Outcomes and Complications of Autologous Fat Transfer for Total Breast Reconstruction and Augmentation: Systematic Review and Meta-analysis of Randomized Controlled Trials

Abstract

Background:

Autologous fat transfer (AFT) for total breast reconstruction and augmentation is increasingly applied due to its advantages over implants and autologous flaps, including minimal invasiveness, minimal donor-site morbidity, and quick recovery. However, AFT is not without complications when applied for full breast reconstruction, underscoring the need to evaluate its safety and effectiveness. This systematic review and meta-analysis assesses the oncological and surgical safety of AFT as a stand-alone procedure for total breast reconstruction and augmentation, including the effectiveness of different AFT techniques and patient-reported satisfaction.

Methods:

A MEDLINE, Embase, and Web of Science search (from inception to December 2024) focusing solely on randomized controlled trials evaluating AFT outcomes for total breast reconstruction or augmentation was performed. Animal studies, partial reconstruction/augmentation, and combined procedures were excluded. Data were extracted and analyzed using random-effects meta-analyses, following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines. Risk of bias was assessed using the Cochrane tool.

Results:

From 2323 identified articles, 9 randomized controlled trials were included. AFT showed fewer surgical complications compared with implant-based reconstruction. Oncological safety was similar between AFT and implant-based reconstruction. AFT-related complications (eg, oil cysts, fat necrosis) occurred at similar rates across different AFT techniques, but using fat sedimentation and retropectoral grafting were associated with fewer complications. Meta-analysis showed that all enriched AFT techniques—including stromal vascular fraction and botulinum toxin—improved fat retention rates.

Conclusions:

AFT is an effective and technically and oncologically safe option for total breast reconstruction and total breast augmentation. However, limited follow-up duration prevents definitive conclusions on long-term oncological outcomes.

Takeaways

Question: How does autologous fat transfer (AFT) compare to other techniques for total breast reconstruction and total breast augmentation in terms of safety, effectiveness, and patient- and surgeon-reported satisfaction?

Findings: This systematic review and meta-analysis found that AFT for total breast reconstruction/augmentation is oncologically safe, with fewer adverse events than implant-based reconstruction. Side effects were mostly self-limiting, with comparable complication rates across techniques, and fat sedimentation or retropectoral grafting may reduce risks. Enriched AFT (eg, with botulinum toxin A) improves volume retention.

Meaning: AFT is a safe and effective option for total breast reconstruction and total breast augmentation, with low complication rates and high satisfaction.

INTRODUCTION

Breast cancer is the most frequently diagnosed malignancy in women worldwide. As part of breast cancer treatment, many women still undergo full mastectomy, which—if desired—requires reconstruction of the entire breast (ie, total breast reconstruction).^1–3

Women undergoing full mastectomy often experience psychological and physical challenges, especially when they do not undergo total breast reconstruction. Breast reconstruction aims to restore the breast shape and improve quality of life and perceived body image, without compromising cancer prognosis or recurrence detection. Worldwide, implant-based reconstruction (IBR) remains the most selected option, but it raises concerns about complications such as capsular contracture, implant rupture, and breast implant illness, shifting interest toward autologous tissue reconstruction. Autologous flaps provide excellent biocompatibility but involve longer surgery and recovery times, and may lead to significant donor-site morbidity.^3–5

Autologous fat transfer (AFT) for total breast reconstruction offers a novel alternative to implants and autologous flaps, using liposuction and fat injection. Initially considered only suitable for partial defects or smaller breasts, recent studies have shown promising results for total breast reconstruction as the only reconstruction technique in medium- to large-sized breasts.^6,7 Unlike pedicled or free-flap transfer, AFT may achieve total autologous breast reconstruction with minimal invasiveness, low morbidity, and high patient-reported satisfaction.

AFT is also gaining popularity as a method for total breast augmentation in aesthetic procedures, especially in women who undergo breast implant removal. Consequently, the indications and popularity of AFT for total breast procedures are rapidly increasing.^3,8–12

Despite its advantages, AFT is not without complications. Complications include bruising; fat necrosis; oil cyst formation; calcifications; and, in rare cases, fat embolism. Concerns about its oncological safety have also been raised, with in vitro studies suggesting that adipocytes and adipose-derived stem cells (ASCs) can promote angiogenesis and tumor cell growth, potentially increasing the risk of cancer recurrence.^13–15 Moreover, fat necrosis, calcifications, and nodules may complicate cancer surveillance and physical examinations.^16–19

AFT’s growing popularity underscores the need to address these challenges. Although several reviews have explored AFT, a comprehensive review focusing exclusively on total breast reconstruction and total breast augmentation, and a review including only randomized controlled trials (RCTs) to provide the highest level of evidence, is still missing.

