Safety of levonorgestrel 52 mg intrauterine system compared to copper intrauterine device: a population-based cohort study

Bosco‐Lévy, Pauline; Gouverneur, Amandine; Langlade, Claire; Miremont, Ghada; Pariente, Alexandre

doi:10.1016/j.contraception.2019.02.011

Cited by 8 publications

(9 citation statements)

References 18 publications

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“…Almost all these events are described in the SPC. Moreover, the anxio‐depressive safety signal was found in a population‐based cohort study of the safety of the Mirena levonorgestrel IUD compared to copper IUDs and with another recent observational study …”

Section: Discussionmentioning

confidence: 67%

“…Moreover, the anxio-depressive safety signal was found in a population-based cohort study of the safety of the Mirena levonorgestrel IUD compared to copper IUDs and with another recent observational study. 20,21 The media coverage peak highlighted and broadcasted information about AEs of Mirena, informing the users that their symptoms could be related to potential AEs of their levonorgestrel-releasing IUD they were unaware of. Indeed, many consumers reported long-standing symptoms, such as depression, weight gain, abdominal pain or breast tenderness, which they had not attributed previously to their levonorgestrel-releasing IUD.…”

Section: Discussionmentioning

confidence: 99%

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Adverse events reported for Mirena levonorgestrel‐releasing intrauterine device in France and impact of media coverage

Langlade

Gouverneur

Bosco‐Lévy

et al. 2019

Brit J Clinical Pharma

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Aims In 2017, concerns regarding adverse events (AEs) associated with the Mirena levonorgestrel intrauterine device were largely echoed in the media in France. This resulted in a tremendous reporting of AEs to pharmacovigilance centres. The aim of this study was to describe the reporting of AEs regarding Mirena in France and to study the impact of media coverage on this reporting. Methods All cases reports involving Mirena recorded in the French national pharmacovigilance database from marketing (21 July 1995) until 04 August 2017 were extracted. To allow studying the influence of mediatisation, reports were described separately for the periods preceding and following the observed media coverage peak (15 May 2017). Results Overall, 3224 reports were considered, 510 (15.8%) recorded before the media coverage peak, and 2714 (84.2%) after. Before the peak, 76.5% of reports originated from health professionals; median time‐to‐report was of 5.5 months (interquartile range: 1.7–18.6), and median number of AEs per report was 1 (range: 1–17). After the peak, 98.6% originated from patients; median time‐to‐report was 21 months (interquartile range: 8.1–45.5), and median number of AEs per report was 6 (range: 1–37). After the peak, most reports mentioned anxio‐depressive disorders (38.8 vs 10.6% before) or sexual disorders (47.3 vs 6.9%). Other emphasised AEs were weight increase (42.3 vs 10.2%) and pain (gastrointestinal, 19.1 vs 3.5%; musculoskeletal, 22.2 vs 4.5%). Conclusion This study highlighted the importance of mediatisation impact on spontaneous reporting with changes concerning amounts of reports, type of reporter, and type of reported AEs. For Mirena, this led to generate signals regarding anxio‐depressive and sexual disorders.

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Section: Discussionmentioning

confidence: 67%

Section: Discussionmentioning

confidence: 99%

Adverse events reported for Mirena levonorgestrel‐releasing intrauterine device in France and impact of media coverage

Langlade

Gouverneur

Bosco‐Lévy

et al. 2019

Brit J Clinical Pharma

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“…Literatürde rastlanan diğer çalışmalar da göz önüne alındığında genellikle LNG-RİS'in benzer yaş ortalamasında uygulandığı görülmektedir. (20) www.turkishfamilyphysician.com ile %65 arasında değişmekte olup, bunlar daha çok sayıda katılımcı ile yapılmış araştırmalardır. (22,23,24) Kullanıcı sayısının azlığı verilerin yorumlanmasını sınırlamaktadır.…”

