Clinical safety and breast symmetry after injectable acellular dermal fibers reconstruction: an MR-based volumetric study

Introduction

Breast-conserving surgery (BCS) aims to achieve an optimal balance between oncologic safety and cosmetic outcomes. However, depending on the extent of tissue excision and tumor location, aesthetic complications—including breast deformity, contour depression, and asymmetry—may occur due to residual tissue distortion (1-4). To address these issues, various oncoplastic techniques have been developed, with volume-replacement methods becoming increasingly important for their ability to immediately restore breast shape and fill tissue defects (5-7).

Historically, acellular dermal matrix (ADM) or absorbable mesh has been used primarily to fill breast defects, thereby minimizing the need for additional surgeries and reducing incision length (8-12). However, various complications related to ADM use have been reported, including infection, persistent seroma, red breast syndrome, and graft resorption (13-16).

Acellular dermal fibers (ADFs), which is a fiberized form of ADM, a recent innovation in volume replacement, is advantageous over conventional sheet-type or diced materials. Its toothpaste-like consistency allows it to be delivered directly into the defect without the need for an extended incision, preserving small internal air cavities that contribute to volume maintenance. This injectable form also allows for precise three-dimensional (3D) molding of the defect with minimal tissue manipulation—a feature not easily achieved with traditional sheets or meshes. Favorable outcomes have been reported in challenging clinical settings, such as diabetic foot wounds (17).

Despite these promising developments, clinical evidence regarding the safety of injectable ADFs (particularly concerning risks such as seroma, infection, and fat necrosis) and their ability to maintain cosmetic outcomes (e.g., breast symmetry) remains scarce. To address these gaps, this study aimed to evaluate postoperative complications and assess breast symmetry through MR-based 3D volumetric analysis in patients who underwent volume replacement with injectable ADFs. We present this article in accordance with the STROBE reporting checklist (available at https://gs.amegroups.com/article/view/10.21037/gs-2026-1-0056/rc).

Methods

Study population

The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Institutional Review Board (IRB) of the Kyungpook National University Chilgok Hospital (IRB No. 2024-06-017). The requirement for individual informed consent was waived for this retrospective analysis; however, written informed consent was obtained from patients who permitted the use of their images. This observational study included consecutive female patients who underwent BCS for breast cancer between June 2024 and October 2025 at Kyungpook National University Chilgok Hospital. A total of 30 patients received injectable ADFs (CG RealloPutty™; CG Bio, Seongnam, Republic of Korea) for volume replacement of the breast defect without any additional surgical procedures (Figure S1). One patient who showed margin positivity on permanent pathologic evaluation and subsequently underwent re-excision with complete removal of the injected ADFs and four patients with less than 6 months of postoperative follow-up were excluded (Figure S2). Therefore, a total of 25 patients were included in the final analysis.

All patients were diagnosed with breast cancer using ultrasound-guided core needle biopsy. Preoperative mammography and breast ultrasonography were performed for every patient. Breast magnetic resonance imaging (MRI) was additionally performed for 24 patients (except for one patient with severe claustrophobia), and the images were used to determine clinical staging and the extent of surgical resection. For patients who received neoadjuvant chemotherapy, interim imaging was performed between chemotherapy cycles to evaluate tumor response and predict pathologic complete response (pCR). The final surgical plan was established based on post-treatment imaging after completion of all chemotherapy cycles.

Treatment plans were individualized according to tumor stage, subtype and systemic condition, including the use of neoadjuvant chemotherapy, adjuvant chemotherapy, or endocrine therapy. Patients with carcinoma in situ underwent routine breast imaging surveillance, whereas those with invasive carcinoma underwent both routine breast imaging and systemic surveillance every 6 months after surgery.

Routine postoperative surveillance consisted of mammography and breast ultrasonography for breast monitoring, as well as blood tests, tumor marker assays, chest and abdominal computed tomography, and bone scans for systemic surveillance, at 6 months after surgery. At 12 months post-surgery, breast MRI was substituted for breast ultrasonography. Consequently, postoperative breast MRI data were available for seven patients, corresponding to the required postoperative surveillance timeframe. These seven patients were included in volumetric analysis to quantitatively assess postoperative complications and bilateral breast symmetry.

Surgical techniques

Patients were placed in the supine position under general anesthesia with the ipsilateral arm abducted. For non-palpable tumors, preoperative localization was performed using an H-wire under ultrasound guidance. All patients received 1 g of intravenous first-generation cephalosporin preoperatively, with an additional 1 g administered postoperatively. When sentinel lymph node biopsy was indicated, blue dye (indigocarmine) was injected subdermally in the periareolar region.

