Essure

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Essure
Essure Permanent Birth Control device.jpg
Background
Type Sterilization
First use 2002
Failure rates (first year, after occlusion; data disputed)
Perfect use 0.26%
Typical use 0.26%
Usage
Duration effect Permanent
Reversibility reversible
User reminders Additional methods until 3 month check by hysterosalpingogram
Advantages and disadvantages
STI protection No
Benefits Permanent contraception

Essure is a device for female sterilization. It is a metal coil which when placed into each fallopian tube induces fibrosis and blockage.[1] It was developed by Conceptus Inc. and US FDA approved in November 2002.[2] Conceptus was acquired by Bayer AG of Germany in June 2013.[citation needed][3]

Essure was designed as an alternative to tubal ligation, the standard procedure and major surgery done in a hospital, because it can be placed in a doctor's office with less anesthesia. Although Essure was designed to remain in place for a lifetime, it was approved based on short-term safety studies. Of the 745 women with implants in the original premarket studies, only 92% were followed up at 1 year, and 25% for 2 years, for safety outcomes. A 2009 review concluded that Essure appeared safe and effective based on short-term studies, that it was less invasive and could be cheaper than laparoscopic bilateral tubal ligation.[4]

Since 2013, the product has been controversial, with thousands of women complaining of severe side effects leading to surgical extraction,[5] and campaigner Erin Brockovich has been hosting a website where women can share their stories after having the procedure.[5][6][7] As of 2015 a large number of adverse events, including tubal perforations, intractable pain and bleeding leading to hysterectomies, possible device-related deaths, and hundreds of unintended pregnancies occurred, according to the U.S. F.D.A. adverse events database and other studies.[1][8]

In August 2017, the CE marking in the European Union, and thus the commercial license for Essure was suspended for at least three months. Authorities in France and Ukraine recalled the implants, and the manufacturer withdrew the product voluntarily from the market in Canada, United Kingdom, Finland and the Netherlands.[9][10][11][12] In April 2018, the FDA restricted sale and use of Essure.[13] On July 20, 2018 Bayer announced the halt of sales in the U.S. by the end of 2018.[14] The device is featured in the 2018 Netflix documentary The Bleeding Edge.

Use[edit]

A physician places the coils into the fallopian tubes by a catheter passed from the vagina through the cervix and uterus.[15] Once in place, the ingrowth continues over a period of three months, resulting in durable occlusion or blockage in the Fallopian tubes; the tissue barrier formed is supposed to prevent sperm from reaching an egg. During that intervening three month period, women are advised to use an alternate contraceptive method.[15]

Unlike other forms of tubal ligation, no general anaesthetic nor incision through the abdomen is required.[citation needed] Similar to some other methods of birth control, initially additional forms of birth control must be continued for 3 months[4] to prevent pregnancy until the method's effectiveness can be confirmed.

In one 2007 prospective study, the mean time for procedure was 6.8 minutes (range = 5–18 minutes).[15] for a trained physician to perform and can be performed in a physician's office.[citation needed] General anesthesia is not required. Despite this, some women have reported considerable pain during the procedure.[16]

Follow-up[edit]

For the Essure method, three months after insertion a radiologist is supposed to perform a fluoroscopic procedure called a hysterosalpingogram,[17] to confirm that the fallopian tubes are completely blocked and that the woman can rely on the Essure inserts for birth control. 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.[2]

Efficacy[edit]

After successful insertion and occlusion, the Essure procedure is 99.74% effective based on 5 years of follow-up (although one study found failure rates closer to 11%).[18][19]

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%)".[20] Upon follow-up, occlusion was observed to have occurred in 96.5% of patients at 3 months with the remainder occluded by 6 months.[2] A 2015 study published in the BMJ concluded that Essure was as efficacious as laparoscopic sterilization at preventing pregnancy, but with a "10-fold higher risk of undergoing re-operation" when compared to patients who underwent a laparoscopic sterilization procedure.[8]

Cautions and warnings[edit]

