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Bayer glosses over potential harms of Essure with incomplete, one-sided news release on safety study

Five-Year Follow-Up Study Further Supports Effectiveness and Safety of the Essure® Procedure as a Non-Surgical, Non-Hormonal Option for Permanent Contraception

Our Review Summary

essure ABC 15In this news release Bayer HealthCare summarizes a long overdue post-market report on the safety, effectiveness, and tolerability of Essure, an implant and procedure designed to bring about permanent contraception in women. It is the first permanent sterilization alternative to tubal ligation. The Essure implant is a small metal and polyester-like coil that when placed in the fallopian tubes causes an inflammatory response. The resulting scar tissue that develops over a three-month period prevents sperm from entering the fallopian tubes.

Given mounting concerns about the safety of this device, it is crucial for any news release addressing safety to present a complete and balanced portrait of clinical research findings. But this news release is unacceptably one-sided. It never mentions that nearly a third of the women originally enrolled in this study dropped out for various reasons that could reflect a bad experience with the device (e.g. adverse events or pregnancy). It also understates the levels of pelvic pain reported by women who did complete the five-year study, and it never discloses that the study’s lead author (and source quoted in the news release) is a paid consultant to Bayer.

 

Why This Matters

When Essure was approved in 2002, the FDA required the original manufacturer to monitor the outcomes of women who were enrolled in a clinical trial, upon which the agency’s approval was based, for an additional four years. While this news release summary of the report portrays a successful product and process with few serious side effects, several news stories published days before the news release paint a very different picture. According to articles in the New York Times and other media, thousands of women are now asking the FDA to remove Essure from the market and inform the public about risks associated with the implant. Several others have filed legal action against Bayer, which acquired the implant from Conceptus in 2013. The Times article stated that the FDA has received more than 4,000 adverse event reports on Essure and that the original manufacturer received 16,047 complaints from women who had undergone Essure implants. In addition, ABC News in San Francisco reported that dozens of women staged a protest outside an obstetricians meeting while calling for the implant to be removed from the market. Another ABC affiliate in Arizona reported that the FDA will respond to a “Citizen’s Petition” signed by more than 2,100 women asking that Essure be taken off the market. It’s important that the safety of the device be given a fair public hearing so women considering sterilization can make informed judgments about the implants vis–à–vis tubal ligation. It should be noted that Conceptus, the original manufacturer, failed to report the outcome of the five-year study and that the results were submitted for publication a year after Bayer acquired the device. It’s a disappointment that this summary report was delayed nine long years after the study was completed and 13 years after the FDA approved the device.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

There was no discussion of costs associated with the Essure implant procedure. Presumably, the procedure was cost-free for the study participants in this clinical trial, or they received a nominal fee for participating in the trial. However, because the implant has been on the market for 13 years, it would have been beneficial to note the costs and whether the procedure is covered by insurance. An online search revealed the procedure is covered by some, but not all insurance plans. According to Planned Parenthood, costs range between $500 and $2,500.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The news release did mention the rates of pregnancies for Essure users in this study — the main purpose of this device being pregnancy prevention. “Among the 364 women relying on Essure inserts….no pregnancies were reported.” But there’s no mention of the fact that women who dropped out of the study may have done so because they got pregnant (more on this below under the Quality of Evidence criterion). And as the study that’s the basis for the release points out, a recent search of the Manufacturer and User Facility Device Experience database found that “poststerilization pregnancy” accounted for 61 out of 457 (13.3%) adverse events reported by Essure users.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The news release glosses over the harms that are more clearly described in the journal article where the five-year outcomes data are published.

The news release states: “The following severe events were reported as being possibly related to the Essure inserts or procedure: one woman with irregular menstrual bleeding, another woman with lower abdominal pain and very heavy periods, and a third woman with continuous bleeding. The latter two resulted in hysterectomy.”

However, the journal article notes far more instances of side effects, which we describe in more detail under the Quality of Evidence Section below. Notably, 15 hysterectomies were reported in the study overall, and the cause of five them is unknown. The study investigators deemed the other hysterectomies not “definitely or probably” related to the Essure inserts, according to the study.

