Abstract
Background:
Acellular dermal matrix (ADM) is commonly used in implant-based breast reconstruction due to improved soft-tissue support and control of the implant pocket and decreased capsular contracture. However, concerns about complications have prompted the FDA to request more clinical data. This large-scale study aims to examine perioperative outcomes of ADM use in breast reconstruction.
Methods:
This study utilized a national insurance-based database to identify patients who underwent mastectomy between 2011 and 2019, with and without ADM. The groups were matched for age, region, and comorbidities. Complications within 90 days were compared using univariate and multivariate analyses.
Results:
A total of 49,366 patients were identified with 26,266 patients in the ADM group and 23,100 in the non-ADM group. Infection rates (4.7% ADM versus 4.4% no ADM) and seroma rates (3.9% ADM versus 4% no ADM) were similar. However, the ADM group had a 1% higher rate of implant removal (4.9% ADM versus 3.9% no ADM, P < 0.001). In direct-to-implant procedures, ADM use was associated with higher explantation rates (8.2% versus 6.3%, P = 0.002). Multivariate analysis identified tobacco use, hypertension, depression, obesity, ADM usage, and direct-to-implant surgery as risk factors for implant removal.
Conclusions:
This study found comparable infection and seroma rates in implant-based breast reconstruction with and without ADM. ADM use was associated with a 1% higher risk of implant removal, with risk factors including tobacco use, obesity, hypertension, depression, and direct-to-implant procedures. Multicenter studies and registry data on prepectoral breast reconstruction are warranted to help interpret these findings.
Takeaways
Question: What are the risks of using acellular dermal matrix (ADM) in implant-based breast reconstruction?
Findings: This study used a large database to identify similar patients who underwent mastectomy and implant-based breast reconstruction with or without ADM. Postoperative complication rates were comparable, yet the matrix group had slightly higher rates of implant removal (1%), especially with immediate permanent prosthesis (2%). Smoking, high blood pressure, and depression were associated with increased risks.
Meaning: The use of ADM in breast reconstruction is associated with a slightly higher rate of implant removal.
INTRODUCTION
The use of acellular dermal matrix (ADM), a structural graft derived from human or animal dermis, has been adopted as standard practice in implant-based breast reconstruction due to the purported benefits of improved soft-tissue support, implant pocket control, decreased capsular contracture, improved soft-tissue camouflage, and facilitation of subsequent fat grafting.1,2 Perioperative outcomes with ADM use in implant-based breast reconstruction have gradually improved since the initial report of its use in 2005, but the perioperative performance profile of ADM in clinical reports has conflicting outcomes.3–6 This large database study sought to determine the short-term complication profile of ADM utilization in implant-based breast reconstruction in a case-matched study model as the primary outcome, followed by stratification of other surgical risk factors as secondary outcomes.
ADM is a biologic support material that provides a collagen scaffold to encourage neovascularization, fibroblast infiltration, and eventual incorporation into human tissue with a wide range of benefits in various surgical specialties.2,7–9 In breast reconstructive surgery, various human and xenogeneic ADMs have been utilized, such as AlloDerm, AlloMax, FlexHD, and SurgiMend with AlloDerm (LifeCell Corporation) being the first described and most referenced in the literature.4
Breast reconstruction after mastectomy for treatment or prevention of breast cancer has been slowly increasing during the last decade, due in part to better access to information about breast cancer and reports of improved quality of life associated with breast reconstruction. Currently, implant-based breast reconstruction is the most common method of breast reconstruction in the United States.10,11 According to the 2020 American Society of Plastic Surgeons statistical report, more than 70% of tissue expander-based breast reconstruction is being performed with ADM utilization.11
Despite the high volume of implant-based procedures using ADM each year, outcomes studies in the literature are mainly underpowered, commenting on different aspects of recovery. Early studies advocated for ADM use, particularly in one-stage direct-to-implant (DTI) reconstruction due to improved aesthetic outcomes, fewer procedures, and higher patient satisfaction; however, there is conflicting evidence in the literature on early postsurgical outcomes with varying complication and reoperation profiles.12,13 There are reports of significantly decreased rates of capsular contracture with the use of ADM versus no ADM in implant-based reconstruction; however, other studies show increased rates of postoperative seroma, infection, and explantation.14,15 One 2011 review noted that benefits such as reduced postoperative pain, decreased operative time, improved lower breast pole expansion, and better control of inframammary fold and lateral breast border are mostly from anecdotal and opinion pieces rather than supported with objective data.13
In 2019, the FDA classified ADM use in breast reconstruction as a class III medical device, the highest risk category, which stimulated more research on the clinical outcomes associated with ADM use.16 The goal of this study was to examine the short-term postoperative complications of ADM use in tissue expander and DTI implant reconstruction compared with a non-ADM case-matched cohort. The authors suspect that there will be a slightly increased complication rate with ADM use, more so in medically complex patients. Utilizing a large national insurance database and controlling for comorbidities allows for a highly powered retrospective review of the risks of using ADM in implant-based breast reconstruction.
