Essure

Essure was a device for female sterilization. It is a metal coil which when placed into each fallopian tube induces fibrosis and blockage. Essure was designed as an alternative to tubal ligation. However, it was recalled by Bayer in 2018, and the device is no longer sold due to complications secondary to its implantation. The company has reported that several patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse effects, including: perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reaction. Although 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, 92% were followed up at one year, and 25% for two 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. About 750,000 women have received the device worldwide.

Initial trials found about 4% of women had tubal perforation, expulsion, or misplacement of the device at the time of the procedure. Since 2013, the product has been controversial, with thousands of women reporting severe side effects leading to surgical extraction. Rates of repeat surgery in the first year were ten times greater with Essure than with tubal ligation. Campaigner Erin Brockovich has been hosting a website where women can share their stories after having the procedure. As of 2015 many 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 US FDA adverse events database and other studies.