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Breast: Original Article

Acellular Dermal Matrix–Associated Complications in Implant-Based Breast Reconstruction: A Multicenter, Prospective, Randomized Controlled Clinical Trial Comparing Two Human Tissues

Broyles, Justin M. M.D.; Liao, Eric C. M.D.; Kim, John M.D.; Heistein, Jonathan M.D.; Sisco, Mark M.D.; Karp, Nolan M.D.; Lau, Frank H. M.D.; Chun, Yoon S. M.D.

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Plastic and Reconstructive Surgery: April 20, 2021 - Volume PRS Online First - Issue - 10.1097/PRS.0000000000008194
doi: 10.1097/PRS.0000000000008194
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According to the American Society of Plastic Surgeons, 107,238 women underwent breast reconstruction in 2018. In the United States, implant-based breast reconstruction accounts for the vast majority (82 percent) of breast reconstruction procedures performed as either a single-stage implant placement (18 percent) or as a two-stage procedure in which initial tissue expander placement is followed by permanent implant exchange at a later date (82 percent).1 Acellular dermal matrix plays an important role in implant-based breast reconstruction and is widely utilized in an “off-label” manner in breast reconstruction, according to the U.S. Food and Drug Administration.2 When utilized in breast reconstruction, the acellular dermal matrix provides support to the overlying mastectomy skin flaps, and this soft-tissue support of the inferior pole enhances the plastic surgeon’s ability to effectively contour the breast shape and improve aesthetic outcomes.3,4 In addition, the use of acellular dermal matrices in prosthetic breast reconstruction has been associated with increased intraoperative tissue expander fill volumes, decreased time to final expansion, and potential mitigation of capsular contracture.5–8 Acellular dermal matrices also facilitate single-stage implant-based breast reconstruction when native mastectomy skin flaps are adequately perfused after skin-sparing or nipple-sparing mastectomy.9,10 More recently, in the setting of healthy mastectomy skin flaps, prepectoral tissue expander or implant placement is becoming a popular option, with the acellular dermal matrices used in various configurations.11

While some available acellular dermal matrix products are derived from animal sources, including bovine and porcine products, human acellular dermal matrix remains the most commonly used product in breast reconstruction. In 2019, approximately 75 percent of prosthetic-based breast reconstructions used acellular dermal matrices, with 96 percent utilizing human and 4 percent utilizing xenograft acellular dermal matrices.1 Human acellular dermal matrices were first described for use in breast surgery in 2005.12 According to industry reports, the most commonly utilized human matrix in breast reconstruction is AlloDerm (AbbVie/LifeCell, Bridgewater, N.J.), followed by FlexHD Pliable (MTF Biologics, Edison, N.J.).13 Although both products are human-derived, they are processed differently, which may have implications in clinical safety and performance. AlloDerm undergoes a terminal sterilization process that includes electron beam irradiation and is sterile to a sterility assurance level of 10−3, whereas FlexHD is aseptically processed to comply with the requirements of United States Pharmacopeia sterility tests, going through a validated chemical sterilization process to achieve a sterility assurance level of 10−6.14

Complications have long been a primary concern related to the use of acellular dermal matrices. Early reports suggested an increased risk of postoperative complications, most notably seroma and infection, after human acellular dermal matrix–associated implant-based breast reconstruction when compared with total muscle coverage.15–17 Since 2005, more than 300 peer-reviewed articles have been published regarding the use of human acellular dermal matrices in breast reconstruction. The six studies that have compared outcomes between FlexHD and AlloDerm have reported conflicting results and have had significant limitations, including inconsistent outcome measures, potential for selection bias, retrospective study design, and lack of standardization in definitions and reporting methodology.18–24

Given the extensive use of human acellular dermal matrix in breast reconstruction, the lack of high-quality data regarding the relative performance of these products has had widespread clinical implications. Therefore, a multicenter, prospective, randomized clinical trial was designed to evaluate the most common human acellular dermal matrices available to plastic surgeons. The present study is the first prospective, multicenter, randomized controlled clinical trial to report and compare the human acellular dermal matrix–related complications of the two most commonly used human matrices in implant-based breast reconstruction in the United States. This study tested the hypothesis that the incidences of infection, seroma, and reconstructive failure are equivalent between FlexHD Pliable and AlloDerm RTU.



