Serasynth Mesh BR Pocket in Prepectoral Direct-to-implant and Tissue-expander Breast Reconstruction: A Retrospective Single-center Analysis

Abstract

Background:

Prepectoral implant-based breast reconstruction after nipple-sparing mastectomy or skin-sparing mastectomy has already shown several advantages. Synthetic meshes are often used as a supportive layer to achieve satisfying and stable results. We present our data using Serasynth Mesh BR Pocket, a fully dissolvable, ready-to-use mesh pocket.

Methods:

Between December 2021 and August 2023, a single-center retrospective study evaluated 53 breast reconstructions (43 patients) for short-term complications. Complications were classified as major (requiring revision surgery) or minor (managed conservatively). All patients underwent nipple-sparing mastectomy or skin-sparing mastectomy followed by direct-to-implant or direct-to-expander reconstruction using Serasynth Mesh BR Pocket. The minimum follow-up was 4 weeks.

Results:

Of 53 breasts, 44 (83%) required no further surgical intervention, with a mean follow-up of 10 months (range 1–20, mo). Major complications occurred in 9 breasts (17%), and minor complications occurred in 13 (24.5%). Implant loss (13.2%) was primarily due to necrosis (7.5%). A higher body mass index (≥27 kg/m²) and axillary lymph node excision were associated with an increased risk of complications. Notably, 41.9% of patients received adjuvant radiotherapy.

Conclusions:

Serasynth Mesh BR Pocket demonstrates a favorable safety profile in prepectoral breast reconstruction, even in a high-risk cohort with substantial radiotherapy exposure. Outcomes are comparable to those of other synthetic meshes, with the added benefit of full resorbability. Careful patient selection, considering body mass index, soft-tissue quality, and lymph node dissection, is essential to optimize results.

Takeaways.

Question: Can a fully absorbable mesh pocket be safely and effectively used in immediate prepectoral implant-based breast reconstruction?

Findings: In a retrospective single-center study of 53 breast reconstructions using Serasynth Mesh BR Pocket, 83% experienced no major complications. Outcomes were comparable to those reported with nonabsorbable meshes, with implant loss (13.2%) primarily due to necrosis. Notably, 41.9% of patients received adjuvant radiotherapy.

Meaning: Serasynth Mesh BR Pocket is a safe, fully resorbable option for prepectoral breast reconstruction, even in patients receiving radiotherapy.

INTRODUCTION

As breast cancer remains the most prevalent malignancy affecting women, as stated by the World Health Organization in the 2022 report, there is a growing trend toward mastectomy with immediate implant-based reconstruction.^1,2 In earlier studies, satisfying results were observed favoring prepectoral breast reconstruction.^3,4 This approach offers the advantage of avoiding detachment of the origin of the pectoralis major muscle, thereby reducing animation deformity and postoperative pain.⁵ Additionally, it allows placement of the breast implant in its original anatomical position after breast tissue removal.⁶ An analysis comparing the outcomes of 39 cases of prepectoral implants and 50 cases of partial subpectoral implant placement, predominantly conducted through a 2-stage procedure, showed comparable rates for adverse events (22% and 20.5%, respectively).⁷ However, subcutaneous implant positioning after nipple-sparing mastectomy (NSM) or skin-sparing mastectomy (SSM) often presents surgical challenges due to potential skin flap necrosis, implant migration, and difficulties in precisely defining the submammary fold.

With the implementation of acellular dermal matrix (ADM) products and synthetic meshes that envelop the implant and create an additional protective and supportive layer or hammock, and hence overcome the aforementioned difficulties in prepectoral implant placement after NSM or SSM, prepectoral breast reconstruction has gained increased popularity, with similar results in complication rates and cosmetic outcomes, respectively.^8,9 Several studies have demonstrated promising outcomes in the use of synthetic meshes for prepectoral breast reconstruction lately.^10,11 In a study by Choi et al,¹² synthetic meshes demonstrated lower infection and seroma rates compared with ADMs, indicating their potential suitability for breast reconstruction. Although the precise mechanism underlying the reduced risk of infection and seroma is not fully understood, another study showed that synthetic meshes had lower biofilm formation in vitro compared with ADMs.¹³ Furthermore, the use of ADMs has been associated with the development of red breast syndrome, an inflammatory condition characterized by erythema over the area of ADM implantation.¹⁴ Differentiating red breast syndrome from infection is clinically important, as untreated infections may result in reconstructive failure.¹⁵ In this context, absorbable synthetic meshes may represent a potential alternative for selected patients.

