Essure

Last updated
Essure
Essure Permanent Birth Control device.jpg
Background
TypeSterilization
First use2002
Failure rates (first year, after occlusion; data disputed)
Perfect use0.26%
Typical use?
Usage
Duration effectPermanent
Reversibilityirreversible
User remindersAdditional methods until 3 month check by hysterosalpingogram
Clinic reviewNone
Advantages and disadvantages
STI protectionNo
BenefitsPermanent contraception

Essure was a device for female sterilization. It is a metal coil which when placed into each fallopian tube induces fibrosis and blockage. [1] Essure was designed as an alternative to tubal ligation. However, it was recalled by Bayer in 2018, and the device is no longer sold due to complications secondary to its implantation. The company has reported that several patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse effects, including: perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reaction. Although 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, 92% were followed up at one year, and 25% for two 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. [2] About 750,000 women have received the device worldwide. [3]

Contents

Initial trials found about 4% of women had tubal perforation, expulsion, or misplacement of the device at the time of the procedure. [3] Since 2013, the product has been controversial, with thousands of women reporting severe side effects leading to surgical extraction. [4] Rates of repeat surgery in the first year were ten times greater with Essure than with tubal ligation. [3] Campaigner Erin Brockovich has been hosting a website where women can share their stories after having the procedure. [4] [5] [6] As of 2015 many 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 US FDA adverse events database and other studies. [1] [7]

It was developed by Conceptus Inc. and approved for use in the United States in 2002. [8] Conceptus was acquired by Bayer AG of Germany in June 2013.[ citation needed ] [9] In 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 in Canada, the UK, Finland, and the Netherlands. [10] [11] [12] [13] In April 2018, the FDA restricted sale and use of Essure which resulted in a 70% decrease in sales. [14] [15] In July 2018 Bayer announced the halt of sales in the U.S. by the end of 2018. [16] [17] The device is featured in the 2018 Netflix documentary The Bleeding Edge .

Use

A 2015 review found the effectiveness of Essure is unclear due to the low quality of evidence. [18] With perfect use another review found evidence of a 99.8% effective based on 5 years of follow-up. [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. [8] 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. [7]

Follow-up

For the Essure method, three months after insertion a radiologist is supposed to perform a fluoroscopic procedure called a hysterosalpingogram, [21] 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. [8]

Adverse effects

Serious side effects may include persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen. [15]

Because of the stainless steel medical staff need to be notified before magnetic resonance imaging (MRI) can be performed. However, the inserts were found to be safe with MRI using a 3-Tesla magnet and is considered MR-conditional. [22]

Risks

Procedural complications

  • Inability to place inserts (4%)
  • Cramping (30%)
  • Pain (13%)
  • Nausea/vomiting (11%)
  • Dizziness/light headed (9%)
  • Bleeding/spotting (7%)
  • Vasovagal response (fainting) (1.3%)
  • Perforation, expulsion, or other unsatisfactory location of the insert

Long-term complications

Sources: [22] [23]

  • Abdominal pain (3.8%)
  • Back pain (9%)
  • Menstrual cramps, severe (2.9%)
  • Pelvic or lower abdominal pain, severe (2.5%)
  • Gas/bloating (1.3%)
  • Headache (2.5%)
  • Heavier menstrual bleeding (1.9%)
  • Vaginal discharge or infection (1.5%)
  • Pregnancy (0.48%) [23] and increased risk of ectopic pregnancy
  • Allergic reaction to the materials
  • Rash
  • Autoimmune disease (0.99%) [23]
  • Weight changes
  • Depression
  • Hair loss
  • Suicide attempt (0.55%) [23]

Procedure

A physician places the coils into the fallopian tubes by a catheter passed from the vagina through the cervix and uterus. [24] This occurs successfully between 63% and 100% of the time. [25] Once in place, the ingrowth continues over a period of three months, resulting in 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. [24] [2]

Unlike tubal ligation, it may not require a general anaesthetic (though is often done under general anaesthetic).[ citation needed ] Despite this, some women have reported considerable pain during the procedure. [26]

In one 2007 prospective study, the mean time for procedure was 6.8 minutes (range = 5–18 minutes) [24] for a trained physician to perform. The procedure can be performed in a physician's office.[ citation needed ]

The procedure is reported to be permanent and not reversible by the manufacturer. Nevertheless, several Essure reversals have been performed.[ citation needed ]

Device

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, [24] and is held in place by flexible stainless steel inner coil and a dynamic outer nickel titanium alloy coil. [24] 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. [27]

Regulatory history

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, or conceived and gave birth to a child, at a number well above what Bayer has been reporting. [5] Erin Brockovich became involved in the controversy [5] and hosts a website where women can share their stories after having the procedure. [4] [5] Since then Bayer provided two toll-free telephone numbers for patient complaints, [5] has advised that women reporting adverse effects are "consistent with clinical trials and consistent with what the FDA is seeing", [5] and further insisted that it wanted to hear from any women experiencing problems with Essure. [5]