We conducted a Level 1 prospective, randomized, controlled, multicenter clinical trial to assess complications associated with the use of two human acellular dermal matrices in immediate postmastectomy implant-based breast reconstruction. The study was conducted in the United States over 24 months from 2016 to 2018. Institutional review board approval was obtained from all seven study sites before trial initiation.


Female patients aged 18 years or older scheduled to undergo mastectomy and immediate reconstruction were eligible for recruitment. Inclusion criteria included planned surgical treatment consisting of reconstruction with either tissue expanders or one-stage direct implant placement and the ability to understand and comply with the study requirements and follow-up time points. Both therapeutic and prophylactic mastectomies were included. Exclusion criteria included previous breast surgery, with the exception of an excisional biopsy; prior radiation therapy; surgical treatment that involved tissue expander/implant with autologous flap; Wise pattern incisions; corticosteroid use within the last 6 months; prior organ transplant; pregnancy or lactation; and nicotine use within 4 weeks of the procedure.

A total of 230 patients with 384 immediate tissue expander/implant-based breast reconstructions were randomized and included in the study. Surgical variables and outcomes were assessed on a per breast basis.

Treatments and Interventions

Before surgery, patients enrolled in the study were randomized to one of the two human acellular dermal matrix treatment groups. Group A patients received FlexHD Pliable, and group B patients received AlloDerm RTU. Group A (FlexHD Pliable) included 113 patients with 187 breast reconstructions, and group B (AlloDerm RTU) included 117 patients with 197 breast reconstructions.

All patients underwent skin- or nipple-sparing mastectomy and immediate reconstruction. The reconstruction was performed by a plastic surgeon experienced in implant-based breast reconstruction at each site. The indications and performance of prepectoral or partial submuscular placement of the device, as well as the decision to place a tissue expander or permanent implant, were left to the discretion of the plastic surgeon. For patients undergoing partial submuscular device placement, the inferior origin of the pectoralis major muscle was detached from the chest wall after mastectomy and the human acellular dermal matrix was inset between the inferior border of the muscle and the inframammary fold. For patients undergoing prepectoral device placement, the matrix was placed to cover the anterior surface of the tissue expander and sutured to the chest wall. All matrices utilized were perforated. One or two drains were placed in the breast pocket and subsequently removed per the investigator’s protocol, which was generally output of less than 20 cc or less than 30 cc every 24 hours. Postoperative management was conducted in accordance with each institution’s routine protocol.

Power Analysis

A systematic literature review of the two human acellular dermal matrix types used in breast reconstruction was performed to estimate the confidence interval of the effect sizes for the sensitivity analysis of the power estimate. Based on clinical trends at the enrolling sites, we estimated that one-third of the patients would undergo unilateral breast reconstruction and two-thirds of the patients would undergo bilateral breast reconstruction.

The power calculation for sample size was determined using an estimated overall complication rate for FlexHD Pliable and AlloDerm RTU, based on literature review, with a noninferiority limit of 8 percent. The goal of 80 percent power was determined to require a total sample size of 212 patients (n = 106 in each group). The power calculation for each breast was performed using adjusted overall complication rates, and the goal of 80 percent power was determined to require a total sample size of 354 breasts (n = 177 in each group). To allow for 5 percent attrition, an enrollment target of 224 patients (n = 112 in each group) for this study was selected. Using a two-sided type I error rate of 0.05 with a 1:1 two-group experimental design and a within-patient between-breast intraclass correlation coefficient of 0.6, the final sample size of the study (n = 384 breasts) had an 80 percent statistical power to detect a minimum effect size of odds ratio of 1.83.

