Events

Safety Alert for Breast Implant Silicone Gel

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Silimed Industria de Implantes Ltda..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    A1510-469
  • Event Number
    2007DM-0000800
  • Date
    2015-10-14
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=169
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    All
  • Product Description
    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.