This episode's guest

E. Scott Sills, MD, PhD
E. Scott Sills, MD, PhD
Expert Contributor

On this episode of the Drugwatch Podcast, Dr. E. Scott Sills discusses his book Essureal Journey: Concepts, Concerns and Considerations for Hysteroscopic Sterilization. Nova Science Publishers released the 155-page book in July 2017. The book, edited by Sills, features chapters written by a woman who had Essure implanted, an adverse-event data analyst, doctors and lawyers.

The Essure permanent birth-control system hit the market in 2002 and, since then, thousands of women internationally have received the device. The device consists of two metal coils with plastic fibers. When the device is inserted into a woman’s fallopian tubes, causes the tubes to scar, preventing sperm from reaching the egg and preventing pregnancy.

At the time of Essure’s release, the medical community considered it revolutionary, and it remains the only form of hysteroscopic sterilization available. Women were drawn to a procedure that did not require anesthesia or surgery as an alternative to tubal ligation, the gold standard for permanent sterilization.

However, U.S. Food and Drug Administration has received thousands of adverse-events reports, including hundreds of fetal deaths, linked to the device.

Essureal Journey: Concepts, Concerns and Considerations for Hysteroscopic Sterilization is the first book of its kind to pull together medical, legal and patient voices on Essure into one collection. In this podcast, Sills discusses the goals of the book and his perspective on the Essure controversy.

You can also read Michelle Llamas’ review of the book on Nova’s website.

Last modified: November 21, 2017

Michelle Llamas: Hi there, and welcome to another episode of the Drugwatch Podcast. On this episode today, I've got Dr. E. Scott Sills, the medical director of the Center for Advanced Genetics in Carlsbad, California. Dr. Sills has graciously appeared on our podcast before, and he's also been a contributing medical expert for Drugwatch. Welcome to the show, Dr. Sills.

 

Dr. E. S. Sills: Thank you very much for the invitation.

 

Michelle Llamas: It is so great to have you back again and with some really cool news because you have just become the editor of a new book published by Nova, Essureal Journey: Concepts, Concerns, and Considerations for Hysteroscopic Sterilization, which is a mouthful, but a lot of really good stuff in there. You didn't start out looking to specialize in Essure permanent birth control. Let's talk a little bit about how you ended up studying this device.

 

Dr. E. S. Sills: Right. Well, my practice is limited to reproductive endocrinology, so actually I'm in the opposite line of work. I'm trying to help people have babies and to help people avoid miscarriage. As you said, the Essure device is a contraceptive implant. It's a device that's marketed towards women who are through having babies and that want to have control over their fertility. It's been available since 2002 and has probably been placed into close to one million women worldwide here in the present day. So many people have availed of that new technology for permanent contraception. It's just that some patients have had problems. Some women have experienced some symptoms after having this device placed in their body, and I'm sure we'll talk more about exactly how that's done and the techniques in placing the implants inside the female body.

But some patients have expressed some concerns. That's why that word concerns is featured in the subtitle of the book because there have been many news outlets that have drawn attention to patient complaints about Essure. The Federal Health Data Monitoring platform has been littered with thousands of patients who have contacted them complaining about how their health has declined after having the Essure procedure. As a fertility doctor, I confront these patients because they want it out. They come to see me because they do not want a hysterectomy, but they also want to have their life back. That's sort of the short answer as to how I become involved with Essure removal.

 

Michelle Llamas: Can you give anybody that might not quite understand the device just a quick description of it and how it works?

 

Dr. E. S. Sills: Of course. Well, Essure is a pair of metal implants that are about four centimeters long. You go to the doctor, and you get on the exam table. In the same position like a pap test, the lady has this device placed through the cervix and up into the uterus and then into the hole where the fallopian tube joins the uterus on both sides, so it's a two-device set. The purpose of that implant is to block the fallopian tubes, so that again sperm can't combine, thereby effectively offering a very high level of contraceptive protection to patients who undergo this procedure. The doctors who offer this procedure call it a 10-minute tubal because it essentially achieves the same anatomic effect that having your tubes tied would achieve, except there's no incision on the tummy. It's all done from down below. Essure is a permanent method of female contraception that is marketed as an alternative to a standard tubal ligation.

 

Michelle Llamas: When it first came out, I do know it was heralded as a wonder because it was the first of its kind, and I think it's still the only kind of device like it, right?

 

Dr. E. S. Sills: Correct.

