Events

Safety Alert for breast prostheses filled with reticulated silicone gel

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

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
    R1402-87
  • Event Number
    INVIMA 2008DM-0001821
  • Date
    2014-02-24
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=208
  • 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
    Affirms that the health agency of france (ansm) found that the sterilization processes used in the manufacture of this device have not been fully validated in accordance with international regulations for which you must suspend the marketing and use of them until the investigation determines that they are safe for its use or sedecida the definitive withdrawal of the product from the market, additionally states that have not yet been identified health risks associated with the implanted prostheses.

Device

breast prostheses filled with reticulated silicone gel
  • Model / Serial
  • Product Description
    It is used in aesthetic, reconstructive or reconstructive surgeries such as: breast reconstruction after a mastectomy, breast augmentation for esthetic purposes, correction of the breasts by various congenital or acquired anomalies: dissymmetry, amasthesis, aplasia, hypomastia, hypoplasia; replacement of an old or defective implant after its removal.
  • Manufacturer
    Cereplas

Manufacturer

Cereplas
  • Manufacturer Parent Company (2017)
    Cereplas
  • Source
    NIDFSINVIMA