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essurel
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There are 7 letters in ESSUREL ( E1L1R1S1U1 )
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| Essurel might refer to |
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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. |