Important Safety Alerts

Important Safety Alerts

MHRA issues updates on the use of injectable dermal filler, Macrolane for breast augmentation

23 Apr 2012

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.

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