The Bleeding Edge (2018) User Reviews

When Capitalism Meets Medicine Watchdogs become Lapdogs

[jonfolz-588-691082 · 9/10 · 27 July 2018]

Sit back and prepare to be angry. The government has gone and done what we told those no good, pencil pushing, paper shuffling bureaucrats to do. That's right. They've cut costs, regulations, and in some cases even federal jobs. Say it's not so! Oh, but it is so. For 35 years I've had a ringside seat to the privatization of government. I've watched and may have even participated in this devolution of regulation and contracting out not only Federal jobs but actual Federal responsibilities. The Bleeding Edge is the story of the chickens coming home to roost.

When I see the well dressed, cleancut, all American Scott Whitaker, CEO Advanced Medical Technology Association sing the praises of the FDA's newly crowned Commissioner, Scott Gottlieb and refer to the FDA's regulatory function as "robust, thorough, and very effective." I actually see an extremely overpaid and overfunded lobbyist claiming victory over his natural foe: The FDA Regulator. This once feared and vigilant patient advocating watchdog is now no more than an industry lap dog. My mind's eye immediately serves up images of Ajit pai drinking out of his freakishly oversized Reese's Peanut Butter Cup Coffee Mug as he gleefully announces the end of the Internet consumer protection; a.k.a net neutrality Title II Utility regulations , December 14, 2017. I suppose the big difference is that Mr. Pai's subservience to the all mighty dollar will likely only kill new innovation from internet startup competitors. That's not the case with Whitaker and Gottlieb. It can be argued that their dollar driven, regulation slashing mission actually ensures medical device innovation. That innovation comes at a cost but hey, what's a little pain, suffering and death against a 300 billion dollar industry?

This 100 minute documentary packs each one of 'em with well produced and well edited dense content that is sure to hold your interest. So sit back on that sofa and prepare to not only get a little mad, but a lot informed.

Rated NH (No Hypochondriacs)

Concern About the FDA and the Medical Industry

[rdg45 · 9/10 · 27 July 2018]

If this documentary doesn't cause concern about the FDA and the medical industry, then nothing will.

Disturbing, shows corruption of the medical industry which is very scary

[vlceptor · 9/10 · 8 August 2018]

Disturbing, shows the corruption of the medical industry which is very scary, can't believe it's happening in the world. If you're like me and always had little trust in doctors, this will make you hate them for sure

Great eye opener, even working in the medical field!

[hkbateman228 · 10/10 · 29 July 2018]

I have been a Registered Nurse for over 18 years, and I agree this is a HUGE problem we are facing! I will also say (as a medical professional), that until this film, I was not aware there were "loopholes" allowing medical devices to piggyback off of studies that frankly do not apply, and even those studies that were completed lacking in actual data. We are trained that medications and devices go through stringent testing to be considered "safe", and sadly that appears to no longer be the case. I will be encouraging everyone I know to watch this film, but wholeheartedly agree with the "safety warnings" at the end of the film:

Know what is being placed in your body, and how long it's been available on the market Ask for second or even third opinions Ask your surgeon how many times they've performed the specific operation you're undergoing, and Have a family member or friend act as your advocate while incapacitated by surgery.

Disturbing

[marta-wiszo · 10/10 · 6 August 2018]

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.

Been there, done that

[jeomo · 5 August 2018]

For those who aren't too put off by a few facts now and then, here's the chronology:

Essure was approved in 2002.

By 2010, everyone who pays attention to these things was painfully aware of the growing number of reports of safety issues associated with the device, and problems with other implants were also getting attention.

The head of FDA's Office for Device Evaluation resigned in 2010. A number of other top FDA medical device officials resigned in the 2009-2012 time period.

The Institute of Medicine did an extensive evaluation of the 510(k) process and, in July 2011, released a 245-page report with criticisms and recommendations.

Congress took the IOM recommendations to heart and, in July 2012, the Food and Drug Administration Safety and Innovation Act was enacted into law. It including the most significant legislation affecting the regulation of medical devices since the 1976 legislation that first gave FDA authority over the safety and efficacy of these products.

Whether the extensive changes that were included in the 2012 legislation will be effective in reducing the number of medical devices that are associated with safety issues post-market, only time will tell. But FDA oversight of medical devices has been under new management and new regulations for over five years now.

In 2016, FDA required Bayer to include a "black box warning" on Essure. A black box warning is also known in the industry as the "kiss of death," because of its typical impact on sales. So it came as no surprise to anyone, when, on July 20, Bayer announced it was withdrawing the product from the US market, due to declining sales.

The documentary was released on Netflix one week later. Hmmm. I wonder if Netflix might have held it for release because, in order for Bayer to sue for libel, it would have had to show that it incurred damages as a result of the libel. Now that there are no sales to be lost, no damages can be incurred.

