TexasCHLforum.com

Not tested by humans, FDA approved anyway and many, many of these devices from mesh, to sterilization implants, to pace makers, to various joints replacements are making people dreadfully sick all over the world.

This is the rare documentary that had me on the edge of my seat.

It is an eye opening, astounding whistle blower.

Not interested you may say?

Look into Essure, a female sterilization implant. It's injured thousands of women.

Hype?

Well, if you're future or even now necessitates a medical implant of one type or another (pray it doesn't contain cobalt) you are at risk. Big, big risk.

Still think nah, the FDA won't let that happen except they're lobbied so hard by medical device folk, they are no longer on your side. Guess who they really work for...?

The documentary is available on Netflix Streaming.

Watch it for your or a loved ones sake.

You'll be glad you did.

P.S. they also touch on robotic surgery. Stay way, way away from that as the sellers assure doctors they'll get all the training they need in order to be competent. Once they sell the machine, for the most part the doctors are on their own. The sellers say after 10 surgeries a surgeon will be proficient. Wrong.

One surgeon said, he self taught himself to use the robotic surgical machine and only until after 300 or so surgeries using the robotic surgical machine did he feel competent. Wonder about those first 300 or so? Bad news for them as an poorly trained robotic machine surgeon is a hazard to patient health...

Yeah, I know the above is scary, most especially if you're an 'implantee'...

Think what I posted is hyperbole?

I wish...

Abraham wrote: Wed Aug 01, 2018 1:00 pm Yeah, I know the above is scary, most especially if you're an 'implantee'...

Think what I posted is hyperbole?

I wish...

How much of this is just a sales pitch for the malpractice lawyers who salivate at the money they can earn. Us older guys are real happy with our cataract lens implants, getting better every day. Don't believe all the fake news.

Many of us wouldn't be here without those implants, cardiac stents, aortic grafts, and others. This is not hyperbole.

Bayer hits back at Netflix medical device documentary

Bayer said in a statement: “The film presents an inaccurate and misleading picture of Essure by relying almost entirely on anecdotes, cherry-picking information to fit a predetermined conclusion, ignoring the full body of scientific evidence that supports the FDA’s determination that Essure’s benefits outweigh its risks and disregarding the appropriate warnings that accompany the device.”

https://pharmaphorum.com/news/bayer-net ... re-safety/

Getting an insert is a dangerous procedure with long-term potential risks.... Or did you not read the paperwork?
But compared to NOT having that stint put in place, I would say it is much safer.

Are things probably too financially driven? Yes, but it is still scientific development.

Bitter Clinger wrote: Wed Aug 01, 2018 2:06 pm Bayer hits back at Netflix medical device documentary

Bayer said in a statement: “The film presents an inaccurate and misleading picture of Essure by relying almost entirely on anecdotes, cherry-picking information to fit a predetermined conclusion, ignoring the full body of scientific evidence that supports the FDA’s determination that Essure’s benefits outweigh its risks and disregarding the appropriate warnings that accompany the device.”

https://pharmaphorum.com/news/bayer-net ... re-safety/

I actually watched the movie a day or two before Abraham posted the OP. The number of women who have been factually harmed by the E-sure implant now number in the thousands ...... including the nurse who was one of their former spokespersons urging women to have it implanted. A half dozen cases is “anecdotal”. Thousands of cases is a big problem. The issue isn’t just the evidence of harm though, it is the manner in which medical devices for implant are approved by the FDA. There are two different approval methods.

In one method, the applicant has to actually demonstrate that their implant is safe to use commercially. The standards are not that high to begin with, and the tendency is for the manufacturers to leave out negative data in their reporting to FDA for approval.

The second method is under a process known as 510(K), in which the applicant testifies that their new product is substantially the same as a produced that has been previously approved. In fact, you can have generations, where a product is approved because it is substantially the same as second product that was previously approved, because IT was substantially the same as a third product which had previously been approved, because the third product was substantially the same as a fourth product, etc., etc., etc. But what happens sometimes, is that the ORIGINAL product, on which all these other ones’ approvals are based, has been withdrawn from the market because it has been proven to be harmful .......thereby invalidating the subsequent approvals based on that model......BUT, nobody follows up and prevents the 2nd or 3rd generation products from being sold, even though they sometimes turn out to be as dangerous as the original which was withdrawn.

MANY times, the doctors who implant some of these products, receive “kickbacks” from the manufacturers for choosing their implant over a competitors.

The movie, by the way, is NOT “anti-implant”. All it really does is cast a critical - but not dismissive - eye on innovation that doesn’t really innovate, but is driven more by the same kind of market forces that cause car manufacturers to update a model’s body style periodically. In other words, the innovation isn’t driven by actual improvement, it is driven by the need to bring the “latest thing” to market ......even if the latest thing isn’t actually an advancement in the technology.

