FDA’s Secret Database Revealed Millions of Reports of Medical Device Malfunction Injuries

The FDA’s secret database has revealed more than 5 million hidden cases of medical device injuries and malfunctions. Here are the devices and incidents from the report that stand out the most:

In the last twenty years there were 2.4 million reports of problems with blood glucose meters. More than any other medical device. Two of the main common problems diabetic patients had with their blood glucose meters were that they displayed incorrect messages and they lost power. Another major problem patients faced was that their blood glucose meters were damaged before they even began using them.

There were 2.1 million reports of dental implant incidents. Many patient do not know the risks involved. Many problems occur where the bone and implant meet. If an implant has to be removed, it often cannot be replaced because of the damage already dealt to the bone.

More than 66,000 surgical stapler malfunction incidents happened since 2001, but were only reported in this hidden database. Surgical staplers are used to seal tissue during surgery. They can misfire, fire malformed staples, or malfunction. If the patient’s tissue is not sealed properly in surgery, the patient can bleed or get infections.

Over 500,000 breast implant malfunctions in the last two decades were reported via the FDA’s hidden system. These breast implant incidents include implant leakage, implant rupture, implant migration, implant deflation, and lastly, a concern for cancer.

There were 59 deaths reported in the hidden, alternative summary reporting system that should have been ineligible. Only certain cardiac arrest deaths associated with particular kinds of heart valves were eligible for this alternative summary reporting system. Alas, of the 59 that made it into the hidden system, they included deaths related to a Paradigm insulin pump, pacemakers, a ventilator, an intra-aortic balloon pump and a breast implant.

Not only does having this hidden system halt any kind of investigations into the medical device injuries and malfunctions, but it prevents the public from pursuing personal injury class action lawsuits against medical device manufacturers who knowingly continue to market dangerous products without warning.