The procedure is reported to be permanent and not reversible by the manufacturing company. Nevertheless, several Essure reversals have been performed.[21]

Additional birth control must be used for three months after procedure until a hysterosalpingogram has been performed to confirm blockage.[20][22]

Because of the stainless steel medical staff needs to be notified before an MRI or any magnetic imaging can be done.[citation needed]

Risks[edit]

  • Perforation, expulsion, or other unsatisfactory location of the insert
  • Punctured uterine walls
  • Pregnancy and increased risk of ectopic pregnancy
  • Pain, cramping, vaginal bleeding, menstrual pattern changes, light periods at first then longer, heavier periods lasting up to 6–8 weeks due to changing birth control methods to a non-hormonal solution
  • Nausea/vomiting
  • Vasovagal response (fainting)
  • Allergic reaction to the materials
  • Heightened allergic response to other allergens
  • heavy metal toxicity
  • itchy, raised rash
  • brain fog
  • autoimmune disease symptoms
  • weight gain
  • anxiety/depression
  • hair loss
  • severe anxiety
  • numbness of extremities
  • joint pain
  • back pain
  • suicidal thoughts

Device[edit]

The small, flexible inserts are made from polyester fibers, nickel-titanium, stainless steel and solder. The insert contains inner polyethylene terephthalate fibers to induce inflammation, causing a benign fibrotic ingrowth,[15] and is held in place by flexible stainless steel inner coil and a dynamic outer nickel titanium alloy coil.[15] Unlike temporary methods of birth control, the Essure inserts do not contain or release hormones. The inserts do not prevent the transmission of sexually transmitted infections.[23]

Regulatory history[edit]

A Facebook group called Essure Problems which had 33,140 members (as of 04/03/2017) called the method "E-hell" and mentioned mostly pain, bleeding, bloating and other side effects from the device. Some women had coils break and perforate their internal organs, conceived and gave birth to a child, at a number well above what Bayer has been reporting.[6] Erin Brockovich became involved in the controversy[6] and hosts a website where women can share their stories after having the procedure.[5][6]

Since then Bayer provided two toll-free telephone numbers for patient complaints,[6] has advised that women reporting adverse effects are "consistent with clinical trials and consistent with what the FDA is seeing",[6] and further insisted that it wanted to hear from any women experiencing problems with Essure.[6]

In April 2015, a group of six delegates from the Essure Problems group, including a doctor with Essure experience, spoke before 36 members of the FDA and the Congressional HELP committee regarding a citizen's petition filed with the FDA. The FDA began investigating the claims of then over 16,000 members of the group as well as the legalities of the approval process that Essure went through.[citation needed] As of 2015, one postmarketing study was not published for 13 years after the device was approved, and another postmarketing study had not been published as of 2015.[1]

FDA[edit]

The product was approved by the FDA in 2002.[6] In 2013, the product made news in North America, 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.[5]

In October 2013 the FDA stated that since the product was approved in 2002 it had received 943 reports of adverse events related to Essure, mainly for pain (606 of the complaints).[6] An additional 1,000 more complaints have been sent to the FDA in a voluntary reporting system, but physicians are not obliged to report complaints.[6]

In June 2015, the FDA reported an investigation into Essure and its over 5000 complaints, seven reported deaths, and many additional side effects, all linked to Essure, its specific chemical composition, its improper placement and its insertion. The agency announced that its Obstetrics and Gynecology Devices Panel would conduct an evidence-based review of Essure's safety in September 2015 due to the rise in adverse event reports from only 950 reports between 2002 through October 2013, to more than 4,150, or 81 percent of the total, from October 2013 to June 2015.[24]

In February 2016, the FDA issued a "black box" label to warn the public about the harmful complications associated with the use of this device and requested Bayer to conduct a new postmarket surveillance to follow 2,000 women for at least three years, comparing the effectiveness and safety of the device with other surgical contraceptive methods. Women and doctors were required to sign a decision checklist before Essure implantation, and to give consent to a test three months later to ensure the device was properly placed and functioning.[25]