Our aim was to provide a systematic review and meta-analysis of available RCTs, focusing on the oncological and surgical safety, effectiveness, available techniques, and patient- and surgeon-reported satisfaction associated with AFT in total breast reconstruction, as well as total breast augmentation. In addition, the review evaluates the effectiveness of different AFT techniques, postoperative breast volume, and patient-reported quality of life.

METHODS

Search strategy

The protocol for this systematic review was registered in PROSPERO (CRD42024620043).¹ A systematic review of the literature on AFT for total breast reconstruction was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA),²⁰ and adapted based on the following initial PICO strategy: patient/population (ie, patients undergoing total breast reconstruction), intervention (ie, AFT), comparison (ie, other reconstructive techniques, no reconstruction, and/or different AFT techniques), outcome (ie, surgical and oncological safety, patient well-being, and satisfaction).

A comprehensive search was conducted in the bibliographic databases MEDLINE, Embase, and Web of Science from inception through final screening in December 2024. The search strategy included controlled terms (MesH in PubMed, Emtree in Embase), as well as free text terms (and their synonyms or closely related words): “mastectomy” combined with “breast reconstruction,” “auto transplant” or “autograft,” and “lipofilling,” “lipo transfer,” or “fat transplantation.” No restrictions were applied regarding date, language, or publication status. (See table, Supplemental Digital Content 1, which displays the search strategy, https://links.lww.com/PRSGO/E919.)

Eligibility Criteria

Inclusion Criteria

We searched for RCTs evaluating the safety, effectiveness, patient-reported and/or surgeon-reported satisfaction, and various surgical techniques of AFT for total breast reconstruction after mastectomy, as well as for total breast augmentation using AFT for aesthetic indications. Patients with operable breast cancer—either invasive or in situ carcinoma—who had previously undergone mastectomy, as well as patients undergoing total breast augmentation with AFT, were eligible. The RCTs had to evaluate AFT as a stand-alone procedure, without the use of any other reconstructive methods (such as autologous flaps or IBR), in patients who had not undergone prior breast reconstruction or augmentation.

Exclusion Criteria

Animal studies, AFT for partial defects, and studies in which patients had undergone previous reconstruction or augmentation or had undergone AFT combined with another method of breast reconstruction were excluded.

Study Selection

Two authors (G.S.M. and R.C.M.E.) independently assessed each study. Titles and abstracts of all identified studies were reviewed in Rayyan based on the inclusion criteria.²¹ Full-text articles were obtained and evaluated for all studies deemed potentially eligible. In cases of disagreement regarding study eligibility, the issue was resolved through discussion among the 4 authors (G.S.M., R.C.M.E., V.L.N., D.A.Y.A.).

To ensure a more comprehensive review and minimize the impact of reporting biases, corresponding authors of relevant studies were contacted to obtain or confirm data. Studies that initially seemed to meet the eligibility criteria but did not meet them upon closer examination were excluded.

Types of Outcome Measures

We included the following outcomes:

1. Surgical safety: perioperative and postoperative complications, morbidity, and mortality.

2. Oncological safety: tumor recurrence, disease-free survival, metastasis-free survival, and mortality.

3. Health-related quality of life (HR-QoL): as measured by validated patient-reported outcome measures, that is, BREAST-Q and EORTC QLQ C30.^22,23

4. Satisfaction: patient and surgeon satisfaction with the reconstructed breast.

5. Cancer surveillance and radiological follow-up: potential impact of AFT on radiological breast cancer screening due to complications such as fat necrosis and calcification.

6. Breast volume: postoperative breast volume.

Data Extraction and Management

Data from eligible studies were extracted using prestandardized forms. (See appendix, Supplemental Digital Content 2, which displays the data extraction forms, https://links.lww.com/PRSGO/E920.) Before full implementation, the data extraction form was pilot tested on a small sample of studies to ensure accuracy and usability and revised accordingly before finalization.²⁴ Two authors (G.S.M. and R.C.M.E.) independently extracted the data from each study using the data extraction form. A third author (V.L.N.) reviewed and verified both data extraction forms to ensure accuracy and consistency. Any disagreements were resolved through discussion or, if needed, by contacting the original investigators for clarification.

