{ "texte_version": { "JORFTEXT000000378993": { "META": { "META_SPEC": { "META_TEXTE_VERSION": { "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000339724", "#text": "Directive Européenne n°93-42 du 14 juin 1993", "@sens": "source", "@cidtexte": "JORFTEXT000000339724", "@nortexte": "393L0042", "@numtexte": "93-42", "@typelien": "APPLICATION", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "1993-06-14" } ] }, "TITRE": "Décision du 26 mai 1999", "MCS_TXT": { "MC": [ "EMPLOI", "SOLIDARITE", "SANTE PUBLIQUE", "SECURITE DE LA PERSONNE", "PRODUIT DANGEREUX", "PROTHESE MAMMAIRE", "PROTHESE MAMMAIRE INTERNE", "IMPLANTATION", "IMPLANT", "COMMERCIALISATION", "MISE SUR LE MARCHE", "PRODUIT CHIMIQUE", "FABRICATION", "EXPORTATION", "IMPORTATION", "PROTECTION DU CONSOMMATEUR", "INTERDICTION", "SUSPENSION", "TRANSPOSITION DE DIRECTIVE CE", "RAPPROCHEMENT DE LEGISLATION", "HARMONISATION EUROPEENNE" ] }, "MINISTERE": "MINISTERE DE L'EMPLOI ET DE LA SOLIDARITE", "TITREFULL": "Décision du 26 mai 1999 portant suspension de mise sur le marché et d'utilisation de dispositifs médicaux implantables à visée esthétique" }, "META_TEXTE_CHRONICLE": { "CID": "JORFTEXT000000378993", "NOR": "MESM9921620S", "DATE_PUBLI": "1999-06-01", "DATE_TEXTE": "1999-05-26", "ORIGINE_PUBLI": "JORF n°124 du 1 juin 1999", "PAGE_DEB_PUBLI": 8033, "PAGE_FIN_PUBLI": 8033 } }, "META_COMMUN": { "ID": "JORFTEXT000000378993", "URL": "texte/version/JORF/TEXT/00/00/00/37/89/JORFTEXT000000378993.xml", "NATURE": "DECISION", "ORIGINE": "JORF", "ANCIEN_ID": "1SX9990601P4" } }, "VISAS": { "CONTENU": "

Le directeur général de l'Agence française de sécurité sanitaire des produits de santé,

Vu la directive 93/42/CE du Conseil du 14 juin 1993 relative aux dispositifs médicaux, modifiée par la directive 98/79/CE du Parlement européen et du Conseil du 27 octobre 1998 relative aux dispositifs de diagnostic in vitro, et notamment son article 14 ter ;

Vu les livres II bis, V bis et VIII du code de la santé publique, et notamment ses articles L. 209-12, R. 665-25, L. 793-5 ;

Considérant que les prothèses mammaires internes et autres implants à visée esthétique, préremplis d'autre produit que le sérum physiologique, exposent notamment à un risque de rupture de l'enveloppe et de diffusion du produit de remplissage pouvant conduire à la survenue de complications et d'effets secondaires indésirables ;

Considérant que ces injections percutanées de silicone à visée esthétique peuvent conduire à la survenue de complications notamment locorégionales ;

Considérant que ces complications et effets sont susceptibles de compromettre gravement la santé des personnes chez lesquelles de tels produits sont utilisés ;

Considérant que les risques résiduels liés à l'utilisation de ces implants doivent être acceptables au regard des bénéfices escomptés ;

Considérant qu'il n'existe pas de norme européenne pour les prothèses mammaires internes et autres implants à visée esthétique,

Décide :

" }, "SIGNATAIRES": { "CONTENU": "

Fait à Paris, le 26 mai 1999.

P. Duneton

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"MESH9821712V", "@typelien": "APPLICATION", "@naturetexte": "AVISEURO", "@datesignatexte": "1998-05-15" }, { "@id": "JORFTEXT000000330573", "#text": "du 28 mai 1998", "@sens": "cible", "@cidtexte": "JORFTEXT000000330573", "@nortexte": "MESH9821713V", "@typelien": "APPLICATION", "@naturetexte": "AVISEURO", "@datesignatexte": "1998-05-28" }, { "@id": "JORFTEXT000000887726", "#text": "Directive Européenne n°98-79 du 27 octobre 1998", "@sens": "cible", "@cidtexte": "JORFTEXT000000887726", "@nortexte": "31998L0079", "@numtexte": "98-79", "@typelien": "MODIFIE", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "1998-10-27" }, { "@id": "JORFTEXT000000378993", "#text": "DECISION", "@sens": "cible", "@cidtexte": "JORFTEXT000000378993", "@nortexte": "MESM9921620S", "@typelien": "APPLICATION", "@naturetexte": "DECISION", "@datesignatexte": "1999-05-26" }, { "@id": "JORFTEXT000000330630", "#text": "Directive Européenne n°2000-70 du 16 novembre 2000", "@sens": "cible", "@cidtexte": 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