Doctor's Answers (1)
The minimal invasive injection of breast fillers was an attractive alternative to permanent breast implants for many women. This is performed under local anaesthesia, and patients do not require hospitalisation or have long recovery times. However, there have been many breast fillers in the past and they have been associated with high complication rates. Non-absorbent permanent breast fillers such as silicone oil injections and polyacrylamide hydrogel (Ao Mei Ding) form permanent nodules or lumps which are difficult to remove and results in deformation of the breasts and scarring. I have personally treated quite a few of these patients post-injection and some even require mastectomies and reconstruction for treatment of the problem.
When hyaluronic acid gels (non-permanent fillers) such as Macrolane were introduced, there was much excitement that a minimally invasive and safe solution was available. However, this was not the case. Macrolane is a highly cross-linked HA (hyaluronic acid) gel marketed by Q-Med in the early 2008 period. It was used as a body-contour filler and the cross-linkages helped to slow its absorption into the body. Studies have shown that Macrolane remains in the breast for up to 18 months. However, this can also leave long-lasting residues.
Studies have shown that Macrolane complications appear months after treatment. These include nodules, product migration, breast inflammation and breast infections . Despite being absorbable the Macrolane nodules may develop a capsule around it and may not completely resorb.
In 2011, the French AFSSAPS (equivalent of the USA FDA), decided that it would no longer approve Macrolane for breast augmentation based on the following reasons .
Since April 2012, Macrolane has been withdrawn by its distributors from the worldwide breast augmentation market .
1. H Ishii et al. Complications and management of breast enhancement using hyaluronic acid . Plast Surg 2014;22(3):171-174.
2. Chaput B et al. Macrolane is no longer allowed in aesthetic breast augmentation in France. Will this decision extend to the rest of the world? JPRAS April 2012; 65(4):527-528.
3. T. Sibert et al. The latest information on Macrolane™: Its indications and restrictions. Annales de chirurgie plastique esthétique Dec 2013; 59(2): e1-e11