Bleeding Edge – America has the most technologically advanced health care system in the world, yet medical interventions have become the third leading cause of death, and the overwhelming majority of high-risk implanted devices never require a single clinical trial. In THE BLEEDING EDGE, turn their sights on the $400 billion medical device industry, examining lax regulations, corporate cover-ups, and profit driven incentives that put patients at risk daily. Weaving emotionally powerful stories of people whose lives have been irrevocably harmed, the film asks: what life-saving technologies may actually be killing us?
Q-tips say: WHAT an EYE OPENER! A movie your orthopedist does not want you to see. Remember the Dalkon Shield, IUD devices, etc? What about the screws that they use in other parts of your body?
The Bleeding Edge is very frank and blunt about the effects of medical device malfunction, and it has to be. The device it spends the most time discussing is Essure, a contraceptive implant. Another is a mesh implanted in a woman during a gynecological procedure. When devices like that go wrong, expect to hear some squirm-inducing detail. Learn about words like “vaginal cuff dehiscence” and “prolapse” for instance. Intimate details, or details of intimacy, featuring pain and disability, can’t be kept behind closed doors, because that’s one of the device industry’s biggest failings; a lack of risk determination and communication.
For instance, 98% of approvals are based on the 510(k) process, which compares new devices to those considered to be “substantially equivalent to an existing device” already on the market, and are thus exempt from human trials. That includes other devices approved through the same process. It can also include comparison to devices removed from the market due to safety issues. Consider the daisy chain possibility there. First, an initial approved device which had actual human trials, then one slightly different from that requiring no studies (a), then one slightly different from (a), we’ll call (b), and so on. By the time you get to (z), how likely is (z) going to be anything like the initial device? And it’s even possible that the initial device or one of (z)’s precursors has been removed from the market for safety problems, without affecting any of the successor devices!
For those interested, this doesn’t resemble drug studies at all, even though it’s the same regulatory agency. This is because of a 1976 law that made device regulation completely different. And it also included a provision not discussed in this film – federal pre-emption of state tort claims. Confirmed by a Supreme Court ruling (8-1) in 2008, this means that tort claims about an FDA approved device are terribly difficult to pursue. Yet it’s happened, since so many bad devices have been launched. My earliest memories of watching the news are the Dalkon Shield stories on 60 Minutes. Pharma has no such blanket protection.
The film points out that doctors are not aware of how device regulation works, or doesn’t work, and make all kinds of safety assumptions about approved devices.