Randomization and Data Collection

Before surgery, patients were randomized to one of the two human acellular dermal matrix treatment groups, FlexHD Pliable or AlloDerm RTU, utilizing REDCap (Vanderbilt University, Nashville, Tenn.), a secure Web-based application. A 1:1 blocked randomization scheme was utilized to yield “comparable” subjects in each of the two groups within each site to avoid imbalance in the distribution of the two treatment groups at each site. Both subjects and researchers who collected and analyzed data were blinded to the group assignment until the completion of the study. Standardization and consistency of reported predictor and outcome variables, data quality, and the methodology were approved and followed by all clinical investigators, who remained blinded to the overall data analysis throughout the entire study. While the study was targeted to include 224 patients, we ended up enrolling a total of 230 patients. Clinical outcomes were assessed at 1 month, 3 months, 6 months, and 12 months after reconstruction.

Outcome Analysis

The primary endpoints of the study were the overall human acellular dermal matrix–related complications, which included seroma, infection, and associated reconstructive failure, defined by explantation secondary to seroma and/or infection. Other non–human acellular dermal matrix–related postoperative complications included hematoma and mastectomy flap necrosis.

Statistical Analysis

Preoperative and intraoperative variables were compared between the two groups using the chi-square or Fisher’s exact test for categorical variables and the independent t test (parametric) or Mann-Whitney U test (nonparametric) for continuous variables. Postoperative outcomes using number of breast reconstructions, adjusting for nesting effect of multiple breast reconstructions within the same patient as well as the clustering effect within each site, were analyzed using multivariable generalized estimating equation models controlling for potential covariates. For each analysis, patient-related variables (patient demographics and comorbidities) and surgery-related variables (surgical procedure and reconstruction types) showing an association with study endpoints (postoperative complications) of p < 0.2 in the univariate analysis were included in the multivariable models. Significance was established as a p value of less than 0.05. SAS 9.4 statistical software (SAS Inc., Cary, N.C.) was used for all analyses.


Patient Demographics

A total of 230 patients with 384 immediate tissue expander/implant-based breast reconstructions were randomized and included in the study. Group A (FlexHD Pliable) included 113 patients with 187 breast reconstructions, and group B (AlloDerm RTU) included 117 patients with 197 breast reconstructions. Mean follow-up time was 10.7 ± 3.2 months after completing reconstruction. Approximately 65 percent of patients underwent bilateral breast reconstruction. Skin-sparing mastectomy with immediate tissue expander reconstruction was the most common modality of treatment. There was no significant difference between the two groups with respect to patient demographics, comorbidities, and adjuvant treatment modalities (Table 1). In group A, the mean body mass index was 25.6 ± 5.1, versus 24.4 ± 4.9 in group B (p = 0.071). There was no significant difference between groups with respect to type of mastectomy, indications for mastectomy, reconstruction approach (direct implant placement versus staged), tissue plane of acellular dermal matrix placement (prepectoral versus subpectoral), or need for axillary lymph node dissection. Among the two-stage reconstructions, the final tissue expander volume and the total number of expansions were comparable between group A and group B (Table 2).