METHODS
A commercially available national insurance-based database, PearlDiver (www.pearldiverinc.com, Colorado Springs, Colo.) that contains 157 million patients was used for data collection. Patients were queried based on and Current Procedural Terminology (CPT) codes for all mastectomy types with first-instance immediate implant placement (CPT-19340) or immediate tissue expander placement (CPT-19357). Patients who underwent breast reconstruction with free flap (CPT-19364) and other reconstructive procedures (CPT-19342, CPT-19361, CPT-19364, CPT-19366-19369) such as pedicled flap-based reconstruction between 2011 and 2019 were excluded from the study. In addition, patients without active insurance for at least 1 year were excluded from the study so that a complete record of their surgical outcomes would be available. The use of a biological implant such as ADM was determined by querying for CPT-15777. Patients were grouped into those who underwent mastectomy with immediate implant or tissue expander placement, with and without the same-day ADM placement.
Using the R statistical software embedded in the database, these two groups were then matched within the database to yield statistically similar age distributions and proportions of patients from each US region. The groups were also matched for statistically similar comorbidities including all the conditions listed in Table 1.
Table 1.
Demographics of Matched Mastectomy Patients with or without Same-day ADM Placement (CPT-15777) in Implant-based Breast Reconstruction
| Before Matching | After Matching | |||||
|---|---|---|---|---|---|---|
| Same-day ADM, N (%) | No Same-day ADM, N (%) | P * | Same-day ADM, N (%) | No Same-day ADM, N (%) | P * | |
| Total | 41,113 | 35,026 | 26,266 | 23,100 | ||
| Mean age | 52.2 ± 11.1 | 52.4 ± 10.9 | 0.012 | 51.7 ± 10.3 | 51.8 ± 10.4 | 0.280 |
| Region | ||||||
| Midwest | 11,782 (28.7) | 9365 (26.7) | <0.001 | 7574 (28.8) | 6637 (28.7) | 0.799 |
| Northeast | 6627 (16.1) | 8951 (25.6) | <0.001 | 4764 (18.1) | 4242 (18.4) | 0.516 |
| South | 16,572 (40.3) | 11,790 (33.7) | <0.001 | 10302 (39.2) | 9020 (39.0) | 0.692 |
| West | 6132 (14.9) | 4920 (14.0) | 0.001 | 3626 (13.8) | 3201 (13.9) | 0.867 |
| Comorbidities | ||||||
| Asthma | 3006 (7.3) | 1561 (4.5) | <0.001 | 2473 (9.4) | 2321 (10.0) | 0.012 |
| COPD | 6996 (17.0) | 5423 (15.5) | <0.001 | 4274 (16.3) | 3965 (17.2) | 0.008 |
| Chronic kidney disease | 964 (2.3) | 724 (2.1) | 0.010 | 727 (2.8) | 713 (3.1) | 0.036 |
| Depression | 11,247 (27.4) | 7408 (21.2) | <0.001 | 11178 (42.6) | 9912 (42.9) | 0.430 |
| Hypertension | 14590 (35.5) | 11668 (33.3) | <0.001 | 12108 (46.1) | 10806 (46.8) | 0.130 |
| Hypothyroid | 8837 (21.5) | 3591 (10.3) | <0.001 | 6761 (25.7) | 6071 (26.3) | 0.172 |
| Obesity | 7772 (18.9) | 2857 (8.2) | <0.001 | 7715 (29.4) | 6920 (30.0) | 0.156 |
| Tobacco use | 8526 (20.7) | 3204 (9.1) | <0.001 | 8125 (30.9) | 7239 (31.3) | 0.333 |
| Coronary artery disease | 2392 (5.8) | 1133 (3.2) | <0.001 | 1684 (6.4) | 1613 (7.0) | 0.011 |
| Coagulopathy | 1712 (4.2) | 592 (1.7) | <0.001 | 1389 (5.3) | 1302 (5.6) | 0.089 |
Statistical analysis performed using Pearson chi-square test. A P value of less than 0.05 was considered statistically significant.
Primary outcomes of this study included 90-day wound complications such as infection, wound disruption (including hematoma, seroma, dehiscence), and subsequent procedures such as the removal of implant (CPT-19328, CPT-19330, and CPT-19371). Complications were determined by querying the corresponding International Classification of Diseases ninth and tenth revision (ICD-9 and ICD-10) codes. Rates of ninety-day complications among the two groups were compared using chi-square test with a P value of less than 0.05 considered statistically significant. Logistic regressions were performed to determine risk factors for wound complications, subsequent procedures, and any postoperative complications. Costs of care were also compared among the ADM group and no ADM group.
RESULTS
A total of 41,113 patients underwent mastectomy and either permanent implant or tissue expander placement with ADM placement, whereas 35,026 patients did not have ADM placement. After proportion matching for age, region, and comorbidities, the ADM group consisted of 26,266 patients and the non-ADM group consisted of 23,100 patients. The mean age of patients with implant-based reconstruction with ADM versus those without ADM before matching was 52.2 ± 11.1 and 52.4 ± 10.9 (P = 0.012), whereas after matching it was 51.7 ± 10.3 and 51.8 ± 10.4 (P = 0.280, Table 1). Before matching, more patients with ADM placement resided in the Midwest, South, and Western regions of the United States (P < 0.05). Comorbidity rates among the pre- and postmatch groups are reported in Table 1.
Among the matched cohorts, 90-day complication rates were compared, including surgical site infection, seroma, and implant removal (Table 2). Surgical site infections were 4.7% in the ADM group and 4.4% in the non-ADM group (P = 0.178). Seroma rates were 3.9% in the ADM group and 4% in the non-ADM group (P = 0.520). Implant removal rates were higher in the ADM group compared with the no ADM group (4.9% versus 3.9%, P < 0.001), as were any of the complications listed (8.7% versus 7.5%, P < 0.001, Table 2, implant-based reconstruction complications). When comparing 90-day complication rates among patients who had DTI reconstruction, implant removal rates were higher in the ADM group (8.2% versus 6.3%, P = 0.002, Table 2, DTI complications).
Table 2.
Ninety-day Complication Rates among Matched Groups with and without ADM Use in Implant-based Breast Reconstruction*
| ADM Use, N (%) | No ADM, N (%) | P † | |
|---|---|---|---|
| Implant-based reconstruction complications (tissue expanders and DTI) | |||
| Total | 26,266 | 23,100 | |
| Surgical site infection | 1224 (4.7) | 1018 (4.4) | 0.178 |
| Seroma | 1036 (3.9) | 934 (4.0) | 0.520 |
| Implant removal | 1308 (4.9) | 909 (3.9) | <0.001 |
| Any above complications | 2271 (8.7) | 1733 (7.5) | <0.001 |
| Direct-to-implant complications | |||
| Total | 4792 | 2715 | |
| Surgical site infection | 193 (4.0) | 120 (4.4) | 0.414 |
| Seroma | 170 (3.5) | 98 (3.6) | 0.889 |
| Implant removal | 393 (8.2) | 170 (6.3) | 0.002 |
| Any above complication | 509 (10.6) | 259 (9.5) | 0.137 |
See Table 3 for ICD Diagnosis Codes and CPT.
Pearson chi-squared test.
Table 3.
ICD and CPT Codes
| Description of Procedure or Diagnosis | Associated CPT or ICD Code |
|---|---|
| Mastectomy | CPT-19303, CPT-19304, CPT-19305, CPT-19306, CPT-19307 |
| DTI | CPT-19340 |
| Immediate tissue expander placement | CPT-19357 |
| Excluded reconstruction codes | CPT-19364, CPT-19342, CPT-19366, CPT-19367, CPT-19368, CPT-19369, CPT-19361 |
| Seroma | ICD-9-99813, ICD-9-99851, ICD-10-L7634 |
| Surgical site infection | ICD-9-99859, ICD-9-99851, ICD-10-T814XXA, ICD-10-T8140XD, ICD-10-T8140XS, ICD-10-T8141XA, ICD-10-T8141XD, ICD-10-T8141XS, ICD-10-T8142XA, ICD-10-T8142XD, ICD-10-T8142XS, ICD-10-T8149XA, ICD-10-T8149XD, ICD-10-T8149XS, ICD-10-T814XXD, ICD-10-T814XXS |
| Implant removal | CPT-19328, CPT-19330, CPT-19371 |
A multivariate logistic regression was performed to determine the odds of various risk factors leading to implant removal among patients undergoing implant-based breast reconstruction on the same day of mastectomy with or without ADM (Table 4). These risk factors included ADM placement [odds ratio (OR) = 1.22, 95% confidence interval (CI): 1.12–1.34, P < 0.001], DTI reconstruction (OR = 2.00, 95% CI: 1.81–2.21, P < 0.001), chronic obstructive pulmonary disease (COPD) (OR = 1.23, 95% CI: 1.09–1.39, P = 0.001), depression (OR = 1.21, 95% CI: 1.11–1.32, P < 0.001), diabetes (OR = 1.12, 95% CI: 1.01–1.26, P = 0.040), hypertension (OR = 1.26, 95% CI: 1.14–1.38, P < 0.001), obesity (OR = 1.19, 95% CI: 1.08–1.31, P < 0.001), tobacco use (OR = 1.25, 95% CI: 1.14–1.36, P < 0.001), and coronary artery disease (OR = 1.24, 95% CI: 1.06–1.45, P = 0.006, Table 4).
