Contraceptive efficacy and safety of the 52-mg levonorgestrel intrauterine system for up to 8 years: findings from the Mirena Extension Trial

Jensen, Jeffrey T.; Lukkari-Lax, Eeva; Schulze, Andrea; Wahdan, Yesmean; Serrani, Marco; Kroll, Robin

doi:10.1016/j.ajog.2022.09.007

Cited by 22 publications

(6 citation statements)

References 46 publications

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“…The major adverse reaction observed in our study included a 71.23% rate of irregular uterine bleeding, which is higher than the reported rates of 33.33-44.3% in existing LNG-IUS suture xation reports [20,22]. Irregular bleeding associated with LNG-IUS placement is negatively correlated with duration of placement [23][24][25]. Notably, our study had a shorter follow-up duration than the study by Lv et al, which may have contributed to the higher rate of abnormal bleeding.…”

Section: Discussionmentioning

confidence: 46%

Safety and Efficacy of Hysteroscopic Suture Fixation of the Levonorgestrel- Releasing Intrauterine System in Women with an Expulsion History: A Prospective Cohort Study

Ge,

Lin,

et al. 2023

Preprint

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Background The levonorgestrel-releasing intrauterine system (LNG-IUS) is an efficient contraceptive and nonsurgical treatment for gynecological conditions. However, its expulsion rates are concerning. In this study, we suggest the use of non-absorbable suture fixation through hysteroscopy to mitigate expulsions and evaluate the safety and outcomes of this procedure. Methods This study included 73 women (average age: 41.34 years) with a history of LNG-IUS expulsion who underwent hysteroscopic suture fixation of the LNG-IUS at Women’s Hospital, Zhejiang University School of Medicine, between August 2022 and August 2023. Postoperative assessment was conducted using electronic questionnaires at 1, 3, and 7 days, along with outpatient follow-ups and ultrasonography at 1, 3, 6, and 12 months. Results The day surgery team successfully performed 73 procedures with a mean duration of 37.81 ± 15.42 min, encountering no complications. Follow-up was conducted for an average of 183.56 days for all 73 patients. Among them, 70 underwent postoperative imaging examinations, primarily ultrasonography, with an average follow-up imaging time of 117.33 days. This study revealed low expulsion (4.29%) and downward-shift (7.14%) rates. The primary adverse reactions observed were irregular bleeding or spotting in 71.23% of cases and an increased vaginal discharge rate of 8.22%. Conclusion Hysteroscopic LNG-IUS suture fixation is safe and effective for reducing expulsion rates in women with a history of expulsion. However, this procedure is associated with higher rates of irregular postoperative bleeding and increased vaginal discharge.

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Section: Discussionmentioning

confidence: 46%

Safety and Efficacy of Hysteroscopic Suture Fixation of the Levonorgestrel- Releasing Intrauterine System in Women with an Expulsion History: A Prospective Cohort Study

Ge,

Lin,

et al. 2023

Preprint

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“…Off-label use such as extended use of the contraceptive implant is common with many other reproductive devices and medications, including misoprostol for labor induction, the copper intrauterine device (IUD) for emergency contraception, and, prior to its recent FDA-approval for extended use, the 52 mg levonorgestrel (LNG) IUD for pregnancy prevention. The 52 mg LNG IUD was previously FDA-approved for 5 years, however strong published evidence demonstrated longer efficacy up to 8 years, leading clinicians to counsel on extended use and eventually contributing to updated federal guidelines [ 6 , 7 ].…”

Section: Introductionmentioning

confidence: 99%

Offering extended use of the contraceptive implant via an implementation science framework: a qualitative study of clinicians’ perceived barriers and facilitators

Rigler,

Kully,

Hildebrand

et al. 2024

BMC Health Serv Res

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Background The etonogestrel contraceptive implant is currently approved by the United States Food and Drug Administration (FDA) for the prevention of pregnancy up to 3 years. However, studies that suggest efficacy up to 5 years. There is little information on the prevalence of extended use and the factors that influence clinicians in offering extended use. We investigated clinician perspectives on the barriers and facilitators to offering extended use of the contraceptive implant. Methods Using the Consolidated Framework for Implementation Research (CFIR), we conducted semi-structured qualitative interviews. Participants were recruited from a nationwide survey study of reproductive health clinicians on their knowledge and perspective of extended use of the contraceptive implant. To optimize the diversity of perspectives, we purposefully sampled participants from this study. We used content analysis and consensual qualitative research methods to inform our coding and data analysis. Themes arose deductively and inductively. Results We interviewed 20 clinicians including advance practice clinicians, family medicine physicians, obstetrician/gynecologist and complex family planning sub-specialists. Themes regarding barriers and facilitators to extended use of the contraceptive implant emerged. Barriers included the FDA approval for 3 years and clinician concern about liability in the context of off-label use of the contraceptive implant. Educational materials and a champion of extended use were facilitators. Conclusions There is opportunity to expand access to extended use of the contraceptive implant by developing educational materials for clinicians and patients, identifying a champion of extended use, and providing information on extended use prior to replacement appointments at 3 years.

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“…As of 2023, Mirena (52 mg LNG) and Lileta (52 mg LNG) have been approved for usage for up to eight years. In comparison, Kyleena (19.5 LNG) and Skyla (13.5 mg LNG) are approved for five and three years, respectively [ 29 ]. Unlike the LNG IUDs, the Copper IUD (e.g., Paragard) does not release hormonal substances.…”

Section: Introductionmentioning

confidence: 99%

How Can We Address What We Do Not Measure? A Systematic Scoping Review of the Measurement and Operationalization of Social Determinants of Health Research on Long-Acting Reversible Contraceptive among Adolescents in the US

et al. 2023

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Teen pregnancy is often considered an adverse health outcome that accentuates gender inequities, diminishes opportunities, and jeopardizes the safety of adolescent and young adult birthing people. Long-Acting Reversible Contraceptives (LARC) have been hailed as a panacea for teen pregnancy. However, adolescents and emerging adults intersect with multiple assaults on their health and well-being due to gender inequity and racism. To establish equitable care, it is imperative to discern all barriers that influence their reproductive autonomy. This study evaluates the measurement, operationalization, and quality of research conducted on adolescents and emerging adults that analyzed the use of LARC within the social determinant of health framework (SDOH) in the US. SDOH were assessed using the Dahlgren and Whitehead model, and reports were analyzed using a modified version of the Joanna Briggs Institute (JBI) Critical Appraisal tools. Nineteen articles were included in this study. Researchers found the insufficient measurement of race, ethnicity, sexuality, and gender among studies on LARC and SDOH in adolescents and emerging adults. Future studies must measure a full range of identities in data collection to generate knowledge on the impact of SDOH and LARC use among diverse populations.

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Contraceptive efficacy and safety of the 52-mg levonorgestrel intrauterine system for up to 8 years: findings from the Mirena Extension Trial

Cited by 22 publications

References 46 publications

Safety and Efficacy of Hysteroscopic Suture Fixation of the Levonorgestrel- Releasing Intrauterine System in Women with an Expulsion History: A Prospective Cohort Study

Safety and Efficacy of Hysteroscopic Suture Fixation of the Levonorgestrel- Releasing Intrauterine System in Women with an Expulsion History: A Prospective Cohort Study

Offering extended use of the contraceptive implant via an implementation science framework: a qualitative study of clinicians’ perceived barriers and facilitators

How Can We Address What We Do Not Measure? A Systematic Scoping Review of the Measurement and Operationalization of Social Determinants of Health Research on Long-Acting Reversible Contraceptive among Adolescents in the US

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