 

Michelle Llamas: I know people were very excited when it first came out because like you said, hey, this is a great alternative, but then you mentioned in the beginning that some concerns started surfacing. Now, let's go to the idea now for your book because clearly with concerns and all these other things started popping up, there was this sort of void of information. When you were looking at all this, how did you decide that hey, you know what, I think it's time for me to put together this comprehensive book.

 

Dr. E. S. Sills: Well, I was surprised that for a product that had been on the market for over 10 years that there was no book on it. What I did see was a smattering of literature published in medical journals that seemed to kind of cry out for an umbrella to bring it all under one roof and to organize it in a way that was not overwhelming but that could be balanced and accessible, both to providers and then also to patients and their families as well. I tried to do a thorough search to make sure that there was no existing book on Essure and, you're right. The novelty of it was really the compelling factor back in the early 2000s that drew so much favorable notice to Essure because it was the only hysteroscopic sterilization technique that had ever really been made available for females.

The early literature that was published in medical journals extolled its arrival as a great advancement because it was all about choice. It was all about giving women an alternative to having their tubes tied. I suppose we'll talk more about that as we go forward in this discussion, but having options is always a great thing. However, the options have to be safe, and the options have to be effective. Just a choice for choice's sake is usually fraught with difficulties, and that's really what happened, I think, with Essure. The book came into focus after recognizing that there was no single volume in a book form that attempted to assimilate the current knowledge about hysteroscopic sterilization, which is Essure.

I wanted to invite people who were both pro and con. I mean, a good editor is going to exert a moderating effect on a book and not try to make it having some diatribe or a mission. It needs to be a book that will be balanced and try to afford as many different voices in the debate access to the book as possible. I think we did that because there are some authors that contributed chapters that write glowingly about Essure, and then there are some that give a contravailing viewpoint as well.

 

Michelle Llamas: Yeah, now that is, I think, one of the most fascinating and unique things about your book. It's very comprehensive from all angles. I mean, we've got a patient, we've got the legal angle even, all the things that have been happening with lawsuits and such, and then the medical angle. Why did you decide to do that holistic approach as opposed to the straight up medical?

 

Dr. E. S. Sills: Well, I hope that all physicians practicing now are embracing holistic approach and getting away from treating patients as if they're pages out of some medical chart because hopefully medical schools and residency programs are doing a good job of helping train the physicians of today and tomorrow to be good listeners and to be globalists in terms of their holistic respect for all the things that happen in the human body. We're more than a bunch of ultrasounds and lab tests and CAT scans. There is certainly an emotional component to the decision of contraception. After all, it is an elective medical intervention. There is a very big social component to it, and so doctors need to be good counselors. Fertility doctors certainly need to be good listeners.

People who are placing the Essure device need to be good communicators. If they don't know something, they need to admit it and acknowledge that there's no data on what happens 10 years after you have this metal stick stuck into your uterus because that's, unfortunately, the lay of the land in 2017. My hope was that having a book that did, as you correctly mentioned, include a patient's voice as well as attorneys who are expert at product liability issues as well as some real superstar doctors who have done a great job to help women get their lives back and try to remedy the damage that the patients claim Essure has done to them, whether it's with hysterectomy or not. That's another personal decision. In my practice, I've never had to do a hysterectomy, but some patients want that and that's totally fine, but again, having alternatives and minimalist approach for eligible patients who are suitable to have a more conservative surgery, they need to know that that exists. I even approached Bayer. I invited the manufacturer of Essure to contribute a chapter, but they actually declined the invitation.

 

Michelle Llamas: That's unfortunate. A lot of media outlets have been hoping to get their side as well because you're going to get all the patients and everybody saying that this thing's hurting me and sadly, to date, they haven't really given a good statement on it. We talked a little bit about the concerns earlier, and, in fact, a chapter in your book is dedicated to a patient's story. She goes through it and talks about everything that she's been through. Can you talk about some of the basic concerns that women have come to you with?

 

Dr. E. S. Sills: Well, let me just make a quick correction. Actually, the very first chapter is written and contributed by an Essure survivor, but in my practice, I see the most refractory cases. I'm sure there are women who have nothing but great things to say about Essure. I never see those patients. I just wish that Bayer would acknowledge that the opposite is true, that there are people that are really struggling with this device and that want it out, that don't feel like they were properly counseled, that do not feel like that they were given full disclosure on all of the unknowns about it. Really those are the patients that get on Drugwatch, and they try to educate themselves, and they try to find a doctor that's knowledgeable and qualified to help them get the care that they need to remove these devices safely. The sort of stories that I'm hearing would be pelvic pain that started soon after Essure was placed, weight gain that started soon after the Essure procedure, painful intercourse, irregular bleeding, skin changes, hair loss. Even metallic taste in the mouth has been described by a number of women who have had the Essure procedure.

