. 2022 Jan 19;8:20595131211038313. doi: 10.1177/20595131211038313

Table 4.

Clinical evidence for ADMs in breast reconstruction.

Authors	Product name(s), Material	Usage, Population	Summary findings
Case series and case reports
Knabben et al. (2016)	Permacol®, PADM	Breast reconstruction post skin-sparing mastectomy in those with breast cancer 10 patients Mean age: 50.9 years (range = 37–64 years) Mean BMI: 21.1 kg/m² (17.6–26.5 kg/m²) 2 had a history of smoking, 1 had history of diabetes mellitus	No intraoperative complications 1 patient required removal due to necrosis after 3 months, half underwent a corrective surgery Lower BMI and patient satisfaction positive correlation Permacol can physically change implant shape and improve cosmetic outcome
Kornstein A (2013)	Strattice®, PADM	Case 1: 40-year-old white female, postpartum soft-tissue laxity and grade II ptosis Case 2: 30-year-old white woman, congenital soft-tissue laxity and grade 1 ptosis Case 3: 49-year-old white woman, postpartum and post-weight-loss induced laxity and grade III ptosis	All 3 patients had no complications (infection, haematoma, seroma, rippling, malposition or capsular contracture) and were pleased with the outcome
Retrospective studies
Butterfield (2013)	SurgiMend®, FBADM AlloDerm®, HADM	Breast reconstruction 440 reconstructions SurgiMend® (79%) AlloDerm® (21%)	No significant differences in complication rates were observed between SurgiMend and AlloDerm for haematoma, infection, major skin necrosis or breast implant removal Seroma rate for AlloDerm (15.7%) was significantly greater than that for SurgiMend (8.3%) SurgiMend costs less than AlloDerm
Ricci et al. (2016)	SurgiMend®, FBADM AlloDerm®, HADM	Breast reconstruction 952 reconstructions SurgiMend® (39%) AlloDerm® (61%)	Mean follow-up: 587 days Type of matrix was not an independent risk factor for complications Smoking, age, radiotherapy and initial expander fill volume were associated with increased risk of complications
Mazari et al. (2018)	SurgiMend®, FBADM Strattice®, PADM, non-cross-linked	Breast reconstruction 97 reconstructions SurgiMend® (56%) AlloDerm® (44%)	No differences by age, co-morbidities, specimen weight or implant volume Drains were used in all cases of Strattice and 36 cases of (84%) SurgiMend Implant loss rate: higher for Strattice (20%) compared with SurgiMend (7%) but not significant (P = 0.077) ADM loss rate: significantly higher (Fisher’s exact test, P = 0.014) in the Strattice group (n = 7, 14%), zero loss with SurgiMend Reoperation rate: significantly higher (chi-square test, P = 0.002) in the Strattice group (33% vs. 7%) Incidence of red breast: significantly higher (P = 0.022) in the SurgiMend group (21% vs. 6%) Seroma, wound problems and infection rates were similar
Gabriel et al. (2018)	Alloderm RTU® (ready to use) Sterile version of AlloDerm®, HADM	Breast reconstruction 68 patients, 116 biopsy specimens Mean age: 53 years Mean BMI: 26 kg/m² 43% of patients having had chemotherapy and 17% radiotherapy	Short-term postoperative complications: skin necrosis (10.3%), seroma (4.3%) and infection (2.6%) Long-term postoperative complication: capsular contracture (grade 3) (5.2%) Mild-to-moderate neovascularisation and cellular repopulation with no inflammatory cell up to at least 5 years follow-up
Ranganathan et al. (2016)	FlexHD®, HADM AlloDerm®, HADM	Breast reconstruction 309 patients FlexHD (60.2%) AlloDerm (39.8%)	Mean follow-up: 20.0 months Patients with AlloDerm were half as likely to have major infections compared with FlexHD (OR = 0.50; 95% CI = 0.16–1.00; P < 0.05) Rates of other complications were similar between the two groups