Table 1. - Patient Demographics and Clinical Characteristics by Randomized Treatment Group
Variables Group A: FlexHD Pliable Group B: AlloDerm RTU p
Total no. of patients 113 117
Total no. of breasts 187 197
Length of follow-up, mo
 Mean ± SD 10.6 ± 3.3 10.8 ± 3.1 0.673
 Median (IQR) 11.9 (9.8–13.7) 11.9 (9.9–13.5) 0.950
Age, yr 46.5 ± 10.3 46.8 ± 11.4 0.812
BMI, kg/m2 25.6 ± 5.1 24.4 ± 4.9 0.071
Site, no. of patients 0.253
 1 1 (0.9%) 5 (4.3%)
 2 39 (34.5%) 24 (20.5%)
 3 21 (18.6%) 24 (20.5%)
 4 16 (14.2%) 19 (16.2%)
 5 23 (20.4%) 30 (25.6%)
 6 2 (1.8%) 3 (2.6%)
 7 11 (9.7%) 12 (10.3%)
Smoking history, no. of patients 0.524
 Never smoked 85 (75.2%) 83 (70.9%)
 Yes 0 1 (0.9%)
 Previous smoker 28 (24.8%) 32 (28.2%)
Comorbidities, no.
 Diabetes 2 (1.8%) 6 (5.1%) 0.281
 Autoimmune disease 1 (0.9%) 3 (2.6%) 0.622
 Connective tissue disease 0 (0%) 2 (1.7%) 0.498
Preoperative chemotherapy 18 (15.9%) 23 (19.7%) 0.479
Postoperative chemotherapy 36 (31.9%) 36 (30.8%) 0.859
PMRT (per breast) 27 (14.4%) 32 (16.2%) 0.624
Type of surgery 0.641
 Unilateral 39 (34.5%) 37 (31.6%)
 Bilateral 74 (65.5%) 80 (68.4%)
IQR, interquartile range; BMI, body mass index; PMRT, postmastectomy radiation therapy.

Table 2. - Operative Factors by Randomized Treatment Group
Variables Group A: FlexHD Pliable Group B: AlloDerm RTU p
Total no. of patients 113 117
Total no. of breasts 187 197
Type of mastectomy (per patient) 0.272
 Skin sparing 68 (60.2%) 62 (53.0%)
 Nipple sparing 45 (39.8%) 55 (47.0%)
Reconstruction technique (per patient) 0.431
 Single stage 24 (21.2%) 30 (25.6%)
 Two stages 89 (78.8%) 87 (74.4%)
Reconstruction technique (per breast) 0.300
 Single stage 40 (21.4%) 51 (25.9%)
 Two stages 147 (78.6%) 146 (74.1%)
ADM placement (per patient) 0.843
 Prepectoral 22 (19.5%) 24 (20.5%)
 Subpectoral 91 (80.5%) 93 (79.5%)
ADM placement (per breast) 0.905
 Prepectoral 38 (20.3%) 41 (20.8%)
 Subpectoral 149 (79.7%) 156 (79.2%)
Axillary lymph node dissection (per breast) 0.723
 Yes 28 (15.0%) 27 (13.7%)
 No 159 (85.0%) 170 (86.3%)
Indication for mastectomy (per breast) 0.713
 Therapeutic 106 (56.7%) 108 (54.8%)
 Prophylactic 81 (43.3%) 89 (45.2%)
Final expansion volume, ml
 Mean ± SD 418 ± 125 399 ± 135 0.246
 Median (IQR) 527 (365–642) 506 (312–620) 0.737
Total no. of expansions 5.4 ± 1.8 5.0 ± 1.8 0.111
ADM, acellular dermal matrix; IQR, interquartile range.

Surgical Outcomes

A total of 22 human acellular dermal matrix–related postoperative complications (5.7 percent) occurred during the 12-month follow-up period. The overall non–human acellular dermal matrix–related hematoma rate was 2.1 percent (n = 8) and the mastectomy flap necrosis rate was 4.1 percent (n = 16). There was no statistical difference in the overall human acellular dermal matrix–related complications between the FlexHD Pliable (n = 8) and AlloDerm RTU (n = 14) groups (4.3 percent versus 7.1 percent, p = 0.233) (Table 3). The overall seroma rate was 4.2 percent (n = 16), the infection rate was 1.8 percent (n = 7), and the human acellular dermal matrix–related explantation rate was 1.8 percent (n = 7). There were no statistically significant differences in the rates of complications, including seroma (3.7 percent versus 4.6 percent, p = 0.801), infection (1.1 percent versus 2.5 percent, p = 0.450), and human acellular dermal matrix–related explantation (1.6 percent versus 2.0 percent, p = 1.000), between the FlexHD Pliable and AlloDerm RTU groups (Table 3).

