Research ArticleResearch

Extended duration of use of long-acting reversible contraceptives

Systematic review

Edith Guilbert, Hélène Arguin and Mathieu Bélanger
Canadian Family Physician February 2025; 71 (2) e35-e52; DOI: https://doi.org/10.46747/cfp.7102e35

Abstract

Objective To document the efficacy and safety of etonogestrel subdermal contraceptive implants, levonorgestrel (LNG) intrauterine systems (IUS), and copper (Cu) intrauterine devices (IUDs) for birth control when extended beyond prescription limits.

Data sources A systematic search of MEDLINE, Embase, and Global Health electronic databases.

Study selection The search identified articles published between January 2000 and June 2023 on long-acting reversible contraceptive (LARC) methods and extended duration of use. Publications on LNG subdermal implants or the “frameless” IUD (not marketed in Canada), case reports, case series, animal studies, and publications not written in English or French were excluded.

Synthesis Twenty-five publications were included. No pregnancies were reported during prolonged use of the etonogestrel-releasing implant for 1 or 2 additional years beyond the recommended limits (783 participants and 306 participants, respectively), nor with the use of the TCu380A IUD for years 8 to 11 (682 participants), 8 to 12 (356 participants), and 11 to 16 (228 participants). No pregnancies were reported with the LNG-IUS in 9 studies with follow-up from 6 to 15 years, while 2 pregnancies were reported during year 6 in 2 studies, and 4 pregnancies during year 7 in 3 studies. The risk of expulsion persisted during prolonged use of the TCu380A device and the 52-mg LNG-IUS. Other adverse events were infrequent.

Conclusion Prolonged use of LARCs is safe and much more effective than short-acting contraceptive methods. Prolonged use of LARCs might be beneficial for individuals requiring contraception especially those with disrupted access to social and health care services or living in more remote areas.

Long-acting reversible contraceptive (LARC) methods, including nonhormonal copper (Cu) intrauterine devices (IUDs), levonorgestrel (LNG)-releasing intrauterine systems (IUS), and etonogestrel (ENG)-releasing subdermal contraceptive implants, are widely used around the world.1 There are no recent Canadian data on LARC use, but a significant increase in IUD use (4.3% to 8.8%) was observed between 2006 and 2016 in sexually active Canadian women aged 15 to 50 years who reported using contraception (P<.001).2 Available LARC methods are approved for limited durations of use: the ENG implant is approved for 3 years3; most Cu-IUDs, for 5 to 10 years4,5; the 19.5-mg LNG-IUS for 5 years6; and the 52-mg LNG-IUS (in Canada, as of February 2024) for up to 8 years.7

Since it might be difficult for patients to access services and health care professionals,8 especially during periods of social disruption such as the COVID-19 pandemic,9 and because trauma might arise during insertion or removal of these devices (vascular or neurologic trauma for subdermal implants,10,11 uterine perforation for IUDs,12,13 etc), it might be desirable to use these devices for longer durations. As mentioned by Ali et al, extending the use of LARCs could reduce the number of insertion and withdrawal procedures, open up new consultation slots to other contraceptive seekers, and save millions of health care dollars.14

The objective of this systematic review was to document the efficacy and safety of ENG contraceptive implants, LNG-IUS, and Cu-IUDs for birth control when their duration of use is extended beyond the limits approved by Health Canada.

METHODS

Two library science experts searched MEDLINE, Embase, and the Global Health electronic database via the Ovid interface for studies published between January 2000 and June 2023, in either French or English, that identified the concepts of LARC and extended duration of use. The search strategy used terms describing the concepts of ENG implants, Cu-IUDs, LNG-IUS, and extended duration of use (Appendix 1, available from CFPlus*). The reference lists of articles selected for extraction and quality assessment were searched for other relevant studies.

