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Association between menorrhagia and risk of intrauterine device–related uterine perforation and device expulsion: results from the Association of Uterine Perforation and Expulsion of Intrauterine Device study

Published:March 12, 2022DOI:https://doi.org/10.1016/j.ajog.2022.03.025

      Background

      Intrauterine devices are effective instruments for contraception, and 1 levonorgestrel-releasing device is also indicated for the treatment of heavy menstrual bleeding (menorrhagia).

      Objective

      To compare the incidence of intrauterine device expulsion and uterine perforation in women with and without a diagnosis of menorrhagia within the first 12 months before device insertion

      Study Design

      This was a retrospective cohort study conducted in 3 integrated healthcare systems (Kaiser Permanente Northern California, Southern California, and Washington) and a healthcare information exchange (Regenstrief Institute) in the United States using electronic health records. Nonpostpartum women aged ≤50 years with intrauterine device (eg, levonorgestrel or copper) insertions from 2001 to 2018 and without a delivery in the previous 12 months were studied in this analysis. Recent menorrhagia diagnosis (ie, recorded ≤12 months before insertion) was ascertained from the International Classification of Diseases, Ninth and Tenth Revision, Clinical Modification codes. The study outcomes, viz, device expulsion and device-related uterine perforation (complete or partial), were ascertained from electronic medical records and validated in the data sources. The cumulative incidence and crude incidence rates with 95% confidence intervals were estimated. Cox proportional hazards models estimated the crude and adjusted hazard ratios using propensity score overlap weighting (13–16 variables) and 95% confidence intervals.

      Results

      Among 228,834 nonpostpartum women, the mean age was 33.1 years, 44.4% of them were White, and 31,600 (13.8%) had a recent menorrhagia diagnosis. Most women had a levonorgestrel-releasing device (96.4% of those with and 78.2% of those without a menorrhagia diagnosis). Women with a menorrhagia diagnosis were likely to be older, obese, and have dysmenorrhea or fibroids. Women with a menorrhagia diagnosis had a higher intrauterine device–expulsion rate (40.01 vs 10.92 per 1000 person-years) than those without, especially evident in the first few months after insertion. Women with a menorrhagia diagnosis had a higher cumulative incidence (95% confidence interval) of expulsion (7.00% [6.70–7.32] at 1 year and 12.03% [11.52–12.55] at 5 years) vs those without (1.77% [1.70–1.84] at 1 year and 3.69% [3.56–3.83] at 5 years). The risk of expulsion was increased for women with a menorrhagia diagnosis vs for those without (adjusted hazard ratio, 2.84 [95% confidence interval, 2.66–3.03]). The perforation rate was low overall (<1/1000 person-years) but higher in women with a diagnosis of menorrhagia vs in those without (0.98 vs 0.63 per 1000 person-years). The cumulative incidence (95% confidence interval) of uterine perforation was slightly higher for women with a menorrhagia diagnosis (0.09% [0.06–0.14] at 1 year and 0.39% [0.29–0.53] at 5 years) than those without it (0.07% [0.06–0.08] at 1 year and 0.28% [0.24–0.33] at 5 years). The risk of perforation was slightly increased in women with a menorrhagia diagnosis vs in those without (adjusted hazard ratio, 1.53; 95% confidence interval, 1.10–2.13).

      Conclusion

      The risk of expulsion is significantly higher in women with a recent diagnosis of menorrhagia. Patient education and counseling regarding the potential expulsion risk is recommended at insertion. The absolute risk of perforation for women with a recent diagnosis of menorrhagia is very low. The increased expulsion and perforation rates observed are likely because of causal factors of menorrhagia.

