Monday, September 16, 2013

Essure: Non-surgical female sterilization

If you are reading this blog you are most likely in one of Dr. Campisi’s classes at Regis. Most likely you are in your prime reproducing years. You may or may not be thinking about having children. But I doubt you are thinking about permanent contraception.  For the last three years I worked as an Essure case manager for a clinic that provided this service and permanent contraception was all I talked about.

Essure is a procedure similar to inserting an intrauterine device (IUD) for long-term reversible contraception. Instead of inserting a device in the uterus, the Essure procedure places two micro inserts made of nickel titanium inside the opening of each fallopian tube. The procedure is scope-guided and lasts about 15 minutes. Over the course of three months the fallopian tubes develop scar tissue around the coils and occlude the openings. The patient is sterile but without the risks of surgery and anesthesia; patients usually return to daily activity and work within 24 hours. To confirm placement of the coils, the patients undergoes dye test imaging three months after the procedure.

One study shows of 847 women who received this procedure, 94% patient satisfaction was “very high” and 6% reported “high” satisfaction (Mino 2007). In our clinic, one complaint I often heard was  due to the nausea from the oral analgesics, mainly because patients would not eat beforehand. The most common risk during procedure is the inability to place each coil correctly due to tubal spasm or anatomical anomalies. We did see one patient with a unicornuate uterus (only one fallopian tube), which greatly confused the doctors!

During the procedure the scope allows you to watch the doctors place the inserts via a monitor- an amazing view of the uterus and fallopian tubes. Patients could not believe how easy, pain free, and fast Essure was. Bayer, who now owns Essure, is presently conducting studies on a newer form of this device that occludes the fallopian tubes immediately, and patients will not have to wait three months for confirmation. Will Essure become the leading technique for permanent sterilization?
Image retrieved from: http://www.drbullaro.com/images/essurediagram.png

References:


Mino M, Arjona JE, Cordon J, Pelegin B, Povedano B, Chacon E. 2007 May. Success rate and patient satisfaction with the Essure sterilization in an outpatient setting: a prospective study of 857 women. BJOG: An International Journal of Obstetrics and Gynecology. 114(6):763-766. Retrieved form: http://onlinelibrary.wiley.com/doi/10.1111/j.1471-0528.2007.01354.x/full

11 comments:

  1. That was a very interesting blog! Although you did mention that it is a permanent contraceptive option, is there any possibility that a woman could become pregnant after having this procedure? Also, do you know if there are age guidelines for this procedure since it is permanent? I would imagine that younger women (20's and early 30's) may be discouraged from a permanent procedure like this.

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    1. During the 3 months after the insertion of the devices a woman can become pregnant because the tubes are not fully occluded. After the confirmation test it is over 99.9% effective. Many clinics will not perform this on a woman under the age of 30. Some clinics do. Yes, women who decide on permanent sterilization when they are under 30 can often have feelings of regret. However there are often women who cannot become pregnant due to health reasons or because they have many children and therefore doctors will still perform this procedure after screening and counseling.

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    2. In one study that followed patients post procedure, the women who were pregnant had become pregnant prior to the placement of the devices, became pregnant during the 3 month occluding period, the confirmation test showed incorrect placement of the devices, or did not receive a confirmation test. If a patient follows the guidelines, the doctors place the devices correctly, the confirmation is done at 3 months and shows occlusion and correct placement it would be over 99.9% effective.
      ref:Rev Palmer SN, Greenberg JA. 2009. Transcervical Sterilization: A Comparison of Essure® Permanent Birth Control System and Adiana® Permanent Contraception System. Obstet Gynecol. 2(2): 84–92.http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2709331/

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  2. Mia,

    I found your blog post very interesting. I’ve never heard of Essure before, and I did not know there was such a simple way to provide women with permanent contraception. I am curious, however, if during those three months that the fallopian tubes are closing, is a risk for ectopic pregnancy higher? I imagine that if the sperm were able to pass through the location of the insert, this could be an issue.

    Additionally, I found an article in which a woman, who had a history of ectopic pregnancies, used Essure to allow for a healthy pregnancy. She had a left salpingectomy, and her right fallopian tube had what is known as hydrosalpinx, which is essentially the constant accumulation of fluid in the fallopian tube. Hydrosalpinx is a serious issue for women who are trying to get pregnant, as it causes issues with implantation. This woman underwent placement of Essure in her right fallopian tube, allowed for fallopian tube closing to occur, and then proceeded with IVF treatment. She was able to experience a normal, healthy pregnancy.

    This case study is yet another example of medical pharmaceuticals/devices being used for something they weren’t originally intended for…but with great results for the patient.

    References:
    Inocencio G, Coutinho L, Maciel R, Barreiro M. 2013 Mar. Pregnancy after hydrosalpinx treatment with Essure. BMJ Case Report.
    http://www.medicontent.eu/uploads/publication/pdf/518762ccfd897845e000004f/essure.pdf

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    1. Cara, that is a very interesting article! This is a great example that shows that in the case where a woman does not use contraception during the 3 months post procedure and becomes pregnant, the inserts pose no risk to the fetus.

