Abstract
Background
Polyacrylamide hydrogel, commercially referred to as Amazingel, was prohibited for use in China in 2006 owing to its associated high complication rates. Conventional techniques for its removal are frequently insufficient to achieve complete eradication, often leading to persistent complications and suboptimal aesthetic results. This study aims to evaluate the safety and aesthetic outcomes of a novel transaxillary endoscopic-assisted removal of Amazingel (TERA) with or without immediate prepectoral implant-based breast augmentation (IPBA).
Methods
This retrospective study encompassed 42 patients who underwent TERA with or without IPBA between April 2020 and May 2025. Surgical safety was evaluated through the incidence of postoperative complications within the one-month postoperative period. Aesthetic outcomes were assessed three months after surgery using the Harris scale.
Results
The 42 patients were divided into two groups: 25 patients who underwent TERA with IPBA (the IPBA group) and 17 patients who underwent TERA alone (the N-IPBA group). A statistically significant improvement in aesthetic outcomes, as measured by the Harris scale, was demonstrated in the IPBA group compared to the N-IPBA group (P=0.01). Regarding safety, only one patient (2.38%) in the IPBA group developed a local infection, which was successfully managed with a course of oral antibiotics. Minimal residual Amazingel was detected on imaging in two patients (4.76%), with no associated discomfort.
Conclusions
The findings of this study demonstrate that TERA with or without IPBA is a safe and effective method. The TERA technique facilitates a more thorough hydrogel removal and superior aesthetic results compared to conventional methods. Furthermore, the concomitant performance of IPBA significantly enhances postoperative patient satisfaction without elevating the risk of complications. These promising results warrant further validation through large-scale, multicenter prospective trials to generalize the findings.
Keywords: Endoscopic-assisted polyacrylamide hydrogel removal, immediate prepectoral implant-based breast augmentation (IPBA), breast endoscopy
Highlight box.
Key findings
• Transaxillary endoscopic-assisted removal of Amazingel (TERA) with immediate prepectoral implant-based breast augmentation (IPBA) reported better aesthetic outcomes without increasing the incidence of complications.
What is known and what is new?
• Conventional Amazingel removal methods often fail to obliterate it, resulting in high complication rates and poor aesthetic outcomes.
• We reported a new approach that removes the injectable Amazingel under endoscopy with IPBA.
What is the implication, and what should change now?
• We reported a safe and effective method for Amazingel removal. More trials are needed to validate this approach further.
Introduction
Polyacrylamide hydrogel (PAAG), also known as Amazingel, was certified by China’s National Medical Products Administration (NMPA) in 1997 as a non-toxic, environmentally friendly soft tissue filler, widely used in breast augmentation and facial injections for plastic surgery (1). It is estimated that approximately 30 million women worldwide have undergone PAAG injection for breast augmentation (2). However, with extended clinical application, various complications after PAAG injection have gradually emerged, including delayed inflammatory reactions, breast pain, hardness, deformation, and migration of the gel to distant sites such as the lower back, abdomen, and perineum. Additionally, the degradation of PAAG releases acrylamide monomers, which are known toxins associated with potential reproductive, neurotoxic, and mutagenic issues, leading to systemic symptoms such as fever, extremity paresthesia and chronic fatigue, and a suspected increased risk of breast cancer have also been reported (3-12). Studies indicate a complication rate of 30% to 50% ten years after PAAG injection, and some patients may require multiple repair surgeries due to tissue erosion or immune response (2,5,13). Due to these issues, China’s NMPA altogether banned the clinical application of PAAG in 2006. Patients who have received PAAG injections should remove them as soon as possible, regardless of complications (12).
Conventional approaches for PAAG removal mainly consist of suction and debridement surgery. However, suction is often ineffective due to the high viscosity of the injected hydrogel, and the procedure’s limited visualization impedes complete excision of the surrounding capsule. Repeated suction may propagate PAAG into adjacent healthy tissues (14,15). Additionally, a secondary concern is the alteration of breast morphology following PAAG injection, and the removal of the filler can lead to gland parenchymal atrophy, seriously affecting cosmetic outcomes. Debridement surgery typically uses periareolar or inframammary fold incisions, allowing for the resection of gel and lesioned tissue. Nevertheless, intraoperative exposure is often achieved with retractors, which is frequently suboptimal, particularly in patients with large breasts or unclear injection planes, sometimes necessitating extended incisions (2,3,16,17). Given the technical difficulty in achieving complete obliteration of the material, immediate breast prosthesis implantation for cosmetic purposes is generally not recommended (2). While some studies explore immediate implantation to maintain breast shape, the postoperative complication rates reach up to 50% due to residual PAAG, and even with delayed implantation, complication rates remain elevated at 31.3% (16). Consequently, the development of a technique that ensures thorough PAAG removal while facilitating satisfactory aesthetic reconstruction has become a research focus.
