Analysis of surgeries performed after hysteroscopic sterilization as tabulated from 3,803 Essure patient experiences
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Objective: Although previous research has suggested that risk for reoperation among hysteroscopic sterilization (HS) patients is more than ten times higher than for patients undergoing standard laparoscopic tubal ligation, little has been reported about these subsequent procedures. Methods: This descriptive cohort study used a confidential online questionnaire to gather data from women (n=3,803) who volunteered information on HS followed by device removal surgery performed due to new symptoms developing after Essure placement. Results: In this sample, mean age was 35.6 years and women undergoing hysterectomy after HS comprised 64.9% (n=2,468). Median interval between HS and hysterectomy was 3.7 (interquartile range, 3.9) years and mean age at hysterectomy was 36.3 years. Some patients (n=1,035) sought removal of HS devices and fallopian tubes only, while other miscellaneous gynecological procedures were also occasionally performed for Essure-associated symptoms. When data from all patients who had any post-Essure surgery besides hysterectomy were aggregated (e.g., device removal + “other” cases, n=1,335) and compared to those cases undergoing hysterectomy, mean age was significantly lower than for the hysterectomy group (34.4 vs. 36.3 years, respectively; P<0.01); uterus-conserving surgeries were also typically performed significantly earlier than hysterectomy (P<0.01). Conclusion: This investigation is the first to characterize specific gynecological operations after Essure, and suggests that the predominant surgical answer to HS complaints is hysterectomy for many women. Dissatisfaction with HS may represent an important indication for hysterectomy and additional study is needed to quantify this phenomenon.
Abstract
Objective: Although previous research has suggested that risk for reoperation among hysteroscopic sterilization (HS) patients is more than ten times higher than for patients undergoing standard laparoscopic tubal ligation, little has been reported about these subsequent procedures. Methods: This descriptive cohort study used a confidential online questionnaire to gather data from women (n=3,803) who volunteered information on HS followed by device removal surgery performed due to new symptoms developing after Essure placement. Results: In this sample, mean age was 35.6 years and women undergoing hysterectomy after HS comprised 64.9% (n=2,468). Median interval between HS and hysterectomy was 3.7 (interquartile range, 3.9) years and mean age at hysterectomy was 36.3 years. Some patients (n=1,035) sought removal of HS devices and fallopian tubes only, while other miscellaneous gynecological procedures were also occasionally performed for Essure-associated symptoms. When data from all patients who had any post-Essure surgery besides hysterectomy were aggregated (e.g., device removal + “other” cases, n=1,335) and compared to those cases undergoing hysterectomy, mean age was significantly lower than for the hysterectomy group (34.4 vs. 36.3 years, respectively; P<0.01); uterus-conserving surgeries were also typically performed significantly earlier than hysterectomy (P<0.01). Conclusion: This investigation is the first to characterize specific gynecological operations after Essure, and suggests that the predominant surgical answer to HS complaints is hysterectomy for many women. Dissatisfaction with HS may represent an important indication for hysterectomy and additional study is needed to quantify this phenomenon.
참고문헌 (27)
- Mino M, "Success rate and patient satisfaction with the Essure sterilisation in an outpatient setting: a prospective study of 857 women", BJOG, 114, pp.763~766 (2007)
- Thiel JA, "Cost-effectiveness analysis comparing the essure tubal sterilization procedure and laparoscopic tubal sterilization", J Obstet Gynaecol Can, 30, pp.581~585 (2008)
- Levie MD, "Office hysteroscopic sterilization compared with laparoscopic sterilization: a critical cost analysis", J Minim Invasive Gynecol, 12, pp.318~322 (2005)
- Rezai S, "Essure microinsert abdominal migration after hysteroscopic tubal sterilization of an appropriately placed essure device: dual case reports and review of the literature", Case Rep Obstet Gynecol, 2015, pp.402197~ (2015)
- Sills ES, "Referrals for complications following hysteroscopic sterilisation: characteristics associated with symptomatic patients after the Essure procedure", Eur J Contracept Reprod Health Care, 21, pp.227~233 (2016)
- "MAUDE adverse event report: Bayer Pharma AG Essure insert, tubal occlusion" (2015)[URL]
- Scarabin C, "The ESTHYME study. Women’s satisfaction after hysteroscopic sterilization (Essure micro-insert). A retrospective multicenter survey", Gynecol Obstet Fertil, 35, pp.1123~1128 (2007)
- Brito LG, "Essure surgical removal and subsequent symptom resolution:case series and follow-up survey", J Minim Invasive Gynecol, 22, pp.910~913 (2015)
- "The controversial birth control you’ve never heard of" (2014)[URL]
- "Hundreds of women forced to have hysterectomies after reaction to permanent birth control implant" (2013)[URL]
- Doll KM, "Trends in inpatient and outpatient hysterectomy and oophorectomy rates among commercially insured women in the United States, 2000-2014", JAMA Surg, 151, pp.876~877 (2016)
- Whiteman MK, "Inpatient hysterectomy surveillance in the United States, 2000-2004", Am J Obstet Gynecol, 198, pp.34~ (2008)
- Anderson TL, "Hysteroscopic sterilization success in outpatient vs office setting is not affected by patient or procedural characteristics", J Minim Invasive Gynecol, 20, pp.858~863 (2013)
- Howard DL, "What are the factors predictive of hysterosalpingogram compliance after female sterilization by the Essure procedure in a publicly insured population?", Matern Child Health J, 17, pp.1760~1767 (2013)
- E. Scott Sills, "Contraceptive failure after hysteroscopic sterilization: Analysis of clinical and demographic data from 103 unplanned pregnancies", Obstetrics & Gynecology Science, 58(6), pp.487~493 (2015), 대한산부인과학회[DOI]
- "FDA review document:review of the Essure system for hysteroscopic sterilization" (2015)[URL]
- Adelman MR, "Management of complications encountered with Essure hysteroscopic sterilization: a systematic review", J Minim Invasive Gynecol, 21, pp.733~743 (2014)
- Mao J, "Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study", BMJ, 351, pp.h5162~ (2015)
- Albright CM, "Surgical aspects of removal of Essure microinsert", Contraception, 88, pp.334~336 (2013)
- Lannon BM, "Techniques for removal of the Essure hysteroscopic tubal occlusion device", Fertil Steril, 88, pp.497~ (2007)
- Kraemer DF, "An economic comparison of female sterilization of hysteroscopic tubal occlusion with laparoscopic bilateral tubal ligation", Contraception, 80, pp.254~260 (2009)
- Dhruva SS, "Revisiting Essure:toward safe and effective sterilization", N Engl J Med, 373, pp.e17~ (2015)
- la Chapelle CF, "Effectiveness and feasibility of hysteroscopic sterilization techniques: a systematic review and meta-analysis", Fertil Steril, 103, pp.1516~1525 (2015)
- Hoyos LR, "Pregnancy following hysteroscopic sterilization at an Urban Abortion Clinic. A case series: are we looking in the wrong places?", Contraception, 94, pp.78~80 (2016)
- Sills ES, "What is the economic cost of unplanned pregnancy following hysteroscopic sterilization in the US? A new national estimate based on Essure procedure prevalence, failure rates, and workforce productivity", World Health Popul, 17, pp.31~38 (2016)
- Kulseng-Hanssen S, "The development of a questionnaire to measure the severity of symptoms and the quality of life before and after surgery for stress incontinence", BJOG, 110, pp.983~988 (2003)
- Larochelle A, "Accuracy of recall in quality-of-life assessment among women operated on for stress urinary incontinence", Int Urogynecol J Pelvic Floor Dysfunct, 20, pp.1233~1241 (2009)
