Implant-based breast reconstruction—a systematic review and meta-analysis of prepectoral versus submuscular implant placement
Original Article

Implant-based breast reconstruction—a systematic review and meta-analysis of prepectoral versus submuscular implant placement

Alexandria Pumilia ORCID logo, Paulina B. Le, Julia Bian, M. Elise Becker, Harold I. Friedman

Division of Plastic Surgery, Department of Surgery, Prisma Health, University of South Carolina, Columbia, SC, USA

Contributions: (I) Conception and design: All authors; (II) Administrative support: All authors; (III) Provision of study materials or patients: All authors; (IV) Collection and assembly of data: All authors; (V) Data analysis and interpretation: All authors; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.

Correspondence to: Alexandria Pumilia, MD. Division of Plastic Surgery, Department of Surgery, Prisma Health, University of South Carolina, 2 Medical Park Road, Suite 302, Columbia, SC 29203, USA. Email: alexandria.pumilia@prismahealth.org.

Background: Implant based breast reconstruction began in the 1970s. Over the ensuing decades, the placement of silicone breast implants has varied from underneath a muscular chest wall coverage to a subcutaneous location. With the advent of the incorporation of dermal matrix as a component of breast reconstruction, along with more cohesive gel implants, there has been renewed enthusiasm for pre-pectoral (subcutaneous) implant placement. Pre-pectoral reconstruction has the advantage of not detaching the pectoralis muscle from the sternum and ribs, thereby using the same plane of dissection as the mastectomy for reconstruction. In this fashion, there is considerably less pain and many of the procedures, including immediate reconstruction, can be performed on an outpatient basis. The purpose of this research was to perform a meta-analysis of the literature comparing the two planes of reconstruction for risks of complications and outcomes.

Methods: A comprehensive literature review was completed on PubMed, Ovid, and MEDLINE databases using the key search “prepectoral OR pre pectoral AND submuscular OR dual plane OR subpectoral OR sub pectoral AND breast reconstruction”. The search was completed on the seventeenth of July in 2024. Cochrane’s Collaboration tool for assessing risk-of-bias was also conducted on the included studies.

Results: Out of the total of 824 studies that resulted from this search, 47 studies met criteria of directly comparing outcomes between pre-pectoral and sub-pectoral (total or partial) implant-based breast reconstruction and were included in this study. Pre-pectoral cohort had statistically higher rates of seroma than the sub-pectoral counterpart [odds ratio (OR): 1.41, 95% confidence interval (CI): 1.08–1.85]. Rippling was seen at higher rates in the pre-pectoral group (OR: 2.21, 95% CI: 1.52–3.21). The submuscular group was found to have higher rates of animation deformity (OR: 0.09, 95% CI: 0.03–0.25). There was no significant difference in hematoma, infection, wound healing, flap/nipple necrosis, implant exposure, explantation, capsular contracture, implant malposition or readmission rates.

Conclusions: Pre-pectoral implant-based reconstruction has a similar risk profile to sub-pectoral reconstruction, especially in the setting of acellular dermal matrices. Surgeons can confidently utilize either reconstructive plane to best fit the patient and mastectomy flap needs. However, there is a higher expected rate of rippling and seroma formation with prepectoral implants, while there is a higher rate of animation deformity with submuscular implantation. Therefore, the choice of location of the implant may depend on these findings, as well as other factors that could not be determined from this study, such as, thickness of skin flaps, size of implant, number of stages for reconstruction and surgeon experience.

Keywords: Breast reconstruction; prepectoral; submuscular; implant-based; meta-analysis


Received: 26 September 2024; Accepted: 19 February 2025; Published online: 20 May 2025.

doi: 10.21037/abs-24-48


Highlight box

Key findings

• Statistically higher rates of seroma were seen postoperatively in patients undergoing prepectoral implant based breast reconstruction versus submuscular reconstruction.

• Higher rates of rippling were seen in prepectoral implant based breast reconstruction.

• Higher rates of animation deformity were reported in subpectoral implant based breast reconstruction.

What is known and what is new?

• The majority of studies comparing the plane in which implant based reconstruction are retrospective in nature.

• The meta-analysis previously performed focused on this topic have shown mixed results.

• Our meta-analysis including 47 studies, a total of 12,074 breasts, found that the majority of postoperative complications following implant based breast reconstruction was not statistically different regardless of which plane was utilized.

What is the implication and what should change now?

• Based on this knowledge, surgeons should discuss the different planes of breast reconstruction and risk profiles of each with patients to determine whether prepectoral or subpectoral implant based reconstruction better suits the patient’s preferences.

• More true randomized control trials are desired to better investigate this topic.


