The Senator asked for information about how staffs are trained to report adverse events. He also asked for more details on the nature of the previously unsurrendered data.
The Minneapolis-based company stated in an email that it had already received Franken's letter. It is now looking forward to discussing the issues with the Senator.
In an all-embracing response to the news article published by the Star Tribune, the company claimed that once it discovered the study in 2013, it concluded that the adverse event data "were consistent with those already known across a wide body of literature and clinical study." But Franken still asked the FDA Commissioner Dr. Robert Callif to give more details on the extent of the injuries found in the previously unsubmitted adverse event data, as reported by Yahoo! News.
The senator also asked what part of the injuries were linked to the approved versus unapproved uses of the product. He also asked whether the apparent high rate of injury was in line with other data the FDA had on the product prior to receiving the unsubmitted adverse event data.
Meanwhile, the Medtronic insisted that the Star Tribune's claims were "false." A spokesman for the FDA, Angela Stark, said that the FDA had received the letter and would respond directly to the Senator.
