Confirmation Testing of Essure Microinserts in Unintended Pregnancies Using a 10-Year Retrospective Database

Abstract Study Objectives To examine the imaging modality used in cases of Essure failures and determine the cause of the unintended pregnancies (noncompliance to follow-up recommendations, misinterpretation of the imaging test, or device failure). Design Retrospective, single-center interventional cohort (Canadian Task Force classification II-2). Setting Tertiary level hospital. Patients Women who have had Essure placement and subsequent pregnancy. Interventions Coding data from the Regina General Hospital was examined for any pregnancy occurring after an Essure procedure. The hospital charts were then reviewed for data collection. A separate imaging database established over the same time frame was then reviewed to determine the imaging modality used in each case (transvaginal ultrasound [TVU], hysterosalpingogram [HSG], or none). Results of the imaging study were reviewed and the cause of the failure determined. Measurements and Main Results Twenty-four pregnancies in 25 women were identified after Essure procedures from January 1, 2003 to March 31, 2013. There were 4 in vitro fertilization pregnancies and 4 pregnancies where the woman had been instructed not to rely on the devices because of incomplete placement noted at time of the procedure. Therefore, 17 unintended pregnancies occurred of a total 2080 procedures performed. Examination of the imaging studies revealed that 11 were due to patient noncompliance (either early cessation of backup contraception or failure to go for confirmatory imaging), 5 due to misinterpretation of the imaging tests (3 HSG, 2 TVU), and 1 device failure. This reveals a cumulative failure rate of 6 of 2080 or .29% over 10 years with only .04% (1/2080) being device related. Conclusion Essure sterilization is an effective means of permanent contraception with a device failure rate of only .04%. Most unintended pregnancies after the Essure procedure result from a failure to comply with follow-up recommendations, and strategies to improve compliance should be emphasized.