FDA Releases Guidance on the Essure Permanent Female Sterilization Device

News in Context |
November 28, 2016

FDA Releases Guidance on the Essure Permanent Female Sterilization Device

  1. Robert L. Barbieri, MD

Boxed warning and patient decision checklist clarify Essure's risks.

  1. Robert L. Barbieri, MD

The two options for permanent female sterilization are transabdominal tubal surgery or hysteroscopic placement of flexible metal coils (Essure implants) at the tubal-uterine junction. After receiving reports of complications following Essure insertion, the FDA concluded that the risks and benefits of Essure sterilization were not being adequately communicated, and recommended that a boxed warning (see http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm529241.htm) and a patient decision checklist be developed.

The patient decision checklist includes the following key points:

  • Essure is a permanent form of birth control.

  • There are other options for permanent sterilization as well as highly effective contraceptive options that are not permanent.

  • Sometimes, successful placement of the Essure implant is not possible.

  • Confirmatory imaging is required 3 months following placement of Essure.

  • Some women may develop new abdominal, pelvic, and/or back pain following Essure placement.

  • The Essure implant contains nickel, titanium, iron, chromium, and tin, and some women may develop allergic reactions to the device.

  • Some women will require surgical removal of the device, a major operation.

  • The Essure device can “poke through” the wall of the uterus or fallopian tubes (perforation) and/or move to other locations in the abdomen or pelvis (migration).

  • Perforation rates in studies of Essure have ranged from 1% to 4%.

Comment

Tubal sterilization surgery is usually performed laparoscopically under general anesthesia or immediately postpartum under regional anesthesia. Essure implants can be inserted hysteroscopically in a physician's office. Following either tubal surgery or placement of an Essure device, possible adverse events include pregnancy, pelvic pain, and abnormal menstrual bleeding (Obstet Gynecol 2016; 128:843). In my practice, we have inserted three Essure devices in the past 24 months, all in women who wanted permanent sterilization and had cardiovascular disease precluding laparoscopic tubal surgery. Intrauterine devices and contraceptive implants offer highly effective reversible contraception with lower failure rates and costs than surgical sterilization. Vasectomy is also a vastly underutilized method of contraception for stable couples who have completed their families.

Editor Disclosures at Time of Publication

  • Disclosures for Robert L. Barbieri, MD at time of publication Editorial boards UpToDate (Editor-in-Chief, Obstetrics/Gynecology and Women’s Health); OBG Management (Editor-in-Chief)

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