Essure

Essure
Background
Type Sterilization
First use 2002
Failure rates (first year, after occlusion)
Perfect use 0.26%
Typical use 0.26%
Usage
Duration effect Permanent
Reversibility Irreversible
User reminders Additional methods until 3 month check by hysterosalpingogram
Clinic review None
Advantages and disadvantages
STD protection No
Benefits Permanent contraception

Essure is a permanent, less-invasive surgical sterilization procedure for women developed by Conceptus Inc., a subsidiary of Bayer AG.[1][2] With Essure, a coil designed to induce fibrosis and block the fallopian tubes is placed into each fallopian tube to prevent fertilization.[3] It was approved for use in the United States on November 4, 2002.[4]

Essure was designed as an alternative to tubal ligation, the standard procedure for surgical sterilization. In tubal ligation, a surgeon cuts a small hole in the abdomen, and through that hole, blocks or cuts the fallopian tubes. Tubal ligation is major surgery that is done in a hospital and requires anesthesia. Essure can be done in a doctor's office with less anesthesia. A 2009 review concluded that Essure seemed to be safe and effective based on short-term studies, and that it was less invasive and could be cheaper than laparoscopic bilateral tubal ligation.[5]

However, according to the U.S. F.D.A. adverse events database and other studies reported in the medical literature,[3][6] there have been 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.

Some doctors wrote that 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. One postmarketing study was not published for 13 years after the device was approved, and another postmarketing study has never been published.[3]

Since 2013, the product has been the subject of controversy with thousands of women complaining of severe side effects leading to surgical extraction,[7] and campaigner Erin Brockovich hosting a website where women can share their stories after having the procedure.[7][8][9]

Procedure

In one prospective study, the mean time taken for procedure was 6.8 minutes (range = 5–18 minutes).[10] for a trained physician to perform and can be performed in a physician's office. General anesthesia is not required. Despite this, some women have reported considerable pain during the procedure.[11]

Small, flexible inserts are placed into the fallopian tubes by a catheter passed from the vagina through the cervix and uterus.[10] The insert contains inner polyethylene terephthalate fibers to induce inflammation, causing a benign fibrotic ingrowth,[10] and is held in place by flexible stainless steel inner coil and a dynamic outer nickel titanium alloy coil.[10] 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.[10]

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[5] to prevent pregnancy until the method's effectiveness can be confirmed.

Follow-up

For the Essure method, three months after insertion a radiologist performs a fluoroscopic procedure called a hysterosalpingogram,[12] to confirm that the fallopian tubes are completely blocked and that the patient can rely on the Essure inserts for birth control.[4] 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

Following successful insertion and occlusional response, the Essure procedure is 99.74% effective based on 5 years of follow-up (Although one study found failure rates closer to 11%).[13][14]

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%)".[15] Upon follow-up, occlusion is observed to have occurred in 96.5% of patients at 3 months with the remainder occluded by 6 months.[4]

Cautions and warnings

The inserts are made from polyester fibers, nickel-titanium and stainless steel and solder and care should be taken to notify staff before any procedures are done, such as MRI or any magnetic imaging. Unlike many temporary methods of birth control, the Essure inserts do not contain or release hormones. The inserts do not prevent the transmission of sexually transmitted diseases.

The procedure is reported to be permanent and not reversible by the manufacturing company. Notwithstanding the manufacturer's position, several Essure reversals have been performed.[16]

Additional birth control must be used for three months after procedure until a hysterosalpingogram has been performed to confirm blockage.[15][17]

Risks

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.[7] In June 2015, the FDA reported an investigation into Essure and its over 5000 complaints, 7 reported deaths, and many additional side effects, all linked to Essure, its specific chemical composition, its improper placement and its insertion. The FDA released a statement on October 25, 2013, stating that since the product was approved in 2002 that it had received 943 reports of adverse events related to Essure, mainly for pain (606 of the complaints).[8] 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.[8]

