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
Advantages and disadvantages
STI 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. With Essure, a coil designed to induce fibrosis and block the fallopian tubes is placed into each fallopian tube to prevent fertilization. It was approved for use in the United States on November 4, 2002.

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.

However, according to the U.S. F.D.A. adverse events database and other studies reported in the medical literature, 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.

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

In one prospective study, the mean time taken for procedure was 6.8 minutes (range = 5–18 minutes). 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.

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 inflammation, causing a benign fibrotic ingrowth, and is held in place by flexible stainless steel inner coil and a dynamic outer nickel titanium alloy coil. 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.

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