After confirming the tumor location, conventional BCS was performed. Surgical margins were secured by ensuring at least 5 mm of clearance from the tumor edge in all four directions—superior, inferior, medial, and lateral. Intraoperative margin assessment was conducted through specimen mammography and ultrasonography; if any margin was ≤5 mm, immediate re-excision was performed. After confirming negative margins, the surgical cavity was irrigated with 1,000 mL of normal saline to remove debris and hematoma, followed by meticulous hemostasis using electrocautery.

Although primary closure was attempted in all cases, a paste-type ADFs (CG Reallo Putty™) was injected into the defect when breast skin depression occurred. The injectable ADFs used in this study was derived from donated human dermis and processed through decellularization and sterilization procedures to remove cellular components while preserving the extracellular matrix. As the product is acellular, HLA compatibility testing is not required. And the material is approved for clinical use as a soft tissue reinforcement medical device. Although injectable ADFs may be used in variable volumes depending on the defect size (e.g., 3, 5, or 8 cc), a fixed volume of 5 cc was used in all cases in this study. To prevent extrusion of the material, the ADFs was placed within the mid-layer of the breast. Standard primary closure was performed with 3-0 monofilament sutures (Monocryl Plus^®; Ethicon, NJ, USA), and any remaining dead space was filled by injecting the ADFs in a toothpaste-like manner. After injection, no further manipulation was performed to maintain its volume and shape, and the superficial layer was closed. Drains were not routinely inserted because the injected ADFs were intended to fill the lumpectomy cavity and minimize dead space. Negative pressure drainage could potentially displace the injected material or interfere with its stabilization and integration within the surrounding tissue. A simple aseptic dressing without compression was applied, and a skin adhesive (EPI-SEAL^®; DOONE Meditech, Yongin, Republic of Korea) was used for wound closure.

Clinicopathologic characteristics

Data were collected on patient demographics, including age, body mass index, and underlying comorbidities. Clinical parameters, such as tumor size (clinical and pathologic), multifocality, tumor type, and treatment modalities, were also obtained. Surgical factors, including operative time, volume of resected tissue, length of hospital stay, and postoperative complications, were reviewed. All patients were followed up after completion of treatment to assess oncologic outcomes.

Postoperative complications were evaluated during routine outpatient follow-up visits and imaging assessments. Seroma was defined as a clinically or radiologically detectable fluid collection within the surgical cavity. Infection was defined as local inflammatory signs requiring antibiotic treatment, and necrosis was defined as clinically evident tissue necrosis requiring medical or surgical management.

Ultrasound examinations were performed during follow-up to assess postoperative changes within the lumpectomy cavity. When granuloma-like lesions were identified, their size, BI-RADS category, and interval changes on follow-up imaging were recorded. Biopsy was considered if imaging findings were suspicious or showed progressive growth.

Volumetric analysis with breast MRI

Of the 25 patients, 24 of them underwent preoperative 3T-breast MRI (excluding one patient with claustrophobia). Seven patients underwent routine 1.5T-abbreviated breast MRI 12 months after surgery. A systematic difference in acquisition protocols existed between the preoperative (3.0T, 2.0 mm slice thickness) and postoperative (1.5T, 1.0 mm slice thickness) scans (Table S1). Volumetric analysis was performed through paired preoperative and postoperative imaging for these seven patients (Figure 1).

Figure 1 Preoperative and postoperative breast magnetic resonance images of a patient who underwent breast-conserving surgery with injectable acellular dermal fibers for breast cancer. (A,C) Preoperative 3T breast magnetic resonance images. The breast cancer lesion appears as an enhancing mass within the breast parenchyma. The white contour line indicates the guideline used for volumetric measurements. (B,D) Postoperative 1.5T abbreviated breast magnetic resonance images. The slices most comparable to the preoperative images were selected. The skin incisions (yellow arrows) and surgical cavities (*) are shown.

Quantitative assessment was conducted using the deep learning-based volumetric analysis software, PredBMR (v.1.0.0; BeamWorks Inc., Daegu, Republic of Korea). To ensure the pipeline was robust against the aforementioned protocol heterogeneity, several automated standardizations were employed. For each patient, the first subtraction series was selected from the preoperative and postoperative MRI sequences to guarantee temporal consistency in the physiological contrast phase. Preprocessing included anatomical orientation standardization, min-max intensity normalization to mitigate absolute signal differences between the 3.0T and 1.5T scanners, as well as voxel spacing normalization and spatial resizing to uniform matrix dimensions for model inference.

