The federal Food and Drug Administration too often fails to protect patients from defective and dangerous medical devices because it lets manufacturers self-police themselves, cozies up to companies rather than trying to compel safety fixes, and inadequately informs the public and medical community about problem products.
If that sounds like too broad and harsh an indictment of poor performance by a purported watchdog agency, just read the deep dig by ProPublica, the Pulitzer Prize-winning investigative journalism site, into the FDA’s record with the HeartWare Ventricular Assist Device, or HVAD.
ProPublica details the unacceptable actions that put thousands of patients at risk with a heart pump that cost $80,000, required major surgery, and that the FDA knew had significant problems but still allowed highly vulnerable people to have implanted. As reporter Neil Bedi found: