Events

Safety Alert for silicone-filled breast implants

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Poly Implant Prothese.

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
    2010-03-31
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20100401.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
    Press release
  • Reason
    Recall of silicone-filled breast implants the department of health (dh), through its routine surveillance today (march 31), found that a french regulatory authority has announced a recall of the silicone-filled breast implants manufactured by poly implant prothese (pip). the affected models include imghc-tx, imghc-mx and imghc-ls. there is an increase of reported adverse events concerning the problematic products in the past three years. they are mainly breakings and local complications. despite the fact that the products are not listed with dh, the department considered that there may be quality defects and safety concerns of the products after risk assessment. dh decided to inform stakeholders including hospital authority, hospitals and medical professional association about the recall. information on the recall has been posted on the dh's website. members of the public who have implanted with the affected products, or in case of doubt, should consult their doctors. the dh has not received any report of adverse events arising from the affected products. the department will closely monitor the developments of the recall. ends/wednesday, march 31, 2010.

Device

silicone-filled breast implants
  • Model / Serial
  • Product Description
    Press release: Recall of silicone-filled breast implants
  • Manufacturer
    Poly Implant Prothese

Manufacturer

Poly Implant Prothese