Fertility and Sterility
Volume 90, Issue 5 , Pages 2011.e5-2011.e10, November 2008

Tubal perforation by Essure: three different clinical presentations

  • Josje Langenveld, M.D.

      Affiliations

    • Department of Obstetrics and Gynecology, Máxima Medical Center, Veldhoven, The Netherlands
    • Corresponding Author InformationReprint requests: Josje Langenveld, M.D., Department of Obstetrics and Gynecology, Máxima Medical Center, 5500 MB Veldhoven, The Netherlands (FAX: +31 (0)40 8888387).
  • ,
  • Sebastiaan Veersema, M.D.

      Affiliations

    • Department of Obstetrics and Gynecology, St. Antonius Hospital, Nieuwegein, The Netherlands
  • ,
  • Marlies Y. Bongers, M.D., Ph.D.

      Affiliations

    • Department of Obstetrics and Gynecology, Máxima Medical Center, Veldhoven, The Netherlands
  • ,
  • Carolien A. Koks, M.D., Ph.D.

      Affiliations

    • Department of Obstetrics and Gynecology, Máxima Medical Center, Veldhoven, The Netherlands

Received 1 December 2007; received in revised form 9 June 2008; accepted 9 June 2008. published online 11 August 2008.

Objective

To assess the convenience and safety of Essure sterilization in an outpatient setting and the use of ultrasound as diagnostic tool for verification of proper placement for the 3-month follow-up.

Design

Prospective cohort study.

Setting

Teaching hospital department of obstetrics and gynecology.

Patient(s)

Female patients with a request for permanent tubal sterilization.

Intervention(s)

Essure sterilization.

Main Outcome Measure(s)

Bilateral tubal occlusion after Essure sterilization and complication rate.

Result(s)

A total of 149 patients were scheduled for Essure sterilization. Microinsert placement was attempted in 143 patients. Bilateral placement of the device was successful in 95% (95% confidence interval [CI] 92%–99%). Seven attempts were unsuccessful. The complication rate was 2% (n = 3), and all involved a perforation. These three cases are discussed in detail. Vaginal ultrasound was conclusive in 91.7% (95% CI 87%–96%); two perforations were not recognized on the ultrasound.

Conclusion(s)

Essure sterilization is a safe and reliable sterilization method in an outpatient setting. Perforation of the device is the most frequent complication. Vaginal ultrasound is reliable for verification after an uncomplicated procedure. When the procedure is difficult (e.g., higher resistance, more pain then average, more time or more than two devices needed), a hysterosalpingogram should be performed.

Key Words: Essure, female tubal sterilization, female hysteroscopic sterilization, tubal perforation

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 J.L. has nothing to disclose. S.V. and M.B. are consultants of Conceptus (Versailles). C.K. has nothing to disclose.

PII: S0015-0282(08)01306-X

doi:10.1016/j.fertnstert.2008.06.020

Fertility and Sterility
Volume 90, Issue 5 , Pages 2011.e5-2011.e10, November 2008