Introduction

Background

Breast cancer is one of the leading types of malignancy worldwide and the number one cancer diagnosis in women within the United States. Although the incidence is high, the five year survival rate also remains high, at 91% (1). This fact is largely due to the advancements in screening as well as surgical intervention. As the surgical treatment of breast cancer has evolved from radical mastectomy to lumpectomies and nipple sparing mastectomy in select patients, so too has the landscape of breast reconstruction changed throughout the years. Starting as early as 1970, silicone implants were placed in the subcutaneous plane following radical mastectomy for breast reconstruction, and although the cosmesis at that time was limited, a large impact in patient satisfaction was noted (2). Around the same time, the National Surgical Adjuvant Breast and Bowel Project (NSABP) was conducting the NSABP B-04 trial, comparing oncologic outcomes between women receiving radical and total mastectomy from 1971 to 1974. Following the trial’s first result publication in 1977, a shift to less invasive breast cancer surgery gained higher popularity (3). By 1978, studies began looking at the safety profile of prepectoral implant reconstruction. Schlenker et al. focused on the rates of infection, necrosis, extrusion and capsular contracture with an ultimate explantation rate of around 30% (4). This same publication highlighted the utilization of the pectoralis major for coverage of the implant when mastectomy flaps were thin and extrusion was pending in cases where the muscle was spared during mastectomy. By the 1980s, submuscular implant placement became the mainstream implant-based reconstructive option with pre-pectoral implant placement falling out of favor. The addition of muscle allowed for better coverage, although this technique is not without flaws, including capsular contracture, pain, and unwanted animation deformity. However, with continued advancements with acellular dermal matrices, fat grafting, and improvement in silicone implants, a shift has occurred once more to placing implants within the anatomical location of the previously removed natural breast tissue above the muscle (5).

Rationale

The plane in which implant-based reconstruction is performed still remains highly variable and dependent on plastic surgeon preference and intra-operative gestalt based on mastectomy flaps. The purpose of this study was to perform a comprehensive systematic review and meta-analysis in order to compare the outcomes of prepectoral and submuscular implant-based breast reconstruction. This paper will act as an update on the topic. The most recent meta-analyses on this subject had been performed by Ostapenko et al. and Nolan et al. in 2022 and 2024, respectively. Ostapenko et al. ultimately identified 15 studies in which they were able to compare results (6). However, within this narrowed review, Ostapenko’s finding of capsular contracture rates were contradictory to that of Xie et al.’s meta-analysis which were originally published in 2023 (7). Similarly, the review completed by Nolan et al. only compared results only after nipple-sparing mastectomy, leading to six studies meeting criteria for meta-analysis (8). While these two studies both had a limited scope, our analysis planned a more comprehensive criterion for study inclusion and ultimately allowing for a higher power. We present this article in accordance with the MOOSE reporting checklist (available at https://abs.amegroups.com/article/view/10.21037/abs-24-48/rc).


Methods

Search methodology

A systematic review of literature was performed using PubMed, Ovid, and MEDLINE databases, using the following search terms: prepectoral OR pre pectoral AND submuscular OR dual plane OR subpectoral OR sub pectoral AND breast reconstruction. Bibliographies were also searched in the extracted articles. This search and subsequent analysis were performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (Figure 1). Duplicate articles were removed (n=23). Any non-English and non-human articles were excluded. The search was last completed on July 17, 2024. Two investigators initially screened all titles and abstracts.

Figure 1 PRISMA flow chart illustrating the results of the systematic review.

Selection criteria

Abstracts and titles were initially screened, and non-English and non-human studies were immediately excluded. Full-text articles were then assessed for eligibility; conference and abstract presentations, reviews, editorials, narratives, commentaries, opinions, and case reports were excluded. Studies that directly compared outcomes between pre-pectoral and sub-pectoral (total or partial) implant-based breast reconstruction were included. Four investigators, authors of this paper, then reviewed the included studies in their entirety and extracted relevant data and outcomes.

Our PICO (Population, Intervention, Comparator, and Outcome) question is defined as follows:

  • Population: patients who underwent implant-based breast reconstruction after mastectomy;
  • Intervention: placement of breast tissue expander or implant in the pre-pectoral plane;
  • Comparator: placement of breast tissue expander or implant in the sub-pectoral or dual-plane (partial sub-pectoral);
  • Outcomes: post-operative seroma, hematoma, infection, mastectomy flap necrosis, nipple necrosis, other wound healing complications, implant/expander exposure, explantation, capsular contracture, rippling, malposition of implant, animation deformity, and unplanned re-operations.

For risk of bias, the Cochrane’s Collaboration’s tool was utilized (Table 1). Three investigators, authors of this paper, performed the assessment independently. A random effects model was chosen due to the multitude of factors that could possibly impact patient outcomes since a fixed-effects model assumes there is only one true variable that influences the outcome. Given the variability in the patient population, type of mastectomies performed, the use of acellular dermal matrices, history of chemotherapy and/or radiation, among others, a random effects model was more appropriate for this meta-analysis with the large number of studies included.