Results Categories

Results were divided into 2 categories:

1. RCTs comparing total breast reconstruction using AFT with other reconstructive techniques.

2. RCTs comparing different AFT techniques for total breast augmentation.

Risk of Bias Assessment

The risk of bias in the included RCTs was assessed using the Cochrane Collaboration Risk of Bias Tool (RoB 1).²⁵ This tool evaluates bias in the randomization process, blinding of participants, personnel, and outcome assessment. It also considers incomplete data, selective reporting, and other potential sources of bias. Discrepancies in bias assessment were resolved through discussion between reviewers (G.S.M. and R.C.M.E.) or, if needed, with a third author (V.L.N.).

Statistical Analyses

For an outcome to be included in the meta-analysis, at least 2 studies had to report comparable data. Only studies reporting mean values were considered; missing SDs were calculated. Breast volume was pooled using a random-effects meta-analysis with inverse variance weighting. Heterogeneity was assessed with the I² statistic and τ² estimation. All analyses were performed using RevMan (version 5.4) by 2 authors (G.S.M. and R.C.M.E.), in collaboration with epidemiologists from the Department of Epidemiology and Data Science at Amsterdam University Medical Center.

RESULTS

Study Selection and Quality Assessment

A total of 2323 articles were identified. After removing duplicates, 1881 articles remained. Title and abstract screening reduced the selection to 38 eligible studies. Following full-text assessment, 29 articles were excluded, resulting in the inclusion of 9 RCTs for qualitative analysis, of which 3 were included in the quantitative synthesis. The process of article selection is illustrated in the PRISMA flow diagram (Fig. 1). Characteristics of the included RCTs are presented in Table 1. The study cohort consisted entirely of female participants. The RoB1 assessment indicated a low risk of bias in most studies. However, performance bias was high due to lack of blinding, and some studies showed unclear risks in randomization and allocation, suggesting potential selection bias (Fig. 2). In studies assessing quality of life and patient satisfaction, 2 validated patient-reported outcome measures were used in the included studies: the BREAST-Q²² and the EORTC QLQ-C30.²³

Fig. 1.

PRISMA flow diagram.

Table 1.

Patient Characteristics

Study (Year)	Treatment		Follow-up, mo	Sample Size at Baseline (Follow-up)		Age at Baseline (SD) [IQR], y		BMI (SD) [IQR], kg/m2		Reason for Undergoing AFT		Type of Surgery Undertaken		Injected Volume (SD) [IQR], mL
	I	C		I	C	I	C	I	C	I	C	I	C	I	C
Kang and Luan (2018)26	AFT: CG	AFT: SD	3	77 (77)	90 (90)	44.5 (6.2)	42.8 (6.3)	21.24 (2.11)	21.45 (2.56)	Mastectomy/micromastia (breast augmentation)	Mastectomy/micromastia (breast augmentation)	If surgery undertaken: mastectomy	If surgery undertaken: mastectomy.	177.91 (61.72)	174.35 (46.41)
Zheng et al (2019)27	AFT with SM	AFT	3	10 (10)	5 (5)	30.4 (3.2)	29.6 (4.3)	21.6 (2.8)	21.1 (1.25)	Breast augmentation	Breast augmentation	—	—	218.89 (20.251)	175 (40.708)
Kølle et al (2020)28	AFT with ASCs	AFT	4	8 (6)	8 (6)	29 [21–42]	29 [21–42]	19.2 [18–22.5]	20.8 [19.7–23.8]	Breast augmentation	Breast augmentation	—	—	222.5 [270–182.5]	260 [310.6–240]
Hu et al (2022)29	AFT with tSVF	AFT	6	17 (17)	17 (17)	35.5 (6.9)	34.6 (9.2)	20.3 (1.6)	20.1 (1.9)	Breast augmentation	Breast augmentation	—	—	Left: 272.9 (22.2). Right: 290.5 (26.2)	Left: 250.8 (21.2). Right: 268.8 (22.2)
Li et al (2022)30	Two-thirds of fat graft in RPP	Two-thirds of fat graft in RMP	6	20 (20)	20 (20)	29.7 (4.9)	28 (4.7)	20.4 (2.3)	21.6 (2.4)	Breast augmentation	Breast augmentation	—	—	311.5 (20.2)	307.5 (30.4)
Vester-Glowinski et al (2022)31	AFT with ASCs	AFT	12	10 (10)	10 (10)	33 [30.3–40.0]	33 [30.3–40.0]	24.3 [22.9–25.7]	24.3 [22.9–25.7]	Breast augmentation	Breast augmentation	—	—	300 [300–315]	300 [300–315]
Piatkowski et al (2023)6	TBR with AFT	TBR with IBR	12	93 (64)	98 (68)	49.3 (10.3)	49.1 (11)	23.8 (2.6)	23.2 (2.4)	Breast cancer or preventive	Breast cancer or preventive	Mastectomy	Mastectomy	217.8 (74.6) per session per breast	217.8 (74.6) per session per breast
Wederfoort et al (2023)7	TBR with AFT	TBR with IBR	12	25 (25)	25 (25)	49.3 (9.6)	47.2 (10.1)	23.9 (2.8)	23.7 (2.5)	Breast cancer or preventive	Breast cancer or preventive	Mastectomy	Mastectomy	217.8 (74.6) per session per breast	217.8 (74.6) per session per breast
Liu et al (2024)32	AFT with BTX-A	AFT with saline	6	18 (16)	18 (16)	28.38 (6.5)	28.38 (6.5)	20.32 (2.1)	20.32 (2.1)	Breast augmentation	Breast augmentation	—	—	NR	NR

