Review of The Bleeding Edge (2018) by Bob K — 26 Jul 2018

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. That's not a fault of this documentary, but a virtue. 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.

I've been in the drug risk evaluation business for 20 years now, and the film has details about medical device approvals I knew nothing about. 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. The film also rolls out the "revolving door" trope, which I don't agree with. Regulators moving into industry jobs do not mean they are teaching industry "tricks" on avoiding regulation. Everything about my industry experience would well serve the FDA if I wanted a job there.

Essure is going off the market by the end of 2018, according to news released today, so patient activists can claim a well-served scalp. Spokes-whores for Bayer are already claiming this is just another Bendectin-type overreaction to a safe device, but I doubt it.

If for no other reason, watch the beginning of the film featuring an orthopedic surgeon who had a hip replacement using a device containing cobalt chromium parts. His descent is incredible, and his own research into cobalt poisoning is extremely persuasive. He asks the question, how many elderly people have been misdiagnosed with dementia, when they might have a completely reversible condition? It could be huge. If you or a relative have suffered a health decline following a cobalt implant, get blood checked for it. Peer-reviewed research on this topic and others from the film are easily found via Google search.