The FDA has quietly expanded a so-called “exemption database” allowing medical device manufacturers to shield the injuries and fatalities attributed to their devices from public scrutiny. According to a recent article in Kaiser Health News, the number of malfunctioning devices submitted as an “alternative summary report” not available to the public numbered between 431,000 and 481,000 in the last three years. According to the FDA, the alternative database originated two decades ago to prevent medical device makers from reporting the same injuries multiple times. However, since its inception the exemption database has grown exponentially and, no longer providing clarity and efficiency, now assists in concealing harmful devices from public scrutiny. The FDA declined to provide Kaiser Health News with a list of exempt devices, although the federal agency did say the number of devices was “over 100.”
This development is unfortunate for doctors and patients who rely on public information about medical devices to make their health care decisions. Surgical staplers provide a good example of how the FDA’s alternative database harms patients. Surgical staplers are “designed to cut and seal tissues or vessels quickly,” according to the health news organization. These staplers also commonly malfunction, between 1994 and 2001 malfunctioning staplers reportedly caused 112 deaths in the country. In 2001, the medical manufacturers of these surgical staplers received an “exemption” from the FDA, which meant the majority of the injuries and fatalities caused by these devices would no longer show up in the public database. In 2011, the total number of injuries and fatalities attributed to surgical staplers was only 18. In 2017, the FDA removed the device from the exemption list and the number of reports skyrocketed to 79.