In this retrospective study, we analyzed the safety of Serasynth Mesh BR Pocket (Serag-Wiessner GmbH & Co. KG, Naila, Germany), a novel, fully absorbable breast mesh pocket designed for prepectoral breast reconstruction. This implant pocket is provided as a ready-to-use product, entirely composed of polydioxanone and completely absorbable after approximately 6 months. It can be attached to the pectoralis fascia without requiring detachment from its origin and functions as a supportive framework, thereby increasing stability for both the implant and the surrounding tissues. This study aimed to evaluate the product safety of Serasynth Mesh BR Pocket in prepectoral breast reconstruction following prophylactic or oncological mastectomy in a cohort with a high rate of adjuvant radiotherapy.

MATERIAL AND METHODS

Study Design

From December 2021 to August 2023, a total of 43 patients undergoing uni- or bilateral direct-to-implant or direct-to-expander prepectoral breast reconstruction after oncological or prophylactic NSM or SSM at the Academic Hospital of Feldkirch were analyzed. Patients provided preoperative informed consent for mesh application, and this retrospective study was conducted in accordance with the ethical principles of the Declaration of Helsinki. All data were anonymized before analysis. The study was approved by the Ethics Committee of Vorarlberg, Austria (approval no.: EK-0.04-562), and was conducted in accordance with the Declaration of Helsinki.

In total, 53 prepectoral direct-to-implant or tissue-expander breast reconstructions using the Serasynth Mesh BR Pocket were performed. In NSM cases, reconstruction was carried out through an inframammary fold incision, whereas in SSM cases, reconstruction was performed through the existing mastectomy incision. Mastectomy was performed by gynecologic surgeons, followed by immediate reconstruction by a plastic surgeon.

Standard prophylactic antibiotics consisted of a single dose of cefazolin 2 g administered intraoperatively, or clindamycin in case of a penicillin allergy. Standard irrigation of the breast pockets, wound edges, and nipple before implantation of the Serasynth Mesh BR Pocket and implant was performed using a betadine-saline solution. In addition, the prosthesis was bathed in a betadine-saline solution before placement. Standard glove changes were performed before mesh and breast implant or expander placement.

Surgical Technique

The prepectoral pocket was prepared along the pectoralis major fascia. The Serasynth Mesh BR Pocket was positioned to envelop the implant or tissue expander, providing anterior and inferolateral support. The mesh pocket was secured to the pectoralis fascia using 4 single interrupted absorbable sutures (PDS 4.0; Ethicon, Inc., Johnson & Johnson Medical GmbH), placed to ensure stable fixation and appropriate pocket positioning.

After placement of the implant or tissue expander, correct orientation and complete unfolding of the mesh pocket were manually verified. Closed-suction drains were placed before wound closure. Wound closure was performed in 2 layers using Vicryl 4.0 subcutaneous interrupted sutures followed by an intracutaneous continuous suture, either absorbable or nonabsorbable. Drains were removed based on clinical assessment, either once output was below 30 mL within 24 hours or by postoperative day 7 at the latest.

Data were retrospectively collected from medical records. The collected data were subsequently analyzed for complications. In cases of capsule contracture, only instances classified as Baker grade 3 or higher were considered as complications. Only seromas that claimed therapeutic interventions, such as aspiration or surgery, were considered as complications, whereas self-resolving seromas were not counted. The decision for intervention was based solely on clinical criteria, such as swelling and bruising. Inclusion criteria required a minimum 4-week follow-up period.