Keifer et al. (2016)	AlloDerm®, HADM (58.4%) Cortiva®, HADM (41.6%)	Prosthetic-based breast reconstruction 166 patients, 298 total breast reconstructions Cortiva patients, on average, weighed 1.7 kg more and were 1.6 years older	34 complications: 16 in AlloDerm group and 18 in Cortiva group, not significantly different (P = 0.195) Cortiva group: significantly higher incidence of mastectomy flap necrosis (6 vs. 1; P = 0.022), due to BMI differences, though Only current tobacco use (P = 0.033) was a significant predictor for a complication Trending predictors: BMI (P = 0.074) and age (P = 0.093) ADM type: not a significant predictor for any recorded complication (P = 0.160)
Qureshi et al. (2016)	AlloDerm®, HADM	Breast reconstruction 367 patients (265 ADM and 102 non-ADM) Mean age: 50 years for both groups BMI: 28.2 kg/m²	Average hospital 2-year direct cost per reconstruction patient: ADM group = $11,862; average cost for non-ADM group = $12,319 Initial reconstructions more costly in ADM group ($6868 vs. $5615) 2 years later: ADM ($5176) costed less than non-ADM ($6704)
Rose et al. (2016)	AlloDerm®, HADM	Expander-based breast reconstruction 55 patients, 77 ADM-based tissue expander reconstruction Mean age: 48.1 years Mean BMI: 25.9 kg/m²	Increased complication rates seen as ADM thickness increased Significant associations between smokers and skin necrosis (P < 0.0001), seroma and prolonged JP drainage (P = 0.0004) and radiated reconstructed breasts and infections (P = 0.0085) Elevated BMI is a significant predictor for increased infection rate (P = 0.0037)
Salzberg et al. (2016)	AlloDerm®, HADM (93%) Strattice®, non-cross-linked PADM (6.9%) FlexHD®, HADM (0.1%)	Breast reconstruction 863 patients, 1584 total reconstructions Mean age: 47.0 years 14% current/former smokers, 10% other co-morbidities, 25% using chemotherapy, 10% using radiotherapy	Capsular contracture incidence was 0.8% and 1.9% in irradiated breasts All contractures occurred within 2 years <400 mL implants and postoperative radiotherapy increased risk
Prospective studies
Bullocks et al. (2014)	DermACELL®, HADM	Two-stage breast reconstruction 10 female patients, 18 total breasts Age range: 33–59 years 2 smokers	8 completed reconstruction while two patients failed reconstruction (both smokers) due to seromas and infection A few patients required postoperative chemotherapy and radiation 4 breasts developed seromas, 2 surgical site infections, 4 delayed healing and 3 flap necrosis Histology confirms rapid integration of mesenchymal cells into the matrix (compared to non-ADM)
Vu et al. (2015)	FlexHD Pliable®, HADM	Breast reconstruction 41 patients, 72 breasts Age: at least 18 years No patients who experienced complications from previous surgeries or previously underwent reconstruction with tissue expander No patients with BMI >40 kg/m² or who had previous radiation treatment	No cases of infection, seroma, or implant extrusion or malposition BREAST-Q scores: outcome satisfaction (70.13 ± 23.87), breast satisfaction (58.53 ± 20.00), psychosocial wellbeing (67.97 ± 20.93), sexual wellbeing (54.11 ± 27.72) and physical wellbeing (70.45 ± 15.44). 12.5% complication rate
Systematic reviews and meta-analyses
Adetayo et al. (2016)	Alloderm®, HADM	Breast reconstruction and abdominal wall	53 studies for meta-analysis. Majority (68.6%) were retrospective. Mean follow-up in the breast group was 16.8 ± 13.2 months Breast complication rates: 4.4% cellulitis, 6.1% implant failure, 4.1% seroma formation, 2.0% wound dehiscence, 5.1% wound infection

ADM, acellular dermal matrix; BADM, bovine acellular dermal matrix; BMI, body mass index; FBADM, fetal bovine acellular dermal matrix; HADM, human acellular dermal matrix; JP, Jackson Pratt; OR, odds ratio; PADM, porcine acellular dermal matrix.