, Code de la Santé Publique. Article R, pp.5121-161

, Code de la Santé Publique. Article R, pp.5121-162

, Agence nationale de sécurité du médicament et des produits de santé, 2018.

, Agence nationale de sécurité du médicament et des produits de santé

. Pharmacovigilance,

, Screening for adverse reactions in EudraVigilance

. Uppsala-monotoring-centre,

, Reports were described in terms of type of reporter (health professional vs consumer), timeto-report (delay from date of onset to date of reporting), number of AEs per report, age and sex of the patient, and seriousness. AEs were classified according to MedDRA System Organ Class (SOC), A descriptive analysis of the reported cases was performed. Number and proportion were used for qualitative variables, and median and Inter-Quartile Range (IQR) for continuous ones, 2017.

, Results 3.1. Population characteristics and overall description of case report

, Among the 3,224 case reports identified for Mirena®, 510 (15.8%) were recorded before the media coverage peak and 2,714 (84.2%) after this. Most of reported cases were serious, p.272

, 3%) before the media coverage peak and 1,789 (65.9%) after the media coverage peak

, Median age of patients was similar in the two studied periods (37 years, pp.31-41

, Quantitative description of reporting for Mirena®, before and after the media peak Before the media coverage peak, 76.5% of case reports (390/510) were notified by health professionals

M. N. Beatty and P. D. Blumenthal, The levonorgestrel-releasing intrauterine system: Safety, efficacy, and patient acceptability, Ther Clin Risk Manag, vol.5, pp.561-74, 2009.

F. Santé-publique, , 2017.

J. Trussell, Contraceptive failure in the United States, Contraception, vol.83, pp.397-404, 2011.

B. Winner, J. F. Peipert, Q. Zhao, C. Buckel, T. Madden et al., Effectiveness of long-acting reversible contraception, N Engl J Med, vol.366, pp.1998-2007, 2012.

A. Stoddard, C. Mcnicholas, and J. F. Peipert, Efficacy and safety of long-acting reversible contraception, Drugs, vol.71, pp.969-80, 2011.

A. L. Nelson, LNG-IUS 12: a 19.5 levonorgestrel-releasing intrauterine system for prevention of pregnancy for up to five years, Expert Opin Drug Deliv, vol.14, pp.1131-1171, 2017.

C. Kailasam and D. Cahill, Review of the safety, efficacy and patient acceptability of the levonorgestrel-releasing intrauterine system, Patient Prefer Adherence, vol.2, pp.293-302, 2008.

K. Andersson, V. Odlind, and G. Rybo, Levonorgestrel-releasing and copper-releasing (Nova T) IUDs during five years of use: a randomized comparative trial, Contraception, vol.49, pp.56-72, 1994.

A. European-medicine, Pharmacovigilance Risk Assessment Committee (PRAC) Minutes of the meeting on 6-9, 2017.

, Une bombe dans l'utérus' : la mobilisation contre de nombreux effets secondaires du stérilet Mirena

N. Moore, M. Biour, G. Paux, E. Loupi, B. Begaud et al., Adverse drug reaction monitoring: doing it the French way, Lancet Lond Engl, vol.2, pp.1056-1064, 1985.

N. Moore, C. Noblet, C. Kreft-jais, G. Lagier, M. Ollagnier et al.,

, Therapie, vol.50, pp.557-62, 1995.

E. G. Brown, L. Wood, and S. Wood, The medical dictionary for regulatory activities (MedDRA), Drug Saf, vol.20, pp.109-126, 1999.

I. R. Edwards and J. K. Aronson, Adverse drug reactions: definitions, diagnosis, and management, Lancet, vol.356, pp.1255-1264, 2000.

, Agence nationale de sécurité du médicament et des produits de santé

C. Khouri, B. Revol, M. Lepelley, M. Mallaret, and J. Cracowski, Impact of the 'French Levothyrox crisis' on signal detection in the World Health Organization pharmacovigilance database, Pharmacoepidemiol Drug Saf, vol.27, pp.1427-1435, 2018.

P. Bosco-lévy, A. Gouverneur, C. Langlade, G. Miremont, and A. Pariente, Safety of levonorgestrel 52mg intrauterine system compared to copper intrauterine device: a population-based cohort study, Contraception, 2019.

J. Slattery, D. Morales, L. Pinheiro, and X. Kurz, Cohort Study of Psychiatric Adverse Events Following Exposure to Levonorgestrel-Containing Intrauterine Devices in UK General Practice, Drug Saf, vol.41, pp.951-959, 2018.

D. L. Eisenberg, C. A. Schreiber, D. K. Turok, S. B. Teal, C. L. Westhoff et al., Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system, Contraception, vol.92, pp.10-16, 2015.

A. Pariente, F. Gregoire, A. Fourrier-reglat, F. Haramburu, and N. Moore, Impact of safety alerts on measures of disproportionality in spontaneous reporting databases: the notoriety bias, Drug Saf, vol.30, pp.891-899, 2007.

, European Medicines Agency -News and Events -European Medicines Agency to review third-and fourth-generation combined oral contraceptives, 2018.

H. Angus-leppan and R. Liu, Weighing the risks of valproate in women who could become pregnant, BMJ, vol.361, p.1596, 2018.

F. Van-hunsel, A. Passier, and K. Van-grootheest, Comparing patients' and healthcare professionals' ADR reports after media attention: the broadcast of a Dutch television programme about the benefits and risks of statins as an example, Br J Clin Pharmacol, vol.67, pp.558-64, 2009.

P. Inácio, A. Cavaco, and M. Airaksinen, The value of patient reporting to the pharmacovigilance system: a systematic review, Br J Clin Pharmacol, vol.83, pp.227-273, 2017.

G. Bonaldo, A. Vaccheri, D. 'annibali, O. Motola, and D. , Safety profile of human papilloma virus vaccines: an analysis of the US Vaccine Adverse Event Reporting System from, Br J Clin Pharmacol, vol.85, pp.634-677, 2007.

T. Backman, S. Huhtala, R. Luoto, J. Tuominen, I. Rauramo et al., Advance information improves user satisfaction with the levonorgestrel intrauterine system, Obstet Gynecol, vol.99, pp.608-621, 2002.

, Vertige 15 (2,8) 584 (21,2)

T. Soc and . Préférentiel,

, Après le, vol.15, 2017.

C. Langlade, A. Gouverneur, P. Bosco-lévy, A. Gouraud, M. Pérault-pochat et al., Reports of adverse events with levonorgestrel-releasing IUD Mirena in France before and after the 2017 media intense coverage, Fundam Clin Pharmacol, vol.32, p.30, 2018.

C. Langlade, A. Gouverneur, P. Bosco-lévy, A. Gouraud, M. Pérault-pochat et al., Reports of adverse events with levonorgestrel-releasing IUD Mirena in France before and after the 2017 media intense coverage, Pharmacoepidemiology and Drug Safety, vol.27, p.608, 2018.

C. Langlade, A. Gouverneur, P. Bosco-lévy, A. Gouraud, M. Pérault-pochat et al., Reports of adverse events with levonorgestrel-releasing IUD Mirena in France before and after the 2017 media intense coverage, Drug Safety, vol.41, p.1227, 2018.