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.
The harm caused by the FDA’s decision on surgical staplers is not benign. Surgeons describe using these medical devices without knowing their potential for harm – until it is too late. In one instance, a staple malfunction caused a patient to bleed to death. In another instance, a surgeon said a stapler “misfired” during a “minimally invasive surgery” caused so much bleeding that the procedure was “converted to an open procedure.” The patient, Mark Levering, lost three quarts of blood during the operation and was in a coma for weeks. After waking up, Levering realized he could “no longer walk, comb his hair, or recognize letters of the alphabet.”
Mark Levering and other families harmed by “exempted devices” say they feel the FDA has not only withheld important information but actively deceived them. By allowing a medical device to skip the public reporting requirements, the FDA is creating the impression that certain devices are less harmful than they appear. One surgical stapler manufacturer, Medtronic, reported 1,000 staple malfunctions in the public database during 2015. Last year, after its medical device was removed from the exemption list, that number increased to 11,000. Americans harmed by surgical staplers wish they had known about the probability of a malfunction when making healthcare decisions and wonder what policy goal the FDA is hoping to achieve by obscuring this important information from the public.