Segmentation was performed using a U-Net architecture with a MobileNetV2 backbone, trained to simultaneously segment the breast and tumor (18,19). To ensure accurate boundary delineation and exclude non-breast tissue, the raw probability maps were subjected to 3D Gaussian smoothing followed by morphological operations, including erosion, connected component analysis, and dilation. These steps preserved the breast volume while eliminating spurious detections. To ensure volumetric reliability, a quality assurance protocol was implemented. All automated segmentations were independently reviewed slice-by-slice by a board-certified breast surgeon to confirm anatomical accuracy, specifically verifying the proper exclusion of the pectoral muscle and adequate coverage of the breast parenchyma. The AI-generated boundaries were confirmed to be accurate across all seven patients in the MRI subset; therefore, no manual corrections or edits were required, rendering the volumetric pipeline fully automated and reproducible. The segmentation predictions were then transformed back into the original digital imaging and communications in medicine (DI-COM) space for volumetric analysis.

The breast volume was calculated by summing the segmented voxels, each multiplied by the individual voxel dimensions derived from the DI-COM header (Pixel Spacing × Slice Thickness). This dynamic, physical voxel-based calculation inherently accounted for the variations in spatial resolution (e.g., 2.0 vs. 1.0 mm slice thickness) across the different MRI protocols. Total breast volume was defined as the volume within the breast mask, inclusive of the tumor. Bilateral breast segmentation allowed for the independent calculation of left and right breast volumes to assess symmetry.

Statistical analysis

Continuous variables are expressed as the mean ± standard deviation. To assess changes in breast symmetry after volume replacement with injectable ADFs, preoperative and postoperative symmetry values were compared for the seven patients who underwent MR-based volumetric assessment. The difference between preoperative and postoperative symmetry (Δ symmetry) was calculated for each patient. To account for baseline variations in breast size, a normalized metric for symmetry change, defined as the Δ ratio, was calculated. The Δ ratio was computed as the difference between postoperative and preoperative volume asymmetry, divided by the preoperative ipsilateral breast volume, and expressed as a percentage: [(postoperative asymmetry − preoperative asymmetry) / preoperative ipsilateral volume] × 100. Furthermore, for the purpose of right-left breast symmetry statistics, any patient with a prior history of contralateral total mastectomy was excluded from the analytical cohort to ensure a valid bilateral comparison. Because of the very small sample size of the valid MRI subset (n=6), normal distribution of the data could not be reliably assumed or tested. Therefore, a non-parametric approach was chosen a priori, and the Wilcoxon signed-rank test was utilized to compare paired preoperative and postoperative measurements. A two-tailed P value <0.05 was considered statistically significant.

Results

The mean age of the overall patient cohort was 54.2 years [standard deviation (SD), ±9.6]. The subgroup of seven patients who underwent postoperative MRI had a slightly higher mean age of 59.9 years (SD, ±8.9). The mean body mass index was 24.4 kg/m² (SD, ±3.9). Among underlying comorbidities, hypertension was the most common (n=5, 20.0%), followed by diabetes mellitus (n=2, 8.0%) and dyslipidemia (n=1, 4.0%).

The mean clinical tumor size, as measured by preoperative breast ultrasonography, was 2.7 cm (SD, ±1.5), whereas the mean pathologic tumor size was slightly smaller at 2.3 cm (SD, ±1.2). The most common clinical T stage was T2 (n=16, 64.0%), and multifocal disease was identified in 5 patients (20.0%). All patients underwent BCS, and sentinel lymph node biopsy was performed in 18 patients (72.0%). Postoperative radiotherapy was administered to all patients, with a mean of 16.5 fractions (SD, ±5.1).

After radiation therapy, patients visited the outpatient clinic within 4–6 weeks of radiation therapy to check for breast complications or cosmetic results. None of the patients complained of clinical symptoms such as pain or hard breasts (Figure 2). Routine postoperative surveillance was conducted at 6, 12, and 18 months. During the first 2 years, mammography combined with breast ultrasonography and mammography combined with breast MRI were alternated every 6 months. The demographic characteristics of the seven patients who underwent MRI at 12 months were comparable to those of the overall cohort (Table 1).

Figure 2 Clinical and ultrasound findings 4–6 weeks after completion of postoperative radiotherapy in patients who received breast conserving surgery with injectable ADFs. (A-C) Post-radiation photographs showed mild skin pigmentation and edema in the treated breast area, but overall breast symmetry was well maintained. (D-F) Ultrasonography revealed a hypoechoic area in the injectable ADFs implanted in the breast, but no specific clinical symptoms were observed. ADFs, acellular dermal fibers.