I am NOT one of those people who are anti-vaccines or anti-implants, nor am I one of those people who think that the medical profession unnecessarily kills hundreds of thousands of patients every year. Medicine, for all of its avances, is still as much art as it is science, and sometimes, just plain bad luck plays a part in patient outcomes. I worked inside a hospital environment to know that there are no 100% guarantees in medicine .....only scales of probability. But even I was impressed with the hard data presented in the movie, in addition to the anecdotal evidence.

I’d recommend watching it, and then deciding for yourself where you think the truth lies. Of course Bayer issued that statement. Bayer was ALSO given opportunity to state its case within the context of the movie, and it declined to do so. That the movie is a bit one sided is their fault, because they refused to participate, so the producers went with the data they could get. Even so, the numbers presented seem legit. You should watch it and see for yourself if you think it is bunk or not, instead of just taking Bayer’s word for it.

I think that I now have a broader view of that part of medicine than I had before watching it, and more knowledge is a good thing. It doesn’t mean that I would refuse an implant for myself, but it DOES mean that I would research it before blindly agreeing to whichever implant that particular doctor is pushing.

Added to me Netflix que.
Thanks for the follow-up. I'll pop back in once I've had the chance to watch it.

The Annoyed Man wrote: Thu Aug 02, 2018 12:02 am

Bitter Clinger wrote: Wed Aug 01, 2018 2:06 pm Bayer hits back at Netflix medical device documentary

Bayer said in a statement: “The film presents an inaccurate and misleading picture of Essure by relying almost entirely on anecdotes, cherry-picking information to fit a predetermined conclusion, ignoring the full body of scientific evidence that supports the FDA’s determination that Essure’s benefits outweigh its risks and disregarding the appropriate warnings that accompany the device.”

https://pharmaphorum.com/news/bayer-net ... re-safety/

I’d recommend watching it, and then deciding for yourself where you think the truth lies. Of course Bayer issued that statement. Bayer was ALSO given opportunity to state its case within the context of the movie, and it declined to do so. That the movie is a bit one sided is their fault, because they refused to participate, so the producers went with the data they could get. Even so, the numbers presented seem legit. You should watch it and see for yourself if you think it is bunk or not, instead of just taking Bayer’s word for it.

I think that I now have a broader view of that part of medicine than I had before watching it, and more knowledge is a good thing. It doesn’t mean that I would refuse an implant for myself, but it DOES mean that I would research it before blindly agreeing to whichever implant that particular doctor is pushing.

Bayer did not "refuse to participate". Bayer said it provided The Bleeding Edge’s producers with “extensive scientific information on Essure before the completion of the film”, insisting that they chose to use “cherry-picked anecdotes”.

Why should a world class ethical pharma co. like Bayer participate in a film designed to denigrate them and thereby lend give credence to it? The filmmakers are the ones guilty of avarice and greed. It would not surprise me to find that the filmmakers were bank-rolled by contingency fee liability lawyers.

I might suggest that until you have actually stood before the FDA and filed a 510K and truly understand how much objective evidence, data and extensive work is required to bring a Class III medical device on-market, that you give the benefit of the doubt to the manufacturer and not to folks who make their living not by saving lives, but through the marketing of sensationalism and fear-mongering.

As someone else pointed out, none of these medical solutions are a slam dunk deterministic success. All such procedures and devices have inherent risk. What a company like Bayer is really good at is reducing, to the maximum extent practicable, any non-systemic risk.

Bitter Clinger wrote: Thu Aug 02, 2018 7:59 am

The Annoyed Man wrote: Thu Aug 02, 2018 12:02 am

Bitter Clinger wrote: Wed Aug 01, 2018 2:06 pm Bayer hits back at Netflix medical device documentary

Bayer said in a statement: “The film presents an inaccurate and misleading picture of Essure by relying almost entirely on anecdotes, cherry-picking information to fit a predetermined conclusion, ignoring the full body of scientific evidence that supports the FDA’s determination that Essure’s benefits outweigh its risks and disregarding the appropriate warnings that accompany the device.”

https://pharmaphorum.com/news/bayer-net ... re-safety/

I’d recommend watching it, and then deciding for yourself where you think the truth lies. Of course Bayer issued that statement. Bayer was ALSO given opportunity to state its case within the context of the movie, and it declined to do so. That the movie is a bit one sided is their fault, because they refused to participate, so the producers went with the data they could get. Even so, the numbers presented seem legit. You should watch it and see for yourself if you think it is bunk or not, instead of just taking Bayer’s word for it.

