Events

Safety Alert Or Field Safety Notices for Macrolane™ Volume Restoration Factor (VRF) dermal filler for breast augmentation

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Q-Med AB - a Galderma division.

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
    Safety alert / Field Safety Notice
  • Event Number
    MDA/2012/022
  • Date
    2012-04-25
  • Event Date Posted
    2014-12-17
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-macrolane-volume-restoration-factor-vrf-dermal-filler-for-breast-augmentation-diagnosis-of-breast-cancer-difficult-in-some-cases
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
    Use of Macrolane VRF20 and Macrolane VRF30 for breast augmentation can make diagnosis of breast cancer more difficult, particularly with the use of mammography.The MHRA has been made aware of a Dear Doctor Letter (160Kb) issued in April 2012 to clinicians by Q-Med about the use of Macrolane recommending that it is not used for injection into breasts because it can make diagnosis of breast cancer more difficult, particularly during mammography.The manufacturer has stated:
    ‘Macrolane is detectable in mammography, ultrasound examination and MRI examination of the breasts.Mammograms
    A clinical study indicates that the presence of Macrolane may significantly reduce the diagnostic quality of mammograms, since Macrolane will appear as a gray/white shadow in the mammogram. In this case ultrasound can be used as a complementary examination.Ultrasound
    Ultrasound can be used to diagnose lumps in the breast after a Macrolane treatment. Ultrasound may also be a complement to mammography at breast screening and diagnosing. Some radiologists explain that Macrolane has a typical appearance in an ultrasound, similar to that of water, but with a snowstorm appearance.’Breast diagnostics and MarolaneThere is no association with cancer and no safety concerns have been identified for this product. The product remains on the market for use elsewhere in the body.  The manufacturer plans to issue updated instructions for use in due course with updated indications for Macrolane use.
  • Reason
    (q-med ab - a galderma division) problem with use of macrolane vrf20 and macrolane vrf30 for breast augmentation which can make diagnosis of breast cancer more difficult. (mda/2012/022).
  • Action
    Do not use Macrolane for breast augmentation.Have procedures in place for radiographers to check with patients presenting for breast examination for any history of breast injection.  Staff should request the card (appendix 1) that the patient was given at the time of injection, identifying Macrolane as the product used, and pass it on to the examining radiologist.Women may present with concerns that the injected Macrolane has affected mammogram results. GPs may wish to consider referral for repeat imaging.

Device

Macrolane™ Volume Restoration Factor (VRF) dermal filler for breast augmentation
  • Model / Serial
  • Product Description
    Dermal filler for breast augmentation.Macrolane™ Volume Restoration Factor (VRF).Manufactured by Q-Med AB (a Galderma division).Macrolane VRF20 and VRF30 is an injectable filler for volume restoration and body contouring in a range of indications including breast augmentation.
  • Manufacturer
    Q-Med AB - a Galderma division

Manufacturer

Q-Med AB - a Galderma division
  • Manufacturer Address
    David Wall Director of Sales & Marketing, Q-Med, OTC & Ireland Galderma UK & Ireland Meridien House 69-71 Clarendon Road Watford WD17 1DS Tel: 01923 208 950 Fax: 01923 208 998Email: David.wall@galderma.com
  • Manufacturer Parent Company (2017)
    Nestlé S.A.
  • Source
    MHRA