Dr. E. Scott Sills of the Center for Advanced Genetics in Carlsbad, Ca. joins me on this episode of Drugwatch Podcast. On this episode, we discuss the controversial medical device, Essure.
Since 1998, Dr. Sills has helped parents grow their families. Recently, however, he found himself using his expertise to remove Essure devices from women who suffered a wide array of complications from the device. Using a specialized, targeted surgical technique, Dr. Sills is able to remove the metal coils of Essure while sparing the uterus and cervix, avoiding a hysterectomy.
The Essure Permanent Birth Control System consists of two metal coils and is a type of permanent sterilization. A healthcare practitioner implants each coil in the woman’s fallopian tubes. After about 90 days, scar tissue builds up in the fallopian tubes, blocking the path of sperm to the egg and preventing pregnancy.
In his practice, Dr. Sills has seen women with Essure suffering from complications such as severe pelvic pain to perforated bowels and fractured devices in the fallopian tubes. An Essure Facebook support group called Essure problems has more than 30,000 members. Many claim the device ruined their lives.
Part of the reason the device is problematic is the lack of studies. Many of Dr. Sills’ patients have actually found themselves in clinical studies of successful Essure removals. On this show, he discusses the problems with the device, and how he helps women regain their quality of life.
Hi there and welcome to Drug Watch Radio. This is Michelle Llamas your host. Today I've got a special guest on the show and his name is E. Scott Sills. Dr. Sills is with the Center for Advanced Genetics in Carlsbad, California. He's going to discuss some issues with Essure with us. Welcome to the show, Dr. Sills.
Thanks for having me.
Essure has been in the media a lot lately and we've been getting a lot of questions about this device and also a lot of news about some terrible complications that some women are suffering. Tell us a little bit about your practice and how that relates to women that are looking for help with Essure.
Thank you for your interest on this issue. My practice is limited to reproductive surgery and in-vitro fertilization and embryo transfer so what my team does is help people grow their families, help people achieve pregnancy and a lot of patients who have Essure, just like with many types of contraceptive decisions, eventually regret their choice and want to undo the sterilization event so they come to a fertility doctor such as myself and we discuss ways to help them get pregnant, even though they've had what was supposed to be described as a permanent form of surgical sterilization.
So a lot of the patients then come to you to reverse the Essure procedure?
Well, I'm glad you used that term because that's a good chance to distinguish removal of the Essure device from reversal of the injury that is caused by the Essure device. I mean first of all, just to kind of put this in context, permanent sterilization is the 2nd most common contraceptive approach used by women in this country; probably close to 400,000 women every year go to their doctor to talk about getting their tubes tied or some comparable procedure for family planning purposes and a lot of the patients have relied on laparoscopic tubal ligation as the answer to that problem and in 2002 a new technique was approved by the FDA called the Essure Procedure, as you correctly said, and this procedure was different in a very remarkable way, it was able to place a metal device from the cervix, so this did not require an abdominal access, it did not require laparoscopic surgery but this device could be placed into a trans-cervical approach to block the fallopian tubes in as little as 10 minutes in the doctor's private office so it didn't require anesthesia and it did not require a hospital visit and it did not require any incisions on the tummy.
This had tremendous appeal to a lot of patients who were considering other contraceptive options and once this metal device was placed inside the fallopian tube it sets up a scarring reaction, a fibrosis reaction to lock the fallopian tubes. In a parallel way to what would have happened had the tubes been cut or burned or tied with a conventional tubal ligation approach. So when you say about reversing Essure I'm not really sure that it's possible to undo the fibrotic scarring that the Essure device causes but it is, I believe, possible to remove the device and make the uterus a more hospitable place for embryo transfer and IVF.
I got you. So that definitely is the distinction there, because I hear those 2 things mentioned, you know, removal and reversal, like you mentioned. So when women come to you your practice do you also help them when they're coming in with complications from the device?
