Essure

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Essure
Background
Birth control typeSterilization
First use2002
Failure rates (first year, after occlusion)
Perfect use0.26%
Typical use0.26%
Usage
Duration effectPermanent
ReversibilityIrreversible
User remindersAdditional methods until 3 month check by hysterosalpingogram
Clinic reviewNone
Advantages and disadvantages
STD protectionNo
BenefitsPermanent contraception
 
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Essure Permanent Birth Control device.jpg
Essure
Background
Birth control typeSterilization
First use2002
Failure rates (first year, after occlusion)
Perfect use0.26%
Typical use0.26%
Usage
Duration effectPermanent
ReversibilityIrreversible
User remindersAdditional methods until 3 month check by hysterosalpingogram
Clinic reviewNone
Advantages and disadvantages
STD protectionNo
BenefitsPermanent contraception

Essure is a permanent, non-surgical transcervical sterilization procedure for women developed by Conceptus Inc. It was approved for use in the United States on November 4, 2002.[1]

Two economic studies, one of which implemented Essure as an in-office procedure, suggest that Essure could be more cost-effective than laparoscopic bilateral tubal ligation.[2]


Procedure[edit]

Small, flexible inserts are placed into the fallopian tubes by a catheter passed from the vagina through the cervix and uterus. The insert contains inner polyethylene terephthalate fibers to induce benign fibrotic reaction and is held in place by flexible stainless steel inner coil and a dynamic outer nickel titanium alloy coil.[3] Once in place, the device is designed to elicit tissue growth in and around the insert over a period of three months to form an occlusion or blockage in the fallopian tubes; the tissue barrier formed prevents sperm from reaching an egg.

Unlike other forms of tubal ligation, no general anaesthetic nor incision through the abdomen is required.

Similar to some other methods of birth control, initially additional forms of birth control must be continued for 3 months[2] to prevent pregnancy until the method's effectiveness can be confirmed.

Follow-up[edit]

For the Essure method, three months after insertion a Radiologist physician performs an x-ray procedure called a hysterosalpingogram[4] to confirm that the fallopian tubes are completely blocked and that the patient can rely on the Essure inserts for birth control.[1] A contrast agent (dye) is injected through the cervix, and an x-ray technologist takes photos of the Essure coils to ensure no contrast leaks past the Essure.

Efficacy[edit]

Following successful insertion and occlusional response, the Essure procedure is 99.74% effective based on 5 years of follow-up, with zero pregnancies reported in clinical trials.[5][6]

The reported insertional failure rates are "failure to place 2 inserts in the first procedure (5%), initial tubal patency (3.5%), expulsion (2.2%), perforation (1.8%), or other unsatisfactory device location (0.6%)".[7] Upon follow-up, occlusion is observed to have occurred in 96.5% of patients at 3 months with the remainder occluded by 6 months.[1]

Cautions and warnings[edit]

The inserts do not prevent the transmission of sexually transmitted diseases. The procedure takes about 10 minutes[8] for a trained physician to perform and can be performed in a physician's office. General anesthesia is not required. Unlike many temporary methods of birth control, the Essure inserts do not contain or release hormones.

The inserts are made from polyester fibers, nickel-titanium and stainless steel and solder and are safe to use with MRI equipment. The Essure procedure is reported to be permanent and not reversible by the manufacturing company. Notwithstanding the manufacturer's position, several Essure reversals have been performed.[9]

Additional birth control must be used for three months after procedure.[7][10]

Risks[edit]

2013 Controversy[edit]

In 2013, the product made news with women complaining of severe side effects leading to surgical extraction. According to one article, women who have gotten pregnant are naming these children e-babies. There is a Facebook group of over 6,000 women, as of March 3, 2014, titled Essure Problems. Erin Brockovich also hosts a website where women can share their stories after having the procedure.[11]

References[edit]

  1. ^ a b c "Essure™ System - P020014". US Food and Drug Administration. 2009-06-29. Retrieved 2011-05-21. 
  2. ^ a b Hurskainen, R.; Hovi, S.; Gissler, M.; Grahn, R.; Kukkonen-Harjula, K.; Nord-Saari, M.; Mäkelä, M. (2010). "Hysteroscopic tubal sterilization: a systematic review of the Essure system". Fertility and Sterility 94 (1): 16–19. doi:10.1016/j.fertnstert.2009.02.080. PMID 19409549.  edit
  3. ^ Miño M, Arjona JE, Cordón J, Pelegrin B, Povedano B, Chacon E. Success rate and patient satisfaction with the Essure sterilisation in an outpatient setting: a prospective study of 857 women. BJOG. 2007 Jun;114(6):763-6.
  4. ^ "Essure Confirmation Test". Conceptus Inc. Retrieved 2011-05-30. 
  5. ^ control methodsbyConceptus/Understanding/ClinicalTesting/tabid/58/Default.aspx "Clinical Testing". Essure. Conceptus. Retrieved 2006-12-12. [dead link]
  6. ^ Smith RD (January 2010). "Contemporary hysteroscopic methods for female sterilization". Int J Gynaecol Obstet 108 (1): 79–84. doi:10.1016/j.ijgo.2009.07.026. PMID 19716128. 
  7. ^ a b "Prescribing Information" (PDF). Essure. Conceptus. 2005-09-08. Archived from the original on 2006-11-11. Retrieved 2006-12-12. 
  8. ^ http://www.marketwatch.com/story/conceptusr-to-promote-gynecare-thermachoicer-to-us-physician-offices-2010-11-10?reflink=MW_news_stmp
  9. ^ "Doctors Confirm First Successful Essure Tubal Ligation Reversal". 2008-10-08. Retrieved 2010-02-15. , referring to Dr. William A.C. Greene Jr. and Dr. Wendell Turner at Lakeshore Surgical Center
  10. ^ Hurskainen R, Hovi SL, Gissler M, et al. (April 2009). "Hysteroscopic tubal sterilization: a systematic review of the Essure system". Fertil. Steril. 94 (1): 16–19. doi:10.1016/j.fertnstert.2009.02.080. PMID 19409549. 
  11. ^ Women report complicatidiseasesons from Essure birth control from Chicago Tribune retrieved 2 March 2014

External links[edit]