A medical device alert has been issued by the Medicines and Health Care Products Regulatory Agency in the UK concerning the use of Macrolane VRF20 and Macrolane VRF 30 which are injectable viscoelastic gels used as fillers for breast augmentation. The products are manufactured by Q-Med AB in Swedan. They have been used for many years as fillers to treat wrinkles.
Macrolane is usually injected below the mammary gland and above the pectoral muscle but in some patients the product is placed under the pectoral muscle in order to achieve good results. It is used for breast enhancement, volume, restoration and contouring of body surfaces.
The safety alert has been issued to breast and cosmetic surgeons and GP’s who have been warned about the use of Macrolane. The MHRA has recommended 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 that Macrolane is detectable in mammography, ultrasound examination and MRI examination of the breasts.
A clinical study indicates that the presence of Macrolane may significantly reduce the diagnostic quality of mammograms, since Macrolane will appear as a grey/white shadow in the mammogram. In this case ultrasound can be used as a complimentary examination.
Ultrasound can be used to diagnose lumps in the breast after a Macrolane treatment. Ultrasound may also be a compliment to mammography at breast screening and diagnosing. Some Radiologists complain that Macrolane has a typical appearance in an Ultrasound, Similar to that of water, but with a snow storm appearance. The product remains on the market for use elsewhere in the body.
Speaking about the latest Product Safety Alert Liam Moloney, Product liability Solicitor said today “the cosmetic Industry here is now regulated by the Irish Medicines Board and they should immediately instruct all Clinics and Plastic Surgeons who have used these products to notify their patients of this safety alert”.