Below are some of our videos explaining the potential dangers of Essure, and especially the connection to severe abdominal injuries. To learn more about the types of injuries that have been linked to this medical device, and the legal claims that have been filed, click Essure Birth Control.
Essure Birth Control Pulled From Market After Thousands of Lawsuits
Mike Papantonio: The Bayer HealthCare companies announced that they're going to stop selling their controversial birth control called Essure. The company says it's because it wasn't selling well, which is likely because it was destroying the lives of women all over the country. That's really why they're doing this.
This is a simple story to understand, okay? This company, Bayer, has made this product. They know it's a birth control, it's totally and unnecessary birth control. There are more birth controls out there that whatever the problem is that a woman is having with a particular kind of birth control, there are other alternative out there for them.
Essure was one of these lookalike kind of deals. Other people are doing something similar, we want to try this ourselves. Now what they're finding is the Essure that's embedded in the body is breaking off in the body, migrating throughout the body and causing real serious injuries to people. That's why they're pulling the product from the market.
As you know, I handled the, years ago, handled case against Bayer for another birth control pill and the problem with it sometimes is, they're always looking for that cash cow. They're always looking, this was called Yaz. It was a pill called Yaz. This is not a pill. This is, it's implanted in the body, this Essure. But they're always looking to get on the very edge of the new cash cow.
That's what happened here, isn't it, Farron?
Farron Cousins: It absolutely is and now they're saying well, this cash cow stopped giving us milk. It has nothing to do with these 16,000 lawsuits we're facing over this product in the US alone. No, no, no, it's because it wasn't selling well. And there's a reason. It's because, as you just pointed out, it's destroying the lives of women like so many other products that we see.
Essure is a permanent form of birth control. It's this implantable device and just like every other implantable, small, metallic device we see in bodies, it breaks apart.
Mike Papantonio: IVC filters, the same thing.
Farron Cousins: IVC filters is a great example.
Mike Papantonio: Same kind of deal. Breaks apart, moves systemically through the body. Lodges in organ systems, including the brain, by the way. The heart. This is the same problem here with Essure. They knew. They've known the science of implant fracture for ages. They know the science on it. They know it's bad. They know there's never been a good experience with this.
Farron Cousins: Due to the location of the device in the Fallopian tubes, most of the injuries that they're seeing involve, there's a lot of kidney damage, a lot of abdominal pain, because usually when it breaks off it'll embed almost immediately wherever it can get to. Sometimes it will migrate. It will go to the brain. It will go to the heart. If you're lucky enough, it's not going to go there and immediately kill you. Instead, it'll ruin a kidney.
Mike Papantonio: Right.
Farron Cousins: It'll ruin a bowel, a bladder. Anything it can latch itself onto and Bayer knew it.
Mike Papantonio: Actually pierce the bowel. That's one of the bigger problems.
Farron Cousins: Yeah.
Mike Papantonio: Let me tell you a quick story. I think this is pretty instructional about Bayer as a company, generally. I've been toe to toe with Bayer on several occasions that's the same culture. It is a culture of, we want to follow the cash cow. We're going to make as much money as we can. We're going to leave what I call quick profits, horrible risks. Quick profits for the company, horrible risks for the consumer.
This was in the Yaz case. This woman that was testifying on Bayer, her name was North. She was the number three PR person for Bayer. Her job was to go across the country telling the story about how noble Bayer was. Talk about the actual character of Bayer, which in a civil suit, it's important to know, character of either party is never at issue. You don't allow character into a discussion. If somebody robbed a bank years before, yeah, maybe that comes in, but general character doesn't come in.
Okay, so she testifies, Farron, and I think you've seen this. I actually put it in one of the books, the first book I wrote called, Law and Disorder. It was a book about the Yaz case and several other cases. A fiction. It's a fiction book, but this is a true part of it. Where I have her on cross-examination, I said, "Mrs. North, now you've been testifying here about what a wonderful corporation this is, their honesty. You testified about their integrity. You testified how they just do things right and they always have the consumer in mind and they would never..." Basically her bottom line, we would never do anything wrong. We would never hire people who do things wrong. That's the catch.
So I said, "Well, Ms. North, have you seen this picture?" I put a picture up of a fellow named Fritz ter Meer. She says, "I've never seen that picture." Well, the picture was Fritz ter Meer, who was CEO of Bayer at the time. Actually, continued to be CEO of Bayer after this incident. Fritz ter Meer was a war criminal. In Auschwitz, he helped design the gas that killed hundreds of thousands of Jews in Auschwitz. I said, "Well nobody ever told you, talking about the integrity of this company, nobody ever told you about Fritz ter Meer?" "No, I didn't know about Fritz ter Meer."
