Objective: The aim of this study was to determine the ability of in-office 2-dimensional transvaginal sonography, 10–12 weeks, after an Essure® (Conceptus, Mountain View, CA) procedure, to predict proper tubal occlusion/microinsert location, compared with subsequent low-pressure hysterosalpinography (HSG). Secondary Outcomes: In addition, this study sought to discover the rate of bilateral placements, on HSG follow-up by 12 weeks and the clinical pregnancy rate. Design: This was a prospective, single-group cohort trial. Setting: The trial was conducted at a community-based, private obstetrics/gynecology medical office. Materials and Methods: After successful bilateral microinsert placement, patients participating in the study returned for in-office transvaginal sonography (pro-bono) at 10–12 weeks postinsertion for microinsert localization. After the sonographic evaluation, study patients were then referred within the following 1–2 weeks for radiologist performance of the Essure HSG confirmation test. Results: One hundred and sixty-three (163) patients were treated. Of these, 158 (97%) had successful bilateral placement. One hundred and thirty-nine (139; 88%) of patients with bilateral placements underwent sonographic study, and 127 of those (91%) underwent HSG confirmation, with 98% having successful bilateral occlusion. Two percent (2%; n = 2) had unilateral occlusion at 12 weeks. Both of these 2 patients had bilateral occlusion at the 6 month HSG testing. The overall HSG completion rate was 78% (127/163). The sensitivity of 2-dimensional pelvic ultrasound in predicting tubal occlusion, compared with HSG was 94% (a positive predictive value of 99%); specificity was 50% (a negative predictive value 12.5%.). As of June 2010, no pregnancies were noted in the 127 members of evaluable cohort who had both sonographic and radiologic confirmation testing. Conclusions: Transvaginal ultrasound is an acceptable method of confirming proper location of the Essure microinsert at 10–12 weeks postinsertion, and has reproducible value as a surrogate HSG confirmation test. (J GYNECOL SURG 27:57)
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Conceptus, Inc.Conceptus receives FDA approval on Essure's bilateral placement rate to 96.9%May 19, 2010. Online document at:www.MedicalNewsToday.com/articles/189244.php. 2010 June 12.
