Why are breast fillers not allowed in Singapore?

Doctor's Answers (1)

Dr Terence Goh
5.0

"Plastic Surgeon at AZATACA Plastic Surgery"

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 [1]. 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 [2].  

  1. Use of a non-permanent filler requires repeated invasive injections and this may cause inflammation in the breast tissue which may lead to an increased risk of breast cancer.
  2. The injection of a substance freely into the breast tissue results in a mobile product within the breast which can lead to problems such as nodule formation and also capsular contractures around these nodules which may require excision and problems in the future.
  3. The injection of HA fillers leading to nodules or inflammation may lead to difficulties in breast cancer screening during both physical examination and interpretation of breast scans which may cause delays in the diagnosis of breast disease.
  4. This may interfere with the early diagnosis of breast cancer which is a health priority.

Since April 2012, Macrolane has been withdrawn by its distributors from the worldwide breast augmentation market [3]

 

References

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

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