This is an intriguing film.

[elmoslively · 6/10 · 7 August 2018]

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.

Great.

[idude-97646 · 10/10 · 29 July 2018]

Brilliantly produced documentary about how 4 current-day medical devices have had catastrophic health effects for some patients, and how the FDA and industry have failed to prevent this from happening.

One of the best documentaries I've ever seen--coming from one who has seen a lot! I wasn't bored for a minute of this film.

Makes me sick

[popcolin · 6/10 · 23 November 2019]

What bothers me more than the attrocities displayed in the documentary is the reviews on this website which bash the movie, the reviews probably written by white men who may or may not have a problem with women being equal to them and definitely have never suffered or seen anyone suffer in their life because if they had maybe it would be appropriate to exercise a little compassion versus just pretty much laughing at some one else's pain. But clearly there are many many people like that out there, the poor reviewers not the problem but the ones allowing these mind-numbingly bad side-effect devices into the public's body. Wow. Just incredible.

6 points for the documentary because it was a non-stop fest of beating you over the head with tragedy after tragedy that made me not even want to finish it.

Also should definitely have a more strict rating than TV-14. Honestly more disturbing than NC-17 movies I have seen. But I guess reality is far worse than fiction so take that into account. Very graphic. Some of these situations they showed I'm having a very hard time leaving my brain. That's all.

A MUST-WACH

[sciachir · 10/10 · 12 August 2018]

I encourage everyone to watch this documentary! You will think twice before ever having a surgical procedure

75% of the movie is about Essure

[catmanids · 7/10 · 27 August 2018]

It's a really good eye opening documentary, but sadly most of the film is about Essure and nothing else... There was only mention of 2 other medical story's which lasted only 5-10 minutes, mostly about female anatomy.

The ultimate reason of why we created films

[clairelang · 10/10 · 26 August 2018]

If there's a film that can literally save lives, this is it.

Shocking for the ignorant

[Erik_Stone · 6/10 · 12 December 2020]

This documentary really does show how dumb so many Americans are when they trust doctors with their lives. They trust government, the media, and doctors, as if they were all gods. Even when these entities betray them, they immediately go right back to them for solutions, starting the cycle over.

A bias and sloopy documentary

[leovnmemo · 5/10 · 9 August 2018]

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.

Sad truth

[inkthestreetac · 10/10 · 5 March 2019]

There is a reason that mostly women are targeted, no one listens to us. I had the iud's, the pill, the depo and finally my tubal and I can say each one was a horror story. I bleed so much for WEEKS after getting the iud's and was told I was lying and it was impossible. I told them if it's impossible then why ask me the question. The pill made me itch so much I scratched skin off and the depo gave me a horrible rash. With my tubal, I was never told I would suffer horrible pain years after getting it. After all these problems I honestly don't believe doctors and question everything. Like one of the women in the documentary I went online and found multiple women like me. I went to the fda site and none of my symptoms where there. It's a scary feeling.

Excellent ! Important if you want to be an educated patient making the best decisions for yourself

[Cookiejar55 · 10/10 · 10 May 2020]

The documentary covers Essure, pelvic mesh,the Depuy ASR hip implant and the Davinci surgical robot. I wish it had also covered the insanely dangerous pain pumps they push on pain patients (they can never be removed one implanted) and the medtronic SC stimulator (also for pain, can leave you paralysed or with severe nerve damage). Then this documentary would have been perfect. It's important to remember to never trust everything your dr says and to always do your research. New means unproven. I for the same reason have always refused IUDs which in my opinion are dangerous and even deadly. (they can migrate inside the body).

Eye-opening Documentary

[hlinhvu96 · 10/10 · 26 August 2018]

I wasn't aware of the medical devices industry and how evil the FDA is before watching this movie. This documentary is a must watch for everyone!

Scary Truth About the Health Care System

[lornak-18008 · 8/10 · 9 October 2021]

Very well done documentary about medical devices and the people that have had their lives ruined because of several very flawed devices. The FDA's reputation is on the line here and I think I will never be surprised again when the FDA messes up and okays a product for medical use that should never been approved. The loop hole they utilize to circumvent more study and more experiments should have been closed decades ago. Instead, more and more companies use the loopholes to get their product on the market when they never should have been. It all seems to lead back to greed. Big bucks to be had in this industry for sure.

I thought it was well written and easy to follow. But more importantly, I think the message about the medical devices is impressive because it educated about the many adverse reactions medical devices cause in human bodies in some or more than some people. I also was very interested in hearing the patients stories told by the actual patients and also where the people ended up. Very sad actually.

Excellent documentary

[henorychlik · 10/10 · 4 August 2018]

One of the best film I have seen in this topic. The Pill, The Sugar Film and Bleeding Edge are very important messages explaining how western system of control, run by government agencies is broken and is serving big corporations, not the people.

