Too much of everything

From my favorite movies..

By the time the dramatic fireworks start popping off, each one feels earned.

Just intense enough to provide a much-needed diversion, just lightweight enough to make you forget about it soon after it’s over. It’s not exactly “good,” per se, but it does what it sets out to do in terms of putting us on edge, which makes it … successful?

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.

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.

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.

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.