Table 4.
Multivariate Logistic Regression Determining the Odds of Implant Removal among Patients Undergoing Implant-based Breast Reconstruction on Same Day of Mastectomy
| Risk Factors | Odds Ratio (95% CI) | P * |
|---|---|---|
| ADM placement | 1.22 (1.12–1.34) | <0.001 |
| DTI | 2.00 (1.81–2.21) | <0.001 |
| Asthma | 0.94 (0.80–1.09) | 0.403 |
| COPD | 1.23 (1.09–1.39) | 0.001 |
| Chronic kidney disease | 0.87 (0.68–1.11) | 0.260 |
| Depression | 1.21 (1.11–1.32) | <0.001 |
| Diabetes | 1.12 (1.01–1.26) | 0.040 |
| Hypertension | 1.26 (1.14–1.38) | <0.001 |
| Hypothyroidism | 0.94 (0.85–1.04) | 0.204 |
| Obesity | 1.19 (1.08–1.31) | <0.001 |
| Tobacco use | 1.25 (1.14–1.36) | <0.001 |
| Coronary artery disease | 1.24 (1.06–1.45) | 0.006 |
| Coagulopathy | 1.06 (0.88–1.27) | 0.541 |
Homer and Lemeshow goodness-of-fit test: X2 9.33, df 8, P value 0.316.
A P value of less than 0.05 was was considered statistically significant.
Another multivariate logistic regression including only patients with immediate ADM placement was done to uncover risk factors for implant removal. The risk factors identified included DTI reconstruction (OR = 2.10, 95% CI: 1.86–2.38, P < 0.001), depression (OR = 1.34, 95% CI: 1.19–1.50, P < 0.001), hypertension (OR 1.16, 95% CI: 1.02–1.32, P = 0.020), obesity (OR = 1.27, 95% CI: 1.12–1.44, P < 0.001), and tobacco use (OR = 1.37, 95% CI: 1.22–1.54, P < 0.001, Table 5). Finally, risk factors for implant removal among patients with DTI breast reconstruction alone included ADM use (OR = 1.36, 95% CI: 1.13–1.65, P = 0.001), depression (OR = 1.26, 95% CI: 1.05–1.50, P = 0.012), and tobacco use (OR = 1.47, 95% CI: 1.23–1.77, P < 0.001, Table 6).
Table 5.
Multivariate Logistic Regression Determining the Odds of Implant Removal among Patients Undergoing Implant-based Breast Reconstruction with ADM Placement on Same Day of Mastectomy
| Risk Factors | Odds Ratio (95% CI) | P * |
|---|---|---|
| DTI | 2.10 (1.86–2.38) | <0.001 |
| Asthma | 1.01 (0.82–1.24) | 0.927 |
| COPD | 1.17 (1.00–1.38) | 0.054 |
| Chronic kidney disease | 0.78 (0.55–1.11) | 0.174 |
| Depression | 1.34 (1.19–1.50) | <0.001 |
| Diabetes | 1.09 (0.94–1.27) | 0.231 |
| Hypertension | 1.16 (1.02–1.32) | 0.020 |
| Hypothyroidism | 1.00 (0.88–1.14) | 0.969 |
| Obesity | 1.27 (1.12–1.44) | <0.001 |
| Tobacco use | 1.37 (1.22–1.54) | <0.001 |
| Coronary artery disease | 1.19 (0.97–1.47) | 0.096 |
| Coagulopathy | 1.15 (0.91–1.46) | 0.247 |
Homer and Lemeshow goodness-of-fit test: X2 10.14, df 8, P value 0.255.
A P value of less than 0.05 was considered statistically significant.
Table 6.
Multivariate Logistic Regression Determining the Odds of Implant Removal among Patients Undergoing DTI Breast Reconstruction
| Risk Factors | Odds Ratio (95% CI) | P * |
|---|---|---|
| ADM use | 1.36 (1.13–1.65) | 0.001 |
| Asthma | 1.00 (0.72–1.37) | 0.976 |
| COPD | 1.24 (0.96–1.60) | 0.098 |
| Chronic kidney disease | 0.75 (0.43–1.29) | 0.295 |
| Depression | 1.26 (1.05–1.50) | 0.012 |
| Diabetes | 1.06 (0.84–1.35) | 0.614 |
| Hypertension | 1.20 (0.99–1.45) | 0.062 |
| Hypothyroidism | 0.85 (0.69–1.04) | 0.121 |
| Obesity | 1.17 (0.96–1.42) | 0.131 |
| Tobacco use | 1.47 (1.23–1.77) | <0.001 |
| Coronary artery disease | 1.32 (0.95–1.84) | 0.093 |
| Coagulopathy | 1.00 (0.68–1.48) | 0.982 |
Homer and Lemeshow goodness-of-fit test: X2 6.68, df 8, P value 0.571.
A P value of less than 0.05 was considered statistically significant.
DISCUSSION
ADM use in implant-based breast reconstruction is known to have a number of benefits, including assisting in implant pocket control, implant camouflage, and decreased capsular contracture.1,17 After its first use in 2001, ADM use has become one of the cornerstones of breast reconstruction. However, in 2019, the FDA conducted a review of the data and has yet to determine the safety of its use in this setting, currently considering it a high-risk or class III medical device being used off-label in breast reconstruction.4,16,18,19 This is due to the conflicting data in the literature and the lack of high-quality studies comparing complications following immediate breast reconstruction with and without ADM.20 This study utilized a large national database to investigate the short-term complications associated with immediate implant-based breast reconstruction with or without ADM use and risk factors for implant removal.
Before matching for patient-related factors and regions within the United States, the same-day ADM use was more frequent in patients located in the Midwest, South, and Western states (Table 1). This could be due to regional trends and experiences shared among local plastic surgeons. After matching two cohorts by demographics and comorbidities, 90-day complication rates were reported, including surgical site infection, seroma, and implant removal. There was no statistically significant difference in surgical site infections or seromas among the ADM and no ADM matched groups, yet there was a 1% higher rate of implant removal among the ADM group (4.9% versus 3.9%, P < 0.001). When looking at the composite outcome of all combined complications, the ADM group had an absolute 1.2% increased rate compared with the no ADM group. Historically the pathophysiology of ADM-associated short-term perioperative complications has been described as resulting from the body’s initial inflammatory response to implanted collagen early in the healing process.3
After isolating patients with DTI surgery with or without ADM, the ADM group was found to have a 1.9% higher rate of implant removal, whereas the other complications were not statistically different (Table 2, DTI complications). Of note, overall complications were higher within the DTI group than the tissue expander population in this study.
In this study, multivariate logistic regression showed increased odds of explantation for patients with ADM used, DTI surgical technique, COPD, hypertension, obesity, and tobacco use (Table 4). The DTI procedure was the greatest risk factor for implant removal with two-fold increased odds. This is not surprising given that the weight of a permanent implant is generally greater than unfilled tissue expanders, risking pressure on the mastectomy skin flaps, and incisions potentially resulting in wound complication or implant exposure. ADM placement also showed 1.22-fold increased odds of explantation, confirming the small but statistically present risk increase. Prior published comparisons of short-term safety outcomes between DTI and staged expander-to-implant reconstruction have been inconsistent, seeming to vary by physician experience and mastectomy technique.21
The greatest patient-related risk factors for implant removal in this cohort were hypertension with a 26% increased odds and tobacco use with a 25% increased odds of implant removal. Prior studies have shown that relative intraoperative hypotension is a risk factor for developing postoperative hematomas in breast surgery which could explain this finding.22 A hematoma in implant-based breast reconstruction could contribute to poor wound healing, implant exposure or infection, and explantation. Tobacco use is an expected risk factor for explantation in this setting, as the effect of nicotine and tobacco products on microcirculation is well documented.23
Of the other assessed comorbidities, COPD, obesity, and depression also had a statistically significant increased odds of explantation. COPD contributes to chronically lower oxygen saturation, which compromises microcirculation of the healing wound similar to tobacco use and has been identified as a risk factor for postsurgical wound complications in breast reconstruction and other procedures.24–27 Obesity is associated with increased seroma formation by lymphatic system alteration, leading to dehiscence and implant exposure.28–32
Furthermore, the logistic regression analysis of the subset of patients with ADM placement in implant-based breast reconstruction had similar findings with regard to risk factors for explantation. DTI procedures had more than two-fold increase in odds of explantation (P < 0.001) over tissue expander placement, and hypertension, obesity, and tobacco use were also associated with increased odds of implant removal (Table 5). Interestingly, depression was also found to be a risk factor in this group with 34% increased odds of explantation. There is considerable data in the literature suggesting that stress is associated with downregulation of the early inflammatory response, among other mechanisms, resulting in delayed wound healing.33,34 This would explain this finding, as depression often coincides with stress and anxiety.
This retrospective matched cohort study provides evidence that there are no significant differences in surgical site infection or seroma, yet a mildly increased rate of implant removal with ADM use in implant-based breast reconstruction (1%) and DTI procedures (1.9%). Much of the existing evidence supporting the use of ADM in breast reconstruction procedures is related to personal experience and known aesthetic benefits.13 There have been, however, some clinical reports that have noted a higher rate of postoperative complications with ADM use.6,35–37 Some studies describe an increased inflammatory response possibly due to either variations in sterility rating or other features of the proprietary processing used to degrade or hide donor immunogenic material.38 Although tissue expanders and implants are also foreign bodies, they are fully sterile and cause a foreign body response with capsule formation rather than the cellular response required for the bioincorporation of ADM.38 As ADM bioincorporation is histologically complete by 3 weeks of implantation, an evaluation of 90-day outcomes would be an adequate report of ADM perioperative performance.39
The limitations of this study include its retrospective nature and insurance reliance. Using the PearlDiver database has inherent limitations including the exclusion of patients without insurance. These exclusions could lead to bias in the results. Although extensive, the population of the PearlDiver patient records database is not randomly sampled. Therefore, trend analysis and generalizations to the whole population should be interpreted with caution.40 Furthermore, CPT codes were not developed for research use and were collected from insurance claims. Therefore, the assignment of certain codes may be influenced by reimbursement strategies or coded by nonmedical team members which could lead to inconsistencies and inaccuracies in the subsequent analyses.40
Perhaps, the most important limitation of this study is the lack of extractable data regarding surgical details. Prior studies have shown comparable complication rates in prepectoral versus subpectoral implant placement in the appropriately selected patient; however, this database cannot delineate the degree of breast ptosis, skin thickness, and quality, and other decision-driving factors.41 The database also cannot determine ADM placement technique or ADM type used, or the mastectomy incision choice, which may influence postoperative outcomes.42,43 Finally, the database does not provide socioeconomic data such as homelessness, education level, and wound care support which could also influence our results.
CONCLUSIONS
This large national database study on ADM use and its associated short-term complications showed no difference in infection or seroma but did show a 1% increase in explantation after tissue expander placement and 1.9% increase in explantation with DTI. Important risk factors for implant removal with ADM use include obesity, hypertension, depression, and tobacco use. The aesthetic benefits of ADM use do not come without risk, especially in patients with these comorbidities with DTI procedures. Multicenter studies and registry data on prepectoral implants in breast reconstruction are warranted to further interpret these findings.
DISCLOSURES
Dr. Campbell has received grant support from Abbvie, Inc. and LifeNet Health for basic science research, serves on a medical advisory board for Integra Life Sciences (with financial compensation), and received compensation for professional education services from Mentor, a subsidiary of Johnson & Johnson. The other authors have no financial interest to declare.
Footnotes
Published online 13 March 2024.
Presented virtually at Plastic Surgery The Meeting, October 2022.
Disclosure statements are at the end of this article, following the correspondence information.