Table 1

Assessment of bias in the included studies

Author, year Random sequence generation bias Allocation concealment bias Blinding of participants and personnel (performance bias) Blinding of outcome assessment (detection bias) Incomplete outcome data (attrition bias) Selective reporting (reporting bias)
Alcon et al., 2023 (9) High risk High risk Unclear risk High risk High risk Low risk
Asaad et al., 2023 (10) High risk Unclear risk Low risk Low risk Low risk Unclear risk
Asaad et al., 2023 (11) High risk High risk Unclear risk Low risk Low risk Low risk
Avila et al., 2020 (12) High risk High risk Low risk Low risk Low risk Low risk
Baker et al., 2018 (13) High risk High risk Unclear risk Low risk Low risk Low risk
Bekisz et al., 2022 (14) High risk High risk Low risk Low risk Low risk Low risk
Bernini et al., 2015 (15) High risk High risk Unclear risk High risk Low risk Low risk
Bozzuto et al., 2021 (16) High risk High risk Low risk Low risk Low risk Low risk
Braun et al., 2020 (17) High risk High risk Low risk Unclear risk Low risk Low risk
Casella et al., 2014 (18) High risk High risk Low risk Low risk Low risk Low risk
Chandarana et al., 2018 (19) High risk High risk Low risk Low risk Low risk Low risk
Chen et al., 2023 (20) High risk High risk Unclear risk Low risk Low risk Low risk
Chinta et al., 2022 (21) High risk High risk Low risk Low risk Low risk Unclear risk
Cogliandro et al., 2023 (22) High risk High risk Low risk High risk Unclear risk Low risk
ElSherif et al., 2024 (23) High risk High risk Low risk Low risk Low risk Low risk
Franceschini et al., 2021 (24) High risk High risk Unclear risk Unclear risk Low risk Low risk
Gabriel et al., 2020 (25) High risk High risk Low risk Low risk Low risk Low risk
Gruber et al., 1981 (26) High risk High risk Low risk Low risk Low risk Unclear risk
Haddock et al., 2021 (27) High risk High risk Low risk Low risk Low risk Low risk
Hassan et al., 2024 (28) High risk High risk Low risk Low risk Low risk Low risk
Houvenaeghel et al., 2022 (29) High risk High risk Unclear risk Low risk Unclear risk Low risk
Houvenaeghel et al., 2024 (30) High risk High risk Unclear risk Unclear risk Low risk Low risk
Kim et al., 2020 (31) High risk High risk Unclear risk Low risk Low risk Low risk
King et al., 2021 (32) High risk High risk Low risk Low risk Low risk Low risk
Kraenzlin et al., 2021 (33) High risk High risk Low risk Low risk Low risk Low risk
Lee et al., 2021 (34) High risk High risk Unclear risk Unclear risk Low risk Low risk
Manrique et al., 2020 (35) High risk High risk Unclear risk Unclear risk Low risk Unclear risk
Mirhaidari et al., 2020 (36) High risk High risk Low risk Low risk Low risk Unclear risk
Moriarty et al., 2022 (37) High risk High risk Low risk Low risk Low risk Low risk
Nahabedian et al., 2017 (38) High risk High risk Low risk Unclear risk Unclear risk Low risk
Nelson et al., 2022 (39) High risk High risk Unclear risk Low risk Unclear risk Low risk
Ng et al., 2021 (40) High risk High risk Low risk Unclear risk Low risk Low risk
Patel et al., 2022 (41) High risk High risk Low risk Low risk Low risk Low risk
Salgarello et al., 2024 (42) High risk High risk Unclear risk Unclear risk Unclear risk Low risk
Sbitany et al., 2017 (43) High risk High risk Low risk Low risk Low risk Low risk
Schaeffer et al., 2019 (44) High risk High risk Unclear risk Unclear risk Low risk Unclear risk
Sinnott et al., 2018 (45) High risk High risk Low risk Unclear risk Unclear risk Low risk
Sobti et al., 2020 (46) High risk High risk Low risk Low risk Low risk Low risk
Suh et al., 2021 (47) High risk High risk Low risk Low risk Unclear risk Unclear risk
Talwar et al., 2024 (48) High risk High risk Low risk Low risk Unclear risk Unclear risk
Teotia et al., 2023 (49) High risk High risk Low risk Low risk Low risk Low risk
Thuman et al., 2021 (50) High risk High risk Low risk Low risk Low risk Low risk
Walia et al., 2018 (51) High risk High risk Unclear risk Low risk Unclear risk Low risk
Walker et al., 2021 (52) High risk High risk Low risk Low risk Low risk Unclear risk
Wormer et al., 2019 (53) High risk High risk Low risk Low risk Low risk Unclear risk
Yang et al., 2019 (54) High risk High risk Unclear risk High risk Low risk Low risk
Zhu et al., 2016 (55) High risk Unclear risk Low risk High risk Low risk Low risk

