{"paper_id":"14b2429b-69d8-4ff0-9334-db792dedcc17","body_text":"Rev. Bras. Saúde Mater. Infant., Recife, 20 (2): 47 9-484 abr-jun., 2020 479\nORIGINAL ARTICLES \nIndications and reasons for discontinuing the levon orgestrel-releasing\nintrauterine system (LNG-IUS)\nAbstract\nObjectives: to identify the main indications and re asons for discontinuing the use of the\nLevonorgestrel-Releasing Intrauterine System (LNG-I US). \nMethods: a cross-sectional study was carried out fr om medical records of 327 women\nwho used the LNG-IUS 52mg between January 2011 and December 2016 at a public hospital\nin the Northeast of Brazil. \nResults: the main indications for the use of the LN G-IUS were: contraception (32.7%),\nmyoma/metrorrhagia (28.7%) and endometriosis/pelvic  pain (22.3%). Of the 327 women, 68\n(20.8%) had discontinued using the device. The most  frequent reasons for discontinuation\nwere: expulsion (9.2%), LNG-IUS expiration (3.7%), bleeding (2.4%) and pain (1.5%). Most\npatients had no difficulty in the insertion and did  not require anesthesia/sedation. Among the\n30 women who expelled the device, 17 (56.7%) had us ed it for metrorrhagia and myoma, 8\n(26.7%) for contraception, and 5 (16.6%) for endome triosis/pelvic pain.  \nConclusions: the LNG-IUS is a well-accepted contrac eptive method, with therapeutic\napplications for some gynecological conditions and a low expulsion rate.\nKey words Contraception, Contraceptive effectiveness, Levonor gestrel, Long-acting\nreversible contraception, Progesterone-releasing in trauterine devices\nThis article is published in Open Access under the Creative Commons Attribution\nlicense, which allows use, distribution, and reprod uction in any medium, without\nrestrictions, as long as the original work is correctly cited.\nhttp://dx.doi.org/10.1590/1806-93042020000200009\nMaria Luíza Lemos Pires 1\nhttps://orcid.org/0000-0003-0615-7669\nAriani Impieri Souza 2\nhttps://orcid.org/0000-0002-7917-5983\nMaria Luisa Borges Roriz Dantas 3\nhttps://orcid.org/0000-0001-7829-8204\nGabriela Delgado Soriano 4\nhttps://orcid.org/0000-0002-3360-8317\n1,3,4 Faculdade Pernambucana de Saúde. Recife, PE, Brasil .\n2,5,6 Departamento de Ginecologia e Obstetrícia. Institut o de Medicina Integral Professor Fernando Figueira.  Rua dos Coelhos, 300. Boa Vista. Recife, PE, Brasi l. CEP:\n50.070-550. E-mail: ariani@imip.org.br\nCláudia Viana Henriques 5\nhttps://orcid.org/0000-0002-7165-543X\nAna Laura Carneiro Gomes Ferreira 6\nhttps://orcid.org/0000-0001-9172-6162\n\n\nRev. Bras. Saúde Mater. Infant., Recife, 20 (2): 47 9-484 abr-jun., 2020480\nIntroduction\nThe Levonorgestrel-Releasing Intrauterine System\n(LNG-IUS) was initially developed as a device for\ncontraception. Its use is now recommended by the\nWorld Health Organization (WHO), and it is consi-\ndered one of the most effective long-acting\nreversible contraception (LARC) methods. 1,2\nIn the mid-1990s, the LNG-IUS was proven to\nbe an effective treatment for menorrhagia and\ndysmenorrhea owing to its inhibitory effect on\nendometrial actions with consequent atrophy and a\ndecrease in the thickness of the uterine\nendometrium. 3,4\nNon-contraceptive benefits of the LNG-IUS,\nincluding treatment of abnormal uterine bleeding,\nwere reported in a systematic review conducted in\n2015. 5 Currently the LNG-IUS is recommended as\nthe first-line treatment for menorrhagia in the Uni ted\nKingdom, and it is approved in 120 countries as a\ncontraceptive method and in 115 countries to contro l\nmenorrhagia. 