The mean weight of resected breast tissue was 35.5 g (SD, ±15.9), and the mean operative time was 76.2 minutes (SD, ±15.6). Final pathology confirmed negative margins in all cases, and the mean length of hospital stay was 2 days (SD, ±0.2). One patient required ultrasound-guided aspiration (approximately 20 mL) for a postoperative seroma, which resolved after a single aspiration. Granuloma formation was detected in 2 patients (8.0%) on follow-up breast ultrasonography. No new calcifications were observed on mammography, nor were any suspicious enhancing lesions found on postoperative breast MRI. The mean follow-up duration was 12.5 months (SD ±5.7) (Table 2).

Among the seven patients who underwent paired breast MRI before and after surgery, minor preoperative breast volume asymmetry was observed, largely within the range of normal anatomical variation. Postoperative MRI demonstrated maintained bilateral symmetry. Although absolute breast volumes were decreased postoperatively—likely due to weight loss after completion of breast cancer treatment—the decrease occurred proportionally in both breasts (Figure 3).

Figure 3 Comparison of preoperative and postoperative breast volumes in patients who underwent breast-conserving surgery with injectable ADFs. (A) Absolute breast volumes before (green) and after (red) surgery. Although postoperative breast volumes were decreased in all cases, overall breast symmetry was well maintained. One patient (*) had previously undergone total mastectomy on the right breast. (B) Patterns of preoperative and postoperative breast volumes in patients who underwent breast-conserving surgery with injectable ADFs. Bilateral breast symmetry was consistently well maintained both before and after surgery. ADFs, acellular dermal fibers.

One patient had a right-sided breast volume of 0 cm³ due to a prior total mastectomy (Table 3). Excluding this patient (Case 6), a true bilateral symmetry analysis was performed on the remaining cohort (n=6). Following surgery, the absolute change in breast volume asymmetry (Δ postoperative − preoperative asymmetry) was minimal, with a median of 27.4 cm³ [interquartile range (IQR), 23.0–41.3 cm³]. When normalized to the patient’s preoperative ipsilateral breast volume, the median Δ ratio was 4.7% (IQR, 3.9–7.0%). A Wilcoxon signed-rank test confirmed there was no statistically significant worsening in right-left volume symmetry after the procedure (P=0.09). Together, these minimal median differences indicate that postoperative breast symmetry closely mirrored preoperative baselines after volume replacement with injectable ADM.

Discussion

This study evaluated the clinical safety and cosmetic outcomes of a paste-type ADFs used for volume replacement following BCS. Postoperative breast symmetry was objectively assessed by MRI-based 3D volumetric analysis. Although previous studies have reported the use of ADM in BCS with sheet-, mesh-, or diced-type materials (8-12), this approach has been associated with a range of postoperative complications (13-16). Unlike sheet- or mesh-type ADM, injectable ADFs, which consist of finely processed fibers derived from the ADM, can be injected through a small incision into deeper defects. Furthermore, the toothpaste-like consistency, as opposed to a singular solid form, allows the creation of small internal air cavities that expand to occupy broader dead spaces, provided the material is not compressed. These features may enhance its ability to integrate with surrounding tissues, potentially reducing scarring or fibrotic reactions.

In the present study, the overall complication rate was remarkably low. Notably, there were no cases of postoperative infection or fat necrosis. Only one patient developed a seroma, requiring a single aspiration—this rate is lower than the seroma rates associated with sheet-type ADM in previous studies (20,21). Granulations were detected in two patients on follow-up breast ultrasonography; however, these were considered mild reactions related to the fibrotic process of ADFs and did not necessitate intervention. Importantly, no calcifications were observed on mammography, nor were any suspicious enhancing lesions detected on postoperative MRI. These findings suggest that injectable ADFs do not interfere with radiologic surveillance or mimic tumor recurrence.

MR-based 3D volumetric analysis of seven patients revealed a decrease in overall breast volume after surgery. This decrease may be attributed to postoperative radiotherapy and weight loss commonly observed after completion of cancer treatment (22-24). Nevertheless, the volume reduction occurred proportionally in both breasts, and bilateral breast symmetry was maintained at the 1-year follow-up. These findings describe postoperative volumetric changes following ADF-assisted BCS and suggest that this approach may help maintain breast contour over time. MRI-based volumetric assessment may be subject to measurement variability related to patient positioning, imaging parameters, and segmentation processes. Previous studies have reported that the margin of error for MRI-based volumetry may reach approximately 5–8% (25,26). In addition, differences in MRI acquisition protocols between preoperative and postoperative scans may introduce further variability in volumetric measurements. Therefore, small volumetric differences observed in this study should be interpreted with caution.