The news release also summarizes one of the side effects claimed by study participants with this sentence: “Throughout the five-year study, pelvic pain was reported in no more than 7% of study participants at any visit.” However, a chart accompanying the published study states that more than one-third of the initial 518 participants experienced some type of pelvic pain (broken down into dysmenorrhea, dyspareunia, ovulatory pain and other), with the highest rates of pain occurring soon after the insertion of the implant.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The basic parameters of the study are misleading as presented. The news release states: “Among the 364 women relying on Essure inserts who completed the full five years of follow-up, no pregnancies were reported. In addition, the Essure inserts were generally well tolerated.” That statement is accurate but doesn’t give the full picture. According to the journal article, 518 were originally enrolled. In that case, nearly one-third of the original study group dropped out for one reason or another over the five-year course of the study. Sixty-five women were described as “lost to followup throughout the course of the study,” which implies they may have simply stopped supplying data to the study coordinators. But an additional 22 women left for other reasons that were listed including nine who underwent hysterectomies, eight who “voluntarily terminated,” one who had unsatisfactory device placement, and others for various unrelated reasons.

Among an additional 25 women followed for “safety assessments only,” 11 experienced unsatisfactory device location and six underwent subsequent hysterectomy after device placement.

Given the relatively small number of volunteers in the study, both the drop out rate and the number of adverse events reported deserved further discussion in this news release.

Does the news release commit disease-mongering?

Satisfactory

The release doesn’t promote fear-mongering. It is summarizing results from a mandated monitoring study.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

The news release was clearly authored and provided by Bayer.  However, the impression given by the news release is that the study is an independent one, which is not the case. One of the authors (and a person whose quote is used in the news release), John E. Nichols, is also a paid consultant for Bayer as disclosed in the agenda for a recent scientific meeting. Nichols’s relationship with Bayer is not disclosed in the news release (or even in the actual manuscript), and he is quoted as the study’s author.

Similarly, the third author, Mark Levie, is a paid consultant for Bayer and on the company’s speaker’s bureau, according to a disclosure from a medical conference. This fact is not disclosed in the news release.

It is interesting to note that at the end of the actual manuscript, there is an “acknowledgement” of “Editorial support in the form of manuscript writing, styling and submission” by a paid consultant for Bayer, who is not one of the authors of the study. The practice of employing non-bylined commercial writers in the development of academic manuscripts (a practice sometimes referred to as “ghostwriting”) is widely viewed as a threat to the integrity of academic research. According to rules from the International Committee of Medical Journal Editors, the authors themselves are granted the authority to determine who meets the criteria to be listed as an author on an academic paper. This subjective standard makes it possible to downplay the role of commercial writers and exaggerate the contributions of academics. Critics of these rules have pointed to the ease with which they are circumvented by industry.

This is, perhaps, more about the manuscript than about the news release. However, it would have been nice to know that in the study itself, at least two of the investigators as well as writers are on Bayer’s payroll.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

The news release says Essure is “the only available hysteroscopic approach,” which is currently true, though there were, at some point, other commercially available systems and devices. More importantly, the news release does not mention other common forms of permanent contraception such as tubal ligation (both regular and laparoscopic).

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

The news release states that the procedure was approved by the FDA in 2002 and further that “Essure is supported by more than a decade of science and real world clinical experience.” In other words, it has already been on the market for 13 years.

Does the news release establish the true novelty of the approach?

Satisfactory

The novelty of the implant is described in the release as “the only available hysteroscopic approach, does not require incisions and represents an important contraceptive option for women who have completed their families.”

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

We observed no unjustifiable or sensationalistic language.

Total Score: 4 of 10 Satisfactory

Comments (80)

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We will delete comments that include personal attacks, unfounded allegations, unverified facts, product pitches, or profanity. We will also end any thread of repetitive comments. Comments should primarily discuss the quality (or lack thereof) in journalism or other media messages about health and medicine. This is not intended to be a forum for definitive discussions about medicine or science. Nor is it a forum to share your personal story about a disease or treatment -- your comment must relate to media messages about health care. If your comment doesn't adhere to these policies, we won't post it. Questions? Please see more on our comments policy.

Angela

May 11, 2015 at 12:57 pm

Love it! Thank you so much for helping expose the disgusting truth behind Essure!

Angela

May 11, 2015 at 12:59 pm

Finally, a true breakdown of the truth! Thank you!

Tamara

May 11, 2015 at 1:32 pm

Thank you for reporting on the glaringly apparent misrepresentation or omission of crucial information in determining the safety and efficacy of this product. Thank you for stating the clear and accurate truth of the matter.

Crystal

May 11, 2015 at 1:37 pm

Thank you for telling the truth! Essure has ruined my health and almost killed me at 32 yrs old. A lot of women are suffering from Essure just take a look at the Essure Problems Facebook page. There are over 17,000 members!