Statistical analysis

Outcomes from included studies were collected and reported as odds ratios (ORs). The following outcomes were analyzed: seroma, hematoma, infection, mastectomy flap necrosis, nipple necrosis, other wound healing complications, implant/expander exposure, explantation, capsular contracture, rippling, malposition of implant, animation deformity, and unplanned re-operations. Total sub-pectoral and partial sub-pectoral, or dual-plane, reconstructions were pooled together and compared to pre-pectoral reconstructions. Meta-analysis using a random-effects model was performed to synthesize the extracted data into ORs with 95% confidence interval (CI). Additionally, forest plots were created for each outcome. I2 statistic values were calculated for each outcome to quantify the level of heterogeneity among the studies. Publication bias was assessed using funnel plots.


Results

Included studies

The electronic search yielded a total of 824 studies (after duplicates were removed). Of these, 47 studies met criteria for inclusion in the study (Figure 1). Of these studies, 40 were retrospective cohort studies—with 5 of these being matched cohort studies—and 7 were prospective cohort studies. Of note, none were randomized controlled trials. A total of 8,350 patients and 12,074 breasts were included in this meta-analysis. Patients included underwent skin-sparing, nipple-sparing, simple total, and modified radical mastectomies. Subsequently, the included patient population underwent either two-stage implant-based breast reconstruction with initial tissue expander placement or direct-to-implant reconstruction. In our statistical analysis, total sub-pectoral and partial sub-pectoral, or dual-plane, reconstructions were pooled together and compared to pre-pectoral reconstructions. Table 2 summarizes the characteristics of each study (Table 2). The average age of patients in the prepectoral group ranged from 39–52.9 years of age while the average subpectoral age ranged from 34–57.2 years. The average BMI ranged from 22.74–33.68 and 22.26–33.98 kg/m2 for the prepectoral and subpectoral groups, respectively.