REFERENCES
- 1.Nahabedian MY, Spear SL. Acellular dermal matrix for secondary procedures following prosthetic breast reconstruction. Aesthet Surg J. 2011;31(7 Suppl):38S–50S. [DOI] [PubMed] [Google Scholar]
- 2.Tork S, Jefferson RC, Janis JE. Acellular dermal matrices: applications in plastic surgery. Semin Plast Surg. 2019;33:173–184. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Du Plessis MI, Cottler PS, Campbell CA. Acellular dermal matrix favorably modulates the healing response after surgery. Plast Reconstr Surg. 2022;150:290e–299e. [DOI] [PubMed] [Google Scholar]
- 4.Breuing KH, Warren SM. Immediate bilateral breast reconstruction with implants and inferolateral alloderm slings. Ann Plast Surg. 2005;55:232–239. [DOI] [PubMed] [Google Scholar]
- 5.Namnoum JD. Expander/implant reconstruction with AlloDerm: recent experience. Plast Reconstr Surg. 2009;124:387–394. [DOI] [PubMed] [Google Scholar]
- 6.Chun YS, Verma K, Rosen H, et al. Implant-based breast reconstruction using acellular dermal matrix and the risk of postoperative complications. Plast Reconstr Surg. 2010;125:429–436. [DOI] [PubMed] [Google Scholar]
- 7.Goodarzi P, Falahzadeh K, Nematizadeh M, et al. Tissue engineered skin substitutes. Adv Exp Med Biol. 2018;1107:143–188. [DOI] [PubMed] [Google Scholar]
- 8.Badylak SF, Freytes DO, Gilbert TW. Extracellular matrix as a biological scaffold material: structure and function. Acta Biomater. 2009;5:1–13. [DOI] [PubMed] [Google Scholar]
- 9.Wainwright DJ. Use of an acellular allograft dermal matrix (AlloDerm) in the management of full-thickness burns. Burns. 1995;21:243–248. [DOI] [PubMed] [Google Scholar]
- 10.Albornoz CR, Bach PB, Mehrara BJ, et al. A paradigm shift in U.S. breast reconstruction. Plast Reconstr Surg. 2013;131:15–23. [DOI] [PubMed] [Google Scholar]
- 11.American Society of Plastic Surgeons. Plastic surgery statistics report. 2020. Available at https://www.plasticsurgery.org/documents/News/Statistics/2020/plastic-surgery-statistics-full-report-2020.pdf. Accessed March 27, 2022.
- 12.Salzberg CA. Nonexpansive immediate breast reconstruction using human acellular tissue matrix graft (AlloDerm). Ann Plast Surg. 2006;57:1–5. [DOI] [PubMed] [Google Scholar]
- 13.JoAnna Nguyen T, Carey JN, Wong AK. Use of human acellular dermal matrix in implant- based breast reconstruction: evaluating the evidence. J Plast Reconstr Aesthet Surg. 2011;64:1553–1561. [DOI] [PubMed] [Google Scholar]
- 14.Gerber B, Marx M, Untch M, et al. Breast reconstruction following cancer treatment [published correction appears in Dtsch Arztebl Int. 2016 Apr 22;113(16):286]. Dtsch Arztebl Int. 2015;112:593–600. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 15.Kim SY, Bang SI. Impact of acellular dermal matrix (ADM) use under mastectomy flap necrosis on perioperative outcomes of prosthetic breast reconstruction. Aesthetic Plast Surg. 2017;41:275–281. [DOI] [PubMed] [Google Scholar]
- 16.Boyd CJ, Bekisz JM, Choi M, et al. Catch-22: acellular dermal matrix and U.S. food and drug administration premarket approval—how can we construct studies? Plast Reconstr Surg. 2022;150:1363–1366. [DOI] [PubMed] [Google Scholar]
- 17.Cheng A, Lakhiani C, Saint-Cyr M. Treatment of capsular contracture using complete implant coverage by acellular dermal matrix: a novel technique. Plast Reconstr Surg. 2013;132:519–529. [DOI] [PubMed] [Google Scholar]
- 18.Liu J, Hou J, Li Z, et al. Efficacy of acellular dermal matrix in capsular contracture of implant-based breast reconstruction: a single-arm meta-analysis. Aesthetic Plast Surg. 2020;44:735–742. [DOI] [PubMed] [Google Scholar]
- 19.Badylak S, Freytes D, Gilbert T. Extracellular matrix as a biological scaffold material: structure and function. Acta Biomater. 2009;5:1–13. [DOI] [PubMed] [Google Scholar]
- 20.Hallberg H, Rafnsdottir S, Selvaggi G, et al. Benefits and risks with acellular dermal matrix (ADM) and mesh support in immediate breast reconstruction: a systematic review and meta-analysis. J Plast Surg Hand Surg. 2018;52:130–147. [DOI] [PubMed] [Google Scholar]
- 21.Campbell CA, Losken A. Understanding the evidence and improving outcomes with implant-based prepectoral breast reconstruction. Plast Reconstr Surg. 2021;148:437e–450e. [DOI] [PubMed] [Google Scholar]
- 22.Hussien M, Lee S, Webster M, et al. The impact of intraoperative hypotension on the development of wound haematoma after breast reduction. Br J Plast Surg. 2001;54:517–522. [DOI] [PubMed] [Google Scholar]