Angie Firmalino

May 11, 2015 at 1:57 pm

Thank you for your thorough review of Bayers lack luster attempt at a rebuttal to the new york times article. They keep trying to hold up this device with repetitive statements, all of which continue to crumble and fall.

Tina

May 11, 2015 at 2:02 pm

Thank you for bringing to light many of the false statements and responses Bayer always gives. My issues, for one, have never been discussed or studied! Always the same 1/2 truths and cover ups!

sara

May 11, 2015 at 2:08 pm

Essure has ruined my health. After a yr of having it ive had nothn but pelvic pain. My joints are messed up. Constant lower back pain. I feel like im 90 yrs old and im 34! Bayer needs to take this off the market. I have so many health problems cuzof this! Thank you

Val

May 11, 2015 at 2:18 pm

hmm, nine years late and 1/3 of the patients dropped out- probably because they either got pregnant or had problems. Good review of the study- note that the study was done by a paid consultant of Bayer. Being in a group of over 17,000 women, the number of pregnancies and problems are huge and this study basically says everyone is happy, but leaves out that 1/3 were dropped from the 5 year study and there has been NO long term study done. If anyone has problems with a medical device, drug, etc. do not rely on the FDA to make sure it’s safe, problems are often unreported or made light of. Always fight for answers. I had Essure for over 6 years, The pain and problems are not worth it. I had them removed and the pain is finally gone.

Anngela Beaudoin

May 11, 2015 at 2:21 pm

Thank you thank you, a million times, thank you!! I suffer from numerous side effects caused by Essure. If my doctor had known and communicated these potential side effects with me, I would not have gotten it. So here I sit, 33 years old, preparing for a total hysterectomy Thursday to remove Essure and surrounding tissue. If this article saves one woman, you’ve done an amazing job!

Bonnie Mercer

May 11, 2015 at 2:27 pm

Thank you for reporting the truth. At 27 my family was complete and I got the implants. At 34 I am now scheduled for a hysterectomy in 2 months due to the complications, including a perforated uterus, among others, that Essure has caused in my life.

Jessica

May 11, 2015 at 2:32 pm

Finally someone to tell the truth like it is. I wish more would follow suit. THANK YOU!!!!!

Amanda Rusmisell

May 11, 2015 at 2:35 pm

Thank you for taking apart the information provided by Bayer and reviewing it piece by piece. I, too, was harmed by Essure which led to a hysterectomy 2 1/2 years after it was implanted. Your organization is doing a great service for consumers. Thank you!

Janie

May 11, 2015 at 2:38 pm

O thank you so much for breaking it down. Hopefully all will now see the behind the lies of Bayer. Thank you for exposing the truth. This is very well written. Awesome!

Anne

May 11, 2015 at 2:39 pm

Thank you for this honest review of Bayer’s deceptive “study” of the Essure device. I am one of the many thousands of women who have been harmed by Essure. It’s hopeful to see that others are beginning to take note of the problems with Essure.

Alfa

May 11, 2015 at 2:39 pm

It is sad how easily all of us women that have been harmed by this product are dismissed by Bayer and our own doctors. They claim that our health issues were not caused by these coils but in the majority of our cases we were perfectly healthy UNTIL we were implanted with Essure. We’ve been told this so often that when an article such as this that proves that we are not making things up it is like a ray of light. For this I thank you for this article. We cannot allow for more women to be harmed.

Brandy

May 11, 2015 at 2:39 pm

Thank you for finally exposing the ugly truth behind this horrible device that Bayer is allowing to continue to be on the market after causing so many health problems to us women! We need to be heard and we need to be taken seriously because we are real!!!

Crystal

May 11, 2015 at 2:44 pm

It’s nice to see that not everyone is fooled by the jargon Bayer spouts. Thank you for pointing out the facts that should be obvious to the FDA. As a victim of essure side effects, I truly appreciate it.

melanie

May 11, 2015 at 2:45 pm

Essure was not a healthy choice for me. Thanks for letting the truth known. It made me very sick.

kama

May 11, 2015 at 2:52 pm

As a essure survivor i can personally tell you how bad essure is and the problems essure can leave you with . Essure equals a hysterectomy and autoimmune problems. If they had the studies done right and the fda would have done the job they are paid to do over 17,000 ladies would not have the problems we have . Sad when money is more important than lives of mothers!