Statistical Analysis

Statistical analysis was performed using NCSS (NCSS 2022, NCSS, LLC, Kaysville, UT) and Statistica 13.¹⁶ Data were analyzed for consistency and normality by using the Shapiro–Wilk test. Fisher exact or Pearson chi-square tests were used to analyze cross-tabulations. Logistic regression analysis was used together with odds ratios and 95% confidence intervals to analyze the effects of various continuous variables on binary variables (bootstrap). Because several variables deviated from normality, randomization tests were used to test differences in means, whereas Levene test was used to test the assumption of variance homogeneity. All reported tests were 2-sided, and P values less than 0.05 were considered to indicate statistical significance.

RESULTS

A total of 53 Serasynth Mesh BR Pockets were used in 43 patients receiving prepectoral direct-to-implant/expander breast reconstruction following oncological or prophylactic NSM or SSM. The mean follow-up time was 10 months (range 1–20 mo). The median age of the female patient cohort was 48 years (range 27–73 y), with a median body mass index (BMI) of 23.2 kg/m² (range 17.9–30.8 kg/m²). Detailed patient characteristics are summarized in Table 1.

Table 1.

Patient Demographics

Patients	43
Age, median (range), y	48 (27–73)
BMI, median (range), kg/m2	23.2 (17.9–30.8)
Comorbidities, n (%)
History of smoking	13 (30.2)
Diabetes mellitus	2 (4.7)
Arterial hypertension	5 (11.6)
Breast reconstruction	53
Unilateral	35
Bilateral	9
Indication for surgery, n (%)
Oncological	40 (75.5)
Prophylactic	13 (24.5)
Chemotherapy (per patient), n (%)
>2 y before surgery	1 (2.3)
Neoadjuvant	18 (41.9)
Adjuvant	4 (9.3)
Radiotherapy (per patient), n (%)
>2 y before surgery	2 (4.7)
Adjuvant	18 (41.9)
Type of mastectomy, n (%)
NSM	47 (88.7)
SSM	6 (11.3)
Lymph node excision, n (%)
No lymph node excision	16 (30.2)
Sentinel lymph node excision	23 (43.4)
Axillary lymph node excision	14 (26.4)
Type of reconstruction, n (%)
Direct-to-implant	34 (64.2)
Expander-based	19 (35.8)
Implant type, n (%)
Anatomical	43 (81.1)
Round	10 (18.9)
Implant volume
Expander volume, mean, mL	321
Implant volume, mean, mL	318

NSM or SSM was indicated in 75.5% of breasts (n = 40) for therapeutic reasons and in 24.5% (n = 13) for prophylactic reasons. Of these, 88.7% of breasts received NSM and 11.3%, SSM. Simultaneous sentinel lymph node excision was performed in 23 breasts (43.4%), whereas axillary lymph node excision was necessary in 14 cases (26.4%).

Out of 53 breasts reconstructed in 43 patients, 64.2% (n = 34 breasts) underwent direct-to-implant reconstruction, whereas 35.8% (n = 19 breasts) were reconstructed using saline-prefilled expander prostheses. Implant and expander volumes were comparable across cases. Drains were removed, on average, 6.8 days postoperatively. In total, 18 (41.9%) patients received adjuvant radiotherapy, and 2 (4.7%) patients had a history of prior radiotherapy. Neoadjuvant chemotherapy was administered in 18 (41.9%) patients, whereas 4 (9.3%) patients received adjuvant chemotherapy.

When analyzed by breast reconstruction (n = 53), 31 (58.5%) of these remained free of any adverse events following prepectoral direct-to-implant or tissue-expander reconstruction using Serasynth Mesh BR Pocket. Implant loss or revision surgery occurred in 7 cases, resulting in a reconstructive failure rate of 13.2%. Details of major and minor complications are provided in Table 2.

Table 2.

