Twelve year retrospective review of unintended pregnancies after Essure sterilization in the Netherlands

The incidence of pregnancies after sterilization with Essure is low. Most pregnancies were related to nonadherence to placement and follow-up protocols or misinterpretation of confirmation tests, and seem therefore preventable.

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Authors

Emilie Hitzerd, M.D., Henk W.R. Schreuder, M.D., Ph.D., Michel P.H. Vleugels, M.D., Ph.D., Sebastiaan Veersema, M.D., Ph.D.

Volume 105, Issue 4, Pages 932-937

Abstract

Objective:

To identify factors contributing to the occurrence of unintended pregnancies after Essure sterilization in the Netherlands. Even though Essure is a permanent method of contraception, unintended pregnancies have been reported.

Design

Retrospective case series analysis.

Setting:

Not applicable.

Patient(s):

Thirty-five pregnancies were reported in the Netherlands after Essure sterilization from 2002 through 2014 out of 27,346 placements.

Intervention(s):

Data regarding Essure placement procedure, confirmation tests, and pregnancy outcome of the reported cases were obtained and analyzed to identify a possible cause of failure.

Main Outcome Measure(s):

Four causes of failure were identified: perforation (n = 10), expulsion (n = 7), unilateral placement (n = 7), and luteal pregnancy (n = 2).

Result(s):

The occurrence of most pregnancies was related to physician noncompliance (n = 14). The other cases were associated with patient noncompliance (n = 5) or misinterpretation of the confirmation test (n = 9). Most pregnancies occurred within the first 24 months after the 3-month confirmation test (n = 23).

Conclusion(s):

The results of this study show that the incidence of pregnancies after Essure sterilization is low. Most pregnancies were related to incorrect positioning of a device or unilateral placement, and seem therefore preventable. Unilateral placement without prior history of salpingectomy should always be considered as unsuccessful sterilization. Furthermore, interpretation of the confirmation tests should be done by trained physicians, and with caution. We want to emphasize the importance of strictly adhering to placement and follow-up protocols.

Read the full text at: http://www.fertstert.org/article/S0015-0282(15)02309-2/fulltext


Fertility and Sterility

Editorial Office, American Society for Reproductive Medicine

Fertility and Sterility® is an international journal for obstetricians, gynecologists, reproductive endocrinologists, urologists, basic scientists and others who treat and investigate problems of infertility and human reproductive disorders. The journal publishes juried original scientific articles in clinical and laboratory research relevant to reproductive endocrinology, urology, andrology, physiology, immunology, genetics, contraception, and menopause. Fertility and Sterility® encourages and supports meaningful basic and clinical research, and facilitates and promotes excellence in professional education, in the field of reproductive medicine.

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