Most of the 113 medical devices recalled by the FDA from 2005 to 2009 for serious or life-threatening hazards were not subjected to the Food and Drug Administration's more stringent approval process, known as "PMA", or premarket approval, according to a review of the FDA's recall data.
Instead, they were cleared using the 501(k) process, which is less extensive and does not require clinical testing. For consumers, that means some cleared products including artificial hip joints, heart valves, and automated external defibrillators (AEDs) were marketed and used on patients without being tested beforehand.
Imagine going through hip replacement surgery or heart valve procedure only to discover that the parts were defective. How many patients and their families were affected by this broken regulatory model? How much money did it cost to correct and to compensate these victims of white-collar crime?
Will there be an investigation and/or congressional hearings? Doubtful. Is there a way to protect yourself from being victimized in this manner? No. Surprise! Your government has failed you once again.