Well, that's a good question. It does sort of frame exactly why I got interested in Essure from the first place because initially the patients only wanted to talk about the next chapter after their Essure devices were removed, which would be IVF and an embryo transfer. However, something interesting occurred in about 2014 which I was being approached by people who really didn't want to do IVF but they still wanted to have these devices removed and the reason they wanted them to be removed is because they were suffering with new symptoms that they had never experienced before the Essure procedure, including weight gain, headache, fatigue, visual disturbances, metal taste in the mouth, skin changes, chronic pelvic pain.
I mean these would be healthy patients who only went to the doctor maybe once a year for a regular checkup. Then, after Essure, I mean I've had patients that have brought me their medical charts, 25 doctor's visits in the year following Essure. 35 encounters for pelvic pain and painful intercourse and painful bowel movements. These were problems that they never encountered before one thing happened and that watershed event that changed everything for those patients was they decided to have the Essure procedure and they don't want to get pregnant, they just want their life back.
So what happened, I began to start seeing patients that were not really in the true sense fertility patients as much as they were pelvic pain patients but they had this Essure appliance inside their body, that had been there for many years.
Ah, I see, and since you already had a lot of experience with working with the reproductive system and working with Essure itself you actually had some experience that you could apply to helping these ladies that, like you said, they didn't really want to get pregnant but they wanted the thing removed.
So that became a part of your practice after that. I assume then you've done some research into it after you started seeing all the women coming in. You probably dug into this device further; what have you seen that contributes to all these crazy complications from this device?
Well, it's a tough question to answer because of the conspicuous limitation of data on long-term followup with these Essure patients. Before it was FDA approved the clinical studies that were submitted for evaluation really only followed study patients for 12 to 18 months which is a remarkable fact considering that these are supposed to be lifelong implants that could of course be inside a woman's body for many, many decades. So it really was no body of literature that a clinician could draw on to learn about the long term prospects of what a patient's life quality could be with Essure because the manufacturer, the sponsor of this product really shut off quality of life audits after only about a year and a half.
Now, here we are in 2016, the device has been on the market since 2002. We're way out beyond the range of what the captured data that was available prior to it receiving its FDA approval and so the literature is, it consists mainly of a small series and scattered case reports of patients who have had some sometimes very serious problems with this device, including bowel perforations, the device splintering or fragmenting, sometimes it being expelled, vaginally, outside the body. Nickel allergy has emerged as another key issue because the metal that comprises this device, it's 50% alloy of nickel and a lot of people are thought to have nickel sensitivities and for many years that was not something that was even asked about patients as they were being considered as potential candidates for the Essure procedure.
But the thing that aligned most closely for a reproductive surgeon's practice was the fact that I was open to discussing with those patients a surgical remedy to their problem that did not entail a hysterectomy and that, unfortunately, has been something that a lot of primary care gynecologists had been advocating as the answer to the cluster of Essure symptoms. Well just take everything out and if you're not quite 40 years old and you're trusted OBGYN is telling you that the way to get your life back is to have a hysterectomy that's a very difficult message to hear.
And I'm glad you brought that up actually because that seems to be the go-to for all kinds of issues that could be taken care of, like you said, with alternate surgical techniques, so we're going to talk a little bit about what issues you can help them with specifically to take care of some of these complications when we come back.
Welcome back to the show. I am talking to Dr. E. Scott Sills with the Center for Advanced Genetics in Carlsbad, California and we were discussing some of the issues that women are facing with the Essure procedure and the device so now we're gonna talk about some of the options that are available to women to help them. So doctor, in your practice, what kind of options do you have available to help women with this device?
Well, the literature on Essure symptoms is very scarce. Since the product has been released for public use since 2002 there really are only about, believe it or not, only about 250 published papers in the world medical literature on Essure, which is kind of astonishing considering we've had a decade plus of experience with it.
My approach to patients who have had problems with Essure is to help them get rid of the problematic item, which is the Essure device itself, while conserving the healthy tissues and not having to remove ovaries and not having to remove cervix and the uterine body itself. So that means that there's a minimally invasive approach where a patient for a surgery that takes maybe an hour and a half or 2 hours can have a procedure done to remove a segment of the fallopian tube on each side containing the intact Essure device.