The recent development of the reverse-sequence endoscopic technique has addressed the challenge of poor exposure in traditional approaches, offering a promising alternative for PAAG removal (18-23). Building upon this innovation, we perform it through a concealed axillary incision, utilizing endoscopic visualization to excise the PAAG and its surrounding capsule. When indicated by patient preference, a prosthesis can be implanted immediately. Our preliminary experience has yielded favorable outcomes and now we report the results. We present this article in accordance with the STROBE reporting checklist (available at https://gs.amegroups.com/article/view/10.21037/gs-2025-404/rc).
Methods
Ethical statement
This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This study was approved by the Biomedical Ethics Committee of West China Hospital, Sichuan University [No. 2025(2722)]. Informed consent was waived due to the retrospective nature of this study. All patient information was kept confidential, with all data stripped of any patient identifiers.
Data source and patient selection
This study retrospectively analyzed 42 patients who underwent transaxillary endoscopic-assisted removal of Amazingel (TERA) with or without immediate prepectoral implant-based breast augmentation (IPBA) at West China Hospital of Sichuan University between April 2020 and May 2025. Among them, 25 patients received IPBA. Postoperative follow-up was conducted via telephone by the operating surgeon and his team (composed of specialized surgeons), with a follow-up period ranging from 3.17 to 65.33 months, and a median follow-up of 30.67 months. The follow-up period of IPBA group ranges from 3.17 to 65.33 months, with a median follow-up of 22.57 months. And the follow-up period of the TERA alone group ranges from 14.67 to 55.10 months, with a median follow-up of 48.42 months.
Inclusion criteria: (I) a history of PAAG injection for breast augmentation; (II) good cardiopulmonary function, with no significant organic diseases in major organs; (III) strong desire for PAAG removal. Exclusion criteria: (I) severe breast tissue destruction or infection identified by preoperative physical and imaging examination; (II) presence of mental disorders; (III) pregnant or breastfeeding women.
Surgical procedures
Preoperative examination and assessment
Preoperative routine imaging was performed to evaluate local breast conditions, assessing symptoms such as breast nodules, swelling, pain, induration, infection, PAAG migration, breast asymmetry and capsular contracture. Patients opting for TERA with IPBA needed to be free of severe infection or significant PAAG migration, along with a strong desire for breast augmentation with implants.
Surgical steps of TERA with or without IPBA
The patient is positioned supine, and the breast perimeter is marked. With the upper limb abducted, a 5-cm incision is made along the transverse skin crease of the axilla, ensuring that the anterior margin does not extend beyond the anterior axillary fold. Subsequently, disinfection and draping procedures are performed.
Under direct vision, the tissue layers are sequentially incised through the axillary incision until the PAAG capsule is exposed. After incising the capsule and evacuating its contents, a lavage tube is inserted to irrigate the cavity with normal saline until the effluent was clear. An incision protection sleeve is placed, and CO2 gas is insufflated. Under endoscopic visualization, the adhesion between the capsule and the pectoralis major muscle is assessed to determine the sequence of dissection. Suppose the capsule is tightly adherent to the pectoralis major muscle. In that case, it is recommended to use the sequential method, which involves first dissecting the loose connective tissue between the gland and the capsule. After passing the nipple plane, a 2-mm incision (HUAXI hole 1) is made beside the areola in the outer upper quadrant of the breast. An electrocautery is inserted through this hole, enabling endoscopic dissection of the remaining capsular. Traction with forceps is then used to dissect the capsule off the pectoralis major muscle, minimizing damage to the muscle fibers. If necessary, a localized resection of a portion of the pectoralis major muscle is performed to ensure complete removal of the capsule. Suppose the capsule is loosely adherent, the reverse sequence is adopted, that is, first to dissect in front of the pectoralis major muscle and then behind the gland. After dissection, the entire capsule is removed through the axillary incision and repeatedly irrigated with 2,000 mL of normal saline. Changing sterile gloves before positioning the implant. For patients with particularly thin glands, a mesh can be used to increase tissue coverage over the prosthesis surface. Finally, a drainage tube is placed within each breast cavity and leads out through the axillary incision. The implant we used were the Johnson & Johnson’s Mentor Prosthesis Series, which are of the textured type, filled with high-cohesion medical-grade silicone gel. The TiLOOP Bra we used is a titanium-coated polypropylene mesh specifically designed for breast reconstruction, suturing by the parachute technique. Refer to Video 1 for more details.
