THOUGHTS & MUSINGS ON POLITICS & THE UNIVERSE

A BLOG BY SHANNON FISHER

Is Permanent Birth Control Worth the Risk?

Erin Brockovich is giving a voice to many women who say, “No!”

essure3

UPDATE 11/12/13: There are now even more reasons to avoid the Essure device!  (And more proof that the mission of the group of women spreading word about the device’s severe problems is an extremely valid one.)  The manufacturer of Essure, Bayer, has agreed to add the potentially dangerous side effects of Essure to the patient information booklet.  The FDA claims claim doctors have already been informed of these side effects – but, if that is true, most doctors have clearly not relayed them to their patients.
Link to ABC investigative report:  http://www.abc15.com/dpp/news/local_news/investigations/bayer-changes-essure-patient-booklet-to-include-important-health-warnings-after-abc15-investigation

Erin Brockovich is leading a new crusade, and it appears she has another uphill battle on her hands. She is taking on the FDA and Bayer, the manufacturer of a sterilization device called Essure, in an effort to assist the throngs of women who have contacted her with reports of having experienced severe complications due to the device. Essure was approved for use in the United States in 2002, and more than 600,000 women have had the device implanted to date, but many of these women are being forced to have hysterectomies due to a myriad of Essure-related complications. The only method of complete removal of the device is removal of the uterus.

Essure is a “permanent birth control” device that provides non-surgical sterilization to women. Many gynecologists are implanting these devices in lieu of tubal ligation surgery due to the less invasive nature of the procedure. Small coiled springs containing plastic fibers are placed into the fallopian tubes by a catheter. Over the next three months, body tissue grows around the coils, forming a barrier in the fallopian tubes and thereby permanently preventing sperm from reaching an egg. Essure is essentially absorbed by the body as a permanent part of a woman’s reproductive system, so when complications arise from the device it is often necessary to remove the entire uterus. This negates the purpose of “non surgical” sterilization.

Dr. John Weinstein of Frisco Women’s Health in Frisco, TX, says of a patient, “She had pain on her left side every day after the procedure was performed. She underwent laparoscopy and hysteroscopy and was told the single Essure was removed by pulling it out from inside the uterus. You cannot just pull out an Essure, as it works by becoming part of your fallopian tube and uterus over a 3 month period. The only way to safely remove it is by hysterectomy. I found her Essure just sitting next to her tube, not in her tube at all. Her two years of pain was gone as soon as she woke up [from having a hysterectomy]!”

On her website dedicated to this cause, Brockovich states, “I have been amazed at the number of women who have written to me with their stories and the serious medical issues they are having due to the Essure implant. Stories from debilitating headaches, nausea, allergic response to the nickel the device is made of, hysterectomies, colon perforation due to device moving, to scans that cannot even find where the device has gone to pregnancy – and the women were told that they could not get pregnant, yet none of the women were told of the serious side effects.” You can read some of their stories here: http://www.essureprocedure.net/essure-stories.

More than 700 adverse events reports have been filed with the FDA, in addition to hundreds of letters from other women experiencing complications, with very little response. Knowing there are many more sufferers out there, Brockovich’s goal is to collect 5,000 signatures from women who have had problems with Essure in order to persuade the FDA to take a deeper look into the safety of the device. The goal is to either remove it from the market or mandate that the potential complications of Essure are explained to women before implantation. She also wants them to reverse a pre-emption status that prohibits women who are harmed by this device from seeking legal recourse. (Medical devices that have gone through premarket approval with the FDA can’t be held responsible for injuries caused by the device, even if it is defective.) Anyone suffering from issues related to Essure can connect with others having similar experiences via the website link above.

It isn’t just Brockovich who is taking notice of the rising number of women reporting problems with the device. Angie Firmalino and Michelle Garcia, two women at the forefront of the fight to expose the potential for serious complications with Essure, won a 2013 Justice Served Award from an organization called Let America Know, which grants awards to everyday citizens who fight the system. This award was given for their tireless efforts to raise awareness of the potential risks of this Essure. Their hope is that this issue will receive enough public attention that many more women who are experiencing these kinds of complications will come forward, thereby compelling the FDA to take their reports into account and re-assess the safety of the device.

Written by Shannon Fisher

30 comments on “Is Permanent Birth Control Worth the Risk?

  1. fishershannon
    September 19, 2013

    I am not aware of the ins, outs and details of the large effort(s) to garner awareness of this important women’s health issue, but I hope that everyone who has been injured by Essure steps forward to help raise public awareness about it. The only way other women (and their partners) will know of the potential dangers is if current sufferers speak as loudly and as often as you can on the topic! I hope this article can help spread at least a bit of information to help women make informed decisions about their health.

