title: [Safety profile of etonogestrel contraceptive implant (Nexplanon®and Implanon®) reported in France].
abstract: OBJECTIVE
  The aim of the study was to assess the incidence of adverse effects (AE) reported with etonogestrel contraceptive implant in France (Implanon®and Nexplanon®).
  
  
  METHODS
  All cases of AE or unintended pregnancies reported to health authorities or to the firm were analyzed.
  
  
  RESULTS
  During 10 years, 5433 AE and 789 unintended pregnancies were reported. Only 388 (7 %) were serious. There were 1137 reports of difficulties to remove, failure to locate or migration, 430 of insertion difficulties and 203 of deformation or expulsion of the implant. Among other AE, the most common were 1694 gynecological AE, 524 skin reactions and 437 metabolic AE. Since the marketing of Nexplanon®which causes less deep insertions, the incidence of migrations, removal or insertion difficulties has decreased overall (0.92 vs. 1.31/1000 patients), particularly the incidence of removal difficulties, location failures or migrations (0.12 vs 1.01/1000). The infrequent but serious AE were infectious complications at the implant site and pregnancies. When the circumstances of the pregnancy were known, the contraceptive failure was due to the apparent inefficiency of the implant (n=224), to a technique failure (n=203) or to a drug-drug interaction (n=59).
  
  
  CONCLUSIONS
  This study confirms that AE of this implant are frequent but not serious, except for the pregnancies. The incidence of complications related to insertion decreased with Nexplanon®. Among other preventable AE, unintended pregnancies due to a drug-drug interaction would require to be better known by the practitioner.
authors.affiliation: Service de pharmacologie, centre régional de pharmacovigilance, de pharmacoépidémiologie et d'information sur le médicament, CHRU, 2, boulevard Tonnellé, 37044 Tours cedex 9, France.
authors.forename: C
authors.initials: C
authors.lastname: Simon
authors.affiliation: Service de pharmacologie, centre régional de pharmacovigilance, de pharmacoépidémiologie et d'information sur le médicament, CHRU, 2, boulevard Tonnellé, 37044 Tours cedex 9, France.
authors.forename: M S
authors.initials: MS
authors.lastname: Agier
authors.affiliation: Service de pharmacologie, centre régional de pharmacovigilance, CHRU de Lille, 59045 Lille, France.
authors.forename: J
authors.initials: J
authors.lastname: Béné
authors.affiliation: Centre régional de pharmacovigilance, hôpital Civil, 67091 Strasbourg, France.
authors.forename: C
authors.initials: C
authors.lastname: Muller
authors.affiliation: Service de pharmacologie, centre régional de pharmacovigilance, de pharmacoépidémiologie et d'information sur le médicament, CHRU, 2, boulevard Tonnellé, 37044 Tours cedex 9, France.
authors.forename: L
authors.initials: L
authors.lastname: Vrignaud
authors.affiliation: Service de gynécologie, CHRU, 2, boulevard Tonnellé, 37044 Tours cedex 9, France; Université François-Rabelais, 37032 Tours, France.
authors.forename: H
authors.initials: H
authors.lastname: Marret
authors.affiliation: Service de pharmacologie, centre régional de pharmacovigilance, de pharmacoépidémiologie et d'information sur le médicament, CHRU, 2, boulevard Tonnellé, 37044 Tours cedex 9, France. Electronic address: jonville-bera@chu-tours.fr.
authors.forename: A P
authors.initials: AP
authors.lastname: Jonville-Bera
mesh_terms: D000328:Adult; D003271:Contraceptive Agents, Female / Q000009:adverse effects*; D017135:Desogestrel / Q000009:adverse effects*; D020878:Device Removal / Q000706:statistics & numerical data*; D004343:Drug Implants / Q000009:adverse effects*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D058736:Intrauterine Device Migration; D011247:Pregnancy; D049168:Pregnancy, Unplanned
chemical_list: D003271:Contraceptive Agents, Female; D004343:Drug Implants; C044815:etonogestrel; D017135:Desogestrel
keywords: Adverse effects; Effets indésirables; Etonogestrel; Implant; Étonogestrel