Video 1.
Endoscopic-assisted removal of injectable Amazingel with immediate prepectoral implant-based breast augmentation.
Postoperative management
Patients underwent TERA with IPBA were required to wear a compression bra for three months postoperatively and attend regular outpatient follow-ups. And complete removal of PAAG was defined as no residual PAAG being detected on breast ultrasound and magnetic resonance imaging (MRI).
Study outcomes
The study aimed to explore the surgical safety and aesthetic outcomes of TERA with or without IPBA. Surgical safety can be assessed by the occurrence of intraoperative and postoperative complications within one month after surgery, such as hematoma, wound dehiscence, surgical site infection, skin flap necrosis, or necrosis of the nipple-areolar complex. The aesthetic outcome can be evaluated using the Harris score (24) at three months postoperatively.
Statistical analysis
Statistical analysis was conducted using SPSS version 27.0. Categorical variables will be analyzed using Chi-squared or Fisher’s exact tests; continuous variables via t-tests or non-parametric alternatives (Mann-Whitney/Kruskal-Wallis) as appropriate. All tests were two-tailed, with P<0.05 considered statistically significant.
Results
Patients characteristics
This study included 42 patients, aged 33 to 73 years, with an average age of 50.24 years. Participants had a body mass index (BMI) ranging from 16.85 to 27.47 kg/m2, with an average of 21.67 kg/m2. Among them, one patient had diabetes, four had a history of alcohol abuse, and one was a former smoker. Additionally, 25 patients had gone through menopause. For patients with documented dates, the mean duration from the initial PAAG injection to surgery was 19.13 years, ranging from 10 to 25 years. During preoperative assessment, breast nodules were found in 12 patients. The most common preoperative complications included pain in 34 cases, breast swelling in 27 cases, breast hardness in 11 cases, and breast deformity in 28 cases. There were also 12 cases of PAAG migration, with some shifting towards the clavicle, axillary areas, or both. Additionally, 16 patients experienced breast asymmetry, five cases reported infection, two had mild implant leakage, and one had a mild rupture. See Table 1 for more details.
Table 1. Patients characteristics.
| Characteristics | IPBA group (N=25) | N-IPBA group (N=17) | P |
|---|---|---|---|
| Age (years) | 49.48±7.70 | 51.35±7.85 | 0.45 |
| BMI (kg/m2) | 21.35±2.13 | 22.15±2.83 | 0.30 |
| Diabetes | 1 (100.00) | 0 | >0.99 |
| Alcohol | 3 (75.00) | 1 (25.00) | 0.90 |
| Smoking | 0 | 1 (100.00) | 0.41 |
| Menopause | 15 (60.00) | 10 (40.00) | 0.94 |
| Breast nodule | 5 (41.70) | 7 (58.30) | 0.14 |
| Preoperative complications | 25 (61.00) | 16 (39.00) | 0.41 |
| Pain | 16 | 16 | – |
| Breast swelling | 15 | 12 | – |
| Breast hardness | 9 | 2 | – |
| Breast deformity | 19 | 9 | – |
| Implant displacement | 7 | 5 | – |
| Breast asymmetry | 14 | 2 | – |
| Infection | 2 | 3 | – |
| Implant leakage | 2 | 0 | – |
| Capsular rupture | 1 | 0 | – |
Data are presented as mean ± SD or n (%). IPBA group: patients who underwent TERA with IPBA; N-IPBA group: patients who underwent TERA alone. BMI, body mass index; IPBA, immediate prepectoral implant-based breast augmentation; SD, standard deviation; TERA, transaxillary endoscopic-assisted removal of Amazingel.
Perioperative parameters and medical expenses
Among the 42 patients, 25 underwent TERA with IPBA (the IPBA group), while 17 underwent TERA alone (the N-IPBA group). The implant volume ranged from 180 to 395 cc, with a median size of 315 cc. The operative time varied from 90 to 359 minutes, with an average of 182.90 minutes, and no statistically significant difference was observed between the two groups (P=0.90). Surgical expenses ranged from 1,160.23 to 12,842.48 USD, with an average cost of 3,262.83 USD. A statistically significant difference in surgical expenses was observed between the two groups (P=0.002), with the IPBA group incurring higher expenses. Among all patients, 2 underwent day surgery, while 40 had inpatient surgery. Length of hospitalization time ranged from 1 to 22 days (mean 7.74 days). One patient experienced a flap burn during the procedure, which healed naturally postoperatively without resulting in flap necrosis.