Autologous fat grafting is another widely used technique for volume restoration in breast reconstruction and contour correction. Previous studies have reported that approximately 50–70% of the injected fat volume is retained at 6 months, although outcomes may vary depending on harvesting, processing, and recipient-site factors (27-29). Compared with fat grafting, injectable ADFs function primarily as a structural extracellular matrix scaffold rather than a cellular graft. While fat grafting relies on adipocyte survival and revascularization, ADFs provide a stable framework that may support tissue integration and gradual fibrotic remodeling. In this context, injectable ADFs may offer certain practical advantages, including the absence of donor-site morbidity and a simplified surgical procedure. However, unlike fat grafting, ADFs do not provide living adipose tissue and therefore serve primarily as a structural filler rather than a biologic graft. Further comparative studies are needed to clarify the relative effectiveness of these approaches in maintaining long-term breast volume and contour.

The findings of this preliminary case series suggest potential advantages of injectable ADFs in providing immediate volume compensation and maintaining postoperative breast symmetry after BCS. The low complication rate and absence of radiologic findings suggest that this technique may be safe and compatible with routine oncologic surveillance. Moreover, compared with conventional flap-based volume replacement, injectable ADFs may offer a practical alternative without increasing operative time, particularly for surgeons and patients seeking less invasive options.

This study has several limitations. First, it was a retrospective analysis conducted at a single institution, which may limit the generalizability of the findings. In addition, MR-based volumetric assessment was performed for only seven patients, reducing the robustness of the quantitative symmetry analysis. The relatively short follow-up period also limits the ability to evaluate long-term volume preservation or detect infrequent late-onset complications. Another limitation lies in the systematic difference in MRI acquisition protocols; preoperative assessments were performed using 3.0T breast MRI with 2.0 mm slice thickness, whereas postoperative follow-up relied on 1.5T abbreviated breast MRI with 1.0 mm slice thickness. Although our AI pipeline mathematically mitigated these domain shifts through intensity normalization and dynamic physical voxel-based volume calculations, variations in magnetic field strength and image contrast can still subtly influence deep learning segmentations. Consequently, while the automated measurements strongly suggest symmetry preservation, these volumetric results should be interpreted conservatively as approximations rather than absolute anatomical truths. Furthermore, because MRI-based volumetric analysis was available only for a small subset of patients at the time of this study (n=7), the present results should be interpreted as preliminary observations. MRI-based volumetric analysis was available only for a subset of patients at the time of this study. Therefore, the present results should be interpreted as preliminary observations. Additional analyses including the remaining cohort are currently underway to further evaluate long-term volumetric outcomes. Despite these limitations, postoperative evaluations suggested that bilateral breast symmetry was generally maintained across the available follow-up time points. These preliminary findings indicate that injectable ADFs may represent a feasible option for volume replacement after BCS. Future multicenter or prospective studies with larger cohorts are required to validate these observations. Incorporating patient-reported cosmetic outcomes alongside objective volumetric measurements would also provide a more comprehensive assessment of the clinical value of injectable ADFs.

Conclusions

This study demonstrated that injectable ADFs may be a safe and effective alternative for filling breast defects. This minimally invasive technique can not only provide immediate volume replacement but also help preserve excellent symmetry and cosmetic outcomes. The findings offer compelling evidence supporting the expanded use of injectable ADFs, particularly for patients who may face increased surgical risks or who wish to minimize the extent of their surgical procedures while maintaining breast volume and symmetry.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://gs.amegroups.com/article/view/10.21037/gs-2026-1-0056/rc

Data Sharing Statement: Available at https://gs.amegroups.com/article/view/10.21037/gs-2026-1-0056/dss

Peer Review File: Available at https://gs.amegroups.com/article/view/10.21037/gs-2026-1-0056/prf

Funding: This research was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (No. HR-2022-KH130591). This work was also supported by the “Digital Healthcare Medical Device Demonstration Support Project” through the Ministry of Health and Welfare (MOHW), Daegu Metropolitan City, and the Korea Health Industry Development Institute (KHIDI).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://gs.amegroups.com/article/view/10.21037/gs-2026-1-0056/coif). W.H.K. and J.K. are CEOs of BeamWorks Inc., and M.L. is an employee of the same company, which provided the equipment used in this study. The other authors have no conflicts of interest to declare.

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. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Institutional Review Board (IRB) of the Kyungpook National University Chilgok Hospital (IRB No. 2024-06-017). The requirement for individual informed consent was waived for this retrospective analysis; however, written informed consent was obtained from patients who permitted the use of their images.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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