6 Among other non-contraceptive uses,\nother researchers have reported proven benefits of\nthe LNG-IUS in the management of dysmenorrhea\nby decreasing pelvic pain, premenstrual syndrome\n(PMS) and to treat endometriosis and adeno-\nmyosis.7,8\nOn the basis of the WHO eligibility criteria, the\nLNG-IUS can be used safely by both multiparous\nand nulliparous women, as well as by women in\nother clinical situations. It is contraindicated in  cases\nof suspected or confirmed breast cancer, malignant\ndisease in the cervix, malformation or distortion o f\nthe uterine cavity, active pelvic infection, suspec ted\nor confirmed pregnancy, and uterine bleeding of\nunknown etiology. 8,9\nComplications associated with the insertion of\nthe LNG-IUS include uterine perforation, cervix\nlaceration, inadequate device placement, and expul-\nsion of the device. 10 In addition to complications,\nother situations that make it difficult or impossib le\nfor LNG-IUS insertion include: stenosis of uterine\ncervix, distortion of the uterine cavity and pain. 9 The\npostpartum period while women are still breast-\nfeeding, history of cesarean delivery, and inexperi -\nence of the health professionals can also add to th e\npreviously mentioned difficulties. 10\nThe reasons for the removal of the LNG-IUS\ninclude changes related to menstrual bleeding\npattern, and although less frequent, hormonal\nchanges causing such as weight gain, acne and\nmastalgia. 11,12 Expulsion is another reason for\ndiscontinuation of the use of the LNG-IUS. 13\nIn addition to expanding the contraceptive\noptions available to women seeking effective,\nreversible, and safe methods, the LNG-IUS has been\nvery cost-effective method. 14,15 The study by Pepe\net al .15 showed that the LNG-IUS could be cost-\neffective when compared with other hormonal\nmethods. The present study aims to identify the mai n\nindications to use the LNG-IUS 52mg and the main\nreasons for discontinuation of use.\nMethods\nA cross-sectional observational study was carried o ut\nat the Instituto de Medicina Integral Prof. Fernand o\nFigueira (IMIP). The medical records of 327 women\nwho used the LNG-IUS between January 2011 and\nDecember 2016 were analyzed. \nWe collected the following information from the\npatients’ medical records: sociodemographic vari-\nables (education, residence place, profession, and\nmarital status), biological variables (date of birt h,\nrace, and disease status), reproductive/gynecologic al\ndata (age of menarche, age at first intercourse,\nnumber of sexual partners, number of gestations,\nbirths, abortions and types of births) and LNG-IUS\nvariables (date of insertion, physician who\nperformed the insertion, indications, any difficult y\nin insertion, use of anesthesia/sedation, and\ncontinued use of the device or reason for discontin u-\nation).\nThe data was entered into a database created on\nMicrosoft Excel. The distribution of absolute and\nrelative frequencies was performed by program R,\nversion 3.3.1. Pearson's chi-square test was applie d\nto verify association between two variables. A p-\nvalue <0.05 was considered significant.\nThis project was approved by the Human\nResearch Ethics Committee of IMIP, with CAAE\nNo. 59253516.5.0000.5201.\nResults\nThe mean age of the 327 women at the time of the\nLNG-IUS insertion was 35 ± 8 years, and 107\n(32.7%) had 8 to 11 years of schooling. The majorit y\nof the women (n=256; 78.3%) came from the\nMetropolitan Region of Recife and 168 (51.4%)\nwere married or in a stable union. Only 56 (17.1%)\nwere nulliparous and among the parous, 153 (46.8%)\nhad a previous cesarean section (Table 1).\nAmong the main indications to use the LNG-IUS\ndevice, 107 women (32.7%) chose this method for\ncontraception; 94 (28.7%) women chose for treating\nmyoma and/or metrorrhagia; 73 (22.3%) for\nendometriosis associated with pelvic pain, and 27\nSouza AI et al.\n\nRev. Bras. Saúde Mater. Infant., Recife, 20 (2): 47 9-484 abr-jun., 2020 481\nIndications and reasons for discontinuing the LNG-I US\n(8.3%) for hematological disease. Other indications\n(n=26; 8%), included post-abortion contraception,\nwomen with renal transplantation, and PMS.