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

The product was approved by the FDA in 2002. [5] 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. [4]

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). [5] 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. [5]

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. [28]

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. [29]

In July 2020, Bayer published interim data from the FDA-mandated postmarket surveillance study comparing patients who received Essure to those who receiving a laparoscopic tubal ligation. The interim data reported the incidence of several side effects in each group. In Essure patients, chronic lower abdominal or pelvic pain occurred in 9% and abnormal bleeding in 16%, compared to 4.5% reporting pain and 10% with abnormal bleeding in the tubal ligation group. It also reported new allergic or hypersensitivity reactions in 22% of patients and no reports of new autoimmune disorders, although blinded independent verification was pending. [30] Recruitment of patients receiving Essure into the postmarket surveillance study has ceased as the device is no longer available on the US market.

In 2023, the device was the subject of a class action lawsuit in Australia. Over 1000 women joined the suit claiming that the device caused pain, suffering, and significant bleeding. [31]

Related Research Articles

<span class="mw-page-title-main">Copper IUD</span> Birth control and emergency contraceptive device

A copper intrauterine device (IUD), also known as an intrauterine coil or copper coil or non-hormonal IUD, is a type of intrauterine device which contains copper. It is used for birth control and emergency contraception within five days of unprotected sex. It is one of the most effective forms of birth control with a one-year failure rate around 0.7%. The device is placed in the uterus and lasts up to twelve years. It may be used by women of all ages regardless of whether or not they have had children. Following removal, fertility quickly returns.

<span class="mw-page-title-main">Ectopic pregnancy</span> Female reproductive system health issue

Ectopic pregnancy is a complication of pregnancy in which the embryo attaches outside the uterus. Signs and symptoms classically include abdominal pain and vaginal bleeding, but fewer than 50 percent of affected women have both of these symptoms. The pain may be described as sharp, dull, or crampy. Pain may also spread to the shoulder if bleeding into the abdomen has occurred. Severe bleeding may result in a fast heart rate, fainting, or shock. With very rare exceptions, the fetus is unable to survive.

<span class="mw-page-title-main">Laparoscopy</span> Minimally invasive operations within the abdominal or pelvic cavities

Laparoscopy is an operation performed in the abdomen or pelvis using small incisions with the aid of a camera. The laparoscope aids diagnosis or therapeutic interventions with a few small cuts in the abdomen.

Sterilization is any of a number of medical methods of birth control that intentionally leaves a person unable to reproduce. Sterilization methods include both surgical and non-surgical, and exist for both males and females. Sterilization procedures are intended to be permanent; reversal is generally difficult or impossible.

<span class="mw-page-title-main">Tubal ligation</span> Surgical clipping,removal or blocking of the fallopian tubes

Tubal ligation is a surgical procedure for female sterilization in which the fallopian tubes are permanently blocked, clipped or removed. This prevents the fertilization of eggs by sperm and thus the implantation of a fertilized egg. Tubal ligation is considered a permanent method of sterilization and birth control.

Rubber band ligation (RBL) is an outpatient treatment procedure for internal hemorrhoids of any grade. There are several different devices a physician may use to perform the procedure, including the traditional metal devices, endoscopic banding, and the CRH O'Regan System.

<span class="mw-page-title-main">Hysteroscopy</span> Medical procedure

Hysteroscopy is the inspection of the uterine cavity by endoscopy with access through the cervix. It allows for the diagnosis of intrauterine pathology and serves as a method for surgical intervention.

<span class="mw-page-title-main">Falloposcopy</span>

Falloposcopy is the inspection of the fallopian tubes through a micro- endoscope. The falloposcope is inserted into the tube through its opening in the uterus at the proximal tubal opening via the uterotubal junction; technically it could also be inserted at the time of abdominal surgery or laparoscopy via the distal fimbriated end.

<span class="mw-page-title-main">Salpingectomy</span> Surgical removal of fallopian tube

Salpingectomy refers to the surgical removal of a fallopian tube. This may be done to treat an ectopic pregnancy or cancer, to prevent cancer, or as a form of contraception.

<span class="mw-page-title-main">Hormonal intrauterine device</span> Intrauterine device

A hormonal intrauterine device (IUD), also known as an intrauterine system (IUS) with progestogen and sold under the brand name Mirena among others, is an intrauterine device that releases a progestogenic hormonal agent such as levonorgestrel into the uterus. It is used for birth control, heavy menstrual periods, and to prevent excessive build of the lining of the uterus in those on estrogen replacement therapy. It is one of the most effective forms of birth control with a one-year failure rate around 0.2%. The device is placed in the uterus and lasts three to eight years. Fertility often returns quickly following removal.