      Key words

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      References

        • Fraser I.S.
        • Mansour D.
        • Breymann C.
        • Hoffman C.
        • Mezzacasa A.
        • Petraglia F.
        Prevalence of heavy menstrual bleeding and experiences of affected women in a European patient survey.
        Int J Gynaecol Obstet. 2015; 128: 196-200
        • Cohen S.L.
        • Vitonis A.F.
        • Einarsson J.I.
        Updated hysterectomy surveillance and factors associated with minimally invasive hysterectomy.
        JSLS. 2014; 18: e2014
        • Karlsson T.S.
        • Marions L.B.
        • Edlund M.G.
        Heavy menstrual bleeding significantly affects quality of life.
        Acta Obstet Gynecol Scand. 2014; 93: 52-57
        • Ting S.O.
        • Burke C.
        Ultrasound assessment of uterine morphology in menorrhagia: case control study.
        J Obstet Gynaecol. 2020; 40: 260-263
        • Youm J.
        • Lee H.J.
        • Kim S.K.
        • Kim H.
        • Jee B.C.
        Factors affecting the spontaneous expulsion of the levonorgestrel-releasing intrauterine system.
        Int J Gynaecol Obstet. 2014; 126: 165-169
        • Singh S.
        • Best C.
        • Dunn S.
        • Leyland N.
        • Wolfman W.L.
        • CLINICAL PRACTICE – GYNAECOLOGY COMMITTEE
        Abnormal uterine bleeding in pre-menopausal women.
        J Obstet Gynaecol Can. 2013; 35: 473-475
        • Hapangama D.K.
        • Bulmer J.N.
        Pathophysiology of heavy menstrual bleeding.
        Womens Health (Lond). 2016; 12: 3-13
        • Tower A.M.
        • Frishman G.N.
        Cesarean scar defects: an underrecognized cause of abnormal uterine bleeding and other gynecologic complications.
        J Minim Invasive Gynecol. 2013; 20: 562-572
        • Bayer HealthCare Pharmaceuticals Inc
        Mirena(levonorgestrel-releasing intrauterine system) [prescribing information].
        (Available at:)
        • Kaunitz A.M.
        • Inki P.
        The levonorgestrel-releasing intrauterine system in heavy menstrual bleeding: a benefit-risk review.
        Drugs. 2012; 72: 193-215
        • Anthony M.S.
        • Reed S.D.
        • Armstrong M.A.
        • et al.
        Design of the association of uterine perforation and expulsion of intrauterine device study: a multisite retrospective cohort study.
        Am J Obstet Gynecol. 2021; 224: 599.e1-599.e18
        • Anthony M.S.
        • Armstrong M.A.
        • Getahun D.
        • et al.
        Identification and validation of uterine perforation, intrauterine device expulsion, and breastfeeding in four health care systems with electronic health records.
        Clin Epidemiol. 2019; 11: 635-643
        • Li F.
        • Morgan K.L.
        • Zaslavsky A.M.
        Balancing covariates via propensity score weighting.
        J Am Stat Assoc. 2018; 113: 390-400
        • Austin P.C.
        • Stuart E.A.
        Moving towards best practice when using inverse probability of treatment weighting (IPTW) using the propensity score to estimate causal treatment effects in observational studies.
        Stat Med. 2015; 34: 3661-3679
        • McCaffrey D.F.
        • Griffin B.A.
        • Almirall D.
        • Slaughter M.E.
        • Ramchand R.
        • Burgette L.F.
        A tutorial on propensity score estimation for multiple treatments using generalized boosted models.
        Stat Med. 2013; 32: 3388-3414
        • Madden T.
        • McNicholas C.
        • Zhao Q.
        • Secura G.M.
        • Eisenberg D.L.
        • Peipert J.F.
        Association of age and parity with intrauterine device expulsion.
        Obstet Gynecol. 2014; 124: 718-726
        • Yu O.
        • Reed S.D.
        • Schulze-Rath R.
        • Grafton J.
        • Hansen K.
        • Scholes D.
        Identification of incident uterine fibroids using electronic medical record data.
        EGEMS (Wash DC). 2019; 7: 5
        • Buka S.L.
        • Shenassa E.D.
        • Niaura R.
        Elevated risk of tobacco dependence among offspring of mothers who smoked during pregnancy: a 30-year prospective study.
        Am J Psychiatry. 2003; 160: 1978-1984

      Supplemental References

        • Brookhart M.A.
        • Schneeweiss S.
        • Rothman K.J.
        • Glynn R.J.
        • Avorn J.
        • Stürmer T.
        Variable selection for propensity score models.
        Am J Epidemiol. 2006; 163: 1149-1156
        • Brookhart M.A.
        • Wyss R.
        • Layton J.B.
        • Stürmer T.
        Propensity score methods for confounding control in nonexperimental research.
        Circ Cardiovasc Qual Outcomes. 2013; 6: 604-611
        • Li F.
        • Morgan K.L.
        • Zaslavsky A.M.
        Balancing covariates via propensity score weighting.
        J Am Stat Assoc. 2018; 113: 390-400
        • Desai R.J.
        • Franklin J.M.
        Alternative approaches for confounding adjustment in observational studies using weighting based on the propensity score: a primer for practitioners.
        BMJ. 2019; 367: l5657
        • Zhou Y.
        • Matsouaka R.A.
        • Thomas L.
        Propensity score weighting under limited overlap and model misspecification.
        Stat Methods Med Res. 2020; 29: 3721-3756