Table 2

Included studies’ characteristics

Author, year Type of study Average age (years)* (pre-pec, sub-pec) Average BMI (kg/m2)* (pre-pec, sub-pec) Type of mastectomy Type of reconstruction Use of ADM**
Alcon et al., 2023 (9) Retrospective cohort 46, 48 Not available NSM 2-stage TE Yes
Asaad et al., 2023 (10) Retrospective cohort 52.9, 52.18 33.68, 33.98 NSM, SSM 2-stage TE Mixed
Asaad et al., 2023 (11) Retrospective cohort 50.4, 50 27, 25.1 NSM, SSM 2-stage TE Mixed
Avila et al., 2020 (12) Retrospective cohort 46.5, 45.9 24, 23.7 NSM 2-stage TE and DTI Yes
Baker et al., 2018 (13) Prospective cohort 47.5, 48 26, 23.4 SSM DTI Yes
Bekisz et al., 2022 (14) Retrospective cohort 52,49.7 28.6, 25 SSM, NSM, modified, radical, total 2-stage TE and DTI Mixed
Bernini et al., 2015 (15) Prospective cohort 47, 51 23, 23 NSM, SSM DTI Mesh
Bozzuto et al., 2021 (16) Matched retrospective cohort 49, 48.6 23.7, 23.2 NSM, SSM 2-stage TE and DTI Yes
Braun et al., 2020 (17) Retrospective cohort 45, 46 24, 24 NSM 2-stage TE and DTI Yes
Casella et al., 2014 (18) Prospective cohort 39, 34 23, 23 NSM, SSM DTI Mesh
Chandarana et al., 2018 (19) Retrospective cohort 51, 50 27.32, 25.08 SSM DTI Yes
Chen et al., 2023 (20) Retrospective cohort 49.5, 48.1 24, 23 Not specified 2-stage TE Mesh
Chinta et al., 2022 (21) Retrospective cohort 50.8, 50.3 26.9, 25.8 NSM, SSM 2-stage TE and DTI Yes and mesh
Cogliandro et al., 2023 (22) Retrospective cohort 51, 57.2 24, 23.2 NSM DTI Mesh
ElSherif et al., 2024 (23) Retrospective cohort 48.3, 48.8 25.7, 24.7 NSM 2-stage TE and DTI Yes
Franceschini et al., 2021 (24) Retrospective cohort 47, 44 23.95, 24.77 NSM DTI No
Gabriel et al., 2020 (25) Retrospective cohort 49, 53 34, 33.5 NSM, SSM 2-stage TE and DTI Yes
Gruber et al., 1981 (26) Retrospective cohort Not specified Not specified SSM DTI No
Haddock et al., 2021 (27) Matched retrospective cohort 52.8, 52.6 29.1, 28.8 SSM, NSM, modified, radical, total 2-stage TE Yes
Hassan et al., 2024 (28) Retrospective cohort 49.9, 46.9 26.58, 26.5 NSM, SSM 2-stage TE Mixed
Houvenaeghel et al., 2022 (29) Retrospective cohort Not specified Not specified NSM, SSM, total DTI Mesh
Houvenaeghel et al., 2024 (30) Prospective cohort 48, 48 22.74, 22.26 NSM, SSM, total 2-stage TE and DTI Mesh
Kim et al., 2020 (31) Retrospective cohort 49, 48.6 23.7, 23.2 NSM, SSM DTI Yes
King et al., 2021 (32) Retrospective cohort 52.4, 46.9 29, 25.2 NSM 2-stage TE and DTI Yes
Kraenzlin et al., 2021 (33) Retrospective cohort 48.8, 49.4 27.4, 27.5 NSM, non-NSM 2-stage TE Yes
Lee et al., 2021 (34) Prospective cohort 45.1, 45.5 22.7, 22.6 NSM, SSM DTI Yes
Manrique et al., 2020 (35) Retrospective cohort 54, 47 25.8, 24.9 NSM, SSM DTI Yes
Mirhaidari et al., 2020 (36) Prospective cohort 54, 48 27, 26 NSM, non-NSM DTI Yes
Moriarty et al., 2022 (37) Retrospective cohort 48.6, 46 24.5, 23.1 NSM 2-stage TE and DTI Mixed
Nahabedian et al., 2017 (38) Retrospective cohort 50.4, 49.2 26.1, 25.3 NSM, SSM 2-stage TE Yes
Nelson, 2022 (39) Matched retrospective cohort 50.3, 50.7 26.4, 27.1 NSM, non-NSM 2-stage TE Mixed
Ng et al., 2021 (40) Retrospective cohort 50.6, 48.5 23.6, 23.2 NSM DTI Mesh
Patel et al., 2022 (41) Retrospective cohort 44.4, 48.8 23.4, 23.3 NSM, SSM DTI Mixed
Salgarello et al., 2024 (42) Retrospective cohort 54 21.9 NSM, SSM DTI Yes
Sbitany et al., 2017 (43) Prospective cohort 44.8, 48.2 27.4, 25 NSM 2-stage TE Yes
Schaeffer et al., 2019 (44) Matched retrospective cohort 50, 50 29, 28 NSM, SSM 2-stage TE Yes
Sinnott et al., 2018 (45) Retrospective cohort 52.4, 46.9 29, 25.2 Not specified 2-stage TE and DTI Yes
Sobti et al., 2020 (46) Retrospective cohort 52.3, 49.7 28.5, 24.8 NSM, SSM DTI Mixed
Suh et al., 2021 (47) Retrospective cohort 47.3, 47.9 23.7, 22.2 SSM, simple, modified radical 2-stage TE Yes
Talwar et al., 2024 (48) Matched retrospective cohort 50.2, 50.4 35, 36 NSM, SSM, modified radical 2-stage TE and DTI Mixed and mesh
Teotia et al., 2023 (49) Retrospective cohort 50.9, 49.2 29.4,30.2 NSM, SSM, total/radical 2-stage TE Yes
Thuman et al., 2021 (50) Retrospective cohort 50.1 28.7, 29.8 Not specified 2-stage TE Yes
Walia et al., 2018 (51) Retrospective cohort 51.4, 48.6 24.3, 26.1 NSM, SSM 2-stage TE Yes
Walker et al., 2021 (52) Retrospective cohort 53, 55.5 30.2, 27.8 Not specified 2-stage TE and DTI Yes
Wormer et al., 2019 (53) Retrospective cohort 48.2, 49.9 29.5, 26.8 NSM, SSM 2-stage TE Yes
Yang et al., 2019 (54) Retrospective cohort 49, 46 23, 21 NSM, SSM 2-stage TE and DTI Yes
Zhu et al., 2016 (55) Retrospective cohort 50.5, 52.7 27.8, 27.5 NSM, SSM 2-stage TE Mixed

*If only one number is listed, then only the average for all patients is available; the average for each cohort was not provided or able to be calculated from the given data. **Yes indicates ADM was used in all pre-pectoral (and in all sub-pectoral or dual-plane in some studies) patients; mixed indicates only in some patients; mesh indicates that a type of synthetic mesh was used to wrap implant or expander. SSM, skin-sparing mastectomy; NSM, nipple-sparing mastectomy; DTI, direct-to-implant; TE, tissue expander; ADM, acellular dermal matrix.