AFT, autologous fat grafting; ASCs, adipose-derived stromal cells; BTX-A, botulinum toxin A; C, Control; CG, centrifugation; I, intervention; IBR, implant-based reconstruction; IQR, interquartile range; NR, not reported; RMP, retromammary plane; RPP, retropectoral plane; SD, sedimentation; TBR, total breast reconstruction; tSVF, tissue stromal vascular fraction.

Fig. 2.

Risk of bias assessment.

Total Breast Reconstruction Using AFT Versus Another Reconstructive Technique

One RCT compared AFT with IBR for total breast reconstruction following mastectomy for breast cancer treatment or risk-reducing purposes (Tables 2, 3).⁶

Table 2.

RCT Comparing Autologous Fat Grafting With Other Reconstructive Techniques: Follow-up and Operation/Oncological Safety

Study (Year)	Treatment		Reason for Undergoing AFT	Technique		Follow-up, mo	Operation-related Safety (Perioperative and Postoperative Complications), %		Oncological Safety, %
	I	C		I	C		I	C	I	C
Piatkowski et al (2023),6 Wederfoort et al (2023)7	TBR with AFT	TBR with IBR	Breast cancer or preventive mastectomy	AFT with external expansion (EveBra). Coleman and Saboeiro Technique	Two-stage IBR with tissue expanders	12	Nononcological AEs: n = 43 (12.9). Nononcological SAEs: n = 4 (1.21)	Nononcological AEs: n = 25 (20.2). Nononcological SAEs: n = 13 (10.5)	Oncological SAEs: n = 4 (0.04)	Oncological SAEs: n = 5 (0.06)

SAEs, serious adverse events.

Table 3.

RCT Comparing Autologous Fat Grafting With Other Reconstructive Techniques: QoL, Patient/Surgeon Satisfaction, Breast Volume, and Radiological Follow-up

Study (Year)	Treatment		Reason for Undergoing AFT	Technique		Follow-up, mo	Quality of Life	Patient Satisfaction	Surgeon Satisfaction (SD)	Breast Volume (Preoperative), mL	Breast Volume (Postoperative), mL (SD)	Radiological Follow-up
	I	C		I	C
Piatkowski et al (2023),6 Wederfoort et al (2023)7	TBR with AFT	TBR with IBR	Breast cancer or preventive mastectomy	AFT with external expansion (EveBra). Coleman and Saboeiro technique	Two-stage IBR with tissue expander	12	IG showed significantly greater improvements in QoL over time for satisfaction with breasts (6.2, P = 0.005), physical well-being: chest (4.6, P = 0.001), and sexual well-being (5.2, P = 0.003)	BREAST-Q* scores were higher in the IG in all 5 domains and significantly higher in 3: satisfaction with breasts: IG 70.3 (17.8) versus CG 60.4 (17.2), P = 0.002. Physical well-being, chest: IG 79.9 (14.7) versus CG 72.3 (17.0), P = 0.007. Satisfaction with outcome: IG 73.9 (22.4) versus CG 66.3 (19.8), P = 0.04	IG: 7.12 (0.79) versus CG: 6.84 (0.78), P = 0.22	NR	Postoperative volume: IG 300.3 (111.4) versus CG 384.1 (86.6); −83.8 (95% CI, −116.2 to −51.3)	NR

^*No significant results in other domains of the BREAST-Q questionnaire after 12 months follow-up.

CG, control group; IG, intervention group; NR, not reported.

