Microinsert nonincisional hysteroscopic sterilization
ABSTRACT To assess the safety, effectiveness, and reliability of a tubal occlusion microinsert for permanent contraception, as well as to document patient recovery from the placement procedure and overall patient satisfaction.
A cohort of 518 previously fertile women seeking sterilization participated in this prospective, phase III, international, multicenter trial. Microinsert placement was attempted in 507 women. Microinserts were placed bilaterally into the proximal fallopian tube lumens under hysteroscopic visualization in outpatient procedures.
Bilateral placement of the microinsert was achieved in 464 (92%) of 507 women. The most common reasons for failure to achieve satisfactory placement were tubal obstruction and stenosis or difficult access to the proximal tubal lumen. More than half of the women rated the average pain during the procedure as either mild or none, and 88% rated tolerance of device placement procedure as good to excellent. Average time to discharge was 80 minutes. Sixty percent of women returned to normal function within 1 day or less, and 92% missed 1 day or less of work. Three months after placement, correct microinsert placement and tubal occlusion were confirmed in 96% and 92% of cases, respectively. Comfort was rated as good to excellent by 99% of women at all follow-up visits. Ultimately, 449 of 518 women (87%) could rely on the microinsert for permanent contraception. After 9620 woman-months of exposure to intercourse, no pregnancies have been recorded.
This study demonstrates that hysteroscopic interval tubal sterilization with microinserts is well tolerated and results in rapid recovery, high patient satisfaction, and effective permanent contraception.
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ABSTRACT: A comparative effectiveness analysis was performed to examine the risks and benefits of laparoscopic bilateral tubal ligation (LBTL) compared with hysteroscopic sterilization using the Essure® Permanent Birth Control System (Essure®). Existing evidence shows that both LBTL and Essure® are safe and effective methods of female sterilization. Both have high rates of efficacy and low rates of complications, although when complications do occur, those related to the Essure® procedure are more likely to be minor in nature. The analysis was limited by the restricted number of studies involving head-to-head comparisons of the two approaches. Copyright © 2014 AAGL. Published by Elsevier Inc. All rights reserved.Journal of Minimally Invasive Gynecology 12/2014; DOI:10.1016/j.jmig.2014.12.002 · 1.58 Impact Factor
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ABSTRACT: The US package labeling of the Essure system (Bayer Healthcare, Whippany, NJ) requires hysterosalpingography (HSG) as a confirmatory test after hysteroscopic sterilization to ensure proper placement and tubal occlusion. Previous studies have shown that implementation of a protocol to track patients after Essure procedures can improve HSG adherence. The primary objective of this study was to investigate whether implementation of an electronic reminder for the office staff increases post-Essure HSG adherence. Retrospective cohort study of patients who underwent the Essure procedure between January 2005 and January 2012 (Canadian Task Force classification II-3). University-affiliated hospital. Two hundred eleven patients underwent the Essure procedure during the study period. Implementation of an electronic reminder for the office staff. One hundred thirty-seven (64.9%) patients underwent the procedure before implementation of the electronic reminder, and 74 (35.1%) patients underwent the procedure after implementation. Although the odds of post-Essure HSG adherence increased in the overall (odds ratio [OR] = 1.7; 95% confidence interval [CI], .9-3.2) and faculty practice (OR = 2.1; 95% CI, .2-18.6) patient population, these results were not statistically significant. In contrast, the odds of post-Essure HSG adherence increased by almost 3-fold (OR = 2.9; 95% CI, 1.4-6.3) in the resident clinic patient population (p = .003). Implementation of an electronic reminder increases post-Essure HSG adherence in the resident clinic patient population. Copyright © 2014 AAGL. Published by Elsevier Inc. All rights reserved.Journal of Minimally Invasive Gynecology 10/2014; 22(2). DOI:10.1016/j.jmig.2014.10.008 · 1.58 Impact Factor
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ABSTRACT: Study Objective: To assess the ability of a new iteration of the ESSURE insert (ESS505) to achieve short-term fallopian tube occlusion. Design: Prospective, single center, interventional cohort (Canadian Task Force classification II-1). Setting: Tertiary care hospital. Patients: Women scheduled to undergo hysterectomy. Intervention: Patients underwent placement of the ESS505 in the right fallopian tube and ESS305 (the commercially approved previous version of the device) in the left fallopian tube at 30 (n = 10), 60 (n = 10), or 90 (n = 10) days before a planned hysterectomy. Tubal occlusion was assessed via hysterosalpingography (HSG) both at the time of placement and just before hysterectomy. Ultrasound was used to evaluate acute device placement. Measurements and Main Results: Thirty-five women (mean age, 39.7 years) were enrolled from July 2012 to January 2013, and 30 underwent both ESSURE placement and scheduled hysterectomy. Mean (SD) placement time for the ESS305 and ESS505 devices was 1.4 (0.65) minutes and 1.3 (0.42) minutes, respectively (p = .36). At 1 hour after ESS505 placement, 29 of 30 tubes (97%) exhibited complete occlusion at HSG, compared with only 4 of 30 tubes (13%) after ESS305 placement (p < .001 for difference in occlusion rates). At hysterectomy, the tubal occlusion rate was high in both groups: 97% for ESS505 and 100% for ESS305 tubes. High occlusion rates were observed in each of the 3 duration groups (30, 60, and 90 days). Five women experienced only minor adverse effects. Conclusion: ESS505, a modification to the commercially available ESS305 designed to cause immediate tubal occlusion, demonstrated a high rate of both immediate-term and intermediate-term tubal occlusion. Early tubal occlusion may obviate the need for interim alternative contraceptive methods after ESSURE placement.Journal of Minimally Invasive Gynecology 05/2014; 21(6). DOI:10.1016/j.jmig.2014.04.020 · 1.58 Impact Factor