Q-Med has decided to discontinue the breast indication for Macrolane until consensus for best practices in breast radiology examination following Macrolane treatment has been reached.
April 17, 2012 (Uppsala, Sweden) - Macrolane is a safe and well-tolerated injectable product used to augment body contour and correct soft tissue defects. Introduced in 2008, it has improved the quality of life of thousands of patients in indications ranging from HIV-related lipoatrophy to breast augmentation. A safety reporting system has been in place since launch and no safety concerns have been identified. However, all breast augmentation procedures, including those involving Macrolane, can interfere with the reading of mammograms.
At present, there is a lack of consensus amongst radiologists regarding radiology examination of breasts treated with Macrolane. After reviewing the current situation and in consultation with the regulatory authorities, Q-Med has therefore decided to discontinue the indication until consensus for best practices in breast radiology examination following Macrolane treatment has been reached.