Table 3. - Summary of Postoperative Outcomes by Breast
HADM-Related Complications FlexHD Pliable (n = 187) AlloDerm RTU (n = 197) p
No. % No. %
Seroma (n = 16) 7 3.7 9 4.6 0.801
Infection (n = 7) 2 1.1 5 2.5 0.450
Explantation due to seroma and/or infection (n = 7) 3 1.6 4 2.0 1.000
Overall (n = 22*) 8 4.3 14 7.1 0.233
HADM, human acellular dermal matrix.
*One breast had both seroma and infection.

Multivariate Analysis

Multivariate regression analysis of the human acellular dermal matrix–related surgical complications did not yield a statistically significant difference between the two study groups when patient factors and operative factors were included. Obesity, as measured by body mass index (OR, 1.14; 95 percent CI, 1.05 to 1.24; p = 0.001), and prepectoral placement of human acellular dermal matrix (OR, 4.53; 95 percent CI, 1.82 to 11.3; p = 0.001) were independently associated with greater risks of overall matrix-related complications. Body mass index was also associated with significantly increased risk of several adverse outcomes, including infection (OR, 1.17; 95 percent CI, 1.04 to 1.31; p = 0.007) and explantation (OR, 1.20; 95 percent CI, 1.07 to 1.34; p = 0.002), and trended toward increased risk of seroma (OR, 1.08; 95 percent CI, 0.99 to 1.17; p = 0.076). Prepectoral human acellular dermal matrix breast reconstruction was associated with higher risk of seroma formation (OR, 3.96; 95 percent CI, 1.47 to 10.7; p = 0.007) (Table 4).

Table 4. - Multivariable Analysis of Human Acellular Dermal Matrix–Related Complications
Variables* Seroma Infection Explantation Overall Complication
OR 95% CI p OR 95% CI p OR 95% CI p OR 95% CI p
Group (FlexHD Pliable vs. AlloDerm RTU) 0.85 0.31–2.36 0.761 0.39 0.09–1.71 0.211 0.71 0.17–2.98 0.637 0.45 0.17–1.19 0.106
Age 1.01 0.94–1.08 0.762 1.05 0.98–1.13 0.160 1.01 0.96–1.05 0.867
BMI 1.08 0.99–1.17 0.076 1.17 1.04–1.31 0.007 1.20 1.07–1.34 0.002 1.14 1.05–1.24 0.001
Smoking 1.21 0.43–3.39 0.722
Diabetes 1.57 0.10–25.4 0.750 1.08 0.07–16.5 0.96
ADM placement (prepectoral vs. subpectoral) 3.96 1.47–10.7 0.007 2.25 0.53–9.45 0.270 4.53 1.82–11.3 0.001
Goodness of fit (AUC) 0.68 0.67 0.71 0.76
p (if AUC > 0.5) <0.001 <0.001 <0.001 <0.0001
BMI, body mass index; ADM, acellular dermal matrix; AUC, area under the curve.
*Only variables with p < 0.2 in the univariate analysis were included in the multivariable analysis.


The use of human acellular dermal matrix has increased steadily over the past decade as implant-based breast reconstruction methods have evolved. It has facilitated direct-to-implant and prepectoral reconstruction and enabled greater tissue expander fill volumes, and it may result in better and more durable aesthetic outcomes. However, complications thought to be related to its use have remained a considerable concern to plastic surgeons.16,17,25 Avoidance of complications continues to be a major factor in surgical and institutional decision making, yet there have been little high-quality data to guide these choices.

