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.

hkbateman228 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.

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