Dáil Éireann Debate, Wednesday - 6 June 2012
964 Deputy Tom Fleming asked the Minister for Health his views on the filter product macrolane that has been found to interfere with the diagnosis of breast cancer; if all the women treated with this product have been contacted; and if he will make a statement on the matter. [27275/12]
Amharc ar fhreagraMacrolane (containing hyaluronic acid) is a product which is administered by injection in medical and aesthetic procedures to augment body contours and correct body defects.
Breast augmentation procedures, including those involving Macrolane, may interfere with breast diagnostic imaging, particularly mammography. This interference is widely published and known by the relevant healthcare professionals. Women who previously underwent a procedure with Macrolane would have been advised by clinics before their procedure as part of the consent process of the potential for the product to interfere with the reading of mammograms.
Macrolane was withdrawn from use in breast augmentation by the manufacturer, Q-Med in April 2012 due to a lack of consensus among radiologists regarding examination of breasts treated with injectable products. The Irish Medicines Board has written to Irish clinics using the product and to Irish radiologists via the Royal College of Surgeons, Faculty of Radiology. In addition, clinics have been asked by the Irish Medicines Board to remind women of the potential problems which may arise with the interpretation of mammogram images and the importance of informing healthcare professionals of previous Macrolane treatment before they have any breast assessment carried out. Clinics are in the process of advising women in writing or reminding them of this issue at their next consultation.
