Medical Device Alert: Macrolane™Dermal Filler For Breast Augmentation

In short

UK MHRA has issued a Medical Device Alert(MDA) concerning the use of Q-Med’s Macrolane Dermal Filler for breast augmentation on the basis that the presence of this filler can complicate diagnosis of breast cancer by mammography. The manufacturer, Swedish company Q-Med AB has stopped indicating the product for breast augmentation and issued a Dear Doctor letter earlier this month to this effect.

The MHRA Alert can be found here.

The Dear Doctor letter can be found here.

Background

The MDA states that there is no association with cancer and no safety concerns have been identified for this product. However it points out that 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, for which reason healthcare providers are asked to have procedures in place for radiographers to check with patients presenting for breast examination for any history of breast injection.

Staff are directed to request the card that the patient was given at the time of injection, identifying Macrolane as the product used, and pass it on to the examining radiologist.

GPs are warned that women may present with concerns that the injected Macrolane has affected mammogram results, so they may wish to consider referral for repeat imaging.

The manufacturer plans to issue updated instructions for use in due course with updated indications for Macrolane use.

Source: MHRA