Amber

May 11, 2015 at 2:57 pm

This brought tears to my eyes. Bayer has tried their best to make us women harmed by essure look like idiots. Thank you so much for listening to the truth!

Mishelle

May 11, 2015 at 3:07 pm

Thank you for pointing out in plain English what those of us suffering from Essure’s side effects have said all along. The company has simply been skewing the data in their favor.. instead of stating it as it has really occurred. How this has been acceptable for so long is beyond me. As far back as WW2 doctors/companies have been called upon to allow patients the right of Informed Decision. By omitting these facts, we have not been given that right as patients.

Crystal H

May 11, 2015 at 3:08 pm

Greatful for the light shed on this issue. The life or lack there of I have been deing with for the past 4 years due to this implant,as like the thousands of others is one full of doctors, pain and out of pocket expenses. All of them Could of been prevented if things were properly done!

priscilla

May 11, 2015 at 3:13 pm

This product almost destroyed me. They had to give me hysterectomy 1 week after my 25th birthday due to the complications of this birth control.

Cynthia McCormick

May 11, 2015 at 3:16 pm

Thank you for exposing the truth about this device. It destroyed my health & my life. At now 40 years of age, I’m left with lifelong autoimmune diseases. Bayer needs to provide accurate information!!!

erica

May 11, 2015 at 3:24 pm

Interesting how the original maufacturer received only 53 less complaints than the number of women we have on the Facebook page. 17,000+ women is a pretty hefty number of individuals with problems resulting from a device we were told was safe. Thank you for bringing more attention to this subject as we the victims need all the support and voices with factual information we can get. Appreciated!

Toni

May 11, 2015 at 3:33 pm

Thank for supporting the truth about this device, and the false statements made by Bayer, that has absolutely destroyed the lives and health of so many of us.

dawn

May 11, 2015 at 3:35 pm

Essure is a nightmare. I’m glad that the truth is finally coming out. Essure has caused me and many others extreme pain and suffering.

Ashley

May 11, 2015 at 3:48 pm

thank you for revealing the truth about Essure. I had to have a hysterectomy at 24 because of Essure non stop bleeding for 10 months along with a lot of other complications! This procedure is junk and needs to be taken off the market!

Stacy

May 11, 2015 at 3:49 pm

Thank you SO much! If Bayer was forced to admit the true risks and side effects, I wouldn’t be so enraged about them continuing to promote it – and no matter what Bayer tries to say, the side effects many of us have experienced were not expected (re – my hysterectomy at age 29).

jane jones

May 11, 2015 at 3:53 pm

thank you for shedding some light on the issues that essure has caused. adenomyosis and hysterectomy at 40 is not fun and certainly menopause at my age is not either. if complete
studies were done beforehand many of us may not be where we are
today.

Bridgette

May 11, 2015 at 4:06 pm

This is what we need. We need to get the truth out there to inform the public. People need to be aware of faulty and harmful products and the companies that try to cover them up.

Jennifer

May 11, 2015 at 4:15 pm

Finally!!! The truth.

Hope

May 11, 2015 at 4:17 pm

Essure is the worst invention ever!!
Thank you for helping our voices be heard and thank you for helping to show the truth about this aweful device!!

Crista Sanders

May 11, 2015 at 4:31 pm

Bayer needs to stop portraying this device as a safe nonsurgical device. Should not be implanted in anyone let alone people who already have autoimmune diseases. False advertising should not be allowed.

Cambria

May 11, 2015 at 4:43 pm

Its great that people can see the truth now.

Joyce Lanier

May 11, 2015 at 4:59 pm

Thank you for your review. I too had terible side effects from my Essure implantation. I lived with severe pain from 2010 (essure implanted) to 2014 (essure removed requiring 2 surgeries). We are more than numbers, more than statistics, more than a few problems. We are also not sole victims. Our spouses and children are/were also sufferers. Essure has damaged much more than our uteruses. It has damaged partner intimacy, life vitality, mother/child activities. It has crushed families finacially. Medical bills are mounting for every household. What a sad commentary for the world we live in when profit and savvy legal language trumps the past harm and potential future harm to other women as well.

Casi

May 11, 2015 at 5:35 pm

After having this product for 10.5 years, and many health issues later. I find it great that someone is helping the victims of this contraceptive expose the disgusting truth behind Essure. I am happy to say that since I had the essure device removed my health has finally started returning and I am no longer living in excruciating pain.

