For decades the FDA allowed medical device manufacturers to file “adverse event” reports of defective and harmful medical devices in a database that is only accessible by FDA employees. Adverse events reports contain information on device complications and malfunctions resulting in patient injury, pain and suffering and death. Since 1997 this database, called the Alternative Summary Reporting (ASR) program, effectively hid this critical data pertaining to the safety and efficacy of hundreds of implanted devices from patients and physicians. Until June 21, 2019, thirteen manufacturers were permitted to file ASR reports.

So, how transparent is this newly public information?  There are 15 zip files on the FDA website:  

Here is an example of what you will see when you open one ofthe files as an Excel document (it’s pretty unreadable in the default .txtfile). Included in this file are devices such as a hip replacement, pacemakers, catheters, IVC filters and breast implants made by DePuy, Cook, Osteonics, Zimmer and others:

Well, it’s a start. You can learn more about these hidden files by viewing this report from KVUE. To read the FDA’s announcement, read their June 21, 2019 Statement.

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