I think that I now have a broader view of that part of medicine than I had before watching it, and more knowledge is a good thing. It doesn’t mean that I would refuse an implant for myself, but it DOES mean that I would research it before blindly agreeing to whichever implant that particular doctor is pushing.

Bayer did not "refuse to participate". Bayer said it provided The Bleeding Edge’s producers with “extensive scientific information on Essure before the completion of the film”, insisting that they chose to use “cherry-picked anecdotes”.

Why should a world class ethical pharma co. like Bayer participate in a film designed to denigrate them and thereby lend give credence to it? The filmmakers are the ones guilty of avarice and greed. It would not surprise me to find that the filmmakers were bank-rolled by contingency fee liability lawyers.

I might suggest that until you have actually stood before the FDA and filed a 510K and truly understand how much objective evidence, data and extensive work is required to bring a Class III medical device on-market, that you give the benefit of the doubt to the manufacturer and not to folks who make their living not by saving lives, but through the marketing of sensationalism and fear-mongering.

As someone else pointed out, none of these medical solutions are a slam dunk deterministic success. All such procedures and devices have inherent risk. What a company like Bayer is really good at is reducing, to the maximum extent practicable, any non-systemic risk.

It had not occurred to me that lawyers would fund the movie, and that means that my due diligence includes - apparently - following the money. That shouldn’t be too hard. Look, I’m trying to be an honest broker here. As I previously said, I’m not one of those people who signs onto unproven fads, or medical causes. For instance, I do not jump on “big pharma’s“ case at every opportunity, and I DO believe in better living through chemistry. I worked inside the healthcare industry long enough to know that dumb luck gets a vote, and that medicine is still equal parts art and science; so there are no 100% guarantees, and anyone who tells you there are is not being truthful with you.

Almost three months ago, I had cataract/lens implant surgery in both eyes. I paid extra for the “latest greatest” lenses, because I wanted to maximize the results of an invasive procedure. The surgery was not without some side effects, some of which I am still experiencing. But, even with the side effects, my eyesight is so vastly improved over its previous state, that I call the surgery a success rather than a failure. I followed the link provided in the movie (https://openpaymentsdata.cms.gov) to see if my eye surgeon had accepted money from any implant device manufacturers. Bingo! He had indeed. However, in the world of surgeons, it is a pretty small sum - $32,462.67 for “general payments, and around $110K for research funding, in a total of 186 payments over the years. But here’s the thing....he and his partner are the pioneers in the particular laser surgical techniques they use, and they train other opthamological surgeons in those techniques. That actually seems like a legitimate use of industry funding to me. So I’m not against the actual practice.

What I AM against is physicians who take shortcuts in training for new implant techologies, and I AM against shortcutting approval for new devices. Was the movie NOT being factual when it said that it sometimes happens that a “daisy-chain” of 510K approvals can be based on an original product that was in fact withdrawn from market because it turned out to be dangerous? A point that the movie actually did make is that innovation in and of itself is not a bad thing, but whether or not its use turns out good or bad depends entirely on the decision-makers involved in the process - in other words, the human element.

So, I’ll do my due diligence to see who funded the movie. Will others do theirs to see what the movie actually says, and what it doesn’t say? You can’t have a real evaluation without hearing the arguments of both sides.

OK.... here’s some detail from Bayer’s rebuttal that is cause for concern regarding the integrity of the movie:

https://www.prnewswire.com/news-release ... 87964.html (all emphases below are mine)

The Bleeding Edge also relies on a number of sources to explain and validate its story regarding Essure, but the movie does not disclose conflicts that are essential for viewers to fully evaluate the credibility of these individuals and the film. For instance, psychologist Diana Zuckerman appeared in the film and is well known in the Essure critics community. She spoke at the 2015 FDA Advisory Committee meeting arguing against Essure and participated in another meeting that same year with the FDA organized by an advocacy group that has been critical of Essure. She has also served as a paid expert in litigation for at least one Essure plaintiff, a fact confirmed by The New York Times on July 20, 2018, but not disclosed in the film.

Similarly, Madris Tomes is presented as an independent expert in the film, but she also has a long history working with an anti-Essure advocacy group and joined them in congressional meetings in February of this year. A May 9, 2016, press release by a plaintiff law firm involved in the Essure litigation, Unglesby + Williams, reported on Tomes' work on Essure and described her as someone who was "hired by Unglesby + Williams." Again, this litigation-related work against Essure is not disclosed in the film.

Dr. Julio Novoa was also interviewed in the film, but viewers were not told that he aggressively markets surgery to women to remove Essure and has a financial interest in recommending removal of the product. Dr. Novoa is not a board-certified OB-GYN and has never been trained on the Essure procedure.