One poor lady that came to see me from the East Coast said she couldn't even stand up straight because there was a shooting pain down her back and her leg after having the Essure procedure. The remarkable thing is that these were all young, healthy, productive women before they had the Essure procedure. After the Essure procedure, there was this watershed event, and they started going to the doctor a whole lot more, their consumption of health care resources skyrocketed, their time off from work increased, the number of specialists that they were referred to, allergists, dermatologists, pelvic pain specialists, reproductive endocrinologists like myself, ballooned significantly.

These were people that almost never went to the doctor before Essure, maybe to get an annual physical because their job made them go to the doctor, that was about it. Then everything changed after Essure. Not only from a patient-to-doctor perspective was remarkable, but from a health economic standpoint, I think it's notable because it's really not saving anybody any money in the long run when you have people losing their jobs and even losing their relationships as a result of the fact that they made a decision to have the 10 minute-tubal. They certainly would say that they never signed up for that.

 

Michelle Llamas: Yeah. I know. I think that you hit the nail on the head there with the fact that the concerns, as we mentioned the side effects, complications, whatever you want to call these issues, they go far beyond just typical physical issues. You mentioned a lot of the women would go to multiple doctors, multiple times. A lot of people, of course, there in the ER or anywhere would be unfamiliar with Essure, so a lot of the women would kind of leave with prescriptions for other medications or other strange diagnoses about what was going on with them. With that in mind, what do you hope the book is going to accomplish?

 

Dr. E. S. Sills: Well, I think that programs like this do a great service to patients to educate them about it, and also to doctors because I received an email last week saying that there was a very busy ER here in California that now has issued a memo to all of their attending staff that for any woman with pelvic pain who also happens to have Essure, that they have to include that on the differential diagnosis as a cause or a factor for her symptoms. That was not the case a year ago. I think that the familiarity with Essure is growing. If a person types in Essure onto their favorite search engine, most of the hits that will come back on return after a search will illustrate some concerns and some pretty sad patient stories. The narrative is not very bright. Doctors are not immune to seeing that too. The literature also, I think, is increasingly showing some attention in giving notice to perforations of intestine, migration of device, fragmentation of device. This is not welcome news. A device should not be behaving like that.

The book that is now available I think adds to this discussion as kind of a tangible resource, something that you could actually order and hold in your hand and read the pages and see the pictures that were contributed by the surgeons who shared their secrets, if you will, on how they approach the problem of a device that's never supposed to come out. How do you get it out? I mean, this is supposedly an operation that's never supposed to occur. Unfortunately, many patients say, "I don't care. I want it out, and do whatever you have to do to take it out." Sometimes, as I mentioned a moment ago, that entails a hysterectomy, but for young patients I think that is an overreach. I think that there are much more limited surgical approaches with a faster recovery, fewer complications, much less likely to require a blood transfusion or hospitalization compared to hysterectomy.

All those things need to be on the table so that informed consent truly can be provided to those patients. The medical community already really has failed them because of our ignorance about the long-term effects of Essure. The studies that were available at the time of FDA approval really only studied patients for maybe 18 months, maybe two years, after the product was placed in the human body. It's been on the market since 2002, so we're running our car way out in front of our headlights on this.

 

Michelle Llamas: I think that is probably the number one thing that you have mentioned when we discussed Essure in the past that this is a lifetime implant. I mean, it's supposed to be in women forever, and when you say that it's only been tested about 18 months and I think maybe about 400 people, the sample size and the length of the study have been short of the mark for something that is a permanent implant. With all the information that you provide in the book, I think that this could really be a handle for people. Now, with all this going on with Essure, of course the controversy surrounding it, Bayer has recently stopped marketing it in I believe now it's every other country except the United States, which is pretty interesting. Of course, they released a statement that said it was a financial decision, and it's not related to any of the safety issues. Knowing what you know, you've followed this device now for a little while, do you think that it's likely that they'll also remove it from the U.S. as well?

 

Dr. E. S. Sills: Well, that's a very good question. I believe there are a lot of elements in the decision tree that will influence that outcome, certainly the current status of the device being protected under a pre-market clearance. If that topic is revisited at the congressional level, that will be a very significant development. Currently, as the experts that contributed chapters to the book underscore, the manufacturer currently is protected against product liability action. So even if you feel you've got a good case against the device maker, you can't do anything about it at the court level. Now, there are some loopholes, and there's some bright lawyers that have analyzed this and would correct me in my prior statement and say, "Well, no, Dr. Sills, that's actually not true. You can sue Bayer and here's the recipe for doing that."

