Macrolane™ Volume Restoration Factor (VRF) dermal filler for breast augmentation 를 위한 안전성 경고 / 현장 안전성 서한

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.

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.