<span class="mw-page-title-main">Endometrial ablation</span> Medical procedure

Endometrial ablation is a surgical procedure that is used to remove (ablate) or destroy the endometrial lining of the uterus. The goal of the procedure is to decrease the amount of blood loss during menstrual periods. Endometrial ablation is most often employed in people with excessive menstrual bleeding, who do not wish to undergo a hysterectomy, following unsuccessful medical therapy.

Conceptus Inc. was an American medical products manufacturer and developer. It is now a fully owned subsidiary of Bayer AG of Germany.

Tubal reversal, also called tubal sterilization reversal, tubal ligation reversal, or microsurgical tubal reanastomosis, is a surgical procedure that can restore fertility to women after a tubal ligation. By rejoining the separated segments of the fallopian tube, tubal reversal can give women the chance to become pregnant again. In some cases, however, the separated segments cannot actually be reattached to each other. In some cases the remaining segment of tube needs to be re-implanted into the uterus. In other cases, when the end of the tube has been removed, a procedure called a neofimbrioplasty must be performed to recreate a functional end of the tube which can then act like the missing fimbria and retrieve the egg that has been released during ovulation.

<span class="mw-page-title-main">Fallopian tube obstruction</span> Medical condition

Fallopian tube obstruction, also known as fallopian tube occlusion is a major cause of female infertility. Blocked fallopian tubes are unable to let the ovum and the sperm converge, thus making fertilization impossible. Fallopian tubes are also known as oviducts, uterine tubes, and salpinges.

The fertiloscope is a type of laparoscope, modified to make it suitable for trans-vaginal application, which is used in the diagnosis and treatment of female infertility.

<span class="mw-page-title-main">Intrauterine device</span> Form of birth control involving a device placed in the uterus

An intrauterine device (IUD), also known as intrauterine contraceptive device or coil, is a small, often T-shaped birth control device that is inserted into the uterus to prevent pregnancy. IUDs are one form of long-acting reversible birth control (LARC). One study found that female family planning providers choose LARC methods more often (41.7%) than the general public (12.1%). Among birth control methods, IUDs, along with other contraceptive implants, result in the greatest satisfaction among users.

<span class="mw-page-title-main">National Center for Health Research</span> Organization

The National Center for Health Research is a Washington, D.C.-based non-profit organization founded in 1999, providing health-related services such as providing free information and training based on research findings; educating policy makers and working with the media. The President of the organisation is Diana Zuckerman. The primary program is The Cancer Prevention and Treatment Fund, which utilises an online health hotline.

In the 1960s and 1970s, the Indian Health Service (IHS) and collaborating physicians sustained a practice of performing sterilizations on Native American women, in many cases without the free and informed consent of their patients. In some cases, women were misled into believing that the sterilization procedure was reversible. In other cases, sterilization was performed without the adequate understanding and consent of the patient, including cases in which the procedure was performed on minors as young as 11 years old. A compounding factor was the tendency of doctors to recommend sterilization to poor and minority women in cases where they would not have done so to a wealthier white patient. Other cases of abuse have been documented as well, including when health providers did not tell women they were going to be sterilized, or other forms of coercion including threatening to take away their welfare or healthcare.

Chromopertubation is a method for the study of fallopian tube patency for suspected infertility in women caused by fallopian tube obstruction. Occlusion or pathology of the fallopian tubes is the most common cause of suspected infertility. Chromopertubation is sometimes commonly referred to a "laparoscopy and dye" test. It is currently one of the standard procedures in this field. In most cases, chromopertubation is performed to assess and determine the cause of someone's difficulties in getting pregnant.

