Essure

Essure is a device for female sterilization. It is a metal coil which when placed into each fallopian tube induces fibrosis and blockage. It was developed by Conceptus Inc. and US FDA approved in November 2002. Conceptus was acquired by Bayer AG of Germany in June 2013. Essure is a device for female sterilization. It is a metal coil which when placed into each fallopian tube induces fibrosis and blockage. It was developed by Conceptus Inc. and US FDA approved in November 2002. Conceptus was acquired by Bayer AG of Germany in June 2013. 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. Since 2013, the product has been controversial, with thousands of women complaining of severe side effects leading to surgical extraction, and campaigner Erin Brockovich has been hosting a website where women can share their stories after having the procedure.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. 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.In April 2018, the FDA restricted sale and use of Essure. On July 20, 2018 Bayer announced the halt of sales in the U.S. by the end of 2018. The device is featured in the 2018 Netflix documentary The Bleeding Edge. A physician places the coils into the fallopian tubes by a catheter passed from the vagina through the cervix and uterus. 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. 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 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). 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. For the Essure method, three months after insertion a radiologist is supposed to perform a fluoroscopic procedure called a hysterosalpingogram, 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. 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%).