Well, she didn't know that I had another document. And the other document was a document that showed that every year Bayer continues to have a celebration for Sir Fritz ter Meer. Literally a celebration, a graveside celebration, where they give a scholarship away to the leading scientist of a university or a student in a university, and she had been there.
So first of all, she's lying about Fritz ter Meer. The real story about Fritz ter Meer is that Bayer was so up to their eyeballs in the Nazi movement in the second World War that they actually designed gas to kill people. Those same people who did that went to work for Bayer after the war.
So it was a startling moment. It was the kind of moment where you go, well it was so startling that when it came up right before trial, they settled the case for all of the Yaz cases throughout the country.
So this'll be another opportunity to tell that story in the Essure Case.
Farron Cousins: Well you know, I think there's also another part to that story, though, because if I remember correctly and I could be wrong, so feel free to correct me, but wasn't this Yaz, 'cause I was here with you, wasn't that the story that when it first came out was pitched to the New York Times-
Mike Papantonio: Yes.
Farron Cousins: ... and the New York Times, after kicking it around for a few months, "Oh, we've got this reporter. They're working on this great, great, great story. This is going to be huge, we're going to blow it out of the water." Publication day came and they said, "We can't. We don't want to ruffle any feathers."
Mike Papantonio: That's exactly right.
Farron Cousins: So-
Mike Papantonio: Exactly right. It's worse that that. It was actually, I was actually working as a contributor for MSNBC. Not regular, but I was a contributor. I would appear once every couple of weeks until I went to work with Ed Schultz. When he had his show, I would be there sometimes two or three times a week. But I remember pitching this story and the producers couldn't do the story because the advertisers wouldn't let them.
Tens of Thousands of Women Injured by Defective Essure “Permanent” Birth Control
Papantonio: When it comes to birth control the drug maker Bayer has the market corner but they also have more problems than any other companies that I’ve seen out there. I handle cases against these companies all the time. I have consumer lawyer, Travis Lepicier, with me now to give us the latest details about birth control devices that are ruining lives of women and in fact, causing the deaths of women. Travis, the FDA drops the ball again. I mean I’ve said it so many times on this show. It seems like almost every month there’s another FDA failure that’s killing people, and this is just another one of them. It’s killing women. It seems like women have become the target of the pharmaceutical industry and the device makers where they’re the ones suffering the most from the negligence of the company. Sometimes it’s pure intent of the company but certainly the dysfunctional nature of the FDA is causing a lot of these problems. Tell us about this Essure, this birth control issue.
Travis: Sure. Well, thank you for having me. Essure is a permanent contraceptive, it’s intended to be a permanent contraceptive for women. What it is is two small metal coils that are inserted into a woman’s fallopian tubes with the intention of her skin, her tissue inside her fallopian tubes wrapping around these coils and blocking the eggs from traveling down her fallopian tubes to prevent her from getting pregnant. These tubes or these metal coils are inserted into her fallopian tubes. What the company says is it’s a non-invasive procedure so it’s supposed to be very simple for the coils to be inserted, and it’s supposed to be a much safer and less invasive alternative to having the woman’s tubes tied which is a traditional form of contraceptive.
Papantonio: Right. The idea is that you create a scar tissue within the fallopian tubes, the scar tissue actually is permanent. This is a permanent sterilization process and rather than going through the other … There are two or three ways to accomplish that but this probably is the least attractive. If you look at this what’s happening from the reports that I’m looking is you have breakage of these coils, and we’ll show the viewers what it looks like on screen here. That you’ll have breakage from those coils, you’ll have nickel allergies, you’ll have heavy metals actually moving through the body and causing all the disease process that heavy metals can cause. Most of the time that’s auto-immune types of problems. Then you’ve got also the idea that this doesn’t even stop pregnancy and the pieces that break off seem to be migrating through the body. Did I get that right? Is that kind of a constellation of the types of illnesses that we start seeing or problems that we start seeing?