Vera Ozmore

May 11, 2015 at 5:44 pm

Great analysis of this fluff response. This product is so harmful to potentially so many women that the vague and unfounded attempts to defend it must be shown for what they truly are…a desperate attempt to salvage a hugely profitable product, It must be recalled immediately for the sake of public safety. Thank you.

jim

May 11, 2015 at 5:54 pm

Thank you! I’m happy to see
someone reporting the truth And seeing the big picture here. Bayer has no comments on their incomplete trials and studies instead they keep repeating the same mumbo jumbo. Yes, of course the results are consistent with previous studies, they are ALL incomplete and missing a very large number of trial participants. they can keep repeating themselves but that means nothing without unfalsified clinical trials. This device us supposed to last a lifetime? Where’s the proof? almost every ingredient in marked hazzardous, and not for medical implant use. 90% are known carcinogens. How is this safe? Did they even do a study on that? I have no idea how in the world this was ever approved. I sure hope somthing is done, enough innocent people have been harmed.

MP

May 11, 2015 at 6:04 pm

Essure ruined my life. I had an intense reaction to the nickel, and had the coils taken out 8 weeks later. A year after that my symptoms worsened and a hysterectomy was scheduled. An MRI before surgery showed metal fragments Embedded into the uterine wall. I hate Bayer for this product.

Beth

May 11, 2015 at 6:19 pm

I almost dies because of a pregnancy that wasn’t supposed to happen because I had Essure. It has been Nothing but failing health from the time I got it until now.

sandra

May 11, 2015 at 6:28 pm

Finally! Essure has ruined many lives including mine. We all suffer daily, we are mom’s with families and yet Bayer has done nothing! Profits over people. This is wrong!

Lisa

May 11, 2015 at 7:30 pm

So disappointing to see a company push so hard to promote a highly flawed medical device. I don’t know how Bayer thinks they can continue to say the Essure device is a safe product. I’ve had Essure for almost 12 years and suffered most of those years without realizing two small coils were causing my pain. I had my fallopian tubes removed in January 2015 with what was supposed to be the two Essure coils. Unfortunately one was missing and now I am having surgery again this week to hopefully remove the missing coil that is somewhere in my pelvic region after having a series of xrays to find it. Even after getting it out i have to wonder if i will ever be pain free again. Again how can Bayer keep selling this? People before Profits. Glad someone could break it down and explain the facts.

Sibrina

May 11, 2015 at 7:47 pm

Thanks for reporting some truth finally

Jackie

May 11, 2015 at 7:51 pm

i had Essure implanted 10/14. Ever since I have had worsening chronic fatigue, joint pain and all over generalized body aches. Constant pelvic pain for which I have seen chiropractor, orthopedist X-rays all negative. Severe hair loss now with constant nausea. I have lost 35 lbs in last2 months. Had blood work 8 months ago. All negative for Lyme, inflammation etc. seeing my OB tomorrow and plan on getting tested for metal toxicity and adrenal fatigue. I cannot take this. I am a pediatric nurse practitioner and I am extremely active. I ran marathons. I worked out. I work in a busy ER and have children. I have never felt this bad. All I want to do is sleep. I’m tired of this and I’m going to get it removed

Tiffanie b.

May 11, 2015 at 7:53 pm

thank you for sharing. Its deeply appreciated I had essure since 2010. until last summer I got it removed due to major health reasons. I’m only 26. and essure ruined my life. I am glad now knowing I’m not the only one feeling lead that this issue of essure isn’t being heard and doctors always say that I’m ok. when I was sicker than I’ve ever been. also I a nurse said due to the coils that were implanted essure was one of the main factors I’m living with an std. thank you for shedding light.

melissia ryan

May 11, 2015 at 8:22 pm

Thank you for bringing light to a very serious, dangerous device. I myself have had 2 babies and chronic pain and emergency surgery. This device needs to go!

Nicole Ludwig

May 11, 2015 at 8:36 pm

Thank you for bringing to light the truth behind this horrid device and company. I have had far less severity in my problems compared to the other victims of essure. I am 29 and sadly looking forward to having a hysterectomy to get my body back. If you are a victim but not one of the 17000 members, please look us up. You are not alone.

jenso

May 11, 2015 at 9:02 pm

Thank you!!! Essure put in 2011. Diagnosed with multiple problems 2013. hysterectomy 2014. Essure is evil.