There's never, to my knowledge, been any successful litigation brought against the manufacturer of Essure, and they're acutely aware of that. They probably enjoy greatly having that shield of protection while they can make seemingly limitless profit without having to be too concerned about any litigation or jury award or a settlement. Usually they don't really have to be too concerned about that. In all the many products that Bayer currently is affiliated with and manufactures and markets, Essure may very well be the only one item in their armamentarium that operates with this kind of protection.

From a shareholder point of view, it was a great investment. They just recently opened the manufacturing plant, I believe in Costa Rica, dedicated to producing more and better Essure implants. It would seem that they have a commitment to it. I just hope that they can meaningfully address the concerns that patients have about their product and help these patients that have had problems, whether it's autoimmune conditions or pelvic pain conditions, help them get their lives back through whatever channels that we can all work on that would be mutually agreeable to all parties. I don't know how long it will take for Bayer to revisit the U.S. market because you're right. This is their last bastion of Essure availability now. Of course, in fairness, this does represent the biggest bastion.

 

Michelle Llamas: It certainly does. Yes.

 

Dr. E. S. Sills: If you had to pick one to hang on to, this portfolio would be the one to retain. It's a very interesting question, and a lot of voices will be involved in that discussion I'm sure.

 

Michelle Llamas: You did mention some legislation that is going out there. I do believe that a lot of the women in the Essure Problems group, which is one of the biggest groups here in the U.S. that is trying to spread awareness about Essure, they've been going to D.C. regularly trying to get congress people involved. They've got a couple bills on the floor right now. What you mentioned, that is probably going to play a big part then in whether or not Bayer continues to sell it, I'm sure.

 

Dr. E. S. Sills: I hope that one component audience of the book actually will be public policy enthusiasts and maybe staffers at the congressional level and maybe even our legislators and congresspeople because it's important for them to be informed about complex medical issues. This is another one that has been the goal of a lot of very motivated patients. They've made multiple trips to Capitol Hill, flying under the flag of ban Essure or repeal the pre-market clearance. The fact is that these women, they were all strangers to each other until one thing brought them together, and they focused with their very common purpose, from all over the country, from all walks of life, every possible educational and social background, that one thing has bound them together, and that is that they are absolutely committed to making sure that no other female suffers like they did.

It's to their credit that they organize themselves so effectively and articulately, I think. To have bipartisan support for a device like this, you'd have to have high-level lobbyists, but I think the missing ingredient that's present here is you've got a lot of angry women. They're very passionate, and they're not afraid to roll their sleeves up and tackle this problem. I hope that it will shed more light on the issue so that other people in Congress will take an interest in it, and say, "Why are we exactly protecting this company again?" That's an important question that I know is being framed by those women who are taking time out of their busy lives and their jobs and their families to fly out to D.C. and knock on doors and educate staffers and occasionally even members of Congress to try to get them to pay attention to this issue.

 

Michelle Llamas: No, you're right because whether or not it is removed from the market as a choice because we were talking before that choice is important. I think the main there is that you're right, Bayer is being protected currently from any liability, which at the very least, women should be able to be educated about the concerns, right?

 

Dr. E. S. Sills: Right.

 

Michelle Llamas: Then there should also be that sort of safety net there. If a bunch of people are seriously harmed by this, they should be able to have some sort of accountability against Bayer or any company for that matter.

 

Dr. E. S. Sills: That's right. It's important not to single out Bayer. They do good work. It's just this particular product. If you were going to sign a consent form for any medical procedure and were told, "Oh, by the way, if anything goes wrong, just so you know, you're never going to be able to go after the manufacturer because Congress is protecting them." I think that would make a patient pause for a moment and say, "Wow, that's unlike anything I've really ever encountered in my commercial, medical, life experience." It's whatever happens, you just have to put up with it. The courts can't help you. Don't look to them for recourse.

I'm not even sure in all fairness the physicians even know that, the doctors who are doing the Essure procedure. To their defense, they may not even know that the product that they're using in their clinical practice is shielded in this odd way. If they did, I would hope to think that physicians are good people, and the do-no harm ethos is still alive and well in our profession, that they would revisit the wisdom of offering this as part of their clinical practice and say, "Let's just stick with what we know. Tubal ligation, we know that works. It's been done for a long, long time. Essure is just not ready for primetime."