Surgical safety
Within one month postoperatively, only one patient experienced an infection at the surgical site, which was successfully resolved with a course of oral antibiotics. No other complications such as bleeding, incision dehiscence, or flap necrosis were observed. During the follow-up period, postoperative imaging identified minimal residual PAAG in two patients; both cases were asymptomatic.
Aesthetic outcomes
The aesthetic outcomes were assessed using the Harris score three months after surgery. It revealed that the IPBA group showed a statistically significant difference compared to the N-IPBA group (P=0.01), detailed results are provided in Table 2. Preoperative and postoperative photographs of patients who underwent TERA with or without IPBA are presented in Figures 1-3.
Table 2. Harris scale outcomes.
| Harris scale | IPBA group (N=25) | N-IPBA group (N=17) | P |
|---|---|---|---|
| Excellent | 23 | 10 | 0.01 |
| Good | 2 | 6 | |
| Fair | 0 | 1 | |
| Poor | 0 | 0 |
Data are presented as number. IPBA group: patients who underwent TERA with IPBA; N-IPBA group: patients who underwent TERA alone. PBA, immediate prepectoral implant-based breast augmentation; TERA, transaxillary endoscopic-assisted removal of Amazingel.
Figure 1.
A 47-year-old woman with a 20-year history of bilateral polyacrylamide hydrogel injection who underwent TERA with IPBA. (A) Preoperative photos. (B) Photos at 2 weeks postoperatively. (C) Photos at 6 months postoperatively. IPBA, immediate prepectoral implant-based breast augmentation; TERA, transaxillary endoscopic-assisted approach removal of Amazingel.
Figure 2.
A 61-year-old woman with a 14-year history of bilateral polyacrylamide hydrogel injection who underwent TERA without IPBA. (A) Preoperative photos. (B) Photos at 1 month postoperatively. IPBA, immediate prepectoral implant-based breast augmentation; TERA, transaxillary endoscopic-assisted approach removal of Amazingel.
Figure 3.
A 51-year-old woman with a 20-year history of bilateral polyacrylamide hydrogel injection who underwent TERA with IPBA. (A) Preoperative photos. (B) Photos at 7 months postoperatively. IPBA, immediate prepectoral implant-based breast augmentation; TERA, transaxillary endoscopic-assisted approach removal of Amazingel.
Discussion
This study introduces a novel TERA with or without IPBA. This approach overcomes the limitations of conventional open surgery by providing superior visualization and access, facilitating more complete excision of the surrounding capsule. As a result, it reduces postoperative complications, minimizes visible scarring, and enhances cosmetic outcomes. Patients who underwent IPBA reported higher satisfaction levels on the Harris scale than those undergoing TERA alone. After a median follow-up period of 30.67 months, only two cases of asymptomatic, minimal residual PAAG were detected on imaging. In conclusion, the TERA technique is a safe and effective approach for PAAG removal, with a short learning curve.
The capsule that forms around injected PAAG can affect both the shape and softness of the breast while also creating a potential environment for bacterial colonization and residual hydrogel retention. Therefore, surgical excision is considered essential (17,25). However, achieving complete capsule resection is often challenging due to inaccuracies in the injection layers and the propensity for PAAG migration (6). The conventional suction method, hampered by a lack of direct visualization, often results in high rates of PAAG residue due to ineffective capsule removal. Additionally, debridement surgery performed through a small periareolar incision may not provide sufficient exposure, particularly in patients with larger breasts, increasing the risk of PAAG and capsule residue (3,26,27). Similarly, the inframammary fold incision does not adequately expose the upper pole of the breast, often necessitating additional incisions for better access (28). A study conducted by Ding et al. used MRI to evaluate residual PAAG following removal via these conventional incisions. The findings indicated that approximately 92.2% of patients had less than 10% PAAG residue, 6.2% had between 10% and 30%, and 1.6% had more than 30% (17). In contrast, the endoscopic approach employed in our study facilitates a more complete excision. By utilizing CO2 gas insufflation to create a spacious and transparent operative field, the TERA technique significantly improves visibility and access. This allows for meticulous dissection and removal of the PAAG and its capsule. Furthermore, under direct endoscopic vision, any adherent residual material can be fragmented and irrigated away, minimizing the risk of retention. This technical advantage is reflected in our findings, where only two patients (4.76%) exhibited minimal, asymptomatic residual PAAG on imaging, requiring no further intervention. The Munhoz’s team have described a scarless endoscopic-assisted secondary breast augmentation technique via an axillary incision, preliminarily revealing favorable aesthetic outcomes and high postoperative patient satisfaction (29-31). However, the Munhoz’s team relied on retractors to expose the operative field, resulting in a relatively narrow field of view and limited working space, which also demands greater physical effort. Our study employs carbon dioxide insufflation to create a tenting effect for exposure, offering a significantly improved field of view and a considerably more extensive operative space. Moreover, the degradation of PAAG releases certain toxins, and the surrounding capsule can trigger a range of complications, incomplete removal further increases the risk of post-operative infection. Therefore, complete excision of both the PAAG and its surrounding capsule is essential—a requirement our technique fulfills effectively.