A Facebook group called Essure Problems has 24,953 (as of 12/26/2015) members who call the method "E-hell" and mostly complain about pain, bleeding, bloating and a host of other side effects (see above) from the device. Some say they've had coils break and perforate their internal organs, babies being born, the number of well above what Bayer is reporting.[8] Erin Brockovich became involved in the controversy due to the laws of Federal preemption which presently stop women suing Bayer,[8] and now hosts a website where women can share their stories after having the procedure.[7][8]

Bayer has since provided two Toll-free telephone numbers for patient complaints,[8] advises that women reporting adverse effects are "consistent with clinical trials and consistent with what the FDA is seeing",[8] and further insists that it wants to hear from any women experiencing problems with Essure.[8]

In April 2015, a group of 6 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 is now investigating the claims of the now over 16,000 members of the group as well as the legalities of the approval process that essure went through.

In June 2015, the FDA announced that its Obstetrics and Gynecology Devices Panel will conduct a review of Essure's safety on September 24, 2015 due to the recent rise in adverse event reports. While the agency received only 950 reports from 2002 through October 25, 2013, they have received more than 4,150, or 81 percent of the total, since that time.[18] As of November 24, 2015, FDA was conducting an evidence-based review of the available information data and anticipated making a public announcement of their decisions at the end of February, 2016.[19] On February 29, 2016, the FDA issued a "black box" label to warn the public about the harmful complications associated with the use of this device. The agency also 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. Patients and doctors will also be required to sign a decision checklist before Essure implantation, and to give consent to a test three months later aimed at ensuring the device is properly placed and functioning.[20]

On October 13, 2015, a study published in the BMJ concluded that Essure did not prevent pregnancy any better than a laparoscopic procedure, but they had a "10-fold higher risk of undergoing reoperation" when compared to patients who underwent a laparoscopic sterilization procedure.[6]

References

  1. ↑ Conceptus Inc. was acquired by Bayer AG of Germany on June 5, 2013.
  2. ↑ "Essure Permanent Birth Control". U.S. Food and Drug Administration. Retrieved June 24, 2014.
  3. 1 2 3 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
  4. 1 2 3 "Essure™ System - P020014". US Food and Drug Administration. 2009-06-29. Retrieved 2011-05-21.
  5. 1 2 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.
  6. 1 2 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
  7. 1 2 3 4 "Women report complications from Essure birth control". Chicago Tribune. Retrieved March 2, 2014.
  8. 1 2 3 4 5 6 7 8 9 Regan Morris (June 24, 2014). "Erin Brockovich calls for end to Bayer's Essure". BBC News, Los Angeles. Retrieved June 24, 2014.
  9. ↑ Stein, Rob (21 September 2015). "FDA Revisits Safety Of Essure Contraceptive Device". NPR. Retrieved 21 September 2015.
  10. 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. Retrieved 15 December 2015.
  11. ↑ http://www.marketwatch.com/story/conceptusr-to-promote-gynecare-thermachoicer-to-us-physician-offices-2010-11-10?reflink=MW_news_stmp
  12. ↑ "Essure Confirmation Test". Conceptus Inc. Retrieved 2011-05-30.
  13. ↑ control methodsbyConceptus/Understanding/ClinicalTesting/tabid/58/Default.aspx "Clinical Testing" Check |url= value (help). Essure. Conceptus. Retrieved 2006-12-12.
  14. ↑ 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.
  15. 1 2 "Prescribing Information" (PDF). Essure. Conceptus. 2005-09-08. Archived from the original (PDF) on 2006-11-11. Retrieved 2006-12-12.
  16. ↑ "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
  17. ↑ 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.
  18. ↑ U.S., FDA. "FDA Activities". U.S. Food and Drug Administration. Retrieved 19 August 2015.
  19. ↑ "Update on the status of FDA's evaluation of the Essure System". United States Food and Drug Administration. November 24, 2015. Retrieved 16 December 2015.
  20. ↑ "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

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