Events

Safety Alert for Mentor Breast Implants

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Mentor Medical System B.V. || Mentor || Perouse Plastie.

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
    R1709-422
  • Event Number
    2011DM-0007151
  • Date
    2017-09-13
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=72
  • 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
    The manufacturer reports that it has been able to identify that the labeling of the product does not correspond to the label engraved by the medical device, the latter is the precise description of the product, leading to possible confusions and delays in the procedures.

Device

Mentor Breast Implants
  • Model / Serial
    354-5350, 354-5240, lots 7464368, 7464364
  • Product Description
    Cosmetic enhancement, immediate or delayed breast reconstruction after mastectomy, reconstruction after treatment of breast cancer to mastectomy, revision due to complications or other undesirable results of a previous mastectomy intervention or other treatments other than mastectomy, post-traumatic reconstruction defined as total or partial removal of one or both breasts by means of a surgical intervention (for any reason or as a consequence of the trauma itself).
  • Manufacturer
    Mentor Medical System B.V. || Mentor || Perouse Plastie

Manufacturer

Mentor Medical System B.V. || Mentor || Perouse Plastie