Sepsis 6 Years After Breast Augmentation With Aquafilling: A Case Report and Literature Review

Summary:

Aquafilling is a hydrophilic gel composed of 98% physiological saline and 2% polyacrylamide gel, introduced in Japan in 2015 for breast augmentation. Despite its initial popularity, it has been associated with severe complications, including delayed infections, abscess formation, material migration, and fibrosis. In 2019, the Japanese Society of Aesthetic Plastic Surgery banned its use for breast augmentation due to safety concerns. However, cases of late-onset complications continue to emerge. Here, we report a case of sepsis caused by an abscess at the injection site 6 years after Aquafilling injection. A 34-year-old woman with a history of methamphetamine addiction underwent breast augmentation with Aquafilling. Six years later, she developed erythema, swelling, and fever, leading to sepsis. Contrast-enhanced computed tomography revealed abscess formation at the injection site. Surgical drainage and debridement were performed, and antibiotic therapy was tailored based on culture results. Postoperative management included intensive care unit care, repeated debridement, and wound closure with a split-thickness skin graft. The patient was discharged 55 days after admission. This case highlights the significant risks associated with nonabsorbable fillers, particularly delayed infections and their severe consequences. A review of the literature reveals numerous reports of similar complications worldwide, necessitating surgical intervention in most cases. To prevent such outcomes, rigorous safety evaluations and monitoring systems led by professional societies and governments are essential. Furthermore, a safety network for treating patients with late-onset complications must be established to ensure timely and effective care.

Aquafilling is a hydrophilic gel composed of 98% physiological saline and 2% polyacrylamide gel (PAAG), a nonabsorbable substance, introduced in Japan in 2015 for breast augmentation. However, similar to other PAAG products, it has been associated with complications, including acute and delayed inflammatory reactions; abscess formation; fibrosis; material migration; and, in severe cases, skin deformities or the need for surgical intervention. Due to these concerns, the Korean Academic Society of Aesthetic and Reconstructive Breast Surgery raised alarms, the US Food and Drug Administration has not approved it,¹ and the Japanese Society of Aesthetic Plastic Surgery (JSAPS) banned its use for breast augmentation in 2019 pending further safety studies.

As a result of these statements, the use of Aquafilling in Japan has declined. Although Japan’s universal health insurance system is strictly regulated, cosmetic practices outside this framework face looser regulations. Restrictions remain limited to the JSAPS advisory statement, with no legal enforcement, allowing new patients to still undergo injections. Moreover, due to the widespread use of Aquafilling over time, patients with complications, particularly delayed-onset cases, continue to present at plastic surgery clinics. Here, we report a case of abscess formation at the injection site leading to sepsis, occurring 6 years after breast augmentation with Aquafilling.

CASE REPORT

A 34-year-old woman underwent breast augmentation with Aquafilling 6 years earlier. She had a history of methamphetamine addiction and hypothyroidism and was admitted to another hospital’s psychiatric department for agitation. On the ninth day of hospitalization, the patient developed left axillary pain and a fever of 39°C (102.2°F). Although piperacillin treatment was initiated, her systolic blood pressure dropped to 63 mm Hg, raising suspicion of sepsis. She was transferred to our Advanced Critical Care and Emergency Center on the 14th day of hospitalization.

Physical examination revealed erythema, swelling, and severe pain in the left chest and back. A soft tissue infection was suspected based on clinical findings. Although magnetic resonance imaging provides detailed imaging, it is challenging to perform in emergency settings in Japan. Therefore, contrast-enhanced computed tomography was selected to confirm the injection site and evaluate infection spread. The computed tomography revealed ring enhancement extending from the left thoracic to the left dorsal region, suggestive of abscess formation at the Aquafilling injection site (Fig. 1). Surgical removal of the artifact and abscess drainage were deemed necessary. The patient was diagnosed with an Aquafilling-related abscess resulting in sepsis. Incisional drainage and debridement under general anesthesia revealed extensive pus and tissue necrosis (Fig. 2). Sulbactam/ampicillin was initially administered for its broad-spectrum activity against common Gram-positive and Gram-negative bacteria. Intraoperative cultures identified Staphylococcus aureus, prompting a switch to cefazolin for targeted therapy. The duration of antibiotic treatment was guided by clinical improvement, normalization of inflammatory markers, and resolution of systemic symptoms.

Fig. 1.

Computed tomography of the chest. The right arrow shows a low-absorption area consistent with abscess formation and necrosis from the subcutaneous tissue to the vastus medialis in the left chest. The left arrow shows filled Aquafilling with no inflammatory findings in the right thoracic region.

Fig. 2.

Intraoperative photograph after the left medial axillary line had been incised. The anterior and dorsal thoracic regions are at the top and bottom of the image, respectively. The soft tissues under the pectoralis major and latissimus dorsi muscles were necrotic, and large amounts of necrotic tissue were observed.

