Analysis of Tubal Patency After Essure Placement

Ana Rodriguez, Gokhan Kilic, Thao P. Vu, Yong Fang Kuo, Daniel Breitkopf, Russell Snyder

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

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 November2011. 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 etal 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.

Original languageEnglish (US)
Pages (from-to)468-472
Number of pages5
JournalJournal of Minimally Invasive Gynecology
Volume20
Issue number4
DOIs
StatePublished - Jul 2013

Fingerprint

Fallopian Tubes
Dyspareunia
Tubal Sterilization
Cervical Intraepithelial Neoplasia
Aptitude
Menstruation
Ectopic Pregnancy
Normal Distribution
Live Birth
Ambulatory Care Facilities
Contraception
Hispanic Americans
Fertility
Longitudinal Studies
Cohort Studies
Multivariate Analysis
Confidence Intervals
Equipment and Supplies

Keywords

  • Essure
  • Sterilization
  • Tubal patency

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Analysis of Tubal Patency After Essure Placement. / Rodriguez, Ana; Kilic, Gokhan; Vu, Thao P.; Kuo, Yong Fang; Breitkopf, Daniel; Snyder, Russell.

In: Journal of Minimally Invasive Gynecology, Vol. 20, No. 4, 07.2013, p. 468-472.

Research output: Contribution to journalArticle

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abstract = "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 November2011. 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 etal 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.",
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AU - Snyder, Russell

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N2 - 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 November2011. 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 etal 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.

AB - 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 November2011. 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 etal 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.

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