Surgical and Oncological Safety

Nononcological serious adverse events (AEs) were more frequent in the IBR group (10.5%) than in the AFT group (1.2%). Examples include hematoma requiring reoperation and skin necrosis for both groups, fat necrosis in the AFT group, and implant loss in the IBR group. Nononcological AEs were more common after IBR (20.2%) than after AFT (12.9%). No differences were observed for serious oncological AEs.⁶

Quality of Life, Patient, and Surgeon Satisfaction

BREAST-Q was used to measure HR-QoL and satisfaction, with higher scores (ie, better outcomes) in the AFT group across all 5 domains. Statistically significant differences were observed for satisfaction with breasts, 70.3 (17.8) versus 60.4 (16.7) (P = 0.002); physical well-being: chest 79.9 (14.7) versus 72.3 (17.0) (P = 0.007); and satisfaction with outcome, 73.9 (22.4) versus 66.3 (19.8) (P = 0.04). Linear mixed-effects regression showed that QoL changes over time also favored the AFT group in satisfaction with breasts, 6.23 (1.91–10.55) (P = 0.005); physical well-being: chest, 4.59 (1.84–7.34) (P = 0.001), and sexual well-being, 5.18 (1.77–8.59) (P = 0.003).⁶

The aesthetic outcome of AFT versus IBR was evaluated by laypeople, breast cancer patients, and plastic surgeons. Laypeople reported a statistically significantly higher score for IBR (−1.04, P < 0.001), but plastic surgeons favored AFT outcomes. Among breast cancer patients, no significant difference in evaluation was found between AFT and IBR.⁷

Breast Volume

At 12 months, the mean breast volume was 300.3 mL (SD 111.4 mL) in the AFT group and 384.1 mL (SD 86.6 mL) in the IBR group, with a mean difference (MD) of −83.8 mL (95% confidence interval [CI], −116.2 to −51.3).⁶

Different Techniques of AFT for Total Breast Augmentation

Seven RCTs compared different AFT techniques for total breast augmentation (Tables 4, 5).^26–32

Table 4.

RCTs Comparing Different Techniques of AFT: Follow-up and Operation/Oncological Safety

Study (Year)	Treatment		Reason for Undergoing AFT	Technique		Follow-up, mo	Operation-related Safety (Perioperative and Postoperative Complications)	Oncological Safety
	I	C		I	C
Kang and Luan (2018)26	AFT: CG	AFT: SD	Mastectomy/micromastia	Low-speed centrifugation: harvested fat was placed in a sterile centrifuge tube and centrifuged at 800 rpm for 3 min	Sedimentation: allowing the fat tissue to settle for 15 min to remove impurities without centrifugation	3	Clinically palpable nodules: IG: n = 15 (19.48%) versus CG: n = 6 (6.67%), P < 0.05. Ultrasound-detected hypoechoic cysts IG: n = 45 (58.44%) versus CG: n = 38 (42.22%), P < 0.05	NR
Zheng et al (2019)27	AFT with SM	AFT	Breast augmentation	IV SM injection (20 mL in 500 mL 5% glucose solution daily, 1 wk preoperatively to 3 wk postoperatively) used alongside AFT to the breast	AFT to the breast without SM injection	3	Various degrees of ecchymosis and bruises (resolved within 2 wk) occurred in both groups. No significant AEs were reported during the follow-up period	NR
Kølle et al (2020)28	AFT with ASCs	AFT	Breast augmentation	ASC-enriched fat grafting with ≥20 × 106 viable ASCs per mL fat	Conventional fat grafting without ASC enrichment	4	Common complications such as swelling and bruising occurred in both groups but subsided as expected	NR
Hu et al (2022)29	AFT with tSVF	AFT	Breast augmentation	Coleman technique. Combination of fat grafting and stromal vascular fraction with ASCs	Coleman	6	NR	NR
Li et al (2022) 30	Two-thirds of fat graft in RPP	Two-thirds of fat graft in RMP	Breast augmentation	Coleman technique. Two-thirds of fat injected into RPP, the remaining fat into the subcutaneous layer and RMP	Coleman technique. Two-thirds of fat injected into RMP, the remaining fat into the subcutaneous layer and RPP	6	Higher incidence of oil cysts (>1 cm). IG: n = 2 (10%) versus CG: n = 12 (60%), P = 0.035	No changes were observed in the BIRADS classification
Vester-Glowinski et al (2022) 31	AFT with ASCs	AFT	Breast augmentation	Coleman technique. Fat was harvested, processed, and enriched with a solution containing 10 × 106 ASCs/mL before injection	Coleman technique. Placebo-enriched fat grafting. Fat grafts were mixed with centrifuged fat as placebo	12	Benign cysts (oil cysts). IG: n = 9 (90%) versus CG: n = 9 (90%)	The increase in BIRADS score did not differ between the IG and CG, and no malignant changes were found
Liu et al (2024)32	AFT with BTX-A	AFT with saline	Breast augmentation	Fat mixed with 100 IU BTX-A	Fat mixed with 2 mL of saline	6	MRI/ultrasound-detected masses: IG: n = 5 versus CG: n = 6, with no significant difference. Undercorrection was the most common complication, often necessitating a second operation	NR

EORTC QLQ-C30, quality of life scale; IV, intravenous; MRI, magnetic resonance imaging; RMP, retromammary plane; RPP, retropectoral plane; tSVF, tissue stromal vascular fraction.