 

Michelle Llamas: Talk about also the techniques in the book, and you mentioned that hysterectomy is not always necessary. In the beginning when all these issues were happening, that was kind of like the go to, like, "Oh, you've got all these issues. Let's just take everything out."

 

Dr. E. S. Sills: I think that's an interesting point that I don't even think that the manufacturer was truly aware of. I think it caused some concern at the highest levels of Bayer, that their product was driving a new indication for hysterectomy and needlessly so. My group did a paper on how often various surgeries were performed to manage Essure symptoms and almost two-thirds of the women were having this most serious operation that a gynecologist can perform, which is a hysterectomy. That was the antidote to the Essure problem. In my view, that's way high.

That's an operation that should be reserved for the very most difficult patients because post- hysterectomy life is different for many women also. That's another discussion that I hope is happening for the women who elect to pursue hysterectomy as their antidote to their Essure saga. The cost of hysterectomy is very high, not just economically but socially. This country did a great job of reducing the utilization of hysterectomy for many years. In part, I think that was due to our female colleague. The number of women who joined the ranks of OB/GYN over the past 30, 40 years, has really helped us be better doctors. They really put the kibosh on these needless hysterectomies, and we did great as a result of having them join the profession in increased numbers.

Unfortunately, that good work is largely being undone because now we've got this new problem called Essure that's running up the meter on hysterectomies again in the opposite direction. Our gains that were being made by conserving this surgery and using it for only the most special cases, I'm afraid now hysterectomy is being viewed as kind of a knee-jerk operation. We know it will work, let's do it, and that'll keep the patient quiet. That's just not the way medicine should be practiced in my view.

 

Michelle Llamas: No, no. You're perfectly right. I mean, hysterectomy, while people think of it as a more common thing now, I mean, it's still a major surgery. You've got probably to take hormone supplements maybe in some cases, you have issues where there's prolapse that could occur.

 

Dr. E. S. Sills: In the age class of women that we're talking about for sufferers from Essure would not remove the ovaries at the time of hysterectomy. However, the point that you raised about structural changes, whether it's vaginal prolapse, rectal prolapse, all of these things where people cough and they leak urine after a surgery. Well, if you say that too many times to the doctor who is pro-mesh, then that doctor will say, "Well, we've got an operation for that too."

 

Michelle Llamas: We're going to compound the complications because now mesh is a whole other issue. That's its own show.

 

Dr. E. S. Sills: It's a total train wreck, an operation chasing operation. This is not the oath that we subscribe to. We're trying to help patients have healthy, full, complete lives without having to go to the doctor all the time. When acts of our own surgeries are really foreshadowing more surgeries, like a cascade effect, then somebody needs to stop the Ferris wheel and say, "Whoa, let's stop this show and take a pause and find out how we can make sure that we're really truly helping patients." It really also, in this day and age, it's important to talk about reducing health care service consumption. Nobody wants to go to the doctor. We're supposed to be for kind of difficult cases where health is out of balance.

To go back to your point originally, the holistic approach is very important, and I think that making sure that if you put something that's metal into the body and it's half nickel and you don't test the patient for nickel allergy, then you don't have to be a holistic prescriber to know that that's going to cause problems. Sadly, tens of thousands, if not hundreds of thousands, of Essure patients were never tested for nickel allergy, and they've got this implant embedded deep into their pelvis that's 50 percent nickel. That probably contributes to a lot of the autoimmune issues that patients present with when they come to doctors complaining of pain.

 

Michelle Llamas: So now, you've got the book here that's out, which again, I mentioned earlier, I think it's a great contribution to the information that is out there and obviously an excellent source. Dr. Sills, thank you so much for being on the show and for talking about the book. In closing, can you give us any final words, anything that you would want people to know about this book?

 

Dr. E. S. Sills: Well, I hope that they'll talk about any health decision with their physician and try to get as much information as possible. The book is one resource. There's many other resources available including here on Drugwatch. Maybe there will be a second edition, who knows, but I'm hoping that everybody can make the best decisions for themselves going forward if they have the proper informed consent and information available.

 

Meet Your Host

Michelle Y. Llamas is a senior content writer. She is also the host of Drugwatch Podcast where she interviews medical experts as well as patients affected by drugs and medical devices. She has written medical and legal content for several years — including an article in The Journal of Palliative Medicine and an academic book review for Nova Science Publishers. With Drugwatch, she has developed relationships with legal and medical professionals as well as with several patients and support groups. Prior to writing for Drugwatch, she spent several years as a legal assistant for a personal injury law firm in Orlando. She obtained her English – Technical Communication degree from the University of Central Florida. She is a committee member with the American Medical Writers Association.


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