In March 2019, Drug and Device Watch published an article titled “The FDA’s Hidden Database Protects Companies, Reduces Medical Device Recalls”. In this article, we discussed the thousands, possibly millions, of medical device injury and malfunction reports stored in a hidden database.
The U.S. Food and Drug Administration (FDA) maintains this database, effectively burying any announcement of medical device injury for certain types of devices. The database has been used for almost 20 years.
Public Outrage Elicits FDA Response
A Kaiser Health News report published on March 7, 2019 revealed numerous medical device manufacturers have been using “exemptions” to report device malfunctions. These reports, and any associated harm or injury, were hidden from public view for almost two decades.
The current FDA Commissioner, Scott Gottlieb, professed concern in a tweet over the public outcry and promised to make transparency a priority. He seemed to blame the age of the database for its secrecy, stating, “This is an old database where historical information wasn’t easily accessible electronically owing to the system’s age”.
His stated commitment to transparency and flippant reference to outdated technology fall a little flat compared to Kaiser Health News’s claim of attempting to access the hidden database through Freedom of Information Act requests since September, 2018. Freedom of Information Act requests can take up to two years, and Kaiser Health News claims their requests to expedite the process were denied since the FDA responded there was not a “compelling need” for publication of the information in this database.
Presumably, the FDA Commissioner has been aware of the outdated hidden database and the public interest it has generated for months, but is only now making a statement and a commitment to publish the information.
Claims of Device Injury
Originally intended to streamline redundant reports of device malfunction, the hidden database has actually served as a way for manufacturers to distort the honest picture of the harm their malfunctioning medical devices cause. Some widely publicized examples are:
- Injury from Surgical Staplers – Surgical staplers are a mainstay in modern operating rooms. Manufacturers are allowed to report any injury staplers cause through the hidden database, with the exception of death. Naturally, surgeons have continued to use the staplers because they have no indication of the danger or the true rate of misfires or other malfunctions. Catastrophic injuries caused by the well-meaning surgeons using malfunctioning staplers have turned routine procedures into disastrous ones.
- Breast Implant Illness – The recent deluge of newly-available information from the FDA has medical professionals questioning the safety of breast implants like never before. So much information is now available about the frequency of breast implant illness, breast implant-associated cancer, and other complications that the FDA actually convened a two-day conference to reevaluate concerns.
- Pelvic Mesh – When pressed, the FDA revealed they have received 12,000 litigation summary reports – that is, reports of lawsuits filed – with regard to pelvic mesh in 2017 alone.
Victims of medical device injury whose suffering was silenced by FDA secrecy now have a platform for their struggles. Device injury attorneys across the country are urging the victims of these malfunctioning devices to seek legal advice.
That is the most insidious danger of this hidden database. By distorting the truth about device injury, many victims failed to exercise their rights to monetary compensation from the at-fault parties. The sitting FDA Commissioner announced his resignation effective April 5.
Watchdog Groups and the Medical Community Speak Out
Furiously back-peddling amid the fall-out, FDA spokespeople have repeatedly insisted the public visibility of the reports did not affect the way the agency reviewed and acted on the reports. In a poor attempt at transparency, the agency published a table showing the rising number of medical device reports (MDR) it receives each year. The data they released doesn’t show a breakdown of the types of devices involved or any information about the severity of any device injury the data represents.
Victims of breast implant and surgical stapler injuries may be grabbing headlines, but the truth is no one outside the FDA knows which devices or manufacturers have made use of the hidden reporting channels. Responding to questions from journalists, the FDA has confirmed the following devices have appeared in the database at some point in time:
- Mechanical breathing machines
- Intra-aortic balloon pumps
- Pacemaker electrodes
- Implantable defibrillators
- Pelvic mesh
- da Vinci surgical robots
- Surgical staplers
Data-policing organizations rely on FDA information to keep medical professionals and consumers informed. Even those activist and consulting groups who make their living reporting FDA data to the public were in the dark about the sheer scope of the hidden database, not to mention the contents of the private information.
Healthcare Facilities and Providers Kept in the Dark
The ECRI Institute is a non-profit organization that relies on FDA information to provide safety reports to hospitals and performs accident investigations. A nationwide accident investigation agency reporting incorrectly to hospitals is an unsafe situation.
The consulting company, Lumere, advises hospitals across the country about purchasing decisions for medical devices and equipment. This company also relies on the public FDA database to ensure hospitals get the highest quality and safest medical devices. Again, distorted data is creating an unsafe situation for patients relying on hospitals to keep them safe.
Device Events is an independent medical device report (MDR) tracking agency that has been tracking reports of breast implant illness and injury. Familiar with the rising trend in breast implant related harm, their spokeswoman said that the enormous amount of hidden data means the problem of breast implant illness and injury may be much more massive than anyone previously anticipated.
Hidden Database Impacts Healthcare Education
Medical schools across the country are training tomorrow’s doctors with the FDA’s public warning database, MAUDE. One New York University School of Medicine professor is worried his students won’t have the information they need to keep their future patients safe. That doctor, Dr, Alan Shapiro, was quoted as saying,“The FDA isn’t so capable that they can afford to hide data,” implying that any harm caused by these clandestinely reported malfunctions can be blamed on the FDA for their practices, as well as on the manufacturers of the devices.
With so many agencies and education centers relying on publicly available information, the FDA has no excuse for the long-standing hidden database practice, especially considering the rising number of medical device reports (MDR) it continues to receive every year.
Have You Been Injured by a Medical Device?
A medical device injury can alter the course of your life or even prove fatal. The FDA has no right to be so cavalier about the danger its secretive practices continue to cause Americans. If you have been the victim of a medical device injury or other healthcare negligence, you have options.
Contact Drug and Device Watch to learn more about your rights. Fill out our online form to request a free legal consultation.