Table 5.

RCTs Comparing Different Techniques of AFT: QoL, Patient/Surgeon Satisfaction, Breast Volume, and Radiological Follow-up

Study (Year)	Treatment		Reason for Undergoing AFT	Technique		Follow-up, mo	Quality of Life [IQR]	Patient Satisfaction	Surgeon Satisfaction (SD) [IQR]	Breast Volume Preoperative, mL (SD) [IQR]	Breast volume Postoperative (SD)	Radiological Follow-up
	I	C		I	C
Kang and Luan (2018)26	AFT: CG	AFT: SD	Mastectomy/micromastia (breast augmentation)	Low-speed centrifugation: harvested fat was placed in a sterile centrifuge tube and centrifuged at 800 rpm for 3 min	Sedimentation: allowing the fat tissue to settle for 15 min to remove impurities without centrifugation	3	NR	NR	NR	NR	NR	NR
Zheng et al (2019)27	AFT with SM	AFT	Breast augmentation	IV SM injection (20 mL in 500 mL 5% glucose solution daily, 1 wk preoperatively to 3 wk postoperatively) used alongside AFT to the breast	AFT to the breast without SM injection	3	NR	All participants were satisfied with the results	NR	IG: 250 (29.7) versus CG: 155.9 (55), P = 0.0588	Fat graft retention rate: IG: 60.06% (16.12) versus CG: 34.04% (11.15), P < 0.05. Increased breast volume (mL); IG: 133.44 (39.14) versus CG: 59.13 (21.01). Rate of breast enlargement: IG: 74.65 (30.07%) versus CG: 21.57 (1.19%)	No calcifications, cysts, or abnormal findings on MRI
Kølle et al (2020)28	AFT with ASCs	AFT	Breast augmentation	ASC-enriched fat grafting with ≥20 × 106 viable ASCs per mL fat	Conventional fat grafting without ASC enrichment	4	NR	NR	Significant better augmentation and cosmetic outcomes in IG than the CG 4.50 [4.67–4.33] versus 2.67 [3.33–2.25], P < 0.00001	IG: 155 [50–200] versus CG: 195 [170–275]	Volume retention: IG: 80.2% [124.2–66.1] versus CG: 45.1% [50.7–36.5], P = 0.0022. Factor enlargement: IG: 2.6 [1.94–3.37] versus CG: 1.57 [1.69–1.43], P = 0.0043	MRI used to assess volume retention
Hu et al (2022)29	AFT with tSVF	AFT	Breast augmentation	Coleman Combination of fat grafting and stromal vascular fraction (SVF) with ASCs	Coleman	6	EORTC QLQ-C30: IG 74.8 [61.6–87.7] vs. CG 71.4 [58.2–83.4], P = 0.47	NR	NR	NR	Total effective rate: IG: 88.34% vs. CG: 52.94%, P = 0.024	NR
Li et al (2022) 30	Two-thirds of fat graft in RPP	Two-thirds of fat graft in RMP	Breast augmentation	Coleman technique. Two-thirds of fat injected into RPP, the remaining fat injected into the subcutaneous layer and RMP	Coleman technique. Two-thirds of fat injected into RMP, the remaining in fat injected into the subcutaneous layer and RPP	6	NR	NR	NR	NR	Retention rate: IG: 39.3% (5.1) versus CG: 35.9% (6.6), P = 0.1076	NR
Vester-Glowinski et al (2022) 31	AFT with ASCs	AFT	Breast augmentation	Coleman technique. Fat was harvested, processed, and enriched with a solution containing 10 × 106 ASCs/mL before injection	Coleman technique. Placebo-enriched fat grafting. Fat grafts were mixed with centrifuged fat as placebo	12	NR	NR	NR	NR	Fat graft volume retention: IG: 54.0% [30.4 –77.6] versus CG: 55.9% [28.9 –82.9], P = 0.566	MRI and mammography indicated no malignant changes
Liu et al (2024)32	AFT with BTX-A	AFT with saline	Breast augmentation	Fat mixed with 100 IU BTX-A	Fat mixed with 2 mL saline	6	NR	IG: 3.33 (0.23) versus CG: 2.96 (0.18); MD: 0.37 with a 95% CI of 0.05 –0.69 (P = 0.026)	IG: 3.33 (0.23); CG: 2.96 (0.18); MD: 0.37 with a 95% CI of 0.05–0.69 (P = 0.026).	NR	Fat retention rate: IG: 40.76% (16.62) versus CG: 31.14% (13.14), P = 0.007	NR

EORTC QLQ-C30, quality of life scale; IV, intravenous; MRI, magnetic resonance imaging; tSVF, tissue stromal vascular fraction.

