67: Pregnancies in Women Who Have Undergone the Essure Hysteroscopic Sterilization Procedure: A Summary of 37 Cases

Abstract

A clinical analysis of pregnancies in women that have undergone the Essure hysteroscopic sterilization procedure (Conceptus Inc., San Carlos, CA). All pregnancies reported to the device manufacturer from 1997 to December, 2004 were analyzed. Clinical surgical procedure and office settings. The clinical events associated with the 37 pregnancies were analyzed. All pregnancies occurred in women who had undergone the Essure permanent sterilization procedure reported from worldwide commercial and clinical sites. Of the 37 reported pregnancies following and estimated 29,736 procedures, 6 women (16%) were pregnant prior to placement of the micro-inserts, 21 cases (57%) were associated with a failure of adequate post-procedure follow-up, 7 cases (19%) were attributed to misinterpreted hysterosalpingograms (HSGs) or X-rays followed by an incorrect decision to rely on the method, 1 case (3%) followed expulsion of a prior device design, and 2 cases (5%) are pending further investigation. The data indicate that most pregnancies are avoidable and can be potentially overcome by (1) ensuring the women are using a reliable form of contraception prior to the procedure (2) performing the procedure prior to ovulation and thus avoiding the risk of luteal phase pregnancy (3) improving the quality and accuracy of HSG/X-ray film reporting and encouraging radiologists and clinicians to communicate on film interpretation, and (4) to educate clinicians and patients about the necessity of the 3-month follow-up to confirm both tubal occlusion and correct position of the micro-inserts. The avoidable nature of these failures indicates that with improved care, these failures can be reduced.