    Like

  2. Angie Firmalino
    September 20, 2013

    Shannon, thank you so very much, this is wonderfully written! I will share it everywhere! We are a strong group of over 2200 women at this point, and growing every day. We have recently uncovered many new findings that will be coming out in the media soon! There are several other groups forming on the net as well, as Veronica states. Women everywhere and coming together with the same purpose of exposing this bad device and changing a ridiculous law. Thank you again, your efforts are so appreciated!
    Angie Firmalino

    Like

    • fishershannon
      September 20, 2013

      Glad to help spread the word. I am incensed that this has not gotten more media coverage.

      Like

      • Sherrin Ungren
        September 21, 2013

        It sounds more like a NAZI EXPERIMENT!!! we need to get more exposure to the news, FB and all social medias!! get these women to testify and give their stories and thank you Erib B for getting on this!!

        Like

  3. Tanya Simmons
    September 20, 2013

    “United We Stand, Divided We Fall” We all have one common goal, no matter what our background, beliefs, religion, color etc. We want to help other women dealing with the daily battle of struggling with the side effects of Essure and if we can keep even ONE more from going through the pain that comes from these coils, losing a pregnancy (yes, people have gotten pregnant WITH Essure and had miscarriages), or the pain of having to go through a hysterectomy at a very early age, then our work is well worth the fight! Yes! We all want these pulled off the market or better warnings put on them, We all want justice for our pain & suffering, but we have to stand as a united front against Bayer, even if we are divided on other things. I love my new “E-SIsters” Until I met them I thought all of this was “just me” or “all in my head” .. until I reached out and found thousands of women who are going through something very similar, if not exactly the same. Thank you for your voice!

    Like

    • fishershannon
      September 20, 2013

      It is so sad to me that serious medical issues are so often brushed aside by oth doctors and the media as being “female problems.”

      Like

  4. Melanie Goshgarian
    September 20, 2013

    Thank you Shannon!

    Like

  5. Dolly Peña
    September 20, 2013

    Thank you so much for your support we are all here to fight for one thing is to get #Essure off the market !!

    Like

  6. Michelle Garcia
    September 20, 2013

    Shannon, thank you so much for this story and for always tweeting and re-tweeting our posts. Spreading our message to your following means a lot to all of us!

    Like

    • fishershannon
      September 20, 2013

      We are sharing this on the UW Facebook page this afternoon. Hopefully that will help reach many more women who are potentially suffering from the device – or save others from having to suffer!

      Like

      • Marla
        September 20, 2013

        Thank you!

        Like

      • Angie Firmalno
        September 21, 2013

        That’s awesome! Thank you again!

        Like

  7. peeps
    September 20, 2013

    Years ago I had the IUD. After one year it was removed Several years of pain and clots, a D & C, then a hysterectomy was so difficult. The company settled the claims with 900 dollars. Not enough money for the loss of future children in my life. We always need more truth for women.

    Like

  8. Janice Terry
    September 20, 2013

    This is truly all about women coming together, presenting a united front and telling big pharma, big medicine, and doctors that we will no longer be their guinea pigs. We will no longer silently suffer while more women are duped into having this procedure done. I too thought it was “all in my head” until I found my E-sisters! I am tired of suffering and don’t look forward to the hysterectomy that is inevitably coming before I even hit 30. I hope to see Essure off the market and restitution and apologies to the women who have suffered. This product should not be protected under preemption, no product should be.

    Like

  9. Renee Werdel
    September 20, 2013

    Verionica, what foul language did I have to warrent being kick off Essure Awareness? All pages can be helpful but Essure Problems has more resources and people to to help. It would really do you some good to take a deep breath and process your emotions. I still do not dislike you even though you deleted me twice annd blocked me from Essure Awareness. I understand that people don’t and will not always see eye to eye. We are all in this together whether someone likes it or not. A united front is much stronger than a divide one.

    Like

  10. Marla
    September 20, 2013

    Wow, this is great, we need all the attention we can get to keep other woman safe. Thank you for posting, it will help so many. There are so many side effects of Essure, that we are not told of prior to being implanted. This does not allow woman to make an educated decision over their own health. Had I known that I would have debilitating lupus like inflammation that would then cause the growth of scar tissue that would tether, pull and attach my vital organs together, I would never have been implanted. I also don’t think my dr would have been implanting. She and the Drs in her practice all stopped implanting because of the problems woman were having, these issues are real.

    Like

    • fishershannon
      September 20, 2013

      I’m glad your gyno practice listened and realized the problems were due to the device.

