Efficacy of Mesh Use in Breast Surgery: A Comprehensive Review of Complications and Aesthetic Outcomes

Abstract

Background:

The insertion of a mesh “internal bra” has been used in cosmetic breast procedures for soft-tissue reinforcement as a means to mitigate postoperative ptosis. However, there have been concerns regarding complications as a result of mesh placement and a lack of quantitative data regarding postoperative cosmetic outcomes.

Methods:

Articles that assessed the effects of the mesh internal bra for soft-tissue support on cosmetic and patient-reported outcomes, complications, and surveillance were reviewed. Meta-analysis was performed to determine the overall complication rates, and cosmetic outcomes and patient-reported outcomes were reviewed.

Results:

Meta-analysis showed the following summary effect sizes: infection/abscess had a pooled rate of 3.61% (Q = 33.8, I² = 76.33%), hematoma was 1.34% (Q = 4.16, I² = 68.1%), seroma was 5.04% (Q = 14.8, I² = 73.11%), fat necrosis was 0.86% (Q = 693, I² = 99.7%), and capsular contracture was 2.5% (Q = 693.4, I² = 99.6%). Only 2 of 5 studies attempting to quantify cosmetic outcomes compared outcomes between patients who underwent procedures with and without the use of mesh. Both reported smaller increases in sternal notch-to-nipple distance and nipple-to-inframammary fold distance without clear statistical significance.

Conclusions:

Although there does not seem to be a significant difference in risk profile with and without the use of mesh, the current data do not support the claims of improved cosmetic outcomes. Well-controlled, quantitative studies are necessary to objectively evaluate the cosmetic benefits of using mesh.

Takeaways

Question: Does the use of mesh in cosmetic breast surgery impact complication rates or cosmetic outcomes?

Findings: The risk profiles associated with and without the use of mesh in cosmetic breast surgery do not seem to be significantly different, and the overall data do not support the claims of improvement in breast appearance with the use of mesh.

Meaning: Although there does not seem to be a significant difference in risk profile/complication rates with and without the use of mesh, there is very little objective data supporting improvement in cosmesis.

INTRODUCTION

Breast ptosis and pseudoptosis are common barriers to good long-term cosmetic outcomes following breast surgery, which often rely on atrophied tissue with poor soft-tissue support.^1,2 It has been suggested that reinforcement of the ligamentous suspension system, the primary support system of the breast, with a biocompatible material, could prevent recurrent ptosis.^3,4 Utilization of various synthetic and biologic meshes for soft-tissue support has been tried to improve long-term cosmetic outcomes with varying degrees of success.^3,5–7

One proposed solution is the internal bra technique, which involves the placement of mesh inside the breast pocket as a means of replacing the compromised ligamentous suspension system.⁸ In the case of synthetic mesh, the induction of fibrous tissue then serves to support the breast parenchyma for a long-term, more stable aesthetic outcome. Although the internal bra technique has the potential for improved cosmetic outcomes, there are also concerns about the increased risk of postoperative complications with the use of matrices, including infection, seroma formation, and skin necrosis.^9,10 Additionally, the cost of mesh is not insignificant, although synthetic meshes are a more cost-effective option than the acellular dermal matrix (ADM).¹¹ Concerns have also been raised about the impact of mesh placement on the visualization of the breast parenchyma with various breast cancer screening modalities as well as the impact on rates of cancer recurrence.⁸ In addition, radiation therapy has been found to be an independent predictor of complications with higher rates of implant loss and capsular contracture in patients who underwent implant-based reconstructions with the use of mesh.¹² Although there are increasing data on the use of mesh in breast surgery, this application of ADM or synthetic mesh is considered off-label use by the Food and Drug Administration.¹³

This systematic review and meta-analysis aimed to analyze the proposed impact of the internal bra technique on improving long-term cosmetic outcomes in breast surgery, as well as to assess the potential risks and disadvantages, including increased rates of postoperative complications and interference with breast cancer screening modalities. Studies that included ADM mesh have been excluded, as it is not feasible to directly compare and pool outcomes related to both biologic and synthetic meshes. As such, this study solely focuses on the use of nonabsorbable, partially absorbable, and fully absorbable synthetic meshes in cosmetic breast surgery.

