By Dave B.
At one time or another, nearly everyone in the rich world has had a medical device used on or implanted within them. Overall, many of these devices can objectively be viewed as beneficial. For example, there aren’t many people who will complain about the existence of stethoscopes. However, The Bleeding Edge (Netflix) looks at the darker side of the medical device industry. The side that often doesn’t become illuminated until thousands of people have had their lives destroyed. It’s a harrowing and compelling documentary that everyone should watch, despite the fact that it makes little attempt to remain objective.
One of the main strengths of The Bleeding Edge is that it (mostly) fairly apportions blame for the wretched state of the medical device regulatory environment. The greed of corporate executives, the avarice and ignorance of many doctors, the Food and Drug Administration (FDA) being beholden to corporate interests and operating with insufficient authority, and political cowardice and incompetence from legislators are all mentioned. Individuals at corporations and the FDA are named and shamed. The documentary pulls no punches and is effective at conveying the point that most medical devices in the United States (up to 98% of them!) may not be subject to any human testing at all. Think about that for a minute.
The medical devices that are the main focuses in The Bleeding Edge are the Essure sterilization device, as well as pretty much every type of vaginal mesh device. The 99-minute documentary primarily relies upon anecdotes instead of data, but the anecdotes are truly graphic and horrific. It’s impossible not to feel for the women who used these devices, believing that they were proven to be safe. Given less focus, but likely impacting more people, is the use of cobalt in artificial joints. This cobalt is alleged to cause mental and cognitive issues that resemble Alzheimer’s and dementia, and the documentary speculates that there could be at least hundreds of thousands of people who are diagnosed with those conditions, but instead have reversible cobalt poisoning from metallic joint replacements. Again, although the film doesn’t present a ton of peer-reviewed data, it makes a compelling case that anyone with a metallic artificial joint should consider having it removed immediately if it contains cobalt.
Because the documentary isn’t concerned with objectively measurable facts and data, it fails to effectively convey to viewers the full scale of the how many people may be impacted horrific side-effects from common (and untested) medical devices. There is no attempt to provide hard data to viewers about whether some of the featured devices are causing complications 1%, 50%, or 90% of the time. I understand that concrete data on this is hard to come by or nonexistent, but without that data, The Bleeding Edge can occasionally seem like a collection of horror stories instead of a serious documentary attempting to educate people about a major problem. It would also be a better movie if it focused on fewer devices. The main three that I mentioned above would have been fine, but the documentary doesn’t limit itself to those devices. It seems to want to touch on as many as possible, making the movie longer and potentially less impactful than it otherwise would have been.
People need to be more informed about what medical devices go into their bodies and The Bleeding Edge does a good job of explaining the dangers of our current regulatory regime for these devices. In and of itself, it shouldn’t be taken as gospel and it shouldn’t lead viewers to believe that all medical devices are bad. But it helps to illuminate some of the potential dangers that many of us may face from these devices throughout the course of our lives and therefore is a must see.
I have no clue what I'm doing, but I'll keep doing whatever it is to the best of my ability.