Travis: In a nutshell I think you’ve captured what we are seeing. A lot of the women who have the Essure devices implanted are complaining of your typical general complaints of abdominal pain. Then when you look a little further into what these women are reporting they are reporting that the device has migrated, they are reporting that the device has perforated their uterus, perforated their fallopian tubes, or migrated to other areas in the pelvic region causing them severe pain. To touch on the nickel allergy this device is comprised of nickel and many women have an allergy to that metal. If they’re not adequately tested it can obviously cause problems with having this device inserted inside of a woman’s body and having her scar tissue wrap itself around that nickel and be connected to that nickel constantly. It’s causing-
Papantonio: One problem that most people are aware of when you have and you caught it’s the term is an allergy but what ends up happening when you trigger the autoimmune system like the heavy metals have the ability to do you are able to cause lupus, scleroderma, and a whole host of auto-immune reactions. That’s what we saw with the breast implant cases. That’s what we’ve seen with so many implanted medical devices that women typically end up suffering through these various kinds of diseases. What’s clear to me, Travis is the FDA knows all these and Bayer, I think what you’ll find as you go further into this case, cover it up. There’s no question you’re going to find Bayer covering up some of the truth to the problem here. The FDA knew about it but they allowed it to happen anyway. What’s your take on that?
Travis: That’s correct. I think the FDA certainly knew about it and the company knew about it as well. They knew that the product was comprised of nickel, they knew that if women were not adequately tested for whether or not their body could handle having the device implanted in them that there would be serious repercussions. Unfortunately, this device was approved through something that’s called pre-market approval which is an FDA process that really shields the company who manufacture the device from liability for any harm that their device is causing. When this product first came on the market in 2002 it was approved through FDA’s pre-market approval process and that would, that means-
Papantonio: What that means is they don’t test anything. They don’t have any independent testing, they have to take the word of the people putting it on the market, in this situation Bayer. That’s no protection for the individual.
Travis: That’s correct, and that’s essentially what they did. They took the numbers that the manufacturer had presented to them in the pre-market approval process, they took them at face value, they didn’t really look into them any further as far as the reports of pain that women were indicating in the initial studies when this product was first being looked at by the company. There was plenty of information out there that should have tipped the FDA off that this product was going to be problematic and that it should not have received pre-market approval. Yet, the FDA eventually did grant pre-market approval and we now have this situation where we can tell that these women are being injured by this product but they have very little recourse because the FDA has granted pre-market approval to the Essure.
Papantonio: Not just injured but dying. You have deaths again, where the FDA has done a sloppy awful job, and more people are dying because of it. I don’t see any change coming, to tell you the truth. We thought we would see a change with this administration. It only got worse with this administration. Travis, thank you for joining me.
Travis: Thank you, Pap.
FDA Finally Gets Tough on Deadly Birth Control Product - Essure
Farron: Essure a permanent form of birth control for women received a black box warning recently because it was causing extremely dangerous side effects in women. Joining me now to explain what's happening is attorney Travis Lepisear. So Travis before we get into what has happened so far with Essure tell us quickly what exactly this Essure product is.
Travis: Essure is a female contraceptive that's intended to be permanent and what the device is are small metal coils that are inserted into a woman's Fallopian tubes that will eventually block her Fallopian tubes off and will have the effect of acting as a contraceptive.
Farron: And so just recently the FDA announced that they were going to put a black box warning on this product. What are the side effects, what exactly is happening once women have this implanted, where's the danger?
Travis: Sure well one of the big problems that we're seeing with this device is that it's breaking or migrating inside a woman's body, and that can obviously have serious consequences for the woman, the women that are injured by the device. They often have to have a complete hysterectomy removing their uterus and Fallopian tubes just to get the device out and identify where it's migrated to, that's major surgery for these women and it can often lead to catastrophic life altering process for these women so it's definitely detrimental to these women who are suffering these injuries and the thing about it is there's a lot of women out there who are suffering these injuries. I get calls everyday and we're seeing that the device migrates that it perforates the Fallopian tubes when it's inserted.
There's also an issue with the metal that the device is composed of, there's a nickel component to it and many women are having an allergic reaction to it and they're not warned that nickel is in the device and they're not tested for nickel allergy.
Farron: And with the hysterectomy comes a lot of other medical side effects just from that, it completely throws hormone levels off balance, a woman will likely have to be on a hormone pills or injections for the rest of her life, so I guess kind of like every other case we see involving some kind of faulty product the big question is what did the company know and how long did they know this before the public found out?
Travis: Sure well you know the device has been on the market since 2002 and they clearly had to do studies to get their approval for it before that and at the time they understood that the device was causing perforation, that the device was migrating, and that there were serious complications associated with use of the device. Keep in mind Bayer is a large pharmaceutical company they're the manufacturers of this device and they thoroughly understood what the product was and the issues that are associated with it. There's also indications that they had reports, significant amount of reports, up to 16,000 reports of perforation that they did not report to the FDA and Bayer's explanation was well we didn't report these perforations because the women hadn't reported any pain yet, so that was their whole justification for not reporting something in the neighborhood of 16,000 incidents of perforation.