Following surgery, the patient required respiratory support for sedation and analgesia in the intensive care unit. Debridement was repeated on postoperative day 8, and negative-pressure wound therapy was initiated on day 10. The patient improved and was weaned off the ventilator on day 13. The wound was closed with a split-thickness skin graft on day 40, and the patient was discharged on day 55.

DISCUSSION

Aquafilling was originally developed in the Czech Republic in 2005 as a soft-tissue filler for mild facial defects and later introduced to Japan in 2015 for breast augmentation. Highly hydrophilic and diffusible, Aquafilling has been identified in our literature review as a significant contributor to widespread inflammation and infection. Between 2017 and 2023, 7 studies reported 27 cases of infection following Aquafilling injections, including 1 case of sepsis (Table 1).^2–8 These cases were from South Korea, Japan, Poland, and Austria. Although some infections occurred soon after injection, most presented 2–6 years later. Most cases required surgery, highlighting that severe infection warranting surgical intervention can develop years after Aquafilling injection.

Table 1.

Literature on Aquafilling-related Infectious Complications

Author (Year of Publication)	Actual Treatment Period, y	Country	Complication	No. Cases	Average Period From Injection to Symptom Onset, mo	Amount of Injected Material, mL	Whether Surgery Was Performed
Namgoong et al (2020)2	2015–2019	South Korea	Mastitis*	10	Unknown	50–300 (including all complications)	+
			Sepsis	1†	36		+
Ko et al (2017)3	2017	South Korea	Abscess	1	6	Unknown	+
Son et al (2018)4	2018	South Korea	Abscess	1	4	Unknown	+
Ki Jung et al (2018)5	2018	South Korea	Abscess	1	36	200–250	+
Nomoto et al (2021)6	2018–2020	Japan	Infection	8	0.5–48	80–250	+‡
Chalcarz et al (2023)7	2021	Poland	Abscess	3	3–26	100–250	+
Wünscher et al (2023)8	2022	Austria	Abscess	1	72	300–400	+
Our case (2024)	2023	Japan	Sepsis	1	72	Unknown	+

^*Mastitis may include cases that are not caused by infection; however, this could not be determined from the article.

^†This case involves the injection of Aquafilling into the buttocks.

^‡In 5 of 8 cases.

According to a 2018 survey conducted by the JSAPS,⁹ targeting its members and members of the Japan Society of Plastic and Reconstructive Surgery (respondents: 132), 28 physicians (21%) had experience treating complications following breast augmentation using Aquafilling. A total of 83 cases of filler-related complications were reported, 76% of which were caused by nonabsorbable fillers. Among the nonabsorbable fillers, Aquafilling accounted for the highest proportion at 24%. This indicates that Aquafilling, introduced in Japan in 2015, had already caused numerous complications by the time of the survey, just 3 years later.

In this case, there was no history of trauma or dental treatment as a potential route for the delayed infection. However, the patient had a history of methamphetamine abuse, raising suspicion of bacterial entry through injection. Additionally, methamphetamine has been reported to have immunosuppressive effects,¹⁰ which may have contributed to the worsening of the infection. In conclusion, it is suggested that bacteria entered the body through the injection, and the immunosuppressive effects of methamphetamine facilitated bacterial colonization and proliferation on Aquafilling, an avascular artificial material. This likely led to abscess formation and subsequently progressed to sepsis.

Nonabsorbable fillers used for breast augmentation have included silicone oil from the 1950s to the 1970s, as well as paraffin, PAAG, polymethyl methacrylate, and polyvinyl acetate. All of these materials have been associated with issues such as infection, induration, migration, capsule formation, and difficulty in removal when complications arise. These problems have led to their temporary popularity followed by subsequent regulation. As plastic and aesthetic surgeons, it is essential for us to properly understand the history of nonabsorbable fillers. Even if a new and seemingly attractive filler is introduced in the future, it is our responsibility to rigorously evaluate its safety. To achieve this, we believe that it is crucial to establish a system for information sharing led by professional societies and governments, utilizing an international network. Moreover, late complications in patients who have already undergone filler injections are often avoided by hospitals, highlighting the urgent need for a safety network to provide treatment and support for such patients. Establishing such a system is of paramount importance.

CONCLUSIONS

Nonabsorbable fillers like Aquafilling pose significant risks of long-term complications, including infection, inflammation, migration, and difficulty in removal. In this case, 6 years after injection, the patient developed an abscess and sepsis, requiring surgical intervention. Similar issues have been observed with previous nonabsorbable fillers, emphasizing the need for caution when introducing new fillers with insufficient safety evaluation. Establishing a robust safety network and international information-sharing system is essential to address late-onset complications and ensure patient safety.

DISCLOSURE

The authors have no financial interest to declare in relation to the content of this article.