Essure® permanent birth control effectiveness: a seven-year survey

Essure appears to be a safe reliable contraception. The aim of this study is to report French pregnancies after Essure hysteroscopic sterilization. This study is a retrospective national survey between January 2003 and September 2010. Data were collected in two ways: – a mail-in questionnaire addressed to all surgeons performing Essure procedures in France – pregnancies reported directly to the manufacturer. The surgeons contacted in our study were responsible for 63.4% of all Essure procedures in France. Fifty-eight cases of unintended pregnancies after Essure sterilization in France were reported during the study period. Factors associated to unintended pregnancies were patient’ non compliance with follow-up (22 pregnancies, 38% of cases) and misinterpretation at the 3rd-month confirmation test (19 cases, 33%). Other causes were physician's deviation from protocol (10 cases) and undetected pre-procedure pregnancy (3 cases). Three pregnancies happened before the 3-months confirmation test. Based on the number of kits sold during the period, the estimated pregnancy rate was between 1.07 and 1.09/1000 procedure. The pregnancy risk after hysteroscopic sterilization may be reduced by improving patient education and physician knowledge concerning the 3rd month confirmation test.