LETTER

http://dx.doi.org/10.14730/aaps.2016.22.1.45
Arch Aesthetic Plast Surg 2016;22(1):45-46
pISSN: 2234-0831 eISSN: 2288-9337

aaps
Archives ofAesthetic Plastic Surgery

Position Statement of Korean Academic Society of
Aesthetic and Reconstructive Breast Surgery: Concerning
the Use of Aquafilling® for Breast Augmentation
Tai Suk Roh
President, Korean Academic Society of Aesthetic and Reconstructive Breast Surgery
Department of Plastic and Reconstructive Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea

In the article entitled ‘Correcting shape and size using temporary
filler after breast augmentation with silicone implants’ published atOctober 2015 of the Archives of Aesthetic Plastic Surgery, Shin etal. [1] states that ‘Aquafilling® is a new option for the correction ofminor problems after breast augmentation surgery with implants’.
According to the article, Aquafilling® is composed of 98% of water and 2% of copolyamide. However, In the document submitted
to Korean Food and Drug Administration (KFDA), the exact ingredient of Aquafilling® is 2% of poly (acrylamide-co-N,Nʹ-methy­lene-bisacrylamide) and 98% of sodium chloride solution 0.9%.
Historically, there have been many attempts to augment breasts
using injectable materials including paraffin, liquid silicone, polyacrylamide gel (PAAG) and so on [2]. Up-to-date, all materials resulted in some form of complications such as chronic inflammation, lumps due to foreign body granulomas and even skin ulcerations. For these reasons, U. S. Food and Drug Administration (FDA)
unapproved use of fillers for breast augmentation [3].
There have been numerous reports that augmentation mammoplasty with PAAG filler injection results in serious adverse complications [2,4-6]. Specifically, it can result in local and systemic fever,breast swelling, redness, nipple bulging, tenderness and pain, asymmetry, deformity and even loss of ability for breastfeeding [7-9].
Although Shin et al. described that it is different from the previous
Received: Feb 11, 2016 Revised: Feb 14, 2016 Accepted: Feb 15, 2016
Correspondence: Tai Suk Roh Department of Plastic and Reconstructive
Surgery, Gangnam Severance Hospital, Yonsei University College ofMedicine, 211 Eonju-ro, Gangnam-gu, Seoul 06273, Korea.
E-mail: rohts@yuhs.ac
Copyright © 2016 The Korean Society for Aesthetic Plastic Surgery.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/)
which permits unrestricted non-commercial use, distribution, and reproduction in any
medium, provided the original work is properly cited. www.e-aaps.org

problematic PAAG fillers such as Amazing Gel or Aquamid, themajor component of Aquafilling® is polyacrylamide in itself, nodifferent from the existing fillers that have been commercially available. Furthermore, explanations in regards to how the same chemical constituents can be altered by some changes in the physical properties such as bonding reaction, are obscure if not totally lacking inevidence.
In this regard, members of the Korean Academic Society of Aesthetic and Reconstructive Breast Surgery express serious concerns
over the use of Aquafilling® for breast augmentation, more so considering the short six months follow up from initial procedures.
There have been previous reports that in the early period of PAAGuse, it is well tolerated to breast, and migration resistant [10]. However, this report has become totally out of date and, unacceptable
and abandoned at present. Especially, considering the late onset ofserious complications after PAAG injection to breast, it is too hasty
conclusion that Aquafilling® is new option for correction of unfavorably resulted augmentation mammoplasty.
KFDA only permitted the use of Aquafilling® for temporary improvement of facial wrinkle, asymmetry and shape and volume oflip. Not abiding by the permitted use as in augmentation of breasts
requires much more volume, leading to potential complication andpatients suffering where treatment is not easy [4]. Many cases ofbreast deformity after Aquafilling® injection is irreversible and evenrequires breast reconstruction [4].
The Korean Academic Society of Aesthetic and Reconstructive
Breast Surgeons obviously opposes the use of Aquafilling® for breast
augmentation until sufficient evidences of long term safety are accumulated, and verified. We also caution against commercial utilization of the unapproved filler relying on the preliminary report by
Shin et al. More strict regulations must be applied in the human useof new or unproven injectable fillers. Only the highest standards of
medical ethics can insure the health of our patients.

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Archives ofAesthetic Plastic Surgery

REFERENCES
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3. U S Food and Drug Administration. Soft tissue fillers: Dermal fillers.
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productsandmedicalprocedures/cosmeticdevices/wrinklefillers/default.htm.
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