\nSixty eight (20.8%) women discontinued the use\nof the LNG-IUS. Thirty (9.2%) of them discontinued\nby expulsion, 8 (2.4%) discontinued for bleeding an d\n5 (1.5%) for pelvic pain. Other reasons for discon-\ntinuation (n=13; 4.0%) included weight gain, acne\nand desire to have children. Finally, 12 women\n(3.7%) wished to change the device at the end of\nLNG-IUS lifespan. Among the 30 women who\nexpelled the device, 17 (56.7%) had used it for me-\ntrorrhagia and myoma treatment (Table 2).\nDifficulty in the insertion of the LNG-IUS\noccurred in 49 (15.0%) women and only 15 (4.6%)\nwomen were required anesthesia/sedation. Insertion\ndifficulty was significantly associated with nulli-\nparity ( p = 0.002) and the need for anesthesia/seda-\ntion ( p = 0.006). There was no association between\nthe insertion difficulty and type of delivery\n(p=0.060) (Table 3).\nTable 1\nDistribution of biological and sociodemographic cha racteristics among the women using the LNG-IUS.  \nVariables                                                                                                          N=327                                        %                                \nAge between 30-39 years old  (mean age - 35 ± 8 yea rs) 137 41.9\nSchooling between 8-11 years 107 32.7\nLiving at Metropolitan Region of Recife 256 78.3\nMarried / stable union 168 51.4\nNulliparous 56 17.1\nParous 269 82.2\nPrevious cesarean section 153 46.8\nLNG-IUS = Levonorgestrel-Releasing Intrauterine Sys tem.\nTable 2\nDistribution of the main indications to use the LNG -IUS and the main reasons for discontinuation of th e LNG-IUS.\nMain indications to use                                                                                  N=327                                        %                                \nContraception 107 32.7\nMetrorrhagia / myoma 94 28.7\nEndometriosis / pelvic pain 73 22.3\nHematological disease 27 8.3\nOther indications 26 8.0\nMain reasons for discontinuation\nExpulsion 30 9.2\nBleeding 8 2.4\nPelvic pain 5 1.5\nEnd of LNG-IUS lifespan 12 3.7\nOther reasons 13 4.0\nLNG-IUS = Levonorgestrel-Releasing Intrauterine Sys tem.\n\nRev. Bras. Saúde Mater. Infant., Recife, 20 (2): xx x-xxx abr-jun., 2020482\nSouza AI et al.\nTable 3\nAssociation between difficulty in insertion and par ity, type of delivery and necessity of anesthesia/s edation.\nVariables                                                                Difficulty in insertion                          Total                        p\nYes                             No\nn             %                  n          %                 n           %                                                                            \nParity 0.002\nNulliparous 16 28.6 40 71.4 56 100.0\nParous 33 10.1 236 72.6 325 100.0\nType of delivery 0.060\nVaginal 7 7.0 91 93.0 98 100.0\nPrevious cesarean section 23 15.0 130 85.0 153 100.0\nNecessity of anesthesia/sedation 0.006\nYes 6 40.0 9 60.0 15 100.0\nNo 43 14.0 267 86.0 310 100.0\nDiscussion\nThe women in this study had sociodemographic and\nreproductive characteristics commonly found in\nstudies evaluating long-term contraceptive methods,\nas the LNG-IUS. 10,16,17\nAt the time of LNG-IUS insertion, their mean\nage was 35 (± 8) years old and had between 8-11\nyears of schooling. A study that followed 61,448\npatients over seven years in six European countries\nrecorded a mean age of 37.4 years among women\nwho opted for the LNG-IUS. 10 Probably because\nwomen in reproductive age group are searching for\ncontraceptive methods with high efficacy and\nsafety.14,18\nIn addition, women with higher levels of\nschooling who are more informed about the safety\nand efficacy of LARCs and may be more motivated\nto choose this type of contraception in order to av oid\nan unplanned pregnancy. Most of the women in this\nstudy had eight or more years of schooling, and thi s\nlevel of schooling is similar to PNAD ( Pesquisa\nNacional por Amostra de Domicílio /National\nHousehold Sample Survey) data, which showed an\nimprovement in the educational level in the Brazili an\npopulation. 