METHODS

The primary endpoint of this review was to study rates of complications, including seroma, fat or skin necrosis, hematoma, capsular contracture, wound dehiscence, recurrent ptosis, and nipple or implant loss, as well as quantitative and qualitative cosmetic outcomes with the use of the internal bra soft-tissue support in breast surgery.

Study Selection

An initial review of the PubMed database was conducted with no restrictions. Search terms included “GalaFLEX,” “poly-4-hydroxybutyrate breast,” “polydioxanone breast,” “mastopexy mesh,” and “internal bra breast.” All English-language studies published before the search date were reviewed, with authors and affiliated institutions of each publication blinded. After excluding duplicates and non-English studies, titles and abstracts of each article were screened for relevance. Full text of studies that assessed outcomes or complications in mastopexy, mammoplasty, augmentation, or reconstruction with the use of mesh were accessed and reviewed, and studies that evaluated quantitative or patient-reported cosmetic outcomes, as well as any complications following breast surgery with the use of synthetic mesh for soft-tissue support, were included (Fig. 1). As above, studies that assessed ADM were excluded. However, Glasberg and Light⁹ reported data on breast reconstruction with the use of ADM and synthetic mesh, and only the synthetic mesh data were included in the meta-analysis. Reviews and case reports were excluded. References from the included articles were assessed for studies potentially not captured during the initial database search. The quality of this study was assessed using the guidelines set forth by the PRISMA checklist.

Fig. 1.

Diagram of literature review and systematic inclusion of articles.

Data Collection

Two authors, S.W. and E.J., independently conducted a search of published articles, and data were then extracted by authors S.W., A.M., and E.J. Data extracted included number of patients, number of breasts, patient age, operation performed, mesh type, surgical time, reported follow-up, incidence of recurrent ptosis (sternal notch-to-nipple [SNN] distance and nipple-to-inframammary fold [N-IMF] distance), reported complications, and patient-reported outcomes when reported.

Statistical Methods

A meta-analysis was performed to determine the overall complication rates for patients who underwent breast surgery with the placement of a mesh-based internal bra. Additionally, an analysis of complication rates was completed with weight means based on the reported sample size. Effect summaries were recorded in Excel, and mean differences with 95% confidence intervals for these outcomes and risk ratios with a 95% confidence interval were calculated to estimate pooled differences. Both the fixed-effects and random-effects models were used in all analyses. The heterogeneity of included studies was assessed with the Q and I² statistics, where an I² of less than 50% is considered to be a low amount of data heterogeneity. Publication bias was assessed using the Cochrane Bias Tool and trim and fill method. Sensitivity analysis was performed to detect the influence of a single study on the overall heterogeneity of included studies by sequentially recalculating I² with the omission of a single study. A P value was calculated for all effect summaries, with a P value of less than 0.05 considered significant. Excel was used to perform all statistical calculations. Of note, Johnson² and Chiemi and Kelishadi¹⁴ stated that there were no complications but did not specify which complications were being assessed. Therefore, these studies were not included in the meta-analysis. Additionally, Adams et al¹⁵ and Adams and Moses¹⁶ published 2 articles that were discussed in this review, 1 of which was a pilot study, the data from which were included in their second study. Only the data reported in the second multicenter study were included in the analysis to prevent duplication of their results in the analysis.

RESULTS

The initial search of the literature yielded 1080 citations. After a review of titles and abstracts, 42 were selected for full-text review, and 13 studies with a total of 1305 patients met eligibility requirements after full-text review. (See table, Supplemental Digital Content 1, which displays the article summary, http://links.lww.com/PRSGO/D860.)

