Complications

Aquafilling Breast Filler: What the Evidence Shows

UNE Plastic Surgery · Dr. Kim Uigeon, board-certified plastic surgeon · Published 2026-09-29 · Updated 2026-09-29

“I had aquafilling and have no symptoms — do I still need a scan?” is a common question, and there was little tissue-level data to answer it — until a study looked. To answer plainly: no symptoms does not mean no inflammation. In the reported series, a woman with no complaints for three years still showed active inflammation in the tissue, and the filler had worked its way into the pectoralis muscle. This article covers what aquafilling is, what the tissue analysis found, why it is hard to remove completely, the larger reports, and the verified options. Injectable volume augmentation of the breast is not recommended internationally, and it is not offered at UNE. Every clinical figure is linked to a cited study.

1. The injectable called aquafilling

Aquafilling is a soft-tissue filler launched by the Czech company BIOTRH in 2005 — a hydrophilic gel of about 98% saline and 2% polyacrylamide (per Korean regulatory analysis; the maker labels it polyamide). Its original use was facial and gluteal soft-tissue filling, later extended off-label to breast enlargement. It is used in the EU, Malaysia, Korea, Serbia, and Türkiye, and has never been approved by the U.S. FDA as a breast filler. Reported adverse effects include breast pain, deformity, glandular inflammation, abscess, fistula, breastfeeding difficulty, and filler migration — to the neck, chest wall, abdominal cavity, axilla, pelvis, and labia.

2. What the tissue analysis found

A study analysed the removed tissue of four women who had aquafilling complications, with histopathology and immunohistochemistry for CD3 (T cells), CD20 (B cells), and CD68 (macrophages) (Chalcarz & Żurawski, Aesthetic Plast Surg, 2021).[1] All four had filler that had penetrated into the pectoralis major, with fibrosis, partial hyalinisation, thickened vessel walls, and monocyte infiltration alongside CD3/CD20/CD68 expression — inflammation in progress. The most telling case was Patient 1, who had no symptoms at all for three years: her blood tests were normal, yet the tissue clearly showed B cells and macrophages — at a lower level than the symptomatic patients, but present. Absence of symptoms did not mean absence of a reaction.

3. Why it is hard to remove completely

“Just remove it” is where this procedure is hardest. In all four cases the filler had entered the pectoralis major, and the authors noted they had explained before surgery that complete removal would be difficult: filler mixed into muscle cannot be fully extracted without significant muscle damage. So in practice, as much as possible is removed and the remainder is re-assessed by MRI at six months — it may not end in one operation.

4. The larger reports

Four cases are a clear limitation, but reports point the same way. A Korean team analysed 146 patients who had aquafilling removal: complications took a mean of 38.5 months to appear, a mean 285.5 ml was removed per side, and the commonest problems were induration or mass (83.6%), then pain (52.1%), hardening (24.7%), asymmetry (10.3%), migration (8.2%), and mastitis (6.8%), with one case of sepsis (Namgoong et al., Aesthetic Plast Surg, 2020).[2] A Japanese team analysed the material itself by NMR and found the same properties as polyacrylamide gel (PAAG), which has been restricted in several countries; among 29 patients they saw breast deformity in 17, injection-site infection or glandular inflammation in 8, induration in 5, and migration as far as the back or vulva in 4 (Nomoto et al., Plast Reconstr Surg Glob Open, 2021).[3] The key point across all three: problems often surface around three years after injection, not right away.

5. The verified options

What, then, to use? The methods with confirmed safety and long-term data are silicone implants, saline implants, and autologous fat grafting. Each has its own complications, but they differ from aquafilling in one way: they went through FDA, CE, or regulatory approval, and their removal and revision are standardised. A distinction worth holding: aquafilling is approved in Korea as a device for facial and soft-tissue augmentation, and breast enlargement is not within that approval; the U.S. FDA has no approved injectable filler for breast enlargement and has issued safety warnings against filling large areas like the breast or buttocks. “An approved product” and “a product you may use in the breast” are entirely different statements. Building volume by injection is not recommended internationally, and it is not recommended here.

Summary

References

  1. Chalcarz M, Żurawski J. Injection of aquafilling for breast augmentation causes inflammatory responses independent of visible symptoms. Aesthetic Plast Surg. 2021;45(2):481–490. doi:10.1007/s00266-020-01966-x.
  2. Namgoong S, Kim HK, Hwang Y, et al. Clinical experience with treatment of aquafilling filler-associated complications: a retrospective study of 146 cases. Aesthetic Plast Surg. 2020;44(6):1997–2007. doi:10.1007/s00266-020-01935-4.
  3. Nomoto S, Hirakawa K, Ogawa R. Safety of copolyamide filler injection for breast augmentation. Plast Reconstr Surg Glob Open. 2021;9(2):e3296. doi:10.1097/GOX.0000000000003296.

Medical disclaimer. This article is general information and does not constitute medical diagnosis or treatment advice. If you have an aquafilling injection history, imaging assessment is advisable regardless of symptoms; management is determined through in-person consultation with a board-certified plastic surgeon.

Dr. Kim Uigeon (Board-certified plastic surgeon, Republic of Korea · UNE Plastic Surgery)