The current study is the first multicenter, prospective, randomized clinical trial comparing the two most commonly utilized human acellular dermal matrices, FlexHD Pliable and AlloDerm RTU, in immediate implant-based breast reconstruction. The study design set rigid criteria to standardize the definitions of human acellular dermal matrix–related complications as well as reporting methodology. The study findings demonstrated no significant difference in primary endpoints between FlexHD Pliable and AlloDerm RTU among 384 breast reconstructions at long-term follow-up. Overall rates of surgical adverse events were relatively low in both groups and consistent with previously reported data describing human matrix–related complications in implant-based breast reconstruction, suggesting that human acellular dermal matrix–associated prosthetic breast reconstruction is safe.8,25–29 The overall rate of human acellular dermal matrix–related explantation was low at 1.8 percent. Study groups were well matched with regard to patient demographics, comorbidities, indications for surgery, and mastectomy and reconstruction techniques. This study is consistent with previous reports that patient factors such as postmastectomy radiation and body mass index are more predictive of patient outcomes than human acellular dermal matrix type.30 This study also detected overall low rates of mastectomy skin flap necrosis (4.1 percent) and hematoma (2.1 percent).30

Multivariate regression also demonstrated no statistically significant difference between FlexHD Pliable and AlloDerm RTU in the rate of human acellular dermal matrix–related complications, suggesting that patient factors and the operative approach play more significant roles. Body mass index was a significant independent risk factor for infection, reconstructive failure/explantation, and overall complications (all p < 0.05), and a nearly significant risk factor for seroma (p = 0.07). These findings are consistent with previous studies demonstrating that increasing body mass index is associated with increased perioperative morbidity in implant-based reconstruction.31 Prepectoral placement of the tissue expander or implant was also associated with a significant increase in the risk of seroma (OR, 3.96; p < 005) and overall complication (OR, 4.53; p < 0.05). Previous studies have also suggested an increased risk of seroma formation in prepectoral reconstruction when compared with partial submuscular and/or total submuscular reconstruction, likely due to increasing foreign body exposure early on in the healing process in the setting of significant mastectomy dead space and potentially compromised overlying skin flaps.32,33 While the potential benefits of prepectoral implant-based breast reconstruction, such as elimination of animation deformity, continue to become well recognized, our data reaffirm the importance of seroma management and careful patient selection for this approach.

Although this study presents valuable data from a randomized clinical trial setting, all clinical studies have certain limitations. The clinical outcome assessment was limited to 1-year postoperative complications and did not include patient-reported outcomes or aesthetic outcome evaluation. Evaluation of long-term complications of implant-based breast reconstruction, such as capsular contracture, implant malpositioning, or bottoming out, was not within the scope of the current study and will be an important outcome to assess in the future. In addition, given the nature of a multicenter design with many oncologic and reconstructive surgeons participating, there may be variations in surgical technique and routine postoperative care protocols among the participating institutions. Finally, our study results yielded low overall complication rates, which may limit the power of our study, as it was originally powered for a larger effect size based on the systematic literature review.

The major strengths of this study are the higher quality of data resulting from a prospective, multicenter, randomized clinical trial design, which addresses concerns regarding bias and the lower level of clinical evidence of previously reported retrospective reviews. The multicenter nature of this trial also allowed for randomization of variations in surgical techniques that are more representative of the spectrum of current practice patterns in the United States, such as prepectoral and partial submuscular tissue expander/implant placement and immediate implant placement and staged reconstruction with a tissue expander, as well as a broad spectrum of surgical indications. Inclusion of these different techniques enhances the generalizability of the reported results. Finally, the longer-term 12-month follow-up of this study compared to previous studies allowed for a more comprehensive evaluation of potential complications.34 Future research efforts, expanded to include similar high-level comparative data involving animal-derived dermal matrix or synthetic mesh products in implant-based breast reconstruction, would be invaluable.


This is the first prospective, multicenter, randomized controlled trial to compare the complication rates and safety profiles of the two most commonly used human acellular dermal matrices in implant-based breast reconstruction, FlexHD Pliable and AlloDerm RTU. When patient and surgical factors were properly controlled, the human acellular dermal matrix materials were equivalent in risk of matrix-related seroma, infection, and associated reconstructive failure. This work supports the use of human acellular dermal matrices in implant-based breast reconstruction surgery with low overall matrix-related complication rates and suggests that efforts to improve patient outcomes should continue to focus on patient selection and comorbidities.


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