[Preliminary results from the OPNI observatory: long-term follow-up of a cohort of women using the progestagen contraceptive implant Implanon].

Gynecol Obstet Fertil

Service de gynécologie-obstétrique, institut Mère-Enfant Alix-de-Champagne, CHRU, 45, rue Cognacq-Jay, 51092 Reims, France.

Published: May 2005

Objective: Describe the initiation and follow-up of Implanon insertion in current office-based practice in France and estimate the rate and causes of early removals.

Patients And Methods: A prospective cohort study of 1000 women having been inserted with Implanon by a representative national sample of prescribers (gynaecologists and general practitioners) was designed. The follow-up period was 3 years and the enrolment was planned for 2 years starting July 2002 according to a naturalistic design.

Results: The results are related to an intermediate analysis describing the situation of the cohort at the date 31 December 2003. 872 women were enrolled, of whom 784 (89.9%) by gynaecologists and 88 (10.1%) by GPs. Implanon was inserted in 691 (79.2%) and 360 (52.1%) had at least one follow-up visit at this date. The mean follow-up period after insertion was 10.5 months. 38 early removals were recorded (actuarial rate at 16 months of 8.8% [CI 95% 5.0-12.7]), integrating the distribution of follow-up duration and the assumption that women with no follow-up visit the still had device.

Discussion And Conclusion: The estimated early removal rate was lower than the result of the meta-analysis of international clinical trials but this figure should be confirmed in the final analysis of the study.

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http://dx.doi.org/10.1016/j.gyobfe.2005.03.022DOI Listing

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