Study selection

Eligible study designs were systematic or narrative reviews, randomized controlled trials, cohort studies, case-control studies, descriptive studies, expert opinions, and guidelines. Publications on LNG implants or the “frameless” IUD (not marketed in Canada), case reports, case series, and animal studies were not retained. After excluding duplicates, all titles and abstracts were reviewed by 2 independent reviewers (H.A. and M.B.), and those meeting inclusion criteria were selected and read in their entirety. Any disagreements between the 2 reviewers were resolved by discussion, rechecking of the publication, and consultation with a third party (E.G.), if necessary. The research was documented in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) protocols.15 For each study, its objectives, design, location, population, inclusion and exclusion criteria, recruitment period, ethical aspects and consent, methodology, results, strengths and limitations, discussion points, and authors’ conclusions were documented by 2 data extractors (H.A. and M.B.). The following data were extracted for guidelines: generalities, efficacy, indications and targeted population, contraindications, noncontraceptive benefits, drug interactions, adverse effects, use according to weight or body mass index (BMI), initial assessment, interventions in case of difficulty, replacement, duration of use, and authors’ recommendations.

The quality of selected studies was assessed by 2 independent reviewers (H.A. and M.B.) using the JBI Critical Appraisal Tools,16 the CASP (Critical Appraisal Skills Programme) Systematic Review Checklist,17 and the SANRA (Scale for the Assessment of Narrative Review Articles) tool.18 Guidelines were assessed using the AGREE II (Appraisal of Guidelines for Research and Evaluation II) grid.19

In accordance with article 2.2 of the research ethics board of Laval University, Que, research was exempted from evaluation because it was based exclusively on information that was accessible to the public through a mechanism established by regulation and in the public domain, and because the persons concerned had no reasonable expectation of privacy.20

SYNTHESIS

Results

The search yielded 1488 titles (Figure 1).15 Following exclusions, 22 publications (2 guidelines and 20 scientific articles) were retained. An additional 5 scientific articles were added from 1 author’s (E.G.) bibliographic database. All 27 publications were extracted and assessed for quality. Two articles were rejected because of low quality score: Rocca et al21 (score 17% with CASP Systematic Review Checklist) and Honorato et al22 (score 25% with the JBI checklist for analytical cross-sectional studies). Quality scores were greater than 85% for most of the selected articles and reviews.

Figure 1.
Figure 1.

Flowchart for literature search and study selection based on PRISMA guidelines for systematic reviews

Efficacy and safety of the ENG contraceptive implant beyond the approved duration of use (Table 1).14,23-32 No pregnancy occurred in 783 participants who extended implant use for 1 additional year14,25,28 or in 306 participants who extended use for 2 additional years.14,25 Two prospective studies24,25 and 1 cross-sectional study23 demonstrated median serum ENG levels above the theoretical minimum threshold for ovulation inhibition (90 pg/mL)27 after 3, 4,23-25 and 5 years25 of implant use. A weak relationship between serum ENG and time since insertion was demonstrated in 1 study,23 while no association with BMI was found in 3 studies.23-25 The most frequent adverse events in years 4 and 5 were irregular bleeding, reported by 46.2% of users; headache, reported by 31.8% of users; and lower abdominal pain, reported by 17.9% of users.14

View this table:
Table 1.

Summary of publications on prolonged duration of etonogestrel contraceptive implants: A) Scientific articles and B) guidelines.

In 2022, the Society of Family Planning (SFP)32 recommended informing patients that the contraceptive efficacy of the 68-mg ENG implant was maintained beyond the 3 to 5 years’ duration currently approved by the US Food and Drug Administration (grade 1A evidence).

Efficacy and safety of the Cu-IUD beyond the approved duration of use (Table 2).32-39 The studies by Rowe et al from 1997 and 2016 reported no pregnancies in patients using the TCu380A IUD during, respectively, 1440 women-years of observation from 8 to 12 years after insertion (n=356) and 1342 women-years of observation from 7.2 to 11 years after insertion (n=682).33,37 Combining data from the 1997 study by Rowe et al33 and a 2005 study from Bahamondes et al (n=228),34 Ti et al38 calculated an overall pregnancy rate of 0.0 per 100 women-years (95% CI 0.0 to 0.8) for years 11 and 12. Sivin35 combined data from the Population Council, the World Health Organization, and Bahamondes et al (2005)34 and reported no pregnancies in 1886 women-years of observations from years 10 through 15.

