Elsevier

Contraception

Volume 87, Issue 5, May 2013, Pages 539-548
Contraception

Review article
Pregnancies after hysteroscopic sterilization: a systematic review

https://doi.org/10.1016/j.contraception.2012.08.006Get rights and content

Abstract

Background

Female sterilization is the second most commonly used form of contraception in the United States. Newer approaches to female sterilization, including hysteroscopic methods, have been approved for use in the United States since 2002. Little is known about the occurrence and timing of pregnancies after these procedures.

Study Design

The objective of this systematic review was to identify evidence that assesses when and how often pregnancies occur following hysteroscopic sterilization. The PubMed database was searched for all studies published from database inception through March 2012 that reported whether or not pregnancies occurred following hysteroscopic sterilization.

Results

Twenty-four original research articles of fair quality met the inclusion criteria: 22 studies of women who underwent Essure® placement and 2 studies of women who underwent Adiana® placement. Eleven articles that documented bilateral tubal occlusion with hysterosalpingogram (HSG) or placement with X-ray or ultrasound following Essure® placement did not report any pregnancies with follow-up ranging from 7 months to 7 years. The remaining 11 articles identified 102 reported pregnancies. Eighteen of these pregnancies occurred prior to the 3-month period required before imaging for contraceptive reliability. Two articles did not report what follow-up imaging was performed among women after Essure® placement; one of these articles reported three pregnancies. Two reports from the same study of women who underwent Adiana® placement reported six pregnancies during the first year of follow-up, three pregnancies during the second year of follow-up and no pregnancies during the third year of follow-up.

Conclusions

Fair-quality evidence suggests that among women who were followed beyond 3 months after hysteroscopic sterilization, pregnancies were rare and generally occurred among women who had no imaging follow-up or had inadequate confirmation of placement or occlusion. Few pregnancies occurred in women with documented bilateral tubal occlusion by HSG or correct placement at 3 months by ultrasound or X-ray. Only one study reported follow-up past 5 years. Further studies are needed to address the long-term effectiveness of hysteroscopic sterilization.

Introduction

Female sterilization is the second most commonly used form of contraception in the United States after oral contraceptives and can now be performed by abdominal, laparoscopic or hysteroscopic approaches [1]. Currently, two hysteroscopic systems are approved by the US Food and Drug Administration (FDA): the Essure® system (Conceptus Incorporated, Mountain View, CA, USA) approved in 2002 and the Adiana® Permanent Contraception System (Hologic, Inc., Bedford, MA, USA) approved in 2009. However, the Adiana® System was removed from the US market by Hologic, Inc., in 2012.

The hysteroscopic route may be a safer option than abdominal or laparoscopic approaches for many patients, including those with obesity or previous surgery, as it does not require general anesthesia or entry into the abdominal cavity and may be performed in an office setting [2], [3]. While laparoscopic and abdominal approaches are effective immediately, both hysteroscopic systems require a period of 3 months after the procedure for the fallopian tubes to undergo fibrosis leading to tubal occlusion and contraceptive effectiveness [4], [5]. Product labeling in the United States for both procedures states that patients must use alternative contraception for at least 3 months postprocedure until bilateral tubal occlusion is confirmed by hysterosalpingogram (HSG). FDA directions also include placing the device in the early proliferative phase of the menstrual cycle to avoid placement in the setting of an early undiagnosed pregnancy [4], [5]. Other countries have used pelvic X-ray or ultrasound to confirm proper placement at 3 months. Hysteroscopic sterilization is considered to be reliable for contraception after documentation of bilateral tubal occlusion.

While long-term data from large cohorts of women have examined sterilization failure after abdominal and laparoscopic approaches, less is known about pregnancies following the newer hysteroscopic sterilization approach. The objective of this systematic review is to examine the evidence regarding the occurrence and timing of pregnancies following placement of the two FDA-approved hysteroscopic sterilization devices.

Section snippets

Methods

The PubMed database was searched independently by two authors for all peer-reviewed articles in any language published from database inception through March 2012 using the following search terms: (hysteroscopic sterilization OR hysteroscopic sterilisation OR transcervical sterilization OR essure OR adiana). The search targeted articles that reported whether or not pregnancies occurred among women who have undergone hysteroscopic sterilization with either Essure® or Adiana®. To identify

Results

Using the PubMed search terms, we identified 359 articles, of which 24 articles satisfied inclusion criteria by reporting whether or not pregnancies occurred among women who underwent hysteroscopic sterilization. Twenty-two articles addressed the Essure® device (Table 1), and 2 articles addressed the Adiana® device (Table 2). Follow-up imaging utilized in the studies included HSG, X-ray and ultrasound. Of the 22 articles that involved the Essure® procedure, 11 reported that no pregnancies

Discussion

Among articles that reported pregnancies following hysteroscopic sterilization, 102 pregnancies were reported in 11 articles among women who underwent Essure® placement, of which 15 occurred after imaging confirmation of correct placement or tubal occlusion; the remaining pregnancies occurred most frequently in women who did not have any or accurate follow-up imaging, who were not using effective contraception in the first 3 months after placement or who were already pregnant at the time of

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    Disclaimer: The findings and conclusions in this article are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. Use of trade names and commercial sources is for identification only and does not imply endorsement by the US Department of Health and Human Services.

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