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 | |
STI protection | No |
Benefits | Permanent contraception |
Essure is a permanent, non-surgical transcervical sterilization procedure for women developed by Conceptus Inc., a fully-owned subsidiary of Bayer AG of Germany since June 5, 2013.[1] It was approved for use in the United States on November 4, 2002.[2]
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.[3]
Since 2013, the product has been the subject of controversy with women complaining of severe side effects leading to surgical extraction,[4] and campaigner Erin Brockovich hosting a website where women can share their stories after having the procedure.[4][5]
The procedure takes about 10 minutes,[citation needed] for a trained physician to perform and can be performed in a physician's office.[citation needed] General anesthesia is not required.[6]
Small, flexible inserts are placed into the fallopian tubes by a catheter passed from the vagina through the cervix and uterus.[citation needed] 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.[7] 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.[citation needed]
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[3] to prevent pregnancy until the method's effectiveness can be confirmed.
For the Essure method, three months after insertion a Radiologist physician performs an x-ray procedure called a hysterosalpingogram,[8] to confirm that the fallopian tubes are completely blocked and that the patient can rely on the Essure inserts for birth control.[2] 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.
Following successful insertion and occlusional response, the Essure procedure is 99.74% effective based on 5 years of follow-up.[9][10]
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%)".[11] Upon follow-up, occlusion is observed to have occurred in 96.5% of patients at 3 months with the remainder occluded by 6 months.[2]
The inserts are made from polyester fibers, nickel-titanium and stainless steel and solder and are safe to use with MRI equipment. 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.[12]
Additional birth control must be used for three months after procedure.[11][13]
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]
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).[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]
A Facebook group called Essure Problems has 8,592 members who call the method "E-hell" and mostly complain about pain, bleeding and bloating from the device. Some say they've had coils break and perforate their internal organs.[5] Erin Brockovich hosts a website where women can share their stories after having the procedure.[4][5]
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Birth control methods | |||||||
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Related topics | |||||||
Long-acting reversible contraception (LARC) | |||||||
Sterilization |
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Hormonal contraception |
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Barrier Methods | |||||||
Emergency Contraception (Post-intercourse) | |||||||
Spermicides | |||||||
Behavioral |
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Experimental |
Tests and procedures involving the female reproductive system | |||||||||||
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Ovaries | |||||||||||
Fallopian tubes | |||||||||||
Uterus |
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Vagina | |||||||||||
Vulva | |||||||||||
Medical imaging |