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      Contraceptive failure after hysteroscopic sterilization: Analysis of clinical and demographic data from 103 unplanned pregnancies

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          Abstract

          Objective

          This investigation examined data on unplanned pregnancies following hysteroscopic sterilization (HS).

          Methods

          A confidential questionnaire was used to collect data from women with medically confirmed pregnancy (n=103) registered after undergoing HS.

          Results

          Mean (±SD) patient age and body mass index (BMI) were 29.5±4.6 years and 27.7±6.1 kg/m 2, respectively. Peak pregnancy incidence was reported at 10 months after HS, although <3% of unplanned pregnancies occurred within the first three months following HS. Mean (±SD) interval between HS and pregnancy was 19.6±14.9 (range, 2 to 84) months. Patients age ≥30 years and BMI <25 reported conception after HS somewhat sooner than younger patients, although the differences in time to pregnancy were not significant ( P=0.24 and 0.09, respectively). The recommended post-HS hysterosalpingogram (to confirm proper placement and bilateral tubal occlusion) was obtained by 66% (68/103) of respondents.

          Conclusion

          This report is the first to provide patient-derived data on contraceptive failures after HS. While adherence to backup contraception 3 months after HS can be poor, many unintended pregnancies with HS occur long after the interval when alternate contraceptive is required. Many patients who obtain HS appear to ignore the manufacturer's guidance regarding the post-procedure hysterosalpingogram to confirm proper device placement, although limited insurance coverage likely contributes to this problem. The greatest number of unplanned pregnancies occurred 10 months after HS, but some unplanned pregnancies were reported up to 7 years later. Age, BMI, or surgical history are unlikely to predict contraceptive failure with HS. Further follow-up studies are planned to capture additional data on this issue.

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          Most cited references22

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          Contraceptive failure in the United States.

          This review provides an update of previous estimates of first-year probabilities of contraceptive failure for all methods of contraception available in the United States. Estimates are provided of probabilities of failure during typical use (which includes both incorrect and inconsistent use) and during perfect use (correct and consistent use). The difference between these two probabilities reveals the consequences of imperfect use; it depends both on how unforgiving of imperfect use a method is and on how hard it is to use that method perfectly. These revisions reflect new research on contraceptive failure both during perfect use and during typical use. Copyright © 2011 Elsevier Inc. All rights reserved.
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            Hysteroscopic sterilization using a micro-insert device: results of a multicentre Phase II study.

            Unlike laparoscopic surgery for interval tubal sterilization, a hysteroscopic approach obviates surgical incision and requires only local anaesthesia or intravenous sedation. The safety, tolerability and efficacy of an hysteroscopically placed micro-insert device was evaluated. A cohort of 227 previously fertile women participated in this prospective international multicentre trial. Micro-inserts were placed bilaterally into the proximal Fallopian tube lumens under hysteroscopic visualization in outpatient procedures. Successful bilateral micro-insert placement was achieved in 88% of women. The majority of women reported that intraprocedural pain was less than or equal to that expected, and 90% rated tolerance of the device placement procedure as good to excellent. Most women could be discharged in an ambulatory state within 1-2 h. Adverse events occurred in 7% of the women, but none was serious. Correct device placement was confirmed in 97% of cases at 3 months. Over 24 months follow-up, 98% of study participants rated their tolerance of the micro-insert as very good to excellent. After 6015 woman-months of exposure to intercourse, no pregnancies have been recorded. Hysteroscopic sterilization resulted in rapid patient recovery without unacceptable post-procedure pain, as well as high long-term patient tolerability, satisfaction and effective permanent contraception.
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              Essure(®) for management of hydrosalpinx prior to in vitro fertilisation-a systematic review and pooled analysis.

              Hydrosalpinges in infertile women reduce the success of in vitro fertilisation (IVF) by 50%. Surgical management of hydrosalpinges before IVF improves outcome but these procedures are often contraindicated in women with dense pelvic adhesions. Tubal occlusion achieved by Essure(®) via hysteroscopy provides an alternative.
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                Author and article information

                Journal
                Obstet Gynecol Sci
                Obstet Gynecol Sci
                OGS
                Obstetrics & Gynecology Science
                Korean Society of Obstetrics and Gynecology; Korean Society of Contraception and Reproductive Health; Korean Society of Gynecologic Endocrinology; Korean Society of Gynecologic Endoscopy and Minimal Invasive Surgery; Korean Society of Maternal Fetal Medicine; Korean Society of Ultrasound in Obstetrics and Gynecology; Korean Urogynecologic Society
                2287-8572
                2287-8580
                November 2015
                16 November 2015
                : 58
                : 6
                : 487-493
                Affiliations
                [1 ]Reproductive Research Section, Center for Advanced Genetics, Carlsbad, CA, USA.
                [2 ]Department of Molecular & Applied Biosciences, University of Westminster, London, UK.
                [3 ]Division of Quantitative Research, Rosenblatt Securities, Inc., New York, NY, USA.
                [4 ]Global Health Economics Unit, Center for Clinical and Translational Science, University of Vermont College of Medicine, Burlington, VT, USA.
                [5 ]Reproductive Sciences Medical Center, San Diego, CA, USA.
                [6 ]Progenesis, Inc., La Jolla, CA, USA.
                Author notes
                Corresponding author: E. Scott Sills. Reproductive Research Section, Center for Advanced Genetics, 3144 El Camino Real, Suite 106, Carlsbad, CA, USA. Tel: +1-760-994-0156, Fax: +1-760-994-0159, drsills@ 123456CAGivf.com
                Article
                10.5468/ogs.2015.58.6.487
                4663227
                26623413
                6ad65373-6818-402a-8f00-c5061556e722
                Copyright © 2015 Korean Society of Obstetrics and Gynecology

                Articles published in Obstet Gynecol Sci are open-access, distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 05 June 2015
                : 06 July 2015
                : 06 July 2015
                Categories
                Original Article
                Reproductive Endocrinology

                contraception,contraceptive failure,essure,pregnancy
                contraception, contraceptive failure, essure, pregnancy

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