Events

Field Safety Notices about Breast implants

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Silimed.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2015-09-21
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    During an audit on our manufacturing procedures, a potential source of particles was identified. literature analysis and acceptance criteria for the presence of particles were conducted and support reasonable evidence that the identified particles show low risk. it is important to note that no incident has occurred and our constant, long-term post market surveillance has shown no alarming data. however, during this evaluation, possible ameliorations of manufacturing processes were identified, allowing silimed to lower the risk factor even further.

Device

Breast implants
  • Model / Serial
  • Manufacturer
    Silimed

Manufacturer

Silimed