19 According to the CHOICE contracep-\ntive project, which included 9,256 women from St\nLouis region, in the United States (USA), women\nwith less education and financial restrictions had\ngreater difficulty in obtaining contraceptive\nmethods.18\nAlthough contraception was the most frequent\nindication for the insertion of the LNG-IUS, other\nindications are described as high efficacy of the\ndevice in the reduction of bleeding and gynecolo-\ngical pathologies treatment. 5 In the present study,\nsome women used the method to treat uterine\nbleeding, myoma and adenomyosis. Endometriosis\nassociated with pelvic pain and hematological\ndisease were also the reasons to insert the device,\naccording to other studies. 5,7,17\nThe use of the LNG-IUS for the treatment of\nendometriosis associated with pelvic pain is well\ndocumented. This treatment is effective in relievin g\npain, leading to an improvement in the quality of l ife\nof women with endometriosis. 5,7,8 The expansion of\nthe indications for the LNG-IUS insertion is due to\nits mechanism of action, which promotes endome-\ntrial atrophy with consequent control of uterine\nbleeding and pain. 3 On the other hand, the LNG-IUS\ndevice may present adverse effects that lead women\nto discontinue the method. 20\nAmong the 327 women in this study, 68 (20.8%)\ndiscontinued the use of the device. The main reason\nfor discontinuation was the device expelled sponta-\nneously (9.2%), similar to a study performed with\n481 women in the USA whose percentage of sponta-\nneous expulsion was 9.6% 16 and another study\ncarried out in the USA involving 5,403 women using\nthe device with an expulsion rate of 10.1%. 21 A 7-\nyear randomized controlled trial in 20 centers in n ine\ncountries found a lower expulsion rate (8.2%). 22 It is\ninteresting to observe that this large WHO study 22\nwas a contraceptive trial where all the women\ninvolved had used the LNG-IUS for contraception\nwhile in our study there were patients using LNG-\nIUS for gynecological pathologies treatment which\nmay favor the expulsion. \nOf the thirty women who expelled the LNG-IUS\nin our study, the majority had inserted the device for\ntreating metrorrhagia/myoma. This is in line with a\nstudy that found a significantly high rate of spont a-\nneous expulsion of the device in women with uterine\npathologies. 21 \n\nRev. Bras. Saúde Mater. Infant., Recife, 20 (2): 47 9-484 abr-jun., 2020 483\nIndications and reasons for discontinuing the LNG-I US\nDiscontinuation for bleeding-related complaints\noccurred in 8 (2.4%) LNG-IUS users. This rate was\nhigher than a trial that assessed 3-year data on th e\nefficacy and safety of a LNG-IUS conducted at 29\nclinical sites in the USA (1.5%). 23\nBesides this, the large WHO study 22 found a\ncumulative rate of method discontinuation due to\nbleeding problems higher in the LNG-IUD than the\nTCu380A group. And also, the increased bleeding\nvolume and frequency were associated with reduced\nshort-term satisfaction in LNG-IUS users among\nparticipants. 