Events

Retiro De Equipo (Recall) de Breast implants pre-filled with silicone gel

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por POLY IMPLANT PROTHESE.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • Fecha
    2010-03-30
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-des-implants-mammaires-pre-remplis-de-gel-de-silicone-fabriques-par-la-societe-poly-implant-prothese
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
  • Notas adicionales en la data
  • Acción
    Afssaps, on 30/03/2010, informed the health institutions and surgeons who implanted breast prostheses pre-filled with silicone gel manufactured by the company POLY IMPLANT PROTHESE the decision made by the Director General of the Afssaps concerning the withdrawal and suspension of the placing on the market, the distribution, the export and the use of these devices. The health facilities and surgeons concerned, in France, received the enclosed mail (30/03/2010) (48 KB). The competent European authorities have been informed of this measure by Afssaps. Read more. Animal health policy decision (30/03/2010) (65 KB) Communiqué: Poly Implant Prothes silicone gel breast implants Questions / Answers (15/04/2011) (72 kb Press morning of 30 March 2010

Device

Breast implants pre-filled with silicone gel

Manufacturer

POLY IMPLANT PROTHESE