Abstract
Objective
We hypothesize that the shape of the Essure microinsert on ultrasound is able to predict complications evident on hysterosalpingogram (HSG), the accepted gold standard.
Method and materials
From July 2, 2009 to July 2, 2012, 441 women at our institution received Essure microinsert placement for the purpose of permanent sterilization. 2D and 3D coronal plane transvaginal ultrasounds were performed three months after Essure microinsert placement. Those patients with complications identified on ultrasound, a non-diagnostic ultrasound, or following a difficult insertion were referred for HSG. Patients with both HSG and ultrasound performed were retrospectively selected and anonymized. The ultrasounds were reviewed by a single, blinded radiologist. A total of 122 microinserts in 65 patients were described on ultrasound using a numeric grading system and compared to HSG findings.
Results
Microinsert placement resulted in 37 complications, 31 of which were identified on ultrasound, including uterine and tubal perforations and placement in the endometrial cavity. The sensitivity of Essure microinsert shape on ultrasound in predicting complications, compared with standard HSG, was 94%, with a positive predictive value of 85%; specificity was 95%, with a negative predictive value of 98%. The Kappa coefficient was 0.85 (p < 0.001).
Conclusion
Our results suggest that ultrasound may be used as a frontline imaging modality for patients after Essure microinsert placement.
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Acknowledgments
Dr. Thiel is a consultant for Bayer that manufactures the Essure microinsert. Sudhakar Venkatesh, M.D. and Sonia Watson, Ph.D. provided assistance in editing the manuscript.
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Dr. Thiel is a consultant for Bayer, which manufactures the Essure microinsert. All other authors have no conflicts of interest to disclose. This study received institutional review board approval.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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This was a retrospective study therefore formal consent was not required.
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VanBuren, W.M., Suchet, I.B., Thiel, J.A. et al. Essure microinsert imaging: does abnormal shape on ultrasound predict complications on HSG?. Abdom Radiol 41, 2350–2358 (2016). https://doi.org/10.1007/s00261-016-0718-7
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DOI: https://doi.org/10.1007/s00261-016-0718-7