Essure

Essure is a permanent birth control for women (female sterilization), manufactured by Conceptus and Bayer. Essure is a small metal and polyester coil implanted into the fallopian tubes. Over a three-month period, tissue forms around the inserts and the build-up of scar tissue creates a barrier that keeps sperm from reaching the eggs, thus preventing fertilization.

Thousands of women have reported injuries and complications including:

  • Perforation or migration of the device
  • Re-surgery (removal, hysterectomy, salpingectomy)
  • Irregular and heavy vaginal bleeding (menstrual irregularities)
  • Pelvic Pain
  • Ectopic Pregnancy / Ruptured Fallopian Tube / Miscarriage
  • Nickel Allergy

The FDA has taken recent action, most notably issuing the strongest warning possible – a black box warning indicating:

WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, 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 reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System for Permanent Birth Control during discussion of the benefits and risks of the device.

Timeline of FDA Action
Action Date
FDA Advisory Committee Meeting September 24, 2015
Draft Guidance (BBW & Check List & Post Marketing Studies 522) February 29, 2016
Final Guidance (BBW & Check List) October 31, 2016
FDA Letter (Restricting Sales) April 14, 2018

The FDA’s April 2018 statement restricted the sales of Essure to only doctors and healthcare facilities who use the FDA-approved Patient-Doctor Discussion Checklist.

Quotes from Letter:

The sale and distribution by Bayer of the Essure System for Permanent Birth Control are restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device prior to its use in the form and manner specified in approved labeling to be provided by Bayer

FDA has determined that these restrictions on sale and distribution are necessary to provide reasonable assurance of the safety and effectiveness of the device. Your device is therefore a restricted device subject to the requirements in sections 502(q) and (r) of the act, in addition to the many other FDA requirements governing the manufacture, distribution, and marketing of devices.