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  1. Silicone gel breast implant adverse event reports to the Food and drug administration, 1984-1995.

    Article - En anglais

    Objectives

    To characterize the adverse event reports on silicone gel breast implants (SGBIs), ncluding death reports, submitted to tne Food and Drug Administration (FDA) from 1984 through 1995 and to analyze changes in the type and complexity of resorts following extensive medi a coverage of breast implants.

    Methods

    The authors analyzed mandatory and voluntary reports from the adverse events reporting system for medical devices at the FDA.

    Results

    In 1988, adverse event reports related to SGBIs accounted for 2.4% of the 14,473 mandatory reports entered into the FDA database on medical devices.

    In 1992.

    SGBI-related reports accounted for 30.3% of the total 66,476 mandatory reports of adverse events.

    The most frequently reported adverse event in 1988. before the widespread publicity on breast implants, was implant burst or rupture.

    In contrast, in 1992 the most frequently reported event was reaction, a term used to describe a range of adverse effects.

    Conclusions

    The numbers of mandatory and voluntary reports of SGBI-related adverse events increased exponentially, as did the complexity of the reports, following publicity over the lack of safety data on breast implants and a short voluntary moratorium on their sale.

    A significant proportion of reports lacked information on specific medical symptoms or diagnoses.

    Mots-clés Pascal : Glande mammaire, Implant, Siloxane polymère, Complication, Toxicité, Chirurgie, Traitement, Homme, Femelle, Article synthèse

    Mots-clés Pascal anglais : Mammary gland, Implant, Siloxane polymer, Complication, Toxicity, Surgery, Treatment, Human, Female, Review

    Logo du centre Notice produite par :
    Inist-CNRS - Institut de l'Information Scientifique et Technique

    Cote : 99-0058855

    Code Inist : 002B25K. Création : 31/05/1999.