Safety of Copolyamide Filler Injection for Breast Augmentation

Abstract

Background: Although injections with copolyamide fillers (Aquafilling/Los Deline and Aqualift/Activegel) are currently used widely for breast augmentation, many complications have been reported. A recent position statement by a Korean aesthetic/reconstructive breast surgery society indicated these fillers are the same as polyacrylamide gel (PAAG), which is widely prohibited due to complications. To test this statement, this retrospective cohort study examined the clinical complications after breast augmentation with copolyamide fillers. Nuclear magnetic resonance (NMR) analysis of copolymer and PAAG fillers was also conducted. Methods: All consecutive patients with concerns about or sequelae from copolyamide fillers who visited our hospital in 2018–2020 were identified. The injected formulation, complications, and intraoperative findings were recorded. Copolyamide fillers were compared with PAAG and 2 PAAG fillers (Amazingel and Aquamid) by NMR. Results: Of the 29 patients (all women; average age, 42 years), 17 complained of breast deformity. Eight had puncture site infections and mammary gland inflammation. Five exhibited induration (single large/small lumps). In 4 cases, the filler had migrated outside of the breast, including to the back and vulva; these cases had severe symptoms. NMR showed that the copolyamide and PAAG fillers bore all of the characteristic peaks of PAAG. Conclusions: Our clinical/intraoperative and NMR findings showed, respectively, that copolyamide fillers cause the same complications as PAAG fillers and have the same composition. Thus, the risks of copolyamide fillers for breast augmentation are equivalent to those for PAAG fillers. It is strongly recommended not to use copolyamide fillers until their long-term safety is established.

Complication after Aquafilling® gel-mediated augmentation mammoplasty—galactocele formation in a lactating woman: a case report and review of literature

“…There might exist minimal differences in the polymer structure of the Aquafilling® gel and PAAG filler, but the overall composition of polyacrylamide in both gel types appears to be quite similar. Hence, features of PAAG fillers as well as the known complications after injection as body fillers are expected to be similar for the use of Aquafill-ing® [4,7,9,17,26].…”

“…Even though the manufacturer of Aquafilling®, recently renamed Los Deline® (Biomedica, Prague, Czech Republic), initially claimed that the gel had features differentiating it from PAAG, the overall composition of polyacrylamide in both gel types seems to be quite similar, and the complications after injection of PAAG and Aquafilling® for breast augmentation are thought to be equivalent [1,4,9,17] On these accounts, possible breastfeeding problems subsequent to filler injection for augmentation in young women should not be disregarded. Patients might present with markedly enlarged and painful breasts, and distinction between galactocele formation and inflammatory processes based on physical examination and ultrasound findings can be challenging.…”

Management of a Large Quantity of Permanent Gluteal Copolyamide Fillers (Aqualift/Activegel): Literature Review and Algorithm

“…This similarity was furthermore confirmed by the study “Safety of Copolyamide Filler Injection for Breast Augmentation” by Nomoto et al, showing that these substances share the same chemical composition and complication profile. 14 Our approach was dictated by the severity of the symptoms, and the mentioned aesthetic compromises accepted by the patients. We are aware that our approach cannot be generalized due to the small number of patients.…”

Advances in Biomaterials for Breast Reconstruction

“…The average duration from injection to developing the complication was 6.1 years [97]. Nomoto et al reported that 29 patients who received copolymer-filler injection presented with concerns (deformity, gel migration, infection, induration, pain, and fistula) [98]. The mean duration between injection and consultation was 1.8 years.…”