OBJECTIVE: To assess the convenience and safety of Essure sterilization in an outpatient setting and the use of ultrasound as diagnostic tool for verification of proper placement for the 3-month follow-up. DESIGN: Prospective cohort study. SETTING: Teaching hospital department of obstetrics and gynecology. PATIENT(S): Female patients with a request for permanent tubal sterilization. INTERVENTION(S): Essure sterilization. MAIN OUTCOME MEASURE(S): Bilateral tubal occlusion after Essure sterilization and complication rate. RESULT(S): A total of 149 patients were scheduled for Essure sterilization. Microinsert placement was attempted in 143 patients. Bilateral placement of the device was successful in 95% (95% confidence interval [CI] 92%-99%). Seven attempts were unsuccessful. The complication rate was 2% (n = 3), and all involved a perforation. These three cases are discussed in detail. Vaginal ultrasound was conclusive in 91.7% (95% CI 87%-96%); two perforations were not recognized on the ultrasound. CONCLUSION(S): Essure sterilization is a safe and reliable sterilization method in an outpatient setting. Perforation of the device is the most frequent complication. Vaginal ultrasound is reliable for verification after an uncomplicated procedure. When the procedure is difficult (e.g., higher resistance, more pain then average, more time or more than two devices needed), a hysterosalpingogram should be performed.
OBJECTIVE: To assess the convenience and safety of Essure sterilization in an outpatient setting and the use of ultrasound as diagnostic tool for verification of proper placement for the 3-month follow-up. DESIGN: Prospective cohort study. SETTING: Teaching hospital department of obstetrics and gynecology. PATIENT(S): Female patients with a request for permanent tubal sterilization. INTERVENTION(S): Essure sterilization. MAIN OUTCOME MEASURE(S): Bilateral tubal occlusion after Essure sterilization and complication rate. RESULT(S): A total of 149 patients were scheduled for Essure sterilization. Microinsert placement was attempted in 143 patients. Bilateral placement of the device was successful in 95% (95% confidence interval [CI] 92%-99%). Seven attempts were unsuccessful. The complication rate was 2% (n = 3), and all involved a perforation. These three cases are discussed in detail. Vaginal ultrasound was conclusive in 91.7% (95% CI 87%-96%); two perforations were not recognized on the ultrasound. CONCLUSION(S): Essure sterilization is a safe and reliable sterilization method in an outpatient setting. Perforation of the device is the most frequent complication. Vaginal ultrasound is reliable for verification after an uncomplicated procedure. When the procedure is difficult (e.g., higher resistance, more pain then average, more time or more than two devices needed), a hysterosalpingogram should be performed.
Authors: Mitchell M Conover; Jennifer O Howell; Jennifer M Wu; Alan C Kinlaw; Nabarun Dasgupta; Michele Jonsson Funk Journal: Pharmacoepidemiol Drug Saf Date: 2015-03-31 Impact factor: 2.890
Authors: Chi Y Bahk; Melanie Goshgarian; Krystal Donahue; Clark C Freifeld; Christopher M Menone; Carrie E Pierce; Harold Rodriguez; John S Brownstein; Robert Furberg; Nabarun Dasgupta Journal: Pharmaceut Med Date: 2015-08-05