Wikipedia
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.