If that can be edited out of the reproductive tract, in my experience the patients do much better, their symptoms resolve in some cases remarkably rapidly after this surgery. It's done like a bellybutton surgery so there's a Band-Aid on the tummy and then 2 other incisions that are about as big as a pencil, so they're typically home by lunch time and that's the approach that I have promoted for patients who wanted to get this device outside of their body and reduce this inflammatory process that has been evoked by this device.
So now this is obviously, some of the women have used Essure to do permanent sterilization so in that case if a woman comes in and has this removed, do you also help them with alternate sterilization techniques?
They often ask about that and yes, that's exactly right. But the good news is that when you edit out that section of the fallopian tubes which contains the Essure device, paradoxically that gives them the tubal ligation that many of them initially thought that they wanted when they talked to their doctors years ago but were derailed off onto the Essure procedure instead as an alternative substitute to tubal ligation. So the idea of a person getting an unexpected pregnancy after the surgery we've been talking about would be astronomically low.
It's just, it would be a very, very unlikely, I think it would be a very reliable way for permanent birth control, it's just unfortunate that those patients' quality of life to get to that point has been really dismal. Their partners have been affected by it, your families have been affected by it, they absolutely have been affected by it so the approach for people that do not want to get pregnant is solid because their protection from unplanned pregnancy is very competent with this type of surgery and, for the other population of patients who still have some mothering left in their heart and they want to try to grow their families they absolutely could also do IVF and have an embryo transfer.
What do you feel is the most important thing for women to know about this device? Say they've got one and they're having issues or they're considering having an Essure implanted; what would you say to these women?
Well, first of all I would want to reassure the patients that have already had the Essure procedure that there are many people that don't have any problems at all and so it would be unfair to characterize the Essure experience or the Essure phenomenon as being a irredeemable nightmare for all people who have undergone this cystoscopic sterilization procedure. There are people out there that are very happy.
Now I have a selection bias, I'm not seeing those patients, so in my practice I'm seeing the ones that have gotten on the Internet, they've gotten on PubMed, they've looked up on these medical journals to try to find out a different path to take them away from hysterectomy and that's how I meet my patients, but for a person that had Essure and didn't have any problems that's a real blessing. I mean they probably had a very skilled doctor perform their Essure procedure, a very well trained hysteroscopist who was extremely gifted in placing those devices in a way that it didn't poke a hole in the uterus and it didn't perforate the fallopian tube and they only had 2 implants as opposed to 3 or some other crazy number and there are people out there, believe it or not, who have more than 2.
For those patients who have been lucky I think that's wonderful, but what I think the manufacturer of the device should acknowledge is that while I am willing to recognize the good things that the product can provide for patients the other side needs to concede that there is a population of women out there that deserves to be monitored, they deserve to be counselled properly, the revisions that have had to be made to the package insert, I mentioned a moment ago about the relatively new arrival of the concept of testing for nickel allergy or at least discussing nickel allergy for patients that, believe it or not, wasn't even done for many years, even though the metallic composition of the device is 50% nickel, 50% titanium.
When you go to get your ears pierced at the kiosk in the shopping mall the person will probably ask you, "Hey, do you have nickel allergy?" We have medical doctors that were not even asking that question for years, for thousands of patients that have an internal implant, 2 of them, inside their reproductive system that could be causing a hypersensitivity response and that nobody needs to talk about and I think that's a serious issue that patients should be made aware of.
And for those people who have problems they need to talk it over with their family and certainly with their provider, with their physician and find out if they can get imaging studies done to track the location of these devices, because, as we alluded to a moment ago, they can move. Just because they were in the right place a year ago doesn't mean they're still in the same place now and that can have an impact in helping plan the surgical approach.
That's also another issue that a lot of people aren't made aware of, as well. I don't think they get told, "Hey, by the way, you know, keep an eye on these things." And I think we talk about other sterilization devices as well, like um, IUDs for instance. Um, those have also been known to move so I think any time you implant something in the body there is all these different things that you need to consider that probably aren't talked about as much like you mentioned.
