Augmentation Mammoplasty Filler Migration Hydrogel Aquafilling®
Breast augmentation with injectable material has been performed for decades. Historically, various materials have been used for injection, including paraffin, liquid silicone, and polyacrylamide gel (PAAG) (1). However, all materials resulted in complications such as pain, subcutaneous nodules, breast deformities and even loss of ability of breast feeding (2-4). For these reasons, U.S. food and drug administration (FDA) did not approve use of any kind of filler for breast augmentation.
Recently, we came across a patient who underwent breast augmentation using a brand-new Aquafilling® filler. Some plastic surgeons reported that Aquafilling® filler is a temporary filler providing satisfactory improvement in breast shape and volume without any inflammatory reactions or serious adverse effects (5). However, in this report, we present a 32-year-old woman who experienced severe complications 6 months after bilateral breast augmentation with Aquafilling® filler and discuss the radiologic characteristics.
2. Case Presentation
A 32-year-old woman presented with painful swelling on her left lower abdominal wall. She had received Aquafilling® filler injection for breast augmentation 6 months before at a plastic surgery clinic. She also complained of tenderness of her left breast with volume loss. The laboratory data showed increased levels of C reactive protein (CRP) (3.3 mg/dL) and leukocytosis with neutrophilia (19920/uL, 89.3%). Abdominal computed tomography (CT) showed low attenuated fluid collection in intermuscular and deep subcutaneous spaces with an accompanying ill-defined surrounding soft tissue infiltration spreading from the left upper lateral abdominal wall down to the lower anterior abdominal wall (Figure 1). Breast ultrasound revealed fluid like filler collection in a retroglandular, prepectoral location (Figure 2A). On the right, the large amount of filler collection was anechoic with internal multiple echogenic foci, while the collection on the left showed a marked decrease in volume, ill-defined margin, and heterogeneous internal echogenicity (Figure 2B). On Doppler, increased vascularity was noted on the left lower outer tender area (Figure 2C). In addition, there were multiple, randomly distributed globules of the extravasated filler in bilateral breasts (Figure 2D). An incision was made in the affected lower abdominal wall and yellowish pus flowed out. Culture of the pus showed no bacterial growth. Nevertheless, she received intravenous antibiotic treatment for 10 days with percutaneous drainage of the abscess. The symptom gradually subsided.
One month later, she visited again for a painful swelling in her left vulvar area. On physical examination, her left labium major showed severe redness and swelling and pus was oozing out from a fistula. Contrast-enhanced sagittal T1 weighted image (T1WI) demonstrated skin thickening and focal fluid collection with ill-defined reticular streaky soft tissue enhancement, extending from the left lower abdominal wall to the vulva (Figure 3). Clinician performed the incision and drainage for abscess and necrotic tissue from the left vulva. The patient has been treated for the lesion in the outpatient clinic for 6 months.
Aquafilling® was developed in 2005 as soft tissue filler for facial contouring in Czech Republic and recently, it has been used for breast augmentation in several countries. Some insist that Aquafilling® filler is composed of 98% water and 2% copolyamide with excellent lifting capacity and viscoelasticity which can modify and maintain the breast form (5). However, in the document submitted to Korean food and drug administration (KFDA), the exact ingredient of Aquafilling® filler is 2% of poly (acrylamide-co-N,Nʹ-methylene-bis-acrylamide) and 98% of sodium chloride solution 0.9%. In other words, the major component of Aquafilling® filler is polyacrylamide (6).
To the best of our knowledge, this is the first published case to report on the radiographic features of severe complications after augmentation mammoplasty using Aquafilling® injection. Unukovych et al. (7) reported about management of complications in 106 patients who had received PAAG injection for breast augmentation. The most common complications were breast pain (80%), breast hardening and deformity (74%), followed by gel migration (37%). However, in that report, there was no patient who showed gel migration to the vulvar area, to say nothing of the fistula. According to previous studies, the mean time from the injection to complications was 51 months (range = 3 - 160) (8-10). The complications in this case occurred relatively early, just 6 months after the filler injection. We hypothesize that a large amount of injected filler or poor quality of procedure might cause the rapid onset of severe complications. Like as PAAG, Aquafilling® may absorb body fluid and exudate which could become a good medium for bacterial growth. In addition, it might also flow to a distant place under the influence of gravity, resulting in infection of loose connective tissues and fat layers (2). However, it would be necessary to clarify the exact mechanism of complication with more patients to judge the safety of Aquafilling® mammoplasty.
In this case, the radiologic evaluation was very useful in the investigation of a patient with complications after Aquafilling® mammoplasty. On ultrasound, uncomplicated Aquafilling® filler shows a large anechoic fluid collection with multiple internal echogenic foci. In the event of superimposed infection, the filler collection appears more heterogeneous and ill-defined. CT and MRI could precisely depict the extent of filler migration with adjacent soft tissue inflammatory changes. All of the radiologic findings in this case were very similar to those resulting from PAAG mammoplasty (11).
Polyacrylamide hydrogel (PAAG) was initially considered to be a safe, non-toxic and non-allergenic and biocompatible. Since the discovery of PAAG, it has been widely used for breast augmentation as a minimally invasive technique. However, increasing serious complications after PAAG injection have been reported, for which many women suffered greatly (3, 8, 10, 12). PAAG is now prohibited for clinical use in most countries. Nevertheless today, more than 20 years after the introduction of PAAG, surgeons without any experience with these injections meet patients with PAAG related late complications (9). In order to avoid making the same terrible mistake, the use of Aquafilling® filler for breast augmentation should be strongly restricted until long-term safety is proved and verified.
In conclusion, we have shown the severe complications of bilateral breast augmentation with Aquafilling® injection. Radiologic features of them were very similar to those from PAAG mammoplasty. Knowledge of the radiologic characteristics of Aquafilling® filler injected breasts as well as of related complications is very useful to make an accurate diagnosis and suggest proper management.
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