Field Safety Notices about Macrolane

Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, 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 Croatia.

Q-Med, the manufacturer has decided to discontinue the promotion of Macrolane for breast enhancement as it may interefere with the reading of mammograms. In those cases, additional ultrasound examinations are needed. Macrolane may sometimes in certain cases cause harmless lumps in brest, which results with unnecessary examinations and patient anxiety.
Macrolane is a non-permanent gel consisting of stabilised hyaluronic acid and it is intended for temporary augmentation, volume restauration and body contour shaping. The promotion of Macrolane is being discontinued for breast enhancement only due to the interference in radiology diagnostics. Macrolane is a safe product with regard to the fact that hyaluronic acid is a natural component of human tissues and is in certain time period degradable by natural processes.
Macrolane may be further on promoted for volume augmentation of other body surface parts, i.e. buttocks, calfs, breast in men etc., as well as for restauration and shaping of dammaged body contours, caused by soft tissue defects, i.e. lipoatrophy.
In Croatia, Macrolane is not widely used and it is implanted in only two patients, who will be informed by their doctors about the change in the use of this product. Proximun d.o.o., the registration holder has committed himself to inform all the users about this change. The change in the use of macrolane medical device will be included in the information leaflet and labelling of this product.