Overview of Postoperative Complications

Minor complications (cases), n (%)	13 (24.5)
Seroma	1 (1.8)
Necrosis	6 (11.3)
Infection	3 (5.7)
Implant dislocation	4 (7.5)
Capsular contracture (Baker grade ≥ 3)	1 (1.9)
Major complications (cases), n (%)	9 (17)
Necrosis	4 (7.5)
Hematoma	2 (3.8)
Infection	1 (1.9)
Infected seroma	1 (1.9)
Capsular contracture	1 (1.9)
Major complications resulting in implant loss (cases), n (%)	7 (13.2)
No major complication (cases), n (%)	44 (83)
No major or minor complication (cases), n (%)	31 (58.5)

Eighteen breast reconstructions (34%) were performed in patients who received adjuvant radiotherapy, whereas 35 reconstructions (66%) were performed in patients without adjuvant radiotherapy (Table 3). In the radiotherapy group (n = 18), 3 breast reconstructions (16.7%) developed major complications, including infected seroma, infection, and 1 case of high-grade capsular contracture, whereas 6 (33.3%) had minor complications managed conservatively and 9 (50%) remained complication-free. In the nonradiotherapy group, major complications—namely necrosis and hematoma—occurred in 6 cases (17.1%), minor complications were observed in 7 cases (20%), and 22 reconstructions (62.9%) had no complications. Overall, 83% of all breast reconstructions remained free of major complications at the end of the observation, regardless of adjuvant radiotherapy status.

Table 3.

Complication Rates Related to Adjuvant Radiotherapy

	Adjuvant Radiotherapy	No Adjuvant Radiotherapy	In Total
Breast reconstructions, n (%)	18 (34)	35 (66)	53
No complication	9 (50.0)	22 (62.9)	31 (58.5)
Minor complication	6 (33.3)	7 (20.0)	13 (24.5)
Major complication	3 (16.7)	6 (17.2)	9 (17)
Infected seroma	1	—	1
Infection	1	—	1
Capsular contracture	1	—	1
Necrosis	—	4	4
Hematoma	—	2	2

Overall, 83% of breast reconstructions remained free of major complications by the end of the study, regardless of whether patients received adjuvant radiotherapy or not.

Advanced age (≥65 y) was associated with a higher rate of minor postoperative infections in this cohort (P = 0.01). No differences in overall minor or major complication rates were observed with respect to other patient-related characteristics, including smoking status, hypertension, or oncological treatments (neoadjuvant or adjuvant radiotherapy or chemotherapy), as shown in Table 4.

Table 4.

Univariate Analysis of Patient-related Characteristics as Risk Factors for Major and Minor Complications

	Minor Complications		Major Complications
Characteristics	Odds Ratio	P (2-sided)	Odds Ratio	P (2-sided)
BMI > 27 kg/m2	4.04	0.06	1.70	0.67
Age > 65 y	3.70	0.15	6.83	0.54
Smoking	0.92	1.00	3.33	0.13
Hypertension	0.58	1.00	2.86	0.27
Adjuvant radiotherapy	0.50	0.33	1.03	1.00
Neoadjuvant chemotherapy	0.69	0.75	0.66	0.72

Ipsilateral axillary lymph node excision during the same procedure showed a significant correlation with seromas requiring aspiration (P = 0.04) and infections (P = 0.02). No differences in minor or major complication rates were observed across the procedure-related characteristics listed in Table 5.

Table 5.

Univariate Analysis of Procedure-related Characteristics as Risk Factors for Major Complications

	Minor Complications		Major Complications
Characteristics	Odds Ratio	P (2-sided)	Odds Ratio	P (2-sided)
Axillary lymph node excision	2.81	0.16	1.50	0.68
Sentinel lymph node excision	2.04	0.35	0.95	1.00
Implant versus expander	1.78	0.51	2.68	0.25
Oncological versus prophylactic surgery	0.76	1.00	0.86	1.00
NSM versus SSM	1.42	0.66	2.86	0.27

DISCUSSION

The application of mesh breast pockets in the context of immediate prepectoral breast reconstruction still lacks extensive data or literature, given the relatively recent introduction of these products to the market. The primary aim of this study was to evaluate the short-term safety profile of the Serasynth Mesh BR Pocket, with a particular focus on early postoperative complications. Gruber et al¹⁷ investigated the safety of Serasynth Mesh BR, reporting major and minor complication rates of 15.6% and 12.5%, respectively. The difference between Serasynth Mesh BR and Serasynth Mesh BR Pocket is the ready-to-use feature of Serasynth Mesh BR Pocket; therefore, the results are comparable. However, lower complication rates in their study could possibly be attributed to more restrictive selection criteria, as patients undergoing adjuvant or neoadjuvant radiotherapy were excluded, which strongly differs from our cohort.