Outcomes

Thirty-six of the studies compared seroma rates between patients who underwent pre-pectoral breast reconstruction and sub-pectoral breast reconstruction. The pre-pectoral cohort had statistically significantly higher incidence of seroma than the sub-pectoral cohort (OR: 1.41, 95% CI: 1.08–1.85; Figure 2, Figure S1). No statistically significant difference was found between the two cohorts in regards to incidence of hematoma, infection, other wound healing complications, mastectomy flap necrosis, nipple necrosis, implant/expander exposure, explantation, and capsular contracture (Figures 3-10, Figures S2-S9). Nine studies compared visible rippling of the implant between the two groups. Higher rates of rippling were found in the pre-pectoral group (OR: 2.21, 95% CI: 1.52–3.21; Figure 11, Figure S10). Only five studies analyzed implant malposition as an outcome; no significant difference was found between the two cohorts (Figure 12, Figure S11). Eight studies compared animation deformity rates, which were found to be much higher in the sub-pectoral group (OR: 0.09, 95% CI: 0.03–0.25; Figure 13, Figure S12). No statistically significant difference was found between the pre-pectoral and sub-pectoral cohorts when comparing readmission rates (Figure 14) and unplanned re-operations (Figure 15, Figure S13). Statistical heterogeneity varied across studies for each analysis performed (I2 range: 0.0–53%).

Figure 2 Forest plot comparing seroma incidence. CI, confidence interval; M-H, Mantel-Haenszel.
Figure 3 Forest plot comparing hematoma incidence. CI, confidence interval; M-H, Mantel-Haenszel.
Figure 4 Forest plot comparing infection rates. CI, confidence interval; M-H, Mantel-Haenszel.
Figure 5 Forest plot comparing other wound healing complications. CI, confidence interval; M-H, Mantel-Haenszel.
Figure 6 Forest plot comparing incidence of mastectomy flap necrosis. CI, confidence interval; M-H, Mantel-Haenszel.
Figure 7 Forest plot comparing incidence of nipple necrosis. CI, confidence interval; M-H, Mantel-Haenszel.
Figure 8 Forest plot comparing rates of tissue expander or implant exposure. CI, confidence interval; M-H, Mantel-Haenszel.
Figure 9 Forest plot comparing explantation rates. CI, confidence interval; M-H, Mantel-Haenszel.
Figure 10 Forest plot comparing capsular contracture rates. CI, confidence interval; M-H, Mantel-Haenszel.
Figure 11 Forest plot comparing incidence of visible rippling. CI, confidence interval; M-H, Mantel-Haenszel.
Figure 12 Forest plot comparing incidence of malpositioning of the implant. CI, confidence interval; M-H, Mantel-Haenszel.
Figure 13 Forest plot comparing animation deformity rates. CI, confidence interval; M-H, Mantel-Haenszel.
Figure 14 Forest plot comparing unplanned re-operation rates. CI, confidence interval; M-H, Mantel-Haenszel.
Figure 15 Forest plot comparing readmission rates. CI, confidence interval; M-H, Mantel-Haenszel.

Assessment of bias and sensitivity analysis

An assessment of bias was performed for each included study (Table 1). This was completed with the Cochrane’s Collaboration tool for assessing risk-of-bias as described within the methods section. Again, the random effects model was followed due to the multifactorial variables that were identified as potential influences. Biases assessed included random sequence generation, allocation concealment, performance, detection, attrition and reporting. Most biases were due to the retrospective nature of the majority of the studies. Additionally, none of the prospective studies had randomized cohorts. Funnel plots were performed for each outcome analysis to test for publication bias (Figures S1-S13). No significant asymmetry is seen in any of these plots.


Discussion

With the advent of silicone breast implants, breast reconstruction following mastectomy became feasible (2,56). However, the early implants manufactured by Dow Corning were prone to leak, rupture, and development of capsular contractures, as well as extrusion and infection. These implants were characterized by thin walls and highly fluid silicone miscible with the wall leading to extravasation of silicone outside the implant. Complication rates of subcutaneous breast reconstructions were high and the cosmetic results often not satisfactory. In 1978, Bostwick et al. described the use of the latissimus dorsi musculocutaneous flap to reconstruct the breast following radical mastectomy in one operation (57). The breast implant was placed entirely in the submuscular plane and the skin island replaced the skin removed with the mastectomy specimen.

As knowledge regarding breast tumor biology progressed, lesser extirpative procedures became the norm and the pectoralis muscle was maintained on the chest wall. The latissimus muscle and skin island were then appropriated along the lower border of the pectoralis allowing for a larger implant, with fuller lower poles and complete skin and muscle coverage (58). Problems associated with the use of breast implants persisted including capsular contracture, implant rupture, infection, seroma, and malposition of the implant. In addition, the contracture of the pectoralis muscle could give rise to an animation deformity (59).