Of 13 studies, 9 provided quantitative data and were included in the meta-analysis. The most commonly reported procedure was mastopexy, which was the primary operation in 6 studies. Additionally, 6 studies discussed reconstruction (46.1%), 4 studies assessed the use of mesh in mammoplasty (30.7%), 5 studies assessed mastopexy (38.5%), and 2 studies (15.4%) discussed breast augmentation. Of note, 1 study by Adams et al^5,15 reported outcomes for the first 11 patients who were then included in a 61-patient study, and data analysis was modified to ensure that these patients were not included twice.

Complications

Nine (69.2%) studies reported complication rates for patients who underwent breast surgery with the placement of a mesh-based internal bra. (See table, Supplemental Digital Content 2, which displays the complications, http://links.lww.com/PRSGO/D861.) Three studies reported no complications and were not included in the analysis. The most commonly reported complication was infection, reported in 9 (69.2%) studies. The pooled rate of infection/abscess was 2.36% among 1443 patients from the studies that reported postoperative infection or abscess.

Meta-analysis was conducted on the incidence of infection/abscess, hematoma formation, seroma formation, fat necrosis, capsular contracture, and nipple sensation loss. Summary effect sizes were as follows: infection and/or abscess had a pooled rate of 3.61% (Q = 33.79, I² = 76.33%), hematoma was 1.34% (Q = 4.16, I² = 68.1%), seroma was 5.04% (Q = 14.87, I² = 73.11%), fat necrosis was 0.86% (Q = 693, I² = 99.7%), capsular contracture was 2.51% (Q = 693.4, I² = 99.6%), and nipple sensation loss was 2.93% (Q = 9.33, I² = 67.8%), as summarized in Table 1 and further shown in Supplemental Digital Content 3. (See figure, Supplemental Digital Content 3, which displays the forest plot summary, http://links.lww.com/PRSGO/D862.)

Table 1.

Forest Plot Summary Data

Complication	Summary Effect Size (%)	Q (%)	I2 (%)
Infection/abscess	3.49	10.4	13.8
Hematoma	1.37	9.76	18.0
Seroma	2.27	11.0	45.3
Fat necrosis	0.867	−1.45	238
Capsular contracture	3.50	−44.7	107
Nipple sensation loss	2.93	2.88	−4.07

Other reported complications included mesh extrusion, need for scar revision, nipple retraction, nipple malposition, mesh rippling, replacement with woven mesh, breast cancer with amputation, dehiscent sutures in custom implant, superficial areolar epidermolysis, hypertrophic scarring, delayed wound healing, breast asymmetry, unspecified necrosis requiring excision, localized inflammation, flap necrosis, and implant malposition/migration. A weighted mean of the most commonly reported complications was analyzed, with infection/abscess reported as 2.81%, seroma at 1.51%, hematoma at 1.55%, fat necrosis at 0.85%, and capsular contracture at 0.33% (Table 2).

Table 2.

Weighted Mean and Pooled Rate of Complications Across All Studies That Reported Complications in This Review (n = 11)

Complication	Total Events/Total Breasts	Pooled Rate (%)	Weighted Mean Rate (%)
Infection/abscess	34/1443	2.36	2.81
Fat necrosis	7/613	1.14	0.85
Nipple sensation loss/neuralgia	35/1045	3.35	4.86
Hematoma	16/1429	1.12	1.55
Seroma	25/692	3.61	1.51
Capsular contracture	7/207	3.38	0.33

Cosmetic Outcomes

Four (31.2%) studies attempted to quantify cosmetic outcomes by assessing change in N-IMF and/or SNN postoperatively over varying follow-up periods. József et al¹⁷ compared outcomes with and without synthetic partially absorbable mesh and reported a median SNN difference of 1 cm in the mesh group and 3.5 cm in the nonmesh group, and median N-IMF differences of 0.5 and 0.75 cm, respectively, at the end of the follow-up (range 1–40 mo in mesh group and 1–38 mo in nonmesh group). In their pilot study and multicenter study, Adams and Moses¹⁶ measured change in SNN and N-IMF between 3 and 12 months, 1 and 3 months, and 1 and 12 months postoperatively. In their multicenter study that included the data from their pilot study, they found that at 1 year, 67.9% had grade 0 ptosis, 3.6% had pseudoptosis, 25.0% had grade 1 ptosis, and 2 patients had grade 2 ptosis. De Bruijn and Johannes⁶ measured mean SNN and N-IMF at 3 and 12 months postoperatively and found a mean change in SNN of 0.7 cm and a mean difference in N-IMF of 0.5 cm between 3 months and 1 year. Of the 4 studies that attempted to quantify cosmetic outcomes, only József et al compared outcomes with and without the use of mesh.