Jen

May 11, 2015 at 9:23 pm

Thank you! Since having Essure put in 4 years ago I suffer from sever stomach problems, extreme hair loss, I had to have an ablation and I have constant abdominal cramps. I am scheduled to have my tubes and coils removed May 13th. I just want my health back!

becky shoup

May 11, 2015 at 9:34 pm

Essure is not what the doctors tell u they give you the bare facts about it. Thanks for making this article to show that over a thousand women are not just making the “truth” up.

Pamela Kramer

May 11, 2015 at 9:37 pm

Thank you for sharing the truth about this product. I have suffered through 40 plus side effects from Essure which nearly killed me last year due to metal poisoning. I had to go through a hysterectomy and continue to see doctors regularly due to the long term damage caused by Essure. I have missed out on life for a good couple years due to my declining health and now suffer financial losses thanks to medical bills. Both sides of the story must be told and those of us that suffer should be heard.

Jenni

May 11, 2015 at 9:39 pm

Thank you for showing that Bayer will make essure sound great just to make $$. The funny thing is I was not informed of the plastic in and on the coil, and I believe that is a fact for many other “patients”. The pain is horrible and all I want is a Dr. To listen to me and get these out.

Tricia

May 11, 2015 at 9:46 pm

keep spreading truth. My life was made so much harder by these horrible coils. Suffering still 6 years later and 3 years after hysterectomy.

Michelle

May 11, 2015 at 10:41 pm

Thank you! My life was changed the day Essure was placed in my body. And not for the good. At 42, my athletic body became like an elderly shell…frail and always ill. It affected my job, my children, my husband and shattered my self-esteem because I felt like a burden as I struggled through daily life trying to cope. I literally went from athlete to (near) invalid.
Now I am too young to have had a hysterectomy, but did…and I have regained most of my life but with permanent lasting side effects. I’m so happy to feel as if myself and the people suffering are being heard and future “victims” may be saved from this misrepresented, horrible device!

fundecia

May 11, 2015 at 10:50 pm

All I can say 8 years I’m 36 I’m in full blown menopause but when I got essure I was told nothing can go wrong go figure. Body inflammation is serious. But hey who cares.

Annie

May 11, 2015 at 10:54 pm

Thank you for the wonderful story.Finally someone tells it how horrible it is and what it is doing to all of us women thank you thank you ????

heidi

May 11, 2015 at 11:55 pm

I am glad that there’s some actual information that women can see if they are thinking of getting this device, when I got them all I had heard was it was the best option for me, being that I was afraid of surgery.

Trish Piechal

May 12, 2015 at 12:23 am

I’ve had essure since 2007 and have so many side effects from it. I live in pain daily. It has changed me so much. I want my life back. I’m 47 and I feel like I have the body of a 90 year old.

Tammy

May 12, 2015 at 12:49 am

Thank you for this article. Bayer should have never devoped a product with such toxic materials, PET fibers. It has consumed my mind, body and soul.

Kim Myers

May 12, 2015 at 12:51 am

Thank you! It’s wonderful to see that people are not only becoming aware of the problems with Essure but aware that the clinical trial results aren’t as favorable as reported by the company. Essure has way too many IF’s associated with it. There is the big IF they can even be placed. IF they stay in place, IF the tubes occlude, IF you have problems then you will have a hard time finding a doctor who knows what to do. As a woman I feel we are getting butchered out here while the FDA & doctors sit back waiting, hoping this product will work. It’s been on the market for a long time. It’s not working. The only reason Essure is still on the market is because the FDA gave it Class III status which gives the product Federal Preemption. This prevents anyone from seeking legal recourse should they be harmed. If Essure is such a great product it would not need to be artificially propped up by our government.

Raquel

May 12, 2015 at 1:32 am

I had Essure for 6 years. First couple of years were bearable. Then I started with headaches on a daily basis, fatigue, nausea all the time and the pelvic pain that grew worse over time. I felt like something was stabbing me especially on the right sides. I also developed heart palpitations and anxiety. 3 months ago I had a hysterectomy and I seriously felt better that night. No more bloating or inflammation! I have more energy and the nausea and headaches are gone too. If Essure wasn’t the problem, why do I feel so much better now? Not worth the couple of years that I was ok.

Tamie

May 12, 2015 at 1:59 am

Thank you! I am also a victim of essure. If I had only known the truth, i would have chosen another form of birth control. Now, I’m missing an organ and left with health issues from the damage caused by essure.