References[edit]

  1. ^ a b c Dhruva SS, Ross JS, Gariepy AM. (Oct 8, 2015). "Revisiting Essure--Toward Safe and Effective Sterilization". N Engl J Med. 373 (15): e17. doi:10.1056/NEJMp1510514. PMID 26397951. Free full text
  2. ^ a b c "Essure System - P020014". US Food and Drug Administration. 2009-06-29. Retrieved 2011-05-21. 
  3. ^ "Essure Permanent Birth Control". U.S. Food and Drug Administration. Retrieved June 24, 2014. 
  4. ^ 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. 
  5. ^ a b c d Deirdre Dearhoff (December 22, 2013). "Women report complications from Essure birth control". Chicago Tribune. Retrieved March 2, 2014. 
  6. ^ a b c d e f g h i j Regan Morris (June 24, 2014). "Erin Brockovich calls for end to Bayer's Essure". BBC News, Los Angeles. Retrieved June 24, 2014. 
  7. ^ Stein, Rob (21 September 2015). "FDA Revisits Safety Of Essure Contraceptive Device". NPR. Retrieved 21 September 2015. 
  8. ^ a b Mao, Jialin; Pfeifer, Samantha; Schlegel, Peter; Sedrakyan, Art (13 Nov 2015). "Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study". BMJ. 351: h5162. doi:10.1136/bmj.h5162. PMC 4604215Freely accessible. PMID 26462857. Free full text
  9. ^ Isle, Jay W. Belle (17 August 2017). "Essure Loses Commercial License in European Union - Legal Reader". Legalreader.com. Retrieved 16 May 2018. 
  10. ^ "Essure Sales Halted In European Union, Implants Recalled". Birthcontrolproblems.com. 7 August 2017. Retrieved 16 May 2018. 
  11. ^ "EU suspends sale of contraceptive implant". Medicalspress.com. Retrieved 16 May 2018. 
  12. ^ "Satojen naisten sterilisaatiot menneet pieleen Suomessa – vaeltamaan lähteneitä implantteja löydetty muualta elimistöstä". Yle Uutiset. Retrieved 16 May 2018. 
  13. ^ US FDA Medical Devices--FDA Activities: Essure Page Last updated 04/09/2018, accessed 16 May 2018
  14. ^ Bellon, Tina. "Bayer to phase out Essure birth control device in U.S." U.S. Retrieved 2018-07-26. 
  15. ^ a b c d e Miño M, Arjona JE, Cordón J, Pelegrin B, Povedano B, Chacon E (June 2007). "Success rate and patient satisfaction with the Essure sterilisation in an outpatient setting: a prospective study of 857 women". BJOG. 114 (6): 763–6. doi:10.1111/j.1471-0528.2007.01354.x. PMID 17516970. Retrieved 15 December 2015. 
  16. ^ [1][dead link]
  17. ^ "Essure Confirmation Test". Conceptus Inc. Archived from the original on 2011-06-12. Retrieved 2011-05-30. 
  18. ^ "Clinical Testing". Essure. Conceptus. Retrieved 2006-12-12. [dead link]
  19. ^ 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. 
  20. ^ a b "Prescribing Information" (PDF). Essure. Conceptus. 2005-09-08. Archived from the original (PDF) on 2006-11-11. Retrieved 2006-12-12. 
  21. ^ "Doctors Confirm First Successful Essure Tubal Ligation Reversal". medical news today. 2008-10-08. Retrieved 2010-02-15. , referring to Dr. William A.C. Greene Jr. and Dr. Wendell Turner at Lakeshore Surgical Center
  22. ^ 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. 
  23. ^ "Essure®". www.essure.com. Retrieved 2018-07-26. 
  24. ^ U.S., FDA. "FDA Activities". U.S. Food and Drug Administration. Retrieved 19 August 2015. 
  25. ^ "FDA takes additional action to better understand safety of Essure, inform patients of potential risks". U.S. Food and Drug Administration. February 29, 2016. Retrieved August 21, 2016. 

External links[edit]