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Thanks for the memories!

Good movie but grossly overrated

This movie was so-so. It had it's moments, but wasn't the greatest.

Exactly the movie you think it is, but not the movie you want it to be.

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.

I found this a first class documentary about the countries medical implant industry. How bizarre that these implants don't have to be tested, unlike new drugs, on humans but can be sold if they are similar to those already on the market. The program devotes a lot of time to Bayer's birth control implant Essure. In Europe the EU raised various questions that Bayer didn't want to answer and the product wasn't sold in there, now with thousands of court cases in this country Bayer have decided (for business reasons) to take the product off the market by the end of 2018.Essure is just one of the implants revealed in the film to cause medical problems another was metal hip replacements that can slowly fail over time and cause cobalt poisoning. Medical mesh merges with internal organs and tissue making it extremely hard to correct in later operations when there are problems. The Da Vinci robot surgical operating machine is too complex for surgeons to use unless they have had extensive training, the film revealed that many had not even though the company told the FDA that there would be a serious training program for surgeons, having got their product approved the training option evaporated.One thing that impressed me about this documentary is the absence of those dozens of little clips you get in documentaries these days to fill up time between one main point and another and they usually have annoying background music. In 'The bleeding edge' it's almost all people talking to the camera in a straightforward conversational way that gives the whole thing great credibility. There is background music but it isn't excessive. As a documentary this is an impressive change from the usual over-the-top-production that is the norm these days.

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.