Events

Safety Alert for Cereform silicone gel-filled breast implants

According to Department of Health, this safety alert involved a device in Hong Kong 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
  • Date
    2014-02-24
  • Event Date Posted
    2014-02-24
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140224.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: cereplas cereform silicone gel-filled breast implants the australia therapeutic goods administration (tga) posted a medical device safety alert concerning cereform silicone gel-filled breast implants manufactured by cereplas. the tga was advised on 13 february 2014 that non-implanted cereform silicone gel-filled breast implants have been recalled in france after the french regulatory authority, agence nationale de sécurité du médicament et des produits de santé (ansm), found the sterilisation process used in the manufacture of these devices had not been fully validated in accordance with the most recent international standard. information from the ansm states that the french recall is being undertaken because of regulatory non-compliance. they have further stated that they have not identified a health risk associated with this issue. in australia, the tga has suspended further supply of these implants until it has finalized its investigation and determined that the implants are safe for use. tga has sought information from ansm and from the french manufacturer so that a decision about further supply of these implants can be made. for details, please refer to the following link:http://www.Tga.Gov.Au/safety/alerts-device-cereform-breast-implants-140221.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 24 february 2014.

Device

Cereform silicone gel-filled breast implants
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Cereplas Cereform silicone gel-filled breast implants
  • Manufacturer
    Cereplas

Manufacturer

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