      Like

  11. Camelia Grace
    September 20, 2013

    As a psychologist who works primarily with women regarding trauma, sexuality, and reproductive mental health issues, I appreciate you sharing this information. I will certainly pass this information along to those clients who I know have chosen Essure so they may be alert to the potential complications. It is maddening to me that the FDA is not investigating more extensively. Much gratitude to you, Shannon!

    Like

    • Marla
      September 20, 2013

      Thank you camellia we appreciate any assistance. It would be nice if the FDA actually were investigating, but they just say there are not enough adverse events. It would be nice if the studies done were Independant and not done by people who were paid by the manufacturer but the FDA allows it=biased

      Like

    • Joy Fordham
      September 23, 2013

      SHANNON, Thank you for writing this article and spreading the word about the dangers of ESSURE!!! So many woman still need to be aware of this before they too are victims of the deadly devices! CAMELIA, I can’t tell you what a relief it is to hear a medical professional be on our side for once! I was truly starting to give up all hope on any Doctors! That’s really sad because we are supposed to feel safe when we are trusting them with our life thinking they have our best interest at heart!! So frustrated, wish something could be done!

      Like

  12. florence
    September 20, 2013

    thanks for spreading the word 🙂

    Like

  13. Kim Bialt
    September 20, 2013

    I suffered for years with Essure and every doctor just wanted to put me on anti depressants because they didn’t know what was wrong. All my tests were usually normal so the pain had to be in my head. I knew it wasn’t but when doctor after doctor does not believe you that really takes a toll on you emotionally. I thank God everyday that I found this group on facebook because they turned my life around. I was finally able to put the pieces together and had a hysterectomy done. What a difference from then to now. The major source of my pain is gone. NO ONE can tell that ESSURE wasn’t the problem. Thank you so much for supporting our fight. No one should have to suffer like we are.

    Like

  14. Becky Beesley
    September 20, 2013

    Thank you for your support and efforts to help spread the word about Essure side-effects. I believe Essure is a ticking time bomb…it is not ‘if’ someone has a problem/side-effect from it, but ‘when.’ I would love to see Essure taken off the market for re-evaluation by the FDA.

    Like

  15. Sarah Bengford
    September 20, 2013

    Thank you so much for sharing this!! I suffered through several doctors 8 months of debilitating pain, a pregnancy after having essure for 3 years, and a miscarriage. This device needs to be taken off the market, it is causing so much emotional, and physical pain to so many!! I cannot thank you enough for sharing what this device is doing!!

    Like

  16. Latisha Lemacks
    September 20, 2013

    Thank you so much for your help Shannon. This is a terrible product and it needs removed from the market ASAP. I had a hysterectomy at 25 because of this device. My insides were robbed because of this faulty device. Again, thank you so much for your help in spreading the word.

    Like

  17. KD
    September 20, 2013

    Great Article! Several times a day another woman comes forward with issues. If we can stop any of these women before they have the procedure, then we are doing something to help prevent the misery. I never signed up to have 2 surgeries, Exploratory Laparoscopy and now a Full Hysterectomy plus Salpingectomy, to remove a product deemed “safe” by the FDA. The first OBGYN I went to with problems told me there was no way that the coils could ever cause me pain and assured me it was very safe and FDA approved. I have Adhesive Disease throughout my abdomen and before my laparoscopy, had NEVER had abdominal surgery or any other issues that would cause it. I just want the FDA and our doctors to take us seriously when we go to them. I am so confused why most of them brush off our symptoms. Anyway, Thank you for writing this and getting our cause some well needed attention.

    Like

    • fishershannon
      September 20, 2013

      It makes me angry, too, when doctors brush off pelvic pain and other issues as being imagined or insignificant. I agree – docs and the FDA need to know (and SHARE) all of the potential problems!

      Like

  18. Betti Roosevelt
    September 20, 2013

    Thank you so much for sharing this and helping spread the word with us. Essure has harmed so many women. We can use all the help we can get.

    Like

  19. Sharon Laakko
    September 21, 2013

    Thank you for a great article. More awareness is needed and doctors need an awakening. I cannot believe that the common response to side effects is “It is not Essure”. Over and over again we hear how women have suffered needlessly because their doctors would not believe it was Essure. Because of the Essure Problems facebook page, my daughter was able to have her coils removed earlier than most. However, she lost out on months of holding her son, that irreplaceable feeling is being felt by hundreds to thousands of women. Now it sounds like Bayer is contacting doctors that are treating these women and they are refusing to remove coils. More doctors are coming on board by seeing the damage done by Essure. Migrating coils are the worst side effect as the damages are life threatening. How many deaths from Essure is unknown because after all “It is not Essure”

    Like

  20. Rhiannon
    September 24, 2013

    How scary! Women trying to take control of their reproductive help deserve better!

    Like

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