I think that's true and one of the things that is often skipped over is the fact that Essure is a multi-step method of contraception. When a person takes a birth control pill they need to wait a little while before the birth control pill becomes biochemically active and then they're protected. You mentioned IUD, now that's sort of a special case because once the IUD is placed, assuming that it's placed properly, it can actually provide very rapid contraceptive protection of the patient, but Essure is different. Essure is a situation where you have a procedure that's done, it could be done in the doctor's office, but many times it's actually done in a formal operating room setting in a hospital, under anesthesia, which is another issues to discuss that-
Ah, yes. Actually, let me interrupt you real quick there, because I think a lot of women were also talking about the fact that it's not classified as a surgical procedure however, in all ways, it pretty much is.
You're right. It is. And that caused the manufacturer to redesignate the product as a non-incisional method of birth control instead of a non-surgical method, but to members of the lay public that may be a distinction that doesn't have a lot of traction but the point about Essure being a multi-step process is that you have the procedure done either in the doctor's clinic or in the hospital and then you have to wait 3 months to get an X-ray to confirm that the tubes are actually blocked.
Yeah, so that's important.
That's very important and a lot of patients don't get that HSG, that X-ray is not performed 90 days later and why that happens is a very interesting issue because many times people's jobs change, their insurance reconfigures, they don't have a way to pay for this X-ray and so they just skip it and that means that that's a potential failure of this device. If it's not properly placed, it's sort of like the guy who gets his vasectomy but never bothers to go get a follow-up sperm test, make sure his count really did go to zero.
So there's an obligation on the clinician to clearly communicate that you're not off the hook on the day of the Essure procedure. You still have to use backup method of birth control for 3 months.
Yeah, that's a long time.
And that's kind of a long time, and then you have to remember to go get a X-ray that's not particularly comfortable and crampy and then when we get the findings back from that X-ray, assuming that it shows both tubes are blocked now you can stop your birth control, you can stop the condom, you can stop using any other alternative method of birth control and now you should be covered. But it's very curious because just recently in the British Medical Journal case reports there was an article published from UC Davis that showed that even when the HSG shows that both tubes are blocked unplanned pregnancies can happen with Essure.
Yeah, and that's amazing.
That is amazing.
Yeah. I mean especially when you have other methods like you mentioned, of doing this where they're, well it seems to be more effective and safer, it seems like, for some people.
I think so.
You know, thank you so much for being on the show. Um, is there anything else that you would like to let anybody know about Essure or your practice before we sign off?
Well, just to know that you're not alone if you've had symptoms after Essure that seem to come out of nowhere, you have a lot of company and a lot of people are really trying to find answers and sometimes the manufacturer of the device and sometimes the doctor who placed the device are just too busy to know about this growing population of patients that are really looking to get their life back and if my team can help I'd be happy to. We're in Carlsbad, between LA and San Diego, especially if they're looking to try to grow their family with IVF. That's certainly not a mandatory component, I've had a lot of patients that just really want to have a sense of normalcy back.
Unfortunately the number of practitioners that are able to provide this sort of specialized surgical skill is pretty limited um and I'm always happy to help patients from far away and many of them are seeing their stories published in medical journals. We just had one recently that was published from a Korean gynecology journal from a new surgical approach, non-hysterectomy patient was able to get the Essure coils removed and she did very well.
That's an amazing story so, you know, definitely you seem like you are someone that has taken the time to look into this issue and really connect with a lot of the women and the families that are suffering this so, you know, on behalf of us, I definitely thank you for being one of those people that cares about this issue.
You're very welcome and I'm honored to help and I appreciate your taking the time to focus on a very important women's health issue.
Well, thanks very much, Dr. Sills for being with us. Again, our guest was Dr. Sills at the Center for Advanced Genetics in Carlsbad, California and we will definitely be providing his information for anybody that is interested in contacting his office. So thanks so much, Dr. Sills.
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