Three other studies reported improved cosmetic outcomes and/or soft-tissue support with the use of mesh; however, none provided consistent clinical or quantitative evidence of this conclusion. Three studies used a surgeon questionnaire as a way to subjectively assess aesthetic outcomes. Nguyen et al¹⁸ assessed cosmetic outcomes by Harvard score between 6 and 12 months postoperatively with a reported mean score of 3 (range 1–4). József et al¹⁷ used the Likert scale to assess aesthetic outcomes based on follow-up photographs with the mesh group receiving a score of 4.4 and the nonmesh group receiving a score of 3.8. Adams et al surveyed physicians about their satisfaction with surgical outcomes via a questionnaire that asked physicians to report ptosis grade (none, I–III, pseudoptosis), as well as general satisfaction with outcomes and the use of GalaFLEX, as reported in the supplementary material. However, the time intervals for the mean change in each measurement were not reported. Overall, their article reported rates of pseudoptosis at 1.6%, grade I ptosis at 4.8%, grade II ptosis at 41.9%, and grade III ptosis at 51.6%, but it is unclear from the supplementary material at what time point these evaluations were made.^15,16

Patient-reported Outcomes

Five studies (31.2%) assessed patient-reported outcomes with a variety of questionnaires. Two (14.2%) studies assessed patient satisfaction with the BREAST-Q questionnaire, which assesses breast satisfaction, psychosocial well-being, physical well-being, and sexual well-being. József et al¹⁷ compared outcomes between mesh and nonmesh groups and found that the mesh group had statistically significantly higher scores on breast satisfaction, physical well-being, and sexual well-being when compared with the nonmesh group. Ng et al¹⁹ compared outcomes in prepectoral versus dual-plane implant-based reconstruction and found that the prepectoral groups reported significantly higher satisfaction with outcomes. Buccheri et al²⁰ assessed patient satisfaction with a questionnaire at 6 months that ranked satisfaction on a scale of “worst outcome” to “very good.” Categories surveyed were breast shape (64.7% reported very good and 35.3% reported good), breast size (79.4% reported very good and 20.6% reported good), breast symmetry (85.3% reported very good and 14.7% reported good), scar appearance (41.2% reported very good, 35.3% reported good, and 23.5% reported fair), and overall quality of life (91.2% reported very good and 8.8% reported good). Of note, no patients reported the “worst outcome” option.

Van Deventer et al³ assessed patient-reported outcomes in their pilot study of 15 patients. Of patients who underwent mastopexy, 2 were very satisfied, 2 were satisfied, and 2 were dissatisfied due to poor breast shape and recurrent ptosis (both with large hypertrophic breasts). One was dissatisfied secondary to bilateral loss of nipple sensation. All 4 patients who underwent unilateral breast reduction with mesh were satisfied. Of the 4 patients who underwent bilateral reduction with mesh, 3 were very satisfied and 1 was satisfied.³ Adams and Moses¹⁶ found that at baseline, 2 patients were satisfied with breast shape and 1 was satisfied with breast droop. At 1 year postoperatively, the proportion of patients who were satisfied with breast droop increased to 94.4%, and the proportion of patients satisfied with breast shape was 98.1%.¹⁶

DISCUSSION

Although the use of mesh for soft-tissue support in breast surgery has become increasingly common over the last 2 decades, there is a lack of strong data supporting its use. This systematic review and meta-analysis aimed to further elucidate the potential risks and benefits of using the mesh internal bra system by analyzing the safety data and complication risks, and summarizing qualitative and quantitative evidence regarding cosmetic outcomes.