Previous research indicates that complication rates ranging from 10% to 50% for immediate implant implantation following PAAG removal. In contrast, complication rates for removal without implantation vary from 12.5% to 21% (3,16,26,27). In our study, only one patient (2.38%) in the IPBA group developed a local infection. This incidence is notably lower than the complication rates of 6.7% to 25% documented for immediate implant-based breast reconstruction post-mastectomy (18,19,32-37). Importantly, no complications were observed in the N-IPBA group, suggesting that the transaxillary endoscopic-assisted approach (TERA) contributes to excellent safety outcomes, even in cases with ill-defined injection layers.
Currently, no consensus exists regarding the advisability of immediate implant-based augmentation following PAAG removal. The resection of PAAG and its capsule often results in breast deformities, volume loss, skin laxity, and asymmetry, which profoundly compromise aesthetic outcomes (2,3,12). Patients with high aesthetic expectations desire immediate reconstruction to restore breast contour. The literature on this subject presents conflicting evidence. Liang et al. reported high complication and reoperation rates for both immediate (50% and 26.2%, respectively) and delayed implantation (31% and 18.8%, respectively), concluding that immediate implantation is inadvisable, and even delayed implantation should be subpectoral to isolate the implant from the residual PAAG cavity (16). In contrast, Guan et al. argued that immediate implantation can significantly improve postoperative breast satisfaction and psychological well-being without increasing complications (27). Chen et al. proposed a approach, deeming immediate implantation feasible only in cases with well-defined injection players and minimal residual hydrogel (2). A principal concern cited against immediate implantation is the PAAG capsule during conventional removal procedures, potentially leading to long-term complications. In our study, the transaxillary endoscopic-assisted approach facilitated complete resection of both the PAAG and its surrounding capsule through a concealed axillary incision. The low complication rate observed, demonstrates that immediate implant-based augmentation can be performed safely following thorough hydrogel eradication. Furthermore, the statistically superior Harris scores in the IPBA group confirm that this combined procedure significantly enhances cosmetic outcomes compared to removal alone. These findings collectively indicate that with the visualization and excision afforded by the TERA technique, immediate prepectoral implant placement is a viable and advantageous option that addresses both aesthetic demands and safety concerns.
Conclusions
In conclusion, TERA, whether performed with or without IPBA, is a safe and effective surgical method. The combination of TERA with immediate IPBA yielded statistically superior aesthetic outcomes, as measured by the Harris scale, without incurring a higher incidence of postoperative complications. However, there are some limitations in this study, including its retrospective design, modest sample size, and single-center origin, limiting the generalizability of these findings, and the Harris scale is not validated for implant-based aesthetic or reconstructive surgery. What’s more, the follow-up duration varied widely, making long-term outcome interpretation difficult. Consequently, the long-term outcomes warrant further investigation. Future validation through large-scale, multicenter trials is recommended to firmly establish the clinical value of this technique.
Supplementary
The article’s supplementary files as
Acknowledgments
We want to thank our patients and researchers for participating in this study.
Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This study was approved by the Biomedical Ethics Committee of West China Hospital, Sichuan University [No. 2025(2722)]. Informed consent was waived due to the retrospective nature of this study.
Footnotes
Provenance and Peer Review: This article was commissioned by the Guest Editors (Visnu Lohsiriwat and Chayanee Sae-Lim) for the series “Transformative Approaches in Breast Surgery: Cutting-Edge Innovation, and Practice” published in Gland Surgery. The article has undergone external peer review.
Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://gs.amegroups.com/article/view/10.21037/gs-2025-404/rc
Funding: This study was supported by grants from the Key Projects of the Sichuan Provincial Health Commission (No. 21PJ042), the Incubation Project of West China Hospital of Sichuan University (No. 2022HXFH004), and the Natural Science Foundation of Sichuan Province (No. 22NSFSC2361).
Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://gs.amegroups.com/article/view/10.21037/gs-2025-404/coif). The series “Transformative Approaches in Breast Surgery: Cutting-Edge Innovation, and Practice” was commissioned by the editorial office without any funding sponsorship. The authors have no other conflicts of interest to declare.
Data Sharing Statement
Available at https://gs.amegroups.com/article/view/10.21037/gs-2025-404/dss
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