24\nMost of the women in our study were multi-\nparous, coinciding with data from Youm et al .16\nstudy, in which multiparous women were the\nmajority in the sample. This may be explained\nbecause in the past intrauterine devices have been\nrecommended only for women who have already had\nchildren. The LNG-IUS expanded the indications for\nintrauterine devices, including contraception for\nnulliparous and this indication became more\nfrequently and supported by scientific\nevidence.9,11,25\nParity has also been considered a factor that may\nbe related to the difficulty in insertion of the LN G-\nIUS9,10 although some studies reported no difficulty\nin the insertion in nulliparous. 1,11,25 In the present\nstudy, the nulliparous tended to experience greater\ndifficulty with the insertion of the LNG-IUS. One\nexplanation for this could be because for many\nyears, the insertion of a copper IUD in nulliparous\nwas contraindicated, 11 which has led to a lower\nability of the professionals for inserting the LNG-\nIUS in this group of women.\nIn this study there was no association between\ndifficulty with insertion of the device and women\nwith previous cesarean section. It is known that th e\narea of scar tissue changes in the isthmus region\nafter cesarean section may hinder the passage of th e\ndevice during insertions. Although a history of\ncesarean section is not contraindicated for the LNG -\nIUS insertion, 11 a study compared the difficulty of\ninsertion among women with and without a previous\ncesarean section found that most of the women who\npresented difficulty in insertion had a history of\ncesarean delivery. 9\nIt is important to consider the limitations of the\npresent study. Since it is a cross-sectional retros pec-\ntive study, some medical records were incomplete or\nillegible.\nThis study concluded that the main indication for\nthe use of the LNG-IUS was contraception. Most of\nthe women had good adherence to the method, had\nno difficulty in insertion and did not require anes -\nthesia / sedation. \nRandomized and controlled prospective studies\nevaluating a greater number of women using the\nLNG-IUS, especially in public hospitals and clinics\nmay produce robust scientific evidence. These\nresults could alert public health managers about th e\nbenefits of LNG-IUS in the public service and\nimprove women’s health care.\nAuthor’s contribution\nPires MLL, Souza AI, Henriques CV and Ferreira\nALCG contributed to the conception and design,\nanalysis, interpretation of the data, and writing o f the\narticle. Pires MLL, Dantas MLBR, Soriano GD and\nHenriques CV contributed to the data collection,\nanalysis, and writing of the article. Souza AI and\nFerreira ALCG also contributed to the critical revi ew\nof the intellectual content. All the authors have\napproved the final version to be published.\nReferences\n1. Sabbioni L, Petraglia F, Luisi S. Non-contracepti ve benefits\nof intrauterine levonorgestrel administration: why not?\nGynecol Endocrinol. 2017; 33: 822-9. \n2. WHO (World Health Organization). Family Planning:  A\nglobal handbook for providers. 2018 Edition. [Cited  10 Jul\n2018]. 2018. Available from: http://www.who.int/rep roduc-\ntivehealth/publications/fp-global-handbook/en/\n3. Luo L, Luo B, Zheng Y, Zhang H, Li J, Sidell N.\nLevonorgestrel-releasing intrauterine system for at ypical\nendometrial hyperplasia. Cochrane Database Syst Rev .\n2013; 6: CD009458. \n4. Cruz J, Costa AR. Levonorgestrel-releasing intrau terine\nsystem and breast cancer. Acta Obstet Ginecol Port.  2017;\n11 (4): 276-82. \n5. Bahamondes L, Bahamondes MV, Shulman LP. 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Association of Short-term Bleeding and Cramping\nPatterns with Long-Acting Reversible Contraceptive\nMethod Satisfaction. Am J Obstet Gynecol. 2015; 212  (1):\n50.e1–50.e8. \n25. Lohr PA, Lyus R, Prager S. Use of intrauterine d evices in\nnulliparous women. Contraception, 2017; 95: 529-53.  \n______________\nReceived on November 20, 2019\nFinal version presented on February 20, 2020\nApproved on March 30, 2020","source_license":"CC0","license_restricted":false}