      From what I understand the risk for ectopic pregnancy does not change with the inserts. The chances of implantation outside the uterus (during the 3 months before the tubes are occluded) would be the same if the inserts were not there.

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  3. There have been no long term studies on the effects of Essure. Thousands of women who have had essure implants are suffering from a myriad of symptoms related to their Essure implants however they cannot get the FDA, or the manufacturer to listen to their issues. It's a quick buck for the doctor's that do the implants and when the women go to the doctors about their symptoms they are not being taken seriously. Many of these women have opted for Hysterectomies to get the Essures out of their bodies and when they did this, their symptoms disappeared. If you want to help, research why these women are becoming so sick from the Essure implants instead. Erin Brockovich is acting as an advocate for these women since they cannot sue the manufacturer she is working to try and help the best way she can at www.essureprocedure.net Also there is a facebook page called essureproblems where women are going to post their experiences. It's a real eye opener. I hope you check out these pages!

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    1. Mia, I wonder if you yourself have been implanted with Essure for you to be saying how great it is? I cant imagine that nickel and PET fibers are meant to be placed in the body. Nickel can cause and allergic reaction, even if you don't have an allergy. And the PET fibers cause chronic inflammation which never stops and can cause Lupus like symptoms. Chronic inflammation can cause scar tissue build up which causes its own set of issues like body parts being attached to one another. Just saying Essure is not the safe alternative to birth control

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    2. ESSURE = E-HELL!! VERY FRUSTRATING TO HEAR ANOTHER WOMAN GOING ON AND ON ABOUT HOW GREAT IT IS!! MUST LESS A FUTURE GYNO THAT SOMEONE WILL END UP GOING TO ONE DAY, AND ALSO WRITING IT OFF THAT ITS NOT ESSURE THAT'S CAUSING ALL THE PROBLEMS!! LET ME GUESS THE 2,000 + WOMEN ON A SUPPORT PAGE ON FACEBOOK THAT ONLY FOUND EACH BECAUSE OF ESSURE PROBLEMS MUST BE INSANE RIGHT?? THIS CRAP NEEDS TO BE TAKEN OFF THE MARKET!! UNTIL YOU, YOURSELF MRS. MIA, HAS HAD THIS (WONDERFUL) AS YOU CALL IT, PROCEDURE DONE OR HAVE ACTUALLY REALLY DONE THE RESEARCH ON IT, PLEASE DO NOT GIVE THIS PRODUCT ANYMORE CREDIT AS IT HAS DESTROYED MANY LIVES. SAD THING IS IT WILL CONTINUE UNTIL SOMEONE WAKES UP AND FINALLY DECIDES THAT YES, IT'S POSSIBLE THAT ESSURE CAN BE THE PROBLEM. IF THE DOCTORS WOULD LISTEN AND REMOVE THEM FROM THE LADIES WHO ARE SICK, WATCH FOR THEMSELVES HOW EACH ONE HAS GOTTEN BETTER AFTER REMOVAL, THEN THEY TOO WOULD NOT PROMOTE IT!! I GUESS IT'S SADLY GONNA TAKE WOMEN LOSING THIER LIFE FOR DOCTORS/ FUTURE DOCTORS/ FDA/ BAYER/ CONCEPTUS TO BELIEVE REALIZE THIS AND THEN FINALLY DO SOMETHING ABOUT IT!!
      JOY FORDHAM
      AUGUSTA, GEORGIA

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    3. Kit and Maria,

      1) No, I have not been implanted with the devices, but I have worked closely with doctors and patients that perform this procedure and have only seen positive experiences. The FDA approved Essure in 2002 and I expect there will be long term studies on the rise. I am not sure that I would opt for this procedure, the idea of anything permanent is daunting and there are plenty of long term reversible contraception options to chose from.

      2) The amount of natural nickel that someone gets from food and water per day is 300 micrograms, whereas the amount of nickel that goes into the body from an Essure device is 0.14 micrograms per day (Conceptus 2011).

      3) Yes, Essure is a procedure where foreign objects are placed inside your body. There are lots of procedures and surgeries that change the internal environment or even leave metal inside. What about the inflammation that is caused by a total knee replacement? Stents in the heart?

      4) Essure is not for everyone. I would suggest talking with a doctor who has been placing these devices for years and see what they have seen and what they suggest for each patient. The website www.essureprocedure.net magnifies women who have had bad experiences. What about all the women who have had good experiences?

      ref: Conceptus. 2011 Aug. Conceptus Announces FDA Approval to Remove Nickel Contraindication From the Essure Procedure Instructions. GlobeNewsWire. Retrieved from : http://globenewswire.com/news-release/2011/08/04/453229/228677/en/Conceptus-R-Announces-FDA-Approval-to-Remove-Nickel-Contraindication-From-the-Essure-Procedure-Instructions.html

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  4. This blog is dedicated to constructive discussions related to physiology and we welcome feedback. That said, rude or inappropriate comments have no place in this discussion and will be deleted.

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