View this table:
Table 2.

Summary of publications on prolonged duration of Cu-IUDs: A) Scientific articles and B) guidelines.

The expulsion rate was 1.3 per 100 women-years for years 11 and 12, and 0.7 per 100 women-years from 7.2 to 11 years, in Rowe et al (1997)33 and Rowe et al (2016),37 respectively. In Bahamondes et al (2005),34 the expulsion rates were 2.1 and 1.1 per 100 women-years in years 11 and 12, and 3 expulsions occurred from years 13 to 16. In comparison, in Rowe et al (2016),37 the cumulative expulsion rate was 3.49 per 100 women-years in the first year after insertion, and 7.30 per 100 women-years after 5 years. Bleeding or pain or both led to IUD discontinuation in 4.6 per 100 women-years between years 10 and 12, and 1.2 per 100 women-years from 7.2 to 11 years, in Rowe et al (1997)33 and Rowe et al (2016),37 respectively. In Bahamondes et al (2005),34 these figures were 1.6, 1.1, 2.5, 3.4, and 0 per 100 women-years at years 11, 12, 13, 14, and 15 to 16, respectively. In Rowe et al (2016),37 the cumulative rates for discontinuation due to heavy bleeding and pain were 2.42 and 1.72 per 100, respectively, 1 year after insertion, and 7.42 and 5.01 per 100, respectively, after 5 years. Other problems were found to be rare or nonexistent.33-35,37

The 2014 and 2022 SFP guidelines32,39 recommended prolonged use of the 380-mm2 Cu-IUD (equivalent to TCu380A) for 12 years, regardless of the patient’s age at insertion. The 2022 SFP guideline32 recommended that the use of all 380-mm2 Cu-IUDs be extended beyond 12 years, and up to 20 years or until menopause, for patients older than 30 years of age at the time of insertion.

Efficacy and safety of the LNG-IUS beyond the approved durations of use (Table 3).24-26,32,37-53 Prolonged use was reported only for 52-mg LNG-IUS. No pregnancies were reported in 9 studies at different durations of use, ranging from year 649,50 to years 6 and 7,40,41 years 6 to 8,44 year 8,51,52 years 9 and 10,53 years 6 to 11,37 and years 6 to 15.49 A total of 2 pregnancies were reported in year 6 in 2 studies24,52 (n=625), and 4 pregnancies were reported in year 7 in 3 studies (n=1228).25,51,52 In a 2020 meta-analysis of 4 studies25,38,41,49 by Ti et al,38 the cumulative pregnancy rate during years 6 and 7 was 0.02 per 100 women-years.

View this table:
Table 3.

Summary of publications on prolonged duration of LNG-IUS: A) Scientific articles and B) guidelines.

Expulsions occurred rarely per additional year in several descriptive studies.40,50-53 Rowe et al (2016)37 observed an expulsion rate of 0.7, 1.2, and 0.8 per 100 women-years, in years 6, 7, and from years 8 to 11, respectively. In Bahamondes et al 2018,49 the cumulative rates of discontinuation (per 100 women-years) due to expulsions were 0.3, 0.6, 0, 1.1, and 2.1 for years 5 to 6, 7 to 8, 9 to 10, 11 to 12, and 13 to 14, respectively.

Regarding menstrual-related adverse events, most studies reported discontinuation rates of less than 5% during each additional year of use.37,40,50-53 In Bahamondes et al (2018),49 cumulative rates (per 100 women-years) of discontinuation due to bleeding or pain were 0.2, 2.3, and 0 for years 5 to 6, 7 to 8, and thereafter, respectively. Other adverse events occurred in very low frequencies in all studies.