Machleidt et al¹⁸ observed a reconstructive failure rate of 11.5% with the partially absorbable bicomponent Seragyn BR mesh, primarily attributed to infection (7.4%). Similar to our findings, the results demonstrated a significantly increased reoperation risk linked to sentinel lymph node dissection and elevated BMI. According to Grous et al,¹⁹ comparable revision rates were observed in subpectoral and prepectoral immediate breast reconstruction using Seragyn BR and Serasynth Mesh BR, respectively (5% and 5.1%).

In a retrospective single-center analysis, Nguyen-Strauli et al²⁰ examined the safety of the TiLOOP Bra Pocket, a nonresorbable ready-to-use titanium-coated polypropylene mesh pocket designed for prepectoral breast reconstruction. Results showed a major complication rate of 11.1%, which was slightly lower than our findings (17%). However, minor complications were comparable, at 19% and 22.6%, respectively. It is noteworthy that axillary lymph node excision was performed in 4.8% of cases in their study, which contrasts with our cohort (26.3%), potentially impacting the development of adverse events, as lymph node dissection was shown to have a significant impact on seroma and infection formation, according to our data. Another study focusing on the TiLOOP Bra Pocket by Ng et al²¹ reported an implant loss rate of 8%, which is slightly lower than the 13% observed in our study population. This difference may be associated with stricter patient selection or variations in demographics, as their cohort did not include patients who smoked or patients with diabetes, showing considerable contrast with our cohort. Furthermore, adjuvant radiotherapy was administered in 14% of their cases, whereas in our cohort, it was administered in 34% of cases, which could negatively impact the outcomes. In both of the aforementioned studies analyzing the TiLOOP Bra Pocket, seroma aspiration rates were slightly higher, at 11.1%²⁰ and 14%,²¹ compared with our results (4.5%). Seroma formation is a recognized complication after mastectomy with direct-to-implant reconstruction,²² possibly leading to further complications such as implant dislocation, infection, necrosis, or implant loss.²³ However, it is important to consider that the indication for seroma aspiration may vary across studies.

Recently, Abbott et al²⁴ found similar short-term complication rates in 2-stage breast reconstruction with polydioxanone mesh, biological mesh, or no mesh. The type of mesh was not an independent factor affecting outcomes. Instead, variables such as mastectomy flap quality, radiotherapy, and patient characteristics had a greater impact on complications, especially in prepectoral reconstruction.

Sulkar et al²⁵ reported favorable safety and performance outcomes using polydioxanone mesh DuraSorb in implant-based breast reconstruction, with high procedural success rates and low rates of infection, seroma, and implant loss. These findings further support the role of absorbable synthetic meshes as effective temporary scaffolds during early tissue integration in both 2-stage and direct-to-implant reconstruction.

Additionally, Turin and Gutowski²⁶ evaluated DuraSorb in a prospective case series of 27 breasts and reported a single postoperative complication, a seroma requiring aspiration, resulting in an overall complication rate of 4%. However, only 5 patients had a history of mastectomy, and just 1 had undergone radiotherapy. Despite sharing a polydioxanone composition and resorption profile, the small number of postmastectomy reconstructions and limited radiotherapy exposure make it difficult to compare these results with those from our cohort.

In a large study investigating the application of the nonabsorbable TiLOOP Bra in subpectoral implant-based immediate breast reconstruction,²⁷ a major complication rate of 13.4%, a minor complication rate of 15.6%, and an implant loss rate of 8.7% were documented. Stricter patient selection criteria might have influenced these rates, given that only 2.6% of individuals in the cohort underwent neoadjuvant or adjuvant radiotherapy. Overall, the data regarding the application of mesh products in subpectoral procedures may be only partially comparable with our findings using the prepectoral technique.