True but too long

[patbig-97092 · 5/10 · 29 July 2018]

As always tremendously well executed by Netflix. But the exact same message could have been demonstrated and showed in a much shorter movie. In the end, there are only a few medical devices addressed and the movie unfortunately becomes more and more repetitive.

Business as usual

[b4blue · 10/10 · 26 October 2021]

I am not surprised by what is happening. My mom told me about the operations she was put through, to avoid abortions, back in the 70's and 80's. Same crap. They inserted the spiral, which caused so many problems... then they tied up her tubes and this also caused a lot of problems, and she keeps suffering from the side effects. For all these procedures they told her they are safe and routinely done. Men should never make women go through all these horrors to avoid pregnancy. We should be more responsible. If we do our part, women will not be exposed to these horrors.

if you are an anti-vaxxer you will love this nonsense

[random-70778 · 1 April 2019]

Fact: the US has immensely better health outcomes on the types of conditions that these implant are used for than France, Germany, Denmark or the UK. that ids a stone cold fact attested to by all the data. With the same amount of heart disease, US patients who get devices such as stents live about 20% LONGER than EU patients with the same degree of coronary blockage. They live more active lives after treatment as well

what this nonsense "documentary" does is compare heart disease outcomes in total without taking into account and controlling for overall lifetime levels of exercise and diet. Your US cardiologists is presented with you at 50, 60, 70 or 80 with the existing FACT that Americans on average exercise less throughout their lives, are more sedentary and have worse diets. That is not the fault of the people inventing and placing stents. No one in that field is saying you just need this and go eat a bag of chips while driving to work.

but when we compare a given Americans of a given age, with a given amount of blockage, and other factors held constant to European with that blockage at that age, the Americans patients given stents live longer .

What is being also ignored is the socialized health care countries simply do not want to pay for these and offload risk and cost to the US. The type of stent my grandfather has was not available in Europe for nearly a decade and now it is. His is a pressure stent at the top of spinal column, before he had gotten it his health declined rapidly at 67. He had been quite active, but with balance problems he could not only not be active, he could not walk unaided due to balance problems. he looked terrible and we thought he had a year or two to live. he got the stent and his health changed completely. he just finished a bicycle tour of the canal region of France.

That is just the tip of the iceberg, and the parade of cringeworthy methodology errors/false assertions presented in this junk science film are a huge disservice to the public.

By the way I have no affiliation with any company and do not work in the health care field, although I do work in the sciences. Anyone can see I have many years on IMDB and did not sign up to shill (while some of the ten star reviews here are single use and likely shills)

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Absolutely terrifying and extremely important!

[katier-868-270801 · 8/10 · 9 October 2020]

This film had me in tears and terrified of everything any doctor has ever told me. But it's extremely important. There are so many things I was entirely unaware of, and I feel more informed for having watched this.

If you thought the #Big #Pharmaceutical & #Biotech #industries were horrifically bad & out of control...wait until you see what the #medical #devices #industry is all about...

[surfmantango-50474 · 10/10 · 5 September 2022]

If you thought the #Big #Pharmaceutical & #Biotech #industries were horrifically bad & out of control...wait until you see what the #medical #devices #industry is all about... Talk about a real horror movie...modern medicine has become so financially lucrative and so corrupted by excessive greed and evil men, women who sit in top CEO corporate positions... if you need any kind of surgery, medical device or hip, joint, or other type of replacement from immense pin & suffering, then going to see a medical specialist in this field will make your worst nightmares a dark reality! YOU'VE BEEN WARNED!

My personal suggestion... put your faith in Almighty God and ask Him with a deep and sincere heart in quiet prayer for a miracle to be fully healed by Him directly. It won't cost you a single penny. Many such incredible miraculous stories on 100 Huntley and CBN, The 700 Club...Whatever your illness, pain or suffering, God is there for you, all you need to do is pray & ask...Supernatural Healing Has Woman Asking Everyone, "Would you like to hear my miracle story?" See on Youtube.

Touching (a nerve)

[kosmasp · 8/10 · 22 December 2018]

Actually more than a nerve - some would argue that literally it's also more like cutting. But let's not get ahead of ourselves. The documentary itself may seem to be aimed more at women at first, but if you really think about it, just because it is a female problem, it doesn't mean only they will watch it and find it disturbing. Empathy but also curiosity is strong in this one.

And I don't want to make light of the things that are being depicted in the documentary. On the contrary: You might be baffled what things that should be obvious still happen ... it's preposterous to say the least. But since the documentary was made and came out, some movement seems to be on the Horizon. At least that's what the text before the end credits tells us ... let's hope it is true. And yes you are human if you are deeply disturbed while watching this ...