Salzberg was credited with the first use of human acellular dermal matrix (ADM) in 2001 (60,61). The application of this material replaced the sling function in the lower pole of the reconstruction occupied by the latissimus dorsi musculocutaneous flap making the reconstruction considerably less invasive. It also allowed patients to undergo either immediate reconstruction with a more modern gel implant or a delayed two stage reconstruction with a tissue expander (62). Over the ensuing years, various types of allogenic and xenogeneic matrices were utilized to assist in forming a complete pocket in a submuscular plane for immediate and delayed reconstruction with various round, shaped and textured devices. Outcomes in either single- or two-stage operations were very good. However, complications of implant infections, seroma, capsular contracture, and animation deformity remained. The latter could significantly affect the quality of life (63). In addition, there was still much pain associated with detaching the pectoralis muscle from the rib cage, and in some cases, this pain became chronic, particularly when associated with capsular contracture (64).

As manufacturers developed more cohesive gel implants and extirpative surgeons became more comfortable leaving thicker skin and subcutaneous flaps during mastectomies, there was a resurgence of interest in placing modern implants in the pre-pectoral or subcutaneous plane with the additional supportive coverage of a dermal matrix. The matrix was incorporated into the host tissues providing an additional layer of protection from the skin surface. Implants were either completely covered with dermal matrix or the implant was placed with its posterior surface on the pectoralis muscle and the anterior surface covered in dermal matrix underneath the subcutaneous tissue. Significant advantages of this procedure included eliminating the possibility of animation deformity and greatly reducing postoperative pain. In the latter case, many patients could undergo their mastectomy and reconstruction in an outpatient setting. Furthermore, it was suggested that the dermal matrix reduced the incidence of capsular contracture (65).

The presence of the silicone breast implant in the pre-pectoral position does however give rise to the new complication of skin rippling reflecting the rippling of the upper pole of the implant when in a vertical position. This occurs despite the use of more cohesive gels, particularly in patients with thin mastectomy skin flaps. However, this problem is often easily remedied with autologous fat grafting, which may be needed, regardless, to smooth out the contour between the implant and the chest wall (66).

Key findings

In the current study, a meta-analysis and systematic review was performed comparing outcomes of submuscular versus pre-pectoral implant-based breast reconstructions. Forty-seven studies comparing the two positions and outcomes were included in this analysis of 8,350 patients and 12,074 breasts. Of note, included in the study were patients undergoing various types of mastectomies including skin sparing, nipple sparing, simple, total and modified radical mastectomies, as well as, direct-to-implant or two-stage reconstructions. In addition, submuscular implant positioning included reconstructions completely covered by muscle, those partially muscle covered combined with dermal matrix, and those considered dual-plane, in which the lower border of the implant rests in the subcutaneous space. These are confounding variables which could not be eliminated by this analysis.

The meta-analysis investigated several post-operative complications and found some significant differences between the two cohorts. Seroma rates were significantly higher in patients undergoing pre-pectoral reconstruction, however, no differences in rates of hematoma, infection, or wound problems, mastectomy flap necrosis or capsular contracture were found compared to sub-pectoral reconstructions. Higher rates of visible rippling were observed in the pre-pectoral group, as expected. Animation deformities were much higher in the sub-pectoral group, which is also expected. There were no differences found in unplanned operations or re-operation rates. Additionally, there were no differences found in hospital readmission rates. Given that pre-pectoral reconstructions eliminate animation deformity and reduce postoperative pain often allowing for outpatient surgery, it is not surprising that more procedures are being performed in this fashion recently. However, it should be noted most papers in this review that reported on hospital length-of-stay post-operatively did not find any difference and averaged approximately one day in both cohorts. Due to the duration of both operations being of such short duration, formal analysis was not deemed of value.

In conclusion, this meta-analysis illustrates that pre-pectoral breast reconstruction does not have a higher risk profile than sub-pectoral placement, with the exceptions of implant rippling—easily remedied by fat grafting—and somewhat higher rates of seroma formation, of which the etiology is unclear.

Strength and limitations

Limitations of this systematic review and meta-analysis include inherent weaknesses of this type of study, including the heterogeneity of the patient population, incomplete data provided, and mostly retrospective nature of the included studies. I2 statistic was calculated for each outcome to analyze the heterogeneity, none of which exceeded 53%, but most were under 25%, which is acceptable. Some prospective cohort studies were included, but none were randomized controlled trials. Publication bias was assessed using funnel plots, none of which appeared asymmetric. All other biases were analyzed in all articles, which again, are mainly deemed high-risk due to the retrospective nature of many of these studies. While some studies did investigate patient and surgeon outcome satisfaction, it was difficult to quantitatively analyze these results in a meta-analysis due to heterogeneity in how these outcomes were reported.

