Events

Field Safety Notices about Female breast implants, male pectoral implants, gluteal implants, pelvic, bariatric surgery devices, urology devices

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
    2015-09-24
  • 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 the audit of the production processes at silimed, the notified body tüv süd found the presence of particles on the surface of some breast implants. in order to prevent the possibility of the transfer of particles to the surface of the implants, a corrective action was immediately taken in the manufacturing process of silimed women's breast implants. however, these measures have not completely eliminated the problem, so tüv süd has decided to withdraw the ec certificate by 17 december 2015.

Device

Female breast implants, male pectoral implants, gluteal implants, pelvic, bariatric surgery devic...
  • Model / Serial
  • Manufacturer
    Silimed

Manufacturer

Silimed