Events

Alerta De Seguridad para Breast Implant Silicone Gel

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Silimed Industria de Implantes Ltda..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    A1510-469
  • Número del evento
    2007DM-0000800
  • Fecha
    2015-10-14
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=169
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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
  • Modelo / Serial
    All
  • Descripción del producto
    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.