The Bleeding Edge

2018 "What You Don't Know Can Hurt You"
7.6| 1h39m| NA| en| More Info
Released: 27 July 2018 Released
Producted By: Chain Camera Pictures
Country:
Budget: 0
Revenue: 0
Official Website: http://bleedingedgedoc.com/
Info

Each year in the United States, unparalleled innovations in medical diagnostics, treatment, and technology hit the market. But when the same devices designed to save patients end up harming them, who is accountable?

Genre

Documentary

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The Bleeding Edge (2018) is currently not available on any services.

Cast

Director

Kirby Dick

Production Companies

Chain Camera Pictures

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The Bleeding Edge Audience Reviews

Perry Kate Very very predictable, including the post credit scene !!!
Fluentiama Perfect cast and a good story
Fairaher The film makes a home in your brain and the only cure is to see it again.
FirstWitch A movie that not only functions as a solid scarefest but a razor-sharp satire.
leovnmemo I had high hope for this film because Kirby Dick, an Academy nominated filmmaker, produced it. The film starts on high note and ends like a chaos orchestra. Even though the film does a great job telling real stories about the patients that suffered from a few medical devices, it falls far short from telling the truths about the underlining cause. And because the film stops short of explaining the reason behind all this suffering, it makes this film a whining, sympathy seeking, and bias piece of work rather than a great documentary. I'm truly sorry for the patients in this film but at the same time I feel like my sympany is being exploited and used for personal gain of the filmmaker.Let's temporary agree that FDA was to blame, medical device makers were to blame but how about the health care providers? How about the lawmakers? How about the patients themselves? There are so many important pieces of information that were left out that it make you question the real motive and intention of the producer. Is this film a documentary or is it a drama? The filmmaker proved that he either knows little about medical device and the approval process of it, or choose not to reveal all the truth because it will affect the sympathy that he's trying to paint for the patients and the rendering of medical devices companies as super villians.First and foremost, if you work in medical device field you know that the health care provider skill plays an critical role in the successful of the procedure. Let saying that you have a perfect medical device but if the doctor who perform the procedure doesn't know what he's doing and you will end up as bad as having a faulty device in you. The film barely touches on this issue. When we talking about skill we are talking about something that getting better not by reading or studying in medical school but by practicing in real surgery. Every doctor spends a lot of time studying in medical school but a high grade doesn't make a good doctor. He or she need to practice. He or she need to work on real patient. He or she need to cut people open and put something in. The first patient probably will not achieve 100% satisfaction result but 100th or 1000th patient will.One of the thing the film gets it right is the abusing of 510k process or the lacking of rigid clinical trial like drugs. This leads to a hard to accept fact that FDA and regulatory agencies all over the world in general are far behind in keeping up with the evolving of medical device specifically and technology in general. In the other hand, people need to understand that taking out all the regulations that are hundreds of pages, drug and medical device are basically approved on risk vs benefit calculation. No drug or medical device that has no side effect or certain risk. The film completely omits this important piece of information. All the director want is depicting FDA as corrupted office that approved device that harms patients. Did Bayer or J&J know about the risk or side effect before? Yes, they did. Did FDA know about the risk or side effect before? Yes, they did. Then why company still want to market the product and FDA still want to approve it? Because the benefit is greater than the risk, the company will make profit, and FDA have no reason to not approved it. Now is my question for the filmmaker. There must be people that have no side effect issue and enjoy the benefit of the devices you mention in your documentary, why are they not interviewed in the film? The risk/side effect is clearly printed on the Direction for Use when the device is approved by FDA. The risk/side effect will also be revised as need if anything change to it during the time the product is on the market. Every year medical device companies have to submit a report stating all reported side effect and the FDA supposed to use it to force the company to revise the risk on their labels. The next question is does the patient receive enough information about all the benefit and risk of the device they are going to use by their health care provider? It's the health care providers' fault if they run after profit and don't provide the patients with adequate information. It is also partially the patient fault for not questioning their health care provider. The film ending with good advices to patients. Newer is not necessary better. Have a second opinion. Do your own research about the device (benefit vs risk) and your health care provider (how many procedure he did in the past? Etc.). Ask your healthcare provider directly about risk and benefit. Be a smart consumer especially with your own health.
elmoslively I have to admit that this film made me nervous because I actually underwent surgery having a device implanted in my brain. I had an experimental stent installed to help prevent a series of strokes caused by blood clots drifting away from an aneurysm. I haven't had any problems since the implant, but I think that if I'd seen this documentary before the brain surgery I would have thought twice. It's been over 4 years now with no problems, which is a good thing.
martimarti-271-689547 I can't remember being more shocked watching a documentary since Food Inc. The Bleeding Edge is deeply involving, showing struggles of real people instead of only bombarding viewers with dry facts. You could think that accidents may happen, but the idea that FDA and medical industry could willingly manipulate, cheat and lie to gain as much profit as possible is sickening - and yet it's a reality. Yes, you should research every medicine, every medical device you put in your body, every medical procedure you undergo. Nevertheless, not everyone does, not everyone would think to doubt their doctor's decision - in fact, most people would probably do what they were told. Films like this one are extremely important. Bayer is withdrawing Essure and hopefully they'll be more changes on the way.
jackcurrananimator Absolutely brilliant documentary! Really sums up the current state the medical industry is in. I loved every minute of it, really keeps your attention throughout.