All of this reminds me of a doctor I worked with in the ER, who was a gynecologist in private practice. (He had been an Army trauma surgeon in Vietnam, so he had a LOT of surgical experience outside of the discipline of gynecology, and he was a VERY good ER doctor.) He and I were talking about IUDs, and he said that he would not put any of them in any of his GYN patients....only remove them. I asked him why that was, and he said that it was because of how they ALL worked - and that was to cause a constant, low-grade inflammation inside the uterus, that made fetal implantation impossible; and that constant state of inflammation frequently led to other complications - infections, cancers, endometriosis, etc. He was a big believer in birth control pills, and said that the medical risks from the pills were a lot lower than from the IUDs.

What he never said was whether or not the manufacturers of birth control pills were paying him to promote the pill over IUDs. The thing is, even if he was being paid, I think he’s probably right. It makes sense that the risk from a pill containing a hormone which already exists in the woman’s body, would be lower than the risk from an implanted device designed to irritate and inflame the organ in which it is implanted.

The thing is, I think the truth is somewhere in the middle. I am being intellectually honest enough to consider the counter arguments to the points made in the film. Others should be willing to watch the film and balance what it says against what its critics say.

Or not. Maybe it’s simply not important to others. It is to me, that’s all.

The Annoyed Man wrote: Thu Aug 02, 2018 9:52 am OK.... here’s some detail from Bayer’s rebuttal that is cause for concern regarding the integrity of the movie:

https://www.prnewswire.com/news-release ... 87964.html (all emphases below are mine)

The Bleeding Edge also relies on a number of sources to explain and validate its story regarding Essure, but the movie does not disclose conflicts that are essential for viewers to fully evaluate the credibility of these individuals and the film. For instance, psychologist Diana Zuckerman appeared in the film and is well known in the Essure critics community. She spoke at the 2015 FDA Advisory Committee meeting arguing against Essure and participated in another meeting that same year with the FDA organized by an advocacy group that has been critical of Essure. She has also served as a paid expert in litigation for at least one Essure plaintiff, a fact confirmed by The New York Times on July 20, 2018, but not disclosed in the film.

Similarly, Madris Tomes is presented as an independent expert in the film, but she also has a long history working with an anti-Essure advocacy group and joined them in congressional meetings in February of this year. A May 9, 2016, press release by a plaintiff law firm involved in the Essure litigation, Unglesby + Williams, reported on Tomes' work on Essure and described her as someone who was "hired by Unglesby + Williams." Again, this litigation-related work against Essure is not disclosed in the film.

Dr. Julio Novoa was also interviewed in the film, but viewers were not told that he aggressively markets surgery to women to remove Essure and has a financial interest in recommending removal of the product. Dr. Novoa is not a board-certified OB-GYN and has never been trained on the Essure procedure.

All of this reminds me of a doctor I worked with in the ER, who was a gynecologist in private practice. (He had been an Army trauma surgeon in Vietnam, so he had a LOT of surgical experience outside of the discipline of gynecology, and he was a VERY good ER doctor.) He and I were talking about IUDs, and he said that he would not put any of them in any of his GYN patients....only remove them. I asked him why that was, and he said that it was because of how they ALL worked - and that was to cause a constant, low-grade inflammation inside the uterus, that made fetal implantation impossible; and that constant state of inflammation frequently led to other complications - infections, cancers, endometriosis, etc. He was a big believer in birth control pills, and said that the medical risks from the pills were a lot lower than from the IUDs.

What he never said was whether or not the manufacturers of birth control pills were paying him to promote the pill over IUDs. The thing is, even if he was being paid, I think he’s probably right. It makes sense that the risk from a pill containing a hormone which already exists in the woman’s body, would be lower than the risk from an implanted device designed to irritate and inflame the organ in which it is implanted.

The thing is, I think the truth is somewhere in the middle. I am being intellectually honest enough to consider the counter arguments to the points made in the film. Others should be willing to watch the film and balance what it says against what its critics say.

Or not. Maybe it’s simply not important to others. It is to me, that’s all.

I think you will find the IUD info is very outdated as most IUD's work now by hormonal release of progesterone. They can be used for birth control and also can be used for women with very heavy periods. The IUD is the most used birth control method in the world.

As far as FDA approval of medical devices, I actually went through that process with the FDA and hold several 510(K) forms for devices that I manufactured for use in the operating room. All part of a company that I previously owned. The process is fairly difficult but not impossible although it can be very timely and expensive. Dealing with government bureaucrats is never easy. These were not implanted devices though. Just realize that the reason that drugs and devices cost so much is partly because of the difficulty in getting FDA approval.

Please, be certain to take the time to watch the documentary.

Then decide what you think.

Commenting on it without seeing it is...