Farron: So 16,000 incidences where there was perforation, there was side effects, but because there was no reported pain to the company they just decided that this was something that the FDA, that the rest of the consumers in the United States didn't need to know about. Look this is some truly disgusting corporate behavior that we're seeing here, and unfortunately this has become the norm and especially now that you have the FDA that really works for the pharmaceutical companies does whatever they can in their power to keep products on the market when they shouldn't be, and to approve products that shouldn't be approved, I mean 60% of the testing that the FDA uses to approve a product comes directly from the pharmaceutical industry. The FDA does very little testing of their own anymore, so instead of pulling this product off they've put a black box label on here and so what exactly does that mean?
Travis: Well it means that they're indicating the initial warnings were not sufficient that there are problems with the device that need to be brought to a woman's attention before she makes a decision to have an Essure implant. A black box warning is the most prominent warning that the FDA can have so it's going to be on the product labeling and the product information so that it's clear that this device has serious side effects that are associated with it such as migration, breaking off, and perforation, so the black label, the black box warning is certainly beneficial as far as putting women on notice to these issues, but from another standpoint as far as women who have already been hurt by this device, it perhaps opens up the courthouse doors. Keep in mind Essure device was approved through the pre-market approval process and that often affords defendants a shield against liability when their devices cause harm.
So now that the FDA is updating the label and putting a black box warning on there it takes that pre-preemption argument that comes along with the pre-market approval and makes it not as sturdy of a shield for Bayer. And perhaps the women who have been injured by this device will now be able to pursue litigation against Bayer for their injuries. Before the FDA's action this Monday, many of the women who had been injured by this were facing a very daunting uphill legal battle even though it was clear that this device is what caused their harm.
Farron: Travis luckily we do have people like you out there fighting back against this kind of corporate conduct on behalf of these women who have been severely injured by this defective product. So thank you for telling us the story thank you for all the work that you're out there doing every day.
Travis: Thank you.
Pharma Execs BUSTED Paying Millions To Doctors To Push Deadly Drugs
According to a bombshell new report on CNN, doctors across the country have been paid by big pharma to prescribe you dangerous medications. Specifically, this CNN expose looked at the Bayer Healthcare Corporation, and their conduct regarding their permanent birth control method called Essure.
Now, what this is, it is a small metal device that is implanted into a woman's fallopian tubes, and it's supposed to stay there forever, and prevent her from ever getting pregnant. In reality, what's happening is that little metal device is breaking apart, sending little shards of metal all through women's bodies. According to some of the people interviewed for this CNN piece, it resulted in them having hysterectomies, removing the uterus and fallopian tubes, because they were all embedded with that metal, and to remove the organs was the only way to actually get the medical device out of their body. Bayer announced last week they were taking this thing off the market, but that still doesn't excuse their behavior, and the behavior of the doctors who prescribed it because they were on the dole from Bayer Healthcare Corporation.
Here's what this investigation found. Between 2013 and 2017, Bayer paid $11,850, a combined two and a half million dollars, all related to that Essure permanent birth control device. Two and a half million dollars, spread out between almost 12,000 doctors. So, yeah, some doctors got a little less, maybe a few hundred dollars, maybe a few thousand. A couple of them, though, made close to 200,000. There's this one doctor, Dr. Cindy Basinski, who got $168,000.68 from Bayer, all to promote this device that they knew was faulty. They knew it was destroying the lives of women, and yet these doctors did it anyway.
According to some of the women who were interviewed in this piece, their doctors actually were very pushy about forcing them to get this device. They say they were very aggressive with it. They did not want the women to know that there were other options, other possibilities. They were being paid by Bayer, and damn it, they were going to push those Bayer devices.
This is not unique to Bayer and Essure. This happens every day with medications across the board. Big pharma ... And there is a phenomenal expose on ProPublica Dollars for Docs. It started several years ago, where they document all of the money that doctors take from health care organizations. You can actually go on there and look up your own doctor. But these doctors are more likely to prescribe a medication if they have been paid by that health care company. It's simple cause and effect.
Just like in political campaigns, the candidate who spends the most money typically wins, the same is true with medicine. Whichever pharma company pays the doctor the most money, they're going to be the ones that win that prescription, regardless of whether or not the drug they're given, the device they're given, is going to kill or maim or disfigure that consumer. It happens every day.
The worst part about all of this is, it is 100% legal. It may be unethical, but nobody's getting in trouble for this. They can't have their medical license revoked. This is something that happens daily. Big pharma's a part of it. Too many ... well, apparently thousands upon thousands of doctors in this country are a part of it, and patients never know.