Nicole

May 12, 2015 at 3:16 am

I have had Essure for 10 years and it has destroyed my health. The last four years I have had chronic illnesses and chronic pain from scar tissue pulling on all the ligaments in my hip. I have evidence from a toxic metals assay that the materials are leaching into my body in high doses and thus poisoning me and creating a toxic load on my body. The distress that this has caused with all the related symptoms have made my life almost unbearable. I am so sensitive to chemicals now I can barely leave the house for fear of such basic things as perfumes, deodorants and scented washing powder causing me to become extremely ill. I has ruined my health and ruined my quality of life. I was never informed of the materials in it, I was never asked if I was allergic to nickel and was told it was made from an inert ‘safe’ substance that caused no chemical changes in my body. That is patently untrue, given that the mechanism by which it works is that it’s designed to cause inflammation from the chemicals it’s made from, which then causes scar tissue. This was never made clear when I agreed to this procedure. Now my body is full of chemicals and now I have to have major surgery to remove these implants. Seeing as I got Essure to avoid surgery and because I didn’t want chemicals in my body, then you can see that in the end neither of those things are true. 10 years of cascading failures from one illness to another. This needs to be removed from the market immediately.

Deborah

May 12, 2015 at 5:07 am

Thank you for sharing the truth about this horrid device. I suffered immediate issues after implantation (2011) starting with migraines, joint pain, vertigo, etc.. I am 6 days post op full hystorectomy and can feel the difference now that this inflammatory poison is out of my body. Bayer, stop lying and admit the truths about the toxicity and malfunction that Essure causes, enough already.

Mel

May 12, 2015 at 5:44 am

When will Big Pharma stop seeing women as dollar signs? We are your mothers, your sisters, your best friends. We did not deserve this. We trusted our doctors to recommend a safe permanent method of birth control, and what we got were years of pain, unexpected pregnancies, and medications thrown at us. According to Bayer their product is awesome so they throw the doctors under the bus as not doing the procedure correctly. Why should there be a Class III medical device on the market that doctors–after having been trained by Bayer–are not able to insert correctly EVERY TIME? We’re tired of being lab rats.

Incog Nito (Becky Miller)

May 12, 2015 at 5:49 am

One Step Closer To Saving More Women From HARM! I had to have 2 surgeries in order to remove all of the metal coil. I will live with after affects for the rest of my life due to fact the doctor was not well informed on the proper way to remove and he stated he left “PET Fibers” because they were stuck to the omentum and to hard to remove in the first operative report. The second surgery to remove the remaining coil resulted in a total abdominal hysterectomy, because the coil could not be located and I had an inflamed uterus, via laparscopic making me miss out on 6 weeks of work. Thank you for this article !

Steve . S

May 12, 2015 at 8:13 am

My wife had this done in 2010. She has had nothing but problems from pain, sickness, discomfort, weight gain and mood swings just to name a few. She will be getting a surgery to get these out, here in the near future. These need to be banned and removed from all the women who have these. It is sad that these companies only care about the money they can make off of people and not the aftermath of the women.

Lena

May 12, 2015 at 8:35 am

Thank you for exposing the ugly truth behind Essure. Love this article!

Carole Ann James

May 12, 2015 at 8:51 am

THANK YOU for shedding light on the TRUTH and for exposing Bayers deception pertaining to Essure. Thousands of women have been harmed severely including myself by trusting our doctors and the FDA that this alternative to tubal ligation was safe and effective. It has been a living nightmare and by far the worst mistake of my lifetime! It’s ingredients have no business being approved for human implantation when their own manufacturer warns against it! How did this ever get overlooked?! Women deserve to know the truth! THANKS AGAIN for spreading AWARENESS about the hidden truths behind Essure.

Sarah Erving

May 12, 2015 at 10:10 am

I had essure done in Feb. 2010 – I have gone on to have 4 surgeries – & I now live with chronic pain – I was a healthy woman before essure – never missed a day of work or went to the dr. – this has affected me & my family – emotionally, physcally & financially – I can no longer work as a teacher – ESSURE was the BIGGEST mistake of my life – we have to do as much as we can to prevent this from happening to other women & families

April

May 12, 2015 at 11:56 am

I’m thankful for this article. Essure failed me after a confirmed blocked hsg. And caused chronic pain, fatigue, inflammation, anxiety, hives, depression, felt 80 years old. pain, brain fog , fatigue gone with hysterectomy. Coil embedded in uterus. Essure %200 made me sick!!!!!