Surgical and Oncological Safety

Reported surgical complications included oil cysts, fat necrosis, swelling, bruising, ecchymosis, calcifications, and undercorrection. Kang and Luan²⁶ compared low-speed centrifugation of harvested fat with sedimentation of fat for breast augmentation and found a higher incidence of clinically palpable nodules in the centrifugation group (n = 15, 19.5%) compared with the sedimentation group (n = 6, 6.7%) (P < 0.05). Similarly, ultrasound-detected hypoechoic cysts were more frequent in the centrifugation group (n = 45, 58.4%) versus the sedimentation group (n = 38, 42.2%) (P < 0.05).²⁶

Zheng et al²⁷ compared AFT with Salvia miltiorrhiza (SM) to AFT alone, whereas Kølle et al²⁸ studied AFT with ASCs. Both found common complications such as bruising, with no notable AEs. Similarly, Liu et al³² observed no difference in complications between AFT with botulinum toxin A (BTX-A) and AFT alone.^27,28

Li et al³⁰ compared fat transfer into retropectoral versus retromammary planes, reporting a higher incidence of oil cysts in the retromammary group (P = 0.035). Vester-Glowinski et al³¹ found no difference in oil cyst incidence between AFT with ASCs and AFT alone. Only Li et al³⁰ and Vester-Glowinski et al³¹ assessed radiological findings and oncological safety, reporting no differences in breast imaging reporting and data system (BIRADS) classification and no malignancies after 6 and 12 months, respectively.³¹

Quality of Life

Hu et al²⁹ reported no statistically significant differences in the EORTC QLQ-C30 questionnaire between AFT alone and AFT with tissue stromal vascular fraction.

Patient Satisfaction

Zheng et al²⁷ reported that all patients were satisfied, with no difference between the AFT with SM group and the AFT-only group. Liu et al³² reported a 6-month satisfaction score of 3.54 (SD 0.24) on the AFT with BTX-A side versus 3.05 (SD 0.18) on the AFT-only side, with a statistically significant MD of 0.49 (95% CI, 0.15–0.83, P = 0.032).

Surgeon Satisfaction

Two studies reported superior outcomes in the intervention group based on surgeon photograph evaluations.^28,32 Kølle et al²⁸ found statistically significantly higher scores in the AFT with ASCs group, 4.50 (95% CI, 4.33–4.67) versus 2.67 (95% CI, 2.25–3.33) in the AFT-only group (P < 0.00001). Liu et al³² reported a significantly higher mean score for the AFT with BTX-A group, 3.33 (SD 0.23), compared with the AFT-only group, 2.96 (SD 0.18), with an MD of 0.37 (95% CI, 0.05–0.69, P = 0.026).

Breast Volume

Kølle et al²⁸ and Vester-Glowinski et al³¹ assessed AFT with ASCs as the intervention group and measured fat retention using medians. Kølle et al²⁸ reported statistically significantly higher retention in AFT with ASCs (80.2% versus 45.1%, P = 0.0022), whereas Vester-Glowinski et al³¹ found no statistically significant difference. Li et al³⁰ found no statistically significant difference in postoperative volume retention between various planes of fat injection. Zheng et al²⁷ and Kølle et al²⁸ both found a greater increase in breast volume for AFT plus an additional intervention.

Statistical Analyses

Breast Volume

The meta-analysis demonstrated that AFT with enrichment resulted in significantly higher fat retention compared with AFT alone. The pooled analysis of 3 studies (n = 81) demonstrated a statistically significant MD of 20.27 (95% CI, 5.66–34.88, P = 0.007) in favor of enriched AFT. Despite this positive outcome, moderate heterogeneity was observed (I² = 60%), indicating some variability among the included studies (Fig. 3).^27,29,32

Fig. 3.

Forest plot.

DISCUSSION

This systematic review and meta-analysis assessed outcomes from RCTs evaluating AFT for total breast reconstruction after mastectomy and total breast augmentation for aesthetic purposes, without any added techniques for total breast reconstruction. The findings indicate that AFT is a technically and oncologically safe and effective option for total breast reconstruction, leading to high patient-reported satisfaction for these purposes. It is important to acknowledge that AFT as a cosmetic option may have different outcomes regarding safety, efficacy, and satisfaction for both patients and surgeons compared with AFT used for reconstructive purposes, which could introduce potential bias.

