Original article
Contrast Infusion Sonography in the Post-Essure Setting

https://doi.org/10.1016/j.jmig.2007.07.008Get rights and content

Abstract

Study Objective

To compare contrast infusion sonogram (CIS) to hysterosalpingogram (HSG) for use as a 3-month confirmation test after Essure.

Design

Pilot study (Canadian Task Force classification II-2).

Setting

Healthy women in an academic multispecialty group.

Patients

Seventeen women desiring permanent sterilization who had had successful bilateral Essure placement within 12 weeks.

Intervention

Contrast infusion sonography was performed and immediately followed by an HSG at the same appointment, between 1 and 12 weeks after Essure placement.

Measurements and Main Results

To determine how well microinsert location and tubal status can be assessed with CIS, an adaptation of hysterosalpingo contrast sonography (HyCoSy), when compared with sequential HSG. Tubal occlusion rate within 4 to 8 weeks after Essure placement was also noted. All microinserts were readily identified with ultrasound, and location was accurately determined. In all patients (100%) with at least 1 tube patent on HSG, patency was also demonstrated on CIS by visualizing real-time flow in the tube or the presence of dye in the cul-de-sac or adnexa. There were no significant adverse events, and pain ratings were similar for both tests. The majority (88%) of patients felt strongly that they would prefer to have a 3-month confirmation test performed in the gynecologist’s office rather than an unfamiliar radiologic facility. Tubal occlusion was noted on both CIS and HSG in 82% of patients before 12 weeks.

Conclusion

Based on this pilot study with a small sample, CIS, an adaptation of HyCoSy, has comparable accuracy to HSG in the post-Essure setting. The safety, convenience, and comfort of an in-office test using ultrasound and a non-iodine-based dye would be a welcome alternative to HSG. There was also a high rate of bilateral fallopian tube occlusion noted on HSG at 4 weeks after Essure.

Section snippets

Materials and Methods

Seventeen healthy women desiring permanent sterilization were included in the study from January 2006 through December 2006. Both informed consent and institutional review board approval were obtained. All patients were multiparous, aged 31 to 45 years, and between 1 and 12 weeks post-bilateral Essure microinsert placement. All patients agreed to undergo evaluation within 4 weeks after Essure placement in order to demonstrate patency: 14 presented within 4 weeks, and 3 presented between 8 and 9

Results

A total of 19 paired studies were performed on 17 patients, with 38 fallopian tubes assessed. All microinserts were in satisfactory location on office ultrasound, a finding that was confirmed in all cases on HSG. Localizing the microinserts was more difficult in several patients with an acutely retroverted uterus; however, ultimately all were well seen. Obesity did not impair visualization due to the highly echogenic nature of the microinserts.

Fourteen studies were performed within 4 weeks of

Discussion

Essure is performed in multiple countries, and various methods are used for the 3-month confirmation test. Because proper location of the inserts has been shown to correlate highly with tubal occlusion [6, 7], in Europe a transvaginal ultrasound is considered sufficient for localizing the microinserts. In Australia and New Zealand, a flat-plate x-ray is taken to confirm device presence, position, and symmetry. In the United States, current labeling requires an HSG for both confirmation of

Conclusion

This pilot study suggests that CIS may be a safe, accurate, and convenient ultrasound-based alternative to HSG as a 3-month confirmation test after Essure. The majority of patients felt strongly that a confirmatory test performed by their gynecologist, in the familiar office setting, was preferable to one performed by an unfamiliar physician in an unfamiliar setting. The convenience and comfort of an in-office test may also increase the compliance with any required confirmation test. A high

Cited by (21)

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

    2016, Fertility and Sterility
    Citation Excerpt :

    Some studies suggest tubal occlusion already occurs within those 3 months. For example, a study by Sia et al. (24) showed tubal occlusion after 1 month in 86%–100% of cases (24); Connor et al. (25) found an occlusion rate of 82% after 1 month; and Valle et al. (11) confirmed tubal occlusion in all cases before performing hysterectomy, including in those who were scheduled within 4 weeks after placement. Two patients did not use additional contraceptives, and both patients showed expulsion of one device on additional imaging, explaining the cause of the pregnancy.

  • Contrast ultrasonography for tubal patency

    2014, Journal of Minimally Invasive Gynecology
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    Sensitivity ranges from 75% to 96%, and specificity from 67% to 100% [10,11]. HyCoSy is also accurate when compared with HSG in determining tubal occlusion after hysteroscopic sterilization, with 88% of patients stating they would prefer to undergo the tubal occlusion test in their gynecologist's office [12]. Because HyCoSy also includes evaluation of the uterine cavity using saline solution, sonohysterogram accuracy in evaluating the uterine cavity is >90% when compared with hysteroscopy [2,11].

  • Multimodality imaging of the Essure tubal occlusion device

    2012, Clinical Radiology
    Citation Excerpt :

    In Europe and Australia the HSG is not required and is often replaced with a radiograph of the pelvis or ultrasound.13–18 Contrast-enhanced ultrasound has been proposed as an additional means to confirm tubal occlusion.19,20 However, ultrasound contrast agents are not FDA approved for this use in the United States.

  • The Imaging of Contraception

    2011, Gynecologic Imaging
  • Can hysterosalpingo-contrast sonography replace hysterosalpingography in confirming tubal blockage after hysteroscopic sterilization and in the evaluation of the uterus and tubes in infertile patients?

    2011, American Journal of Obstetrics and Gynecology
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    Our data show excellent concordance of HyCoSy with HSG in confirming tubal blockage, but HyCoSy is more convenient for the patients and often less uncomfortable. In a similar study to ours, Connor reported excellent concordance (31/33 tubes) between HyCoSy and HSG; in addition, her patients experienced less discomfort with the HyCoSy and expressed that “the confirmatory test performed by their gynecologist in the familiar office setting was preferable to the one performed by an unfamiliar physician in radiology.”6 Of the 700,000 tubal sterilizations performed in the United States annually if, as predicted, most of them will switch to hysteroscopic sterilization, the use of HyCoSy instead of HSG will significantly reduce unnecessary radiation exposure to women, as well as reduce costs.

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This study was funded in part by Conceptus, Inc.

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