Events

Alerte De Sécurité sur Breast Implant Silicone Gel

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Silimed Industria de Implantes Ltda..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    A1510-469
  • Numéro de l'événement
    2007DM-0000800
  • Date
    2015-10-14
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=169
  • Notes / Alertes
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notes supplémentaires dans les données
  • Cause
    In response to the publication made by the official gazette of brazil on the 1st of october 2015, in which the national health surveillance agency (anvisa) in support with the secretariat of health sanitary vigilance of the state of rio de janeiro, ordered the suspension of the manufacture, commercialization and use of all the implants of the company silimed industria de implantes ltda based in rio de janeiro, due to the identification of breaches related to good manufacturing practices, which are related to the possible existence of some particles on the surface of breast implants in the same way, the national technosurveillance program has also received direct notification from anvisa confirming the sanitary measure, where it also mentions that the german certification body tüvsüd, announced the temporary suspension of the ec registration of the breast implants industry of the manufacturer silimedimplantes ltda yp the invima alerts as a precautionary measure, due to the high impact on public health that implantation can generate in potential users of a medical device with the described quality problems.

Device

Breast Implant Silicone Gel
  • Modèle / numéro de série
    All
  • Description du dispositif
    They are used in cases of augmentation, reconstitution or correction of the breasts, in cases of unilateral obilateral hypomastia; and reconstruction, providing a natural appearance after surgery.
  • Manufacturer
    Silimed Industria de Implantes Ltda.

Manufacturer

Silimed Industria de Implantes Ltda.