Mesh is commonly used across surgical specialties with a generally well-demonstrated favorable safety profile; however, there is a deficit of high-quality studies regarding safety and rates of complications of mesh in breast surgery specifically.⁸ The majority of studies are limited by a lack of appropriate controls, systematic follow-up, and small sample sizes. For example, Qiu and Seth²¹ assessed short-term complication rates with the use of polydioxanone mesh, but only included 7 patients. Although heterogeneity was high, complication rates were on a par with those reported in the literature for breast surgery without the use of mesh.^8,22–24 The data analyzed on other commonly reported complications, including fat necrosis, capsular contracture, and nipple sensation loss, had significant heterogeneity, posing a challenge to interpretation and application. Given this limitation, to sufficiently power the study for adequate statistical analyses, data reported on primary and secondary breast reconstruction cohorts of patients were not excluded. Weighted means of the most commonly reported complications were not significantly different from complications in breast surgery without mesh. Overall, the use of mesh sling in breast surgery does not seem to have significantly different risks of complications when compared with the risk profile of breast surgery without mesh as reported in the literature. However, given the deficit of studies with sufficient controls and adequate sample sizes as well as the high heterogeneity in this dataset, further studies directly comparing outcomes between breast surgery with and without the use of a mesh sling are needed to make conclusions regarding the risks associated with mesh placement.

Despite myriad reports of improved breast shape and/or decreased incidence of ptosis and pseudoptosis, there are insufficient data to support these claims. The primary approach to quantifying ptosis and pseudoptosis was by measuring the change in N-IMF distance and/or SNN distance over time. Although 2 studies reported smaller increases in SNN and N-IMF in the patients who underwent mesh placement compared with those without mesh over a follow-up period of approximately 3 years, the changes do not seem to be substantial. The other studies did not compare outcomes between patients who underwent surgery with and without mesh, and therefore, it is not possible to conclude with much certainty that cosmetic outcomes in their patients are improved as a result of the use of mesh.

The various physician surveys regarding general satisfaction with outcomes and subjective rating of ptosis, as well as patient-reported satisfaction postoperatively, are insufficient to make conclusions regarding the impact of mesh on cosmetic outcomes. Of note, Mallucci and Bistoni²⁵ attempted to quantify the efficacy of the use of mesh by measuring lower pole descent and arc length increase and found that mesh was effective in preventing lower pole descent and bottoming out; however, this was not included in the meta-analysis because the overall approach to measuring cosmetic outcomes was inconsistent with the other studies.

Another important consideration is the optimal type of mesh to be used in breast surgery. The articles selected for this review report a wide variety of different types of mesh, including biologic and synthetic (absorbable, nonabsorbable, and mixed, partially absorbable). There are too few studies with small sample sizes and a deficit of data in this selection of studies to adequately compare the rates of complications or cosmetic outcomes between different types of meshes, especially considering the lack of reliable data to make generalized conclusions regarding long-term cosmesis with the use of mesh. However, the question of optimizing the type of mesh for breast surgery is an important one. The literature suggests that there are relatively similar rates of complications between synthetic and biologic meshes, although ADM has been shown to have higher rates of hematoma formation. With respect to cosmetic outcomes, mesh with rapid absorption is unable to provide appropriate long-term support to the breast tissue, but the efficacy of materials with longer absorption times has not been proven, despite its relatively common use. It has been theorized that resorbable meshes leave behind a collagen scaffold that can support the breast tissue or implant, but there is insufficient evidence that absorbable meshes can provide long-lasting cosmetic results. It must also be noted that the Food and Drug Administration has not approved the use of any kind of mesh in aesthetic breast surgery.

CONCLUSIONS

The use of the mesh internal bra system has become increasingly popular in practice. Although there does not seem to be a significant difference in risk profile compared with breast surgery without the use of mesh, the current data, albeit limited, do not support the claims of improved cosmetic outcomes. Further well-controlled, quantitative studies are necessary to objectively evaluate the cosmetic benefits of using mesh in breast surgery.

DISCLOSURE

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