<i>The Bleeding Edge</i> 2018 American film

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References

  1. 1 2 3 Dhruva SS, Ross JS, Gariepy AM (October 2015). "Revisiting Essure--Toward Safe and Effective Sterilization". The New England Journal of Medicine. 373 (15): e17. doi:10.1056/NEJMp1510514. PMID   26397951.Free full text
  2. 1 2 Hurskainen R, Hovi SL, Gissler M, Grahn R, Kukkonen-Harjula K, Nord-Saari M, Mäkelä M (June 2010). "Hysteroscopic tubal sterilization: a systematic review of the Essure system". Fertility and Sterility. 94 (1): 16–9. doi: 10.1016/j.fertnstert.2009.02.080 . PMID   19409549.
  3. 1 2 3 Clark NV, Endicott SP, Jorgensen EM, Hur HC, Lockrow EG, Kern ME, et al. (November 2018). "Review of Sterilization Techniques and Clinical Updates". Journal of Minimally Invasive Gynecology. 25 (7): 1157–1164. doi:10.1016/j.jmig.2017.09.012. PMID   28939482. S2CID   24849899.
  4. 1 2 3 4 Dearhoff D (December 22, 2013). "Women report complications from Essure birth control". Chicago Tribune. Retrieved March 2, 2014.
  5. 1 2 3 4 5 6 7 8 9 10 Morris R (June 24, 2014). "Erin Brockovich calls for end to Bayer's Essure". BBC News, Los Angeles. Retrieved June 24, 2014.
  6. ↑ Stein R (21 September 2015). "FDA Revisits Safety Of Essure Contraceptive Device". NPR . Retrieved 21 September 2015.
  7. 1 2 Mao J, Pfeifer S, Schlegel P, Sedrakyan A (October 2015). "Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study". BMJ. 351: h5162. doi:10.1136/bmj.h5162. PMC   4604215 . PMID   26462857.Free full text
  8. 1 2 3 "Essure System - P020014". US Food and Drug Administration. 2009-06-29. Retrieved 2011-05-21.
  9. ↑ "Essure Permanent Birth Control". U.S. Food and Drug Administration. Retrieved June 24, 2014.
  10. ↑ Isle JW (17 August 2017). "Essure Loses Commercial License in European Union - Legal Reader". Legalreader.com. Retrieved 16 May 2018.
  11. ↑ "Essure Sales Halted In European Union, Implants Recalled". Birthcontrolproblems.com. 7 August 2017. Retrieved 16 May 2018.
  12. ↑ "EU suspends sale of contraceptive implant". Medicalspress.com. Retrieved 16 May 2018.
  13. ↑ "Satojen naisten sterilisaatiot menneet pieleen Suomessa – vaeltamaan lähteneitä implantteja löydetty muualta elimistöstä". Yle Uutiset. 17 August 2017. Retrieved 16 May 2018.
  14. ↑ US FDA Medical Devices--FDA Activities: Essure Page Last updated 04/09/2018, accessed 16 May 2018
  15. 1 2 Office of the Commissioner (18 March 2019). "Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency's continued commitment to postmarket review of Essure and keeping women informed". FDA. Retrieved 6 September 2019.
  16. ↑ Bellon T. "Bayer to phase out Essure birth control device in U.S." U.S. Retrieved 2018-07-26.
  17. ↑ "Sales of Essure birth control implant to be halted by Bayer; U.S. last to sell controversial device". Washington Post. Retrieved 6 September 2019.
  18. ↑ la Chapelle CF, Veersema S, Brölmann HA, Jansen FW (June 2015). "Effectiveness and feasibility of hysteroscopic sterilization techniques: a systematic review and meta-analysis". Fertility and Sterility. 103 (6): 1516–25.e1–3. doi: 10.1016/j.fertnstert.2015.03.009 . PMID   25910565.
  19. ↑ Ouzounelli M, Reaven NL (March 2015). "Essure hysteroscopic sterilization versus interval laparoscopic bilateral tubal ligation: a comparative effectiveness review". Journal of Minimally Invasive Gynecology. 22 (3): 342–52. doi:10.1016/j.jmig.2014.12.002. PMID   25499775.
  20. ↑ "Prescribing Information" (PDF). Essure. Conceptus. 2005-09-08. Archived from the original (PDF) on 2006-11-11. Retrieved 2006-12-12.
  21. ↑ "Essure Confirmation Test". Conceptus Inc. Archived from the original on 2011-06-12. Retrieved 2011-05-30.
  22. 1 2 "Essure Label" (PDF). 2002. Retrieved 13 July 2020.
  23. 1 2 3 4 Bouillon K, Bertrand M, Bader G, Lucot JP, Dray-Spira R, Zureik M (January 2018). "Association of Hysteroscopic vs Laparoscopic Sterilization With Procedural, Gynecological, and Medical Outcomes". JAMA. 319 (4): 375–387. doi:10.1001/jama.2017.21269. PMC   5833563 . PMID   29362796.
  24. 1 2 3 4 5 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. S2CID   29737812.
  25. ↑ Frietze G, Leyser-Whalen O, Rahman M, Rouhani M, Berenson AB (December 2015). "® Procedural Placement Success Rates on First Attempt". Journal of Gynecologic Surgery. 31 (6): 308–317. doi:10.1089/gyn.2015.0054. PMC   4657511 . PMID   26633935.
  26. ↑ [ dead link ]
  27. ↑ "Essure® |". www.essure.com. Archived from the original on 2018-07-26. Retrieved 2018-07-26.
  28. ↑ "FDA Activities". U.S. Food and Drug Administration. Retrieved 19 August 2015.
  29. ↑ "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.
  30. ↑ "522 Postmarket Surveillance Studies" . Retrieved 19 July 2020.
  31. ↑ Dow, Aisha (2023-04-09). "'I thought I was bleeding to death': The 'gentler' birth control device about to go on trial in Australia". The Age. Retrieved 2022-04-09.
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