Events

Safety Alert for injectable dermal filler, Macrolane for breast augmentation

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Q-MED.

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
    2012-04-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120423d.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
    Medical Device Safety Alert
  • Reason
    Mhra issues updates on the use of injectable dermal filler, macrolane for breast augmentation the medicines and healthcare products regulatory agency (mhra), united kingdom has issued updated information about macrolane, an injectable dermal filler manufactured by q-med. q-med has decided to discontinue macrolane for use in breast augmentation as the product may interfere with the reading of mammograms and could make diagnosis more difficult. people who have undergone breast augmentation with macrolane should inform the healthcare professional conducting their breast examination of the date of their last macrolane treatment prior to the assessment. according to the manufacturer and the mhra, there are no safety concerns with the product and the product can still be used in its other indications. according to the local supplier, the affected products have been distributed in hong kong. for details, please visit the mhra website: http://www.Mhra.Gov.Uk/newscentre/con149797 if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

injectable dermal filler, Macrolane for breast augmentation
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: [23 Apr 2012] MHRA issues updates on the use of injectable dermal filler, Macrolane for breast augmentation
  • Manufacturer
    Q-MED

Manufacturer

Q-MED