Document Detail


Analysis of Tubal Patency After Essure Placement.
MedLine Citation:
PMID:  23541247     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
STUDY OBJECTIVE: To evaluate tubal patency after hysteroscopic sterilization using the Essure microinsert (Conceptus Inc, San Carlos, CA). DESIGN: A retrospective longitudinal cohort study. DESIGN CLASSIFICATION: II-3. SETTING: Patients undergoing hysteroscopic sterilization in the outpatient clinic of a university-based hospital in Southeast Texas from July 2009 to November 2011. PATIENTS: Two hundred twenty-nine women (ages 21-44 yrs, 71% Hispanic) desiring sterilization with a history of regular menses, demonstrated prior fertility (≥1 live birth), and the ability to use an alternative contraceptive method for at least 90 days after coil placement were included. Twenty six patients in this cohort were excluded because of failure to perform a hysterosalpingogram (HSG), tubal perforation, severe dyspareunia, a history of ectopic pregnancy, tubal surgery, or cervical intraepithelial neoplasia. INTERVENTIONS: Not applicable. MEASUREMENTS AND MAIN RESULTS: HSGs were assessed for microinsert location and tubal occlusion. Two hundred three patients were included for analysis. After the successful bilateral hysteroscopic placement of Essure microinserts in fallopian tubes, all patients returned for the first follow-up HSG a mean of 103 ± 38 days after the procedure. Patients with fallopian tube patency at the initial HSG returned for second and/or third HSGs as needed at 192 ± 45 and 291 ± 97 days, respectively. Correct device placement was confirmed in 100% of cases at the first HSG. The tubal patency rates at the 90-day and 180-day HSGs were 16.1% (95% confidence interval, 7.4%-31.7%) and 5.8% (95% CI, 1.2%-24.4%), respectively. These rates were estimated by the accelerated failure time model with log normal distribution and interval censored time to event. The 16.1% 90-day tubal patency rate is significantly different from the 8% rate reported by Cooper et al in the 2003 multicenter phase III pivotal trial (p <.001). CONCLUSION: Our data indicate that hysteroscopic sterilization with Essure results in a higher initial tubal patency rate than previously reported. Multivariate analyses are needed to identify factors associated with an increased risk of postprocedure tubal patency.
Authors:
Ana M Rodriguez; Gokhan S Kilic; Thao P Vu; Yong-Fang Kuo; Daniel Breitkopf; Russell R Snyder
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-3-26
Journal Detail:
Title:  Journal of minimally invasive gynecology     Volume:  -     ISSN:  1553-4669     ISO Abbreviation:  J Minim Invasive Gynecol     Publication Date:  2013 Mar 
Date Detail:
Created Date:  2013-4-1     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101235322     Medline TA:  J Minim Invasive Gynecol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2013 AAGL. Published by Elsevier Inc. All rights reserved.
Affiliation:
Department of Obstetrics & Gynecology, University of Texas Medical Branch, Galveston, Texas. Electronic address: an3rodri@utmb.edu.
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