Jessica

May 12, 2015 at 5:08 pm

I was implanted with Essure in 2010. My health has been in a downward spiral ever since! After being diagnosed with many conditions ranging from Crohns Disease to Breast nodules to Chronic Ovarian Cysts to Severe Dental Deterioration…the list goes on and on. I’m 28! I was completely fine before Essure! I’m due to have a full hysterectomy in a few weeks to remove this terrible device! ALL my doctors agree it is the underlying issue! They now realize im suffering from metal toxicity! Every single symptom I’ve had…matches thousands of women across the country! We all range in age size ethnicity….the only common denominator is that we all have Essure!!!!! Now u be the judge and jury….what do you think? I assure you it’s no coincidence! Bayer knowingly sold HIV tainted blood to thousands back in the 80s. They’re back at it….the all mighty $ over everything….including my life! I didn’t sign up for this! Please someone help us! The preemption has made it so we can’t sue Bayer! The FDA acts like it’s no big deal! My life is a big deal!!!! Just ask my 5 year old who has no one else in the world! She’ll tell u!

Shelly Elwood

May 14, 2015 at 11:09 am

Thanks for helping to spread awareness about this harmful, dangerous and ineffective procedure. If not for this horrible device, I wouldn’t have needed a hysterectomy at age 44!

Victoria

June 9, 2015 at 9:37 am

I know for a fact the Essure is a dangerous form of birthcontrol ! Thank u! I suffered 8 years in pain. After it was removed from my body 8 years later, I feel like me again. No women should ever suffer from a birth control. I was supposed to gain years of pleasure. Instead I suffered extremely large amounts of uncontrollable blood, pain and blood clots. 8 years! No doctor would listen to my reasoning! I knew it was Essure but doctor let me suffer 8 years. Because Essure andin doctor eyes is the miracle birth control. But I am living proof it (Essure) was torture! I burned so bad I couldn’t walk. Today I can run ..I pray for women daily injured by this device cause I know their journey. But doctors insisted it the best method. But I haven’t talk to 1 implanted with Essure. That’s how sure they are. Its all bout money not the injured. Im so glad the truth is finally being shared. Please join us in our fight to Recall Essure from market so no other women or baby die or become injured. And that is a fact!!!! Thanks again.

Twila Urquhart

August 19, 2015 at 5:09 pm

I do pray they ban these Essures birth control implants and also find Bayer criminally liable FDA for knowing the dangers but were not concerned for any of us test subjects!! My last thought on this of the statistics is I almost died and was in the hospital for 2 weeks because of the infections that were so severe and the pain was so unbearable I was on an epidural and a morphine pump to push the button type and xanax!! The worst was my husband almost losing his wife in her early 30’s because of the Essure birth control devices in 2003!!!

Laura Henze Russell

September 5, 2015 at 2:31 pm

Here is a new piece, Discovering Essure’s problems the hard way: FDA’s medical device standards outdated, ineffective. http://www.metrowestdailynews.com/article/20150904/OPINION/150907597. Please urge Congress to act on medical and dental device safety urgent reform (MEDDSURGE).

Rachel Ulrich

September 5, 2015 at 4:06 pm

So many women are suffering through what doctors are calling phantom pains because they have been lied to by Bayer, previously Conceptus, to believe that there are no major side effects. It is nice to see that someone is able to write something that is able to breakdown and expose the lies of this product.

Lori

October 8, 2015 at 5:43 pm

I had essure in September of 2010 and total hysterectomy January 2015. The pain I experienced was horrible all the time. Periods were almost impossible to get threw due to heavy bleeding and massive bloating. The fatigue was so bad i was eating all kinds of energy supplements and vitamins. Mood swings so bad my kids feared me. Thank you Bayer for forcing a hysterectomy on me at 36 and making me feel broken and less of a women. I hate your products and refuse to buy any more.

Jacqueline Johnson

September 19, 2016 at 1:40 pm

An unbiased review of health news is critical to health consumers. I applaud your reviewers for bringing a critical lens to help us sort out what is useful dissemination/information versus propaganda and self-serving science. Bravo! I truly hope more consumers catch-on to the great work of your team. Unfortunately, marketing practices to doctors and patients alike have yet to reflect what is increasingly surfacing about the RISKS involved with this device, including a 10 fold likelihood of surgeries subsequent to post-Essure implants. With diligent WatchDogs like HealthNewsReviews that may change. THANK YOU!