June. 14, 2019
The Food and Drug Administration (FDA) is tasked with ensuring medical devices are safe for use and patients are kept relatively free from harm at the hands of medical and pharmaceutical companies, but a recent report suggests the FDA might be putting the interests of big companies ahead of patient safety. The report deals with incidents linked to surgical staplers but an earlier report regarding breast implants shows there are many types of devices on the FDA’s hidden list of adverse events linked to potentially defective medical devices.
A Secret List of Medical Device Failures
The FDA’s role is to oversee drugs and medical devices, ensure their safety and keep patients safe from flawed devices and drugs. Part of the process involves the FDA compiling a list of adverse events through its public MAUDE database, so the FDA can track recurring malfunctions or other issues and work with device makers to address those issues or warn the public about the potential for problems with devices.
According to a Huffington Post report, the FDA allows a special exemption to some medical device makers allowing them to report malfunctions without the public’s knowledge. The issue came to light when Dr. Douglas Kwazneski attempted to find out if his experience with a surgical stapler locking up was a recurring problem. Despite finding no reports about that malfunction in the FDA’s database, Kwazneski found that a majority of surgeons he spoke to experienced the same problem.
A Kaiser Health investigation found that from 2016 on, the FDA logged more than 1.1 million incidents linked to 100 devices in its alternative reporting system. Many doctors are not aware of the system and so rely on the MAUDE database when making decisions about devices to use, but that system does not show the full picture when it comes to adverse events, leading physicians to think devices are safer than they are.
In a letter, FDA spokeswoman Deborah Kotz said that any device manufacturer could request an exemption from FDA reporting requirements.
Ultimately, although there were 84 public reports of stapler injuries or other issues in 2016, the FDA’s hidden system logged more than 10,000 malfunction reports, some of them fatal. Thanks to the hidden database, many of those injuries were reported as a single injury, making the total number of malfunctions seem much lower than it actually was
The FDA says it allowed the exemption to increase efficiency and reduce redundant paperwork, but safety experts say it hides the true extent of serious problems linked to defective medical devices.
Hiding the Truth About Breast Implants
A 2018 Associated Press investigation found that between 2008 and 2015, the FDA reported approximately 200 complaints each year regarding breast implants. In the last half of 2017 and the first half of 2018 combined, however, the FDA received more than 12,000 reports linked to breast implants.
Why the drastic jump? In those first years, breast implant makers who had a high number of recurring issues, such as ruptures that required the breast implant be removed, were permitted to report many issues all at once with only one report to stand for them. In other words, thousands of injuries could all be reported as one, and patients had no way of knowing exactly how many injuries were covered by any report.
Astoundingly, the FDA allowed this practice to continue even as reports of cancer linked to breast implants began gaining momentum.
“They were told those devices were safe—the FDA would go back and say ‘We only have this many reports’,” Madris Tomes, a former FDA manager who now analyzes medical device reports. “But data was coming in another way that wasn’t public. It leaves the patients demoralized—they don’t understand how many other people are suffering.”
It was only after the FDA required every report to be filed individually that the true scope of breast implant issues became known. The FDA apparently only did so, however, after a medical device failure attorney discovered that some of his clients’ injuries were not included in the FDA’s reports.
Even in cases where each injury is filed individually, the FDA’s adverse event database is frequently cited as being on the low end of possible injuries because of issues with reporting, including that information is often missing from the reports or that manufacturer names can easily be misspelled. Duke University conducted a study in 2016 that found that the FDA’s ability to adequately track medical device safety is “a generally unfulfilled promise.”
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