Prolonged use of the 52-mg LNG-IUS for 7 years39 or 8 years32 is recommended by the SFP, which also states that contraceptive effectiveness with extended use of 52-mg LNG-IUS is independent of BMI,32,39 and that patients taking cytochrome P450 3A4 inducers might be offered extended use of this IUS.32

DISCUSSION

The evidence reported no pregnancies with prolonged ENG implant use for 1 year14,25,28 and 2 years,14,25 with median serum ENG levels remaining high enough to inhibit ovulation during these additional years and not associated with BMI.23-25

For the TCu380A Cu-IUD, 3 large studies observed participants for prolonged use: 1 during years 8 to 11 in 682 women,37 1 during years 8 to 12 in 356 participants,33 and 1 during years 11 to 16 in 228 participants.34 These studies, mainly carried out in multiparous participants who were under 30 years of age at insertion, did not report any pregnancy.

For the 52-mg LNG-IUS, only a minimal number of pregnancies were reported between 6 and 15 years of use in nulliparous and multiparous participants. Although a statistically significant negative correlation was observed between plasma LNG concentrations and duration of use,44 these concentrations26,54 and in vivo release rates for 52-mg LNG-IUS54 after 7 or 8 years of use were similar to or higher than for 19.5-mg and 13.5-mg LNG-IUS at the end of their approved durations of use (5 and 3 years, respectively). Levonorgestrel levels, although lower in individuals with higher BMI or weight, did not appear to affect effectiveness.42,44,48,54

This reassuring evidence indicate that the long-term efficacy of the ENG implant, TCu380A IUDs, and the 52-mg LNG-IUS are comparable to their short-term efficacy and superior to those of short-acting reversible methods.55 Society of Family Planning guidelines32,39 recommend that the ENG implant be used for 5 years, the TCu380A for 12 years, and the 52-mg LNG-IUS for 8 years in all participants. The SFP also recommends that all 380-mm2 Cu-IUDs be used for 12 to 20 years, or until menopause if inserted after the age of 30.

Limitations

Despite the quality of the studies, none compared the efficacy of prolonged use of LARCs with the efficacy of LARCs replaced after each approved duration of use in a randomized trial. Low pregnancy rates might be explained by the fact that most of the participants who were followed in long-term studies might have low fertility and that their fertility declines with age. The selection of participants recruited in long-term studies, often healthy multiparous individuals, might not be representative of the general population and limits the generalizability of the results. Pharmacokinetic data, obtained on very small samples, do not provide a clear understanding of how much of the efficacy of the LNG-IUS is attributable to LNG or to the shape and size of the IUS. Data on the long-term efficacy of the LNG-IUS and the ENG implant according to BMI, or in relation to other medications, are still limited. High upfront cost of LARCs and the individual economic situations of persons interested in these methods might be factors limiting their use. Further studies are needed to clarify these aspects.

Life-table statistics expressed in terms of “women-years” are reported from original studies. However, we acknowledge that these data are relevant to transgender men and other gender-diverse people with a uterus who desire contraception.

Conclusion

The evidence and several guidelines support the extended use of LARCs. Such an extension can be very useful in standard living conditions and in situations of social and health care service disruption, or for populations living in remote areas. With the help of their health care providers, individuals should discuss the benefits versus the risks associated with LARC use beyond the limits currently recommended for birth control.

Footnotes

  • ↵* Appendix 1 is available from https://www.cfp.ca. Go to the full text of the article online and click on the CFPlus tab.

  • Contributors

    All authors contributed to conceptualizing and designing the study; to collecting, analyzing, and interpreting the data; and to preparing the manuscript for submission.

  • Competing interests

    None declared

  • This article has been peer reviewed.

  • Cet article a fait l’objet d’une révision par des pairs.

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Extended duration of use of long-acting reversible contraceptives
Edith Guilbert, Hélène Arguin, Mathieu Bélanger
Canadian Family Physician Feb 2025, 71 (2) e35-e52; DOI: 10.46747/cfp.7102e35
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