Additional studies would seem to indicate that there is also no difference in outcomes between the two implant locations in the face of postoperative radiation with perhaps an advantage to pre-pectoral placement due to the lack of influence of fibrosis of the pectoralis muscle on implant shape and position (67,68). Several of our included studies directly compared patients who had adjuvant radiation and were pooled into the meta-analysis. Only two papers isolated groups that received radiation from those that did not, which found higher complication rates in post-radiated breast reconstruction regardless of plane, including contracture, infection and seroma (49,50).

There was limitation in the ability to identify patient specific demographics or treatments in order to further isolate causality of certain features as the data was largely published as a percentage of the whole patient population. This included but was not limited to radiation treatment, prophylactic versus therapeutic mastectomies, implant or matrix type, and partial versus total muscular coverage. While further breaking down reconstruction to tissue expander versus definitive implant would add additional data points of interest, a high proportion of literature lumped expanders and final implants together, and the data of which patients received expanders versus implants was not available for analysis. While total submuscular placement is largely different from partial or dual-plane coverage, many of the papers lumped these techniques together as submuscular, which adds a confounding variable to the study. Similarly, while we were able to report whether ADM was used, due to confounding factors, we were unable to use the data to identify if the ADM influenced outcomes. Our review did show that a variety of ADMs were utilized, including cadaveric dermal matrix, porcine mesh, titanium coated mesh, and poly-4-hydroxybutyrate mesh. A prior meta-analysis has been performed looking specifically into the complication rates and the type of human ADM used (69).

Comparison with similar researches

While previous literature reviews and meta analyses have been completed focusing on this topic, our review has been the most in depth completed to date, resulting with 47 studies in which data was pulled to compare the complications associated with the plane in which implant based breast reconstruction is completed. Prior publications have been contradictory in results, specifically in results in which plane has a lower rate of capsular contracture (6,7,70). With our extended review, our goal was to utilize a higher “N” in order to determine true significance between the different reconstructive plane types.

Explanations of findings

While some results of this study followed intuition, largely based on the amount and type of soft tissue was covering the implant, such as submuscular implants presenting with higher animation deformity and prepectoral implants having higher rates of rippling, the etiology of prepectoral implants having statistically higher rates of seroma formation is unknown. One possible explanation for this result is the confounding variable of ADM. While ADM was used as an inferior sling in some of the dual-plane reconstructions, this differs largely in the total amount of ADM used in most of the prepectoral reconstructions, some with complete coverage of the implant with ADM. While studies have yet to show that ADM leads to seroma formation (8,71), some may feel that this is not the case anecdotally. Another speculation is the possibility that the increased vascularity of the pectoralis muscle allows for faster absorption of fluid leading to less seroma formation. Although, the true etiology is undetermined.

Implications and actions needed

Overall, this meta-analysis and systematic review demonstrates that pre-pectoral implant-based reconstruction has a similar risk profile to sub-pectoral reconstruction, but confers advantages, such as less animation deformity. However, there is a paucity of randomized controlled trials that directly compare these planes in breast reconstruction. While completing such a study would allow for direct comparison, the influences of patient desires, mastectomy flap thickness, tumor location, surgeon preference, and comorbidities, limits the viability of performing such studies.


Conclusions

Pre-pectoral implant-based reconstruction has a similar risk profile to sub-pectoral reconstruction. Either reconstruction plane is a reasonable option for surgeons to perform based on the desire of patients and their expectations. Patients should be aware that pre-pectoral breast reconstruction has statistically higher rates of seroma compared to sub-pectoral reconstruction. Rippling does occur at higher rates in pre-pectoral reconstruction, while animation deformity is more likely to occur in sub-pectoral reconstruction.


Acknowledgments

None.


Footnote

Reporting Checklist: The authors have completed the MOOSE reporting checklist. Available at https://abs.amegroups.com/article/view/10.21037/abs-24-48/rc

Peer Review File: Available at https://abs.amegroups.com/article/view/10.21037/abs-24-48/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://abs.amegroups.com/article/view/10.21037/abs-24-48/coif). H.I.F. served as a lecturer in International Hyperbaric Medicine course and as the vice president of South Columbia Philharmonic. The other authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

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


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doi: 10.21037/abs-24-48
Cite this article as: Pumilia A, Le PB, Bian J, Becker ME, Friedman HI. Implant-based breast reconstruction—a systematic review and meta-analysis of prepectoral versus submuscular implant placement. Ann Breast Surg 2025;9:11.

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