Events

Safety Alert for breast implant monobloc silicone

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

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
    R1604-164
  • Event Number
    2008DM-0002042
  • Date
    2016-04-20
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=145
  • 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 attention to the publication made by the health agencyanvisa, through which informs that as of monday, april 18, 2016, it suspended the importation, distribution, sale and implantation of the mandatory prostheses marcaarion, texturized - type 4, manufactured by the laboratoires arion french company, the measure was published in the official gazette (dou), under resolution 987 / 2016.1it was also suspended the authorization for the use of the certificate of conformity, issued by the bauer falcon institute of quality (ifbq), because the product is not complies with the quality requirements established by this certifying organism. invima warns 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 monobloc silicone
  • Model / Serial
    Textured - Type 4, all lots.
  • Product Description
    For aesthetic reconstructive surgery and in cases of augmentation mammoplasty.
  • Manufacturer
    Laboratoires Arion

Manufacturer

Laboratoires Arion