Surgical Safety

Fewer complications were reported with AFT compared with IBR. AFT is generally safe, with self-limiting common side effects (eg, bruising) that do not require medical intervention. Although complications such as oil cysts, calcifications, and fat necrosis have been reported, their incidence seems similar across all groups, regardless of AFT techniques. Fat sedimentation and retropectoral grafting were associated with reduced oil cyst formation.^6,30

Oncological Safety

Oncological safety has been evaluated in 3 RCTs, none of which identified any oncological risks associated with AFT.^6,30,31 However, these trials did not prioritize oncological safety, and follow-up periods were short, with a maximum of 12 months. Due to ethical and practical constraints, further RCTs are unlikely, leaving nonrandomized studies as the best available future evidence supporting the oncological safety of AFT.^11,33

No radiological issues were reported in the included RCTs, and BIRADS scores remained comparable between groups. However, these studies were not specifically designed to evaluate radiological outcomes. Although such changes could theoretically mimic malignancy on imaging and lead to unnecessary biopsies or patient anxiety—particularly in oncological populations—this was not systematically assessed.³⁴ Future studies should address these aspects more explicitly to better understand the diagnostic and emotional implications of AFT in breast cancer surveillance.

Quality of Life and Patient and Surgeon Satisfaction

The outcomes regarding HR-QoL and satisfaction in patients undergoing AFT are mixed. AFT scores significantly better than IBR on BREAST-Q assessments.⁶ Patient-reported satisfaction improved when AFT was used in combination with BTX-A.³²

Surgeons rated aesthetic outcomes higher for AFT. Although laypeople preferred IBR, surgeons clearly favored AFT.⁷ This indicates that laypeople generally find implants more aesthetically pleasing than AFT, whereas professionals rate AFT higher. This may stem from societal ideals of breast appearance—emphasizing volume and roundness—shaped by media.

Breast Volume

There are concerns about AFT’s ability to achieve breast volume comparable to implants due to variable fat retention. Most RCTs in this review evaluated breast volume as an outcome. AFT resulted in a comparable final volume to IBR.⁶ In most studies,^27–32 a single AFT session was performed, although some reported multiple sessions ranging from 2 to 7 sessions,^6,7 or reported 2 sessions in one part of the cohort and 1 session in the other.²⁶

Our meta-analysis demonstrated that enrichment techniques such as tissue stromal vascular fraction, BTX-A, and SM significantly improved fat retention rates, suggesting a beneficial effect of AFT enrichment.^27,29,32 However, this conclusion should be interpreted with caution, as it is based on pooled data from heterogeneous enrichment methods.

Several factors may influence fat retention following AFT. Radiotherapy has been associated with reduced graft survival compared with nonirradiated breast tissue,³⁵ though larger studies are needed to confirm this effect. Preoperative breast volume is another important factor, with a 100-mL increase linked to a 4%–8% rise in fat retention,³⁶ making it a key confounder in outcome assessment.

Body weight fluctuations also significantly affect graft survival. Vester-Glowinski et al³¹ reported a strong correlation between fat retention and weight changes, highlighting the importance of weight stability. The injection plane, however, did not impact fat retention.³⁰

Furthermore, it is notable that many studies primarily report breast volume as the main outcome measure. Although volume retention is important, prioritizing the patient’s reconstructive goals is essential. Future research should emphasize evaluating whether the patient’s specific goals and expectations are met, rather than focusing solely on volume retention. Addressing patient-reported outcomes is crucial for a comprehensive assessment of AFT’s effectiveness.

AFT With Other Reconstructive Techniques

AFT can be combined with other reconstructive techniques to enhance outcomes. For instance, in radiation-damaged breasts, AFT reduced complications in alloplastic reconstruction, promoted capsular remodeling, and increased volume in latissimus dorsi and transverse myocutaneous gracilis flap reconstructions. This approach seemed to be safe and low in morbidity, and enabled fast recovery.^37–39

CONCLUSIONS

This systematic review and meta-analyses based on RCT results shows that AFT is a surgically and oncologically safe and effective method for total breast reconstruction and total breast augmentation. However, studies focusing on long-term outcomes are required to draw definitive conclusions about long-term safety.

DISCLOSURE

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

ACKNOWLEDGMENT

The authors acknowledge Miranda Langendam and Sharon Remmelzaal from the Department of Epidemiology and Data Science at Amsterdam University Medical Center, the Netherlands, for their valuable contribution to the statistical analysis.