Essure® Tubal Sterilization Combined with Subsequent NovaSure® Endometrial Ablation: A Retrospective Analysis

Abstract

Study Objective: To evaluate the safety and outcome of combining the Essure® tubal sterilization system followed by NovaSure® Endometrial Ablation prior to the 3-month Essure Confirmation Test(CoT) .Design: Retrospective cohort study of women who underwent Essure hysteroscopic sterilization followed by NovaSure EA between July 1, 2008 and April 15, 2009. All participants had menorrhagia and desired permanent sterilization. Demographic information, anesthesia type, bilateral placement rate, ablation treatment time, intra-operative and post-procedure complications, Essure confirmation results, and follow-up data were collected and reviewed.Setting: Private gynecologic practice in Indiana.Patients: 59 patients (ages 25-50) were identified who underwent Essure hysteroscopic sterilization followed by NovaSure EA in two in-office sessions separated by an average of 25 days.Intervention: All patients underwent Essure micro-insert placement followed by Novasure EA and had/are scheduled to have a(CoT).Measurements and Main Results: 25/59 patients completed the 3-month CoT. 24/25 patients underwent successful 3-month CoTs. At the 3-month CoT, 22 patients were noted to have bilateral occlusion, 2 patients had unilateral occlusion, and one patient could not tolerate the test. 34 patients are still in the 3-month waiting period prior to CoT. No adverse events have been reported in this cohort. Patients will be followed for the next 12 months for contraceptive and EA effectiveness.Conclusion: To date, in this retrospective medical chart review, Essure hysteroscopic sterilization followed by NovaSure EA, in women who desire permanent birth control and reduction of menorrhagia, appears to be safe and effective. In addition, the present data supports that a majority of 3-month CoTs can be obtained and evaluated post-NovaSure EA. Study Objective: To evaluate the safety and outcome of combining the Essure® tubal sterilization system followed by NovaSure® Endometrial Ablation prior to the 3-month Essure Confirmation Test(CoT) . Design: Retrospective cohort study of women who underwent Essure hysteroscopic sterilization followed by NovaSure EA between July 1, 2008 and April 15, 2009. All participants had menorrhagia and desired permanent sterilization. Demographic information, anesthesia type, bilateral placement rate, ablation treatment time, intra-operative and post-procedure complications, Essure confirmation results, and follow-up data were collected and reviewed. Setting: Private gynecologic practice in Indiana. Patients: 59 patients (ages 25-50) were identified who underwent Essure hysteroscopic sterilization followed by NovaSure EA in two in-office sessions separated by an average of 25 days. Intervention: All patients underwent Essure micro-insert placement followed by Novasure EA and had/are scheduled to have a(CoT). Measurements and Main Results: 25/59 patients completed the 3-month CoT. 24/25 patients underwent successful 3-month CoTs. At the 3-month CoT, 22 patients were noted to have bilateral occlusion, 2 patients had unilateral occlusion, and one patient could not tolerate the test. 34 patients are still in the 3-month waiting period prior to CoT. No adverse events have been reported in this cohort. Patients will be followed for the next 12 months for contraceptive and EA effectiveness. Conclusion: To date, in this retrospective medical chart review, Essure hysteroscopic sterilization followed by NovaSure EA, in women who desire permanent birth control and reduction of menorrhagia, appears to be safe and effective. In addition, the present data supports that a majority of 3-month CoTs can be obtained and evaluated post-NovaSure EA.