Section: Discussionunclassified

Contraceptive Use of Levonorgestrel Intrauterine System: Case Series

Ayaz¹,

Uzuner²

2020

tjtfp

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Aim: Levonorgestrel intrauterine system (LNG-RIS) is a highly effective, safe and reversible contraceptive method. It suppresses endometrial cell proliferation, thickens cervical mucus, disrupts tubal motility by creating a high levonorgestrel concentration in the endometrium and tubal mucosa. In our country, LNG-RIS is mostly used in Gynecology and Obstetrics clinics in the treatment of pathologies such as adenomyosis, endometriosis, hyperplasia and their symptoms such as menorrhagia, dysmenorrhea, pelvic pain, and is prescribed at the hospitals due to a medication report. It has a high level of protection (99.9%), and its contraceptive effect is considered to last five years, and fertility returns rapidly after removal. In this study it was aimed to evaluate retrospectively the continuation rate, the presence of unwanted effects and the patient satisfaction after insertion of LNG-RIS. Method: This is a retrospective, descriptive study of women who had been inserted LNG-IUS with contraceptive purpose in the family planning unit of the Marmara University Pendik Training and Research Hospital, between 2013-2019; the data of a total 38 patients were retrospectively analyzed. Results: The average age of the participants was 36±5 years. No pregnancy is detected during the use of the method. Five-year usage rate was 21% among users. A total of nine patients discontinued the method; one because being diagnosed with a glial tumor, two because of excessive bleeding, one other patient because having hysterectomy due to myoma uteri, two patients because the threads were not visible, two others because they have been told that their LNG-IUS had slipped down and one patient because of her pregnancy plan. The satisfaction rate was 52.6%. There was a decrease in both the duration and the amount of bleeding of menstruation but this decrease was not statistically significant. Conclusion: LNG-RIS is an effective, reliable contraception method with low side effect. It is still limited in primary care and it will be more appropriate to spread its use.

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“…Figure 4B) and Mirena™ (Bayer, Whippany, NJ; Figure 4C)) are physical devices incorporating a slow releasing progestin (levonorgestrel), which in addition to contraception, are commonly used in the management of dysfunctional uterine bleeding, pelvic pain disorders and to counter the effects of oestrogen-base hormonal replacement therapies. 8 Although unlikely, IUCD/IUS can displace causing them to become ineffective as a contraceptive and risk uterine perforation 9,10 (Figure 5). IUCD/IUS devices should be located entirely within the uterine cavity with the barrel straight in a cranial/caudal position and the 'T' bars located at the fundal cavity with each side positioned towards the cornua (Figure 4B).…”

Section: Mullerian Duct Anomaliesmentioning

confidence: 99%

Three‐dimensional gynaecological ultrasound part two: A pictorial essay

Deslandes

Croft²,

Panuccio³

2021

Sonography

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Three‐dimensional ultrasound (3DUS) is becoming a standard part of obstetric and gynaecological ultrasound examinations. With most high‐end ultrasound systems now incorporating three‐dimensional functionality, the technology can be used to enhance and/or confirm a diagnosis in many gynaecological pathologies. Part one of this two‐part series covered the technical aspects of performing three‐dimensional gynaecological ultrasound. This paper, part two, presents a pictorial essay of 3DUS in gynaecological imaging serving to educate sonographers and other ultrasound users on the typical appearance of some common, and not so common ultrasound findings.

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Safety of levonorgestrel 52 mg intrauterine system compared to copper intrauterine device: a population-based cohort study

Cited by 8 publications

References 18 publications

Adverse events reported for Mirena levonorgestrel‐releasing intrauterine device in France and impact of media coverage

Adverse events reported for Mirena levonorgestrel‐releasing intrauterine device in France and impact of media coverage

Contraceptive Use of Levonorgestrel Intrauterine System: Case Series

Three‐dimensional gynaecological ultrasound part two: A pictorial essay

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