Comparative research on ADMs and synthetic absorbable mesh products in implant-based breast reconstruction remains limited. Although ADMs may provide biological integration and additional soft-tissue coverage,²⁸ Serasynth Mesh BR Pocket, composed of fully resorbable polydioxanone, is intended to provide temporary support and implant stabilization during the early healing phase.

Faulkner et al²⁹ reported clinical outcomes following the use of absorbable Vicryl mesh compared with AlloDerm in implant-based reconstruction, describing comparable safety outcomes and lower material costs associated with mesh use in their cohort. However, a direct comparison between ADMs and the Serasynth Mesh BR Pocket is currently lacking. In contrast to other studies, where mastectomy and breast reconstruction were typically performed by the same surgical team, in our setting, mastectomy was conducted by colleagues from the department of gynecology.

The high proportion of oncological patients in our study population may influence the incidence of skin necrosis, as compromising the blood supply to the skin is often necessary for achieving adequate oncological resection in tumors situated close to the skin. Moreover, differences in patient selection—especially the higher proportion of patients receiving adjuvant radiotherapy in our cohort—might have impacted the outcomes, as similar studies on comparable products included notably fewer patients who received adjuvant radiotherapy.

Implant-based breast reconstruction in patients with prior or planned radiotherapy and in patients who smoke remains controversial due to increased complication risks. In these cases, the risks of implant-based reconstruction should be carefully weighed against those of autologous options on an individual basis.

In summary, in cases with a very thin soft-tissue envelope, the surgeon’s expertise becomes important in determining whether subcutaneous implant placement is advisable or whether subpectoral placement would be more appropriate. Moreover, various procedure-related variables, such as additional axillary lymph node dissection or adjuvant radiotherapy, along with patient-specific factors such as smoking and BMI, should guide the selection of the surgical approach.

However, we are convinced that patient selection considering the aforementioned parameters will be crucial in determining whether a patient is suitable for prepectoral breast reconstruction. In appropriately selected patients, the use of Serasynth Mesh BR Pocket seems to be a safe and effective option, while offering the advantage of complete resorption within approximately 6 months and representing a fully absorbable, ready-to-use breast mesh pocket currently available for prepectoral breast reconstruction. The decision to use a fully resorbable mesh should be individualized based on patient characteristics, mastectomy flap quality, and intraoperative findings. Whether the use of a fully resorbable mesh provides additional clinical or aesthetic benefit compared with reconstruction without mesh requires further investigation. This retrospective study is primarily limited by its short follow-up duration and the absence of a control group. To address these limitations, multicenter prospective studies that incorporate control groups and longer follow-up durations are necessary, particularly for observing long-term complications such as capsular contracture.

LIMITATIONS

A limitation of this study is the relatively short follow-up period. Although the average follow-up was 10 months, this duration is not enough to reliably evaluate long-term complications such as capsular contracture. Given the retrospective design and univariate analysis, findings related to patient- and procedure-related variables should be interpreted with caution. Therefore, this analysis mainly addresses early postoperative safety and complication trends, and no conclusions regarding long-term outcomes or the durability of reconstruction can be made. Longer follow-up and prospective studies are needed to better assess late complications in prepectoral breast reconstruction with absorbable mesh pockets.

CONCLUSIONS

Serasynth Mesh BR Pocket is a safe and effective option for immediate prepectoral breast reconstruction, offering the added benefit of complete absorbability. Our results demonstrate outcomes comparable to those reported in studies of other mesh pockets used for prepectoral reconstruction, even in a cohort with a high proportion of patients receiving adjuvant radiotherapy. These findings highlight its effectiveness and emphasize the necessity for additional research to enhance patient selection and assess long-term outcomes.

DISCLOSURES

The authors have no financial interest to declare in relation to the content of this article. This study received support from Serag-Wiessner GmbH & Co. KG in the form of material provision. The sponsor had no role in the study design, data collection, data analysis, interpretation of the data, or preparation of the article.

ACKNOWLEDGMENT

The product used in this study was Serasynth Mesh BR Pocket (Serag-Wiessner GmbH & Co. KG).