- 23.Monfrecola G, Riccio G, Savarese C, et al. The acute effect of smoking on cutaneous microcirculation blood flow in habitual smokers and nonsmokers. Dermatology. 1998;197:115–118. [DOI] [PubMed] [Google Scholar]
- 24.Pastoriza J, McNelis J, Parsikia A, et al. Predictive factors for surgical site infections in patients undergoing surgery for breast carcinoma. Am Surg. 2021;87:68–76. [DOI] [PubMed] [Google Scholar]
- 25.Klasan A, Dworschak P, Heyse TJ, et al. COPD as a risk factor of the complications in lower limb arthroplasty: a patient-matched study. Int J Chron Obstruct Pulmon Dis. 2018;13:2495–2499. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 26.Zhao H, Li L, Yang G, et al. Postoperative outcomes of patients with chronic obstructive pulmonary disease undergoing coronary artery bypass grafting surgery: a meta-analysis. Medicine (Baltim). 2019;98:e14388. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 27.Choi SM, Kim HJ, Lee J, et al. Impact of GOLD groups of chronic pulmonary obstructive disease on surgical complications. Int J Chron Obstruct Pulmon Dis. 2016;11:281. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 28.Gubitosi A, Docimo G, Parmeggiani D, et al. Acellular bovine pericardium dermal matrix in immediate breast reconstruction after skin sparing mastectomy. Int J Surg. 2014;12:S205–S208. [DOI] [PubMed] [Google Scholar]
- 29.Wilson HB. New deep dermal ADM incorporates well in case series of complex breast reconstruction patients. Medicine (Baltim). 2015;94:e745. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 30.Payne SH, Ballesteros S, Brown OH, et al. Skin reducing mastectomy and immediate tissue expander reconstruction: a critical analysis. Ann Plast Surg. 2022;88:485–489. [DOI] [PubMed] [Google Scholar]
- 31.Jordan SW, Khavanin N, Kim JYS. Seroma in prosthetic breast reconstruction. Plast Reconstr Surg. 2016;137:1104–1116. [DOI] [PubMed] [Google Scholar]
- 32.Kurnia A, Suhandi A, Budiningsih S. Correlation between obesity and seroma following modified radical mastectomy. New Ropanasuri J Surg. 2016;1:3–6. [Google Scholar]
- 33.Walburn J, Vedhara K, Hankins M, et al. Psychological stress and wound healing in humans: a systematic review and meta-analysis. J Psychosom Res. 2009;67:253–271. [DOI] [PubMed] [Google Scholar]
- 34.Vileikyte L. Stress and wound healing. Clin Dermatol. 2007;25:49–55. [DOI] [PubMed] [Google Scholar]
- 35.Antony AK, McCarthy CM, Cordeiro PG, et al. Acellular human dermis implantation in 153 immediate two-stage tissue expander breast reconstructions: determining the incidence and significant predictors of complications. Plast Reconstr Surg. 2010;125:1606–1614. [DOI] [PubMed] [Google Scholar]
- 36.Sbitany H, Sandeen SN, Amalfi AN, et al. Acellular dermis–assisted prosthetic breast reconstruction versus complete submuscular coverage: a head-to-head comparison of outcomes. Plast Reconstr Surg. 2009;124:1735–1740. [DOI] [PubMed] [Google Scholar]
- 37.Lanier ST, Wang ED, Chen JJ, et al. The effect of acellular dermal matrix use on complication rates in tissue expander/implant breast reconstruction. Ann Plast Surg. 2010;64:674–678. [DOI] [PubMed] [Google Scholar]
- 38.Hoppe IC, Yueh JH, Wei CH, et al. Complications following expander/implant breast reconstruction utilizing acellular dermal matrix: a systematic review and meta-analysis. Eplasty. 2011;11:e40. [PMC free article] [PubMed] [Google Scholar]
- 39.DeGeorge BR, Ning B, Salopek LS, et al. Advanced imaging techniques for investigation of acellular dermal matrix biointegration. Plast Reconstr Surg. 2017;139:395–405. [DOI] [PubMed] [Google Scholar]
- 40.Alluri RK, Leland H, Heckmann N. Surgical research using national databases. Ann Transl Med. 2016;4:393. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 41.Li Y, Xu G, Yu N, et al. Prepectoral versus subpectoral implant-based breast reconstruction: a meta-analysis. Ann Plast Surg. 2020;85:437–447. [DOI] [PubMed] [Google Scholar]
- 42.Escandón JM, Butterfield JA, Christiano JG, et al. Wise-pattern versus transverse pattern mastectomy in two-stage implant-based breast reconstruction: a propensity score-matched analysis. Plast Reconstr Surg. 2023;152:695–805. [DOI] [PubMed] [Google Scholar]
- 43.Thuman J, Freitas AM, Schaeffer C, et al. Prepectoral Wise-pattern staged implant-based breast reconstruction for obese or ptotic patients. Ann Plast Surg. 2019;82:S404–S409. [DOI] [PubMed] [Google Scholar]