Risk factors and complications in immediate pre-pectoral breast reconstructions with BRAXON^®Fast acellular dermal matrix after skin-sparing and skin-reducing mastectomies

Introduction

Breast reconstruction following mastectomy is an integral component of both breast cancer treatment and preventive care for high-risk individuals. Implant-based reconstruction has been the primary approach for post-mastectomy breast reconstruction, typically involving submuscular or dual-plane implant placement (1,2). The introduction of acellular dermal matrix (ADM) for soft tissue coverage has made pre-pectoral breast reconstruction (PPBR) a more feasible alternative.

The early breast reconstructions using silicone implants placed the implant in a subcutaneous pocket between the mastectomy skin and the pectoralis major muscle. This approach was straightforward and maintained the integrity of the pectoralis muscle. However, it was linked to various complications, including implant malposition (bottoming out), visibility, palpability, rippling, implant exposure due to skin problems, and capsular contracture (3,4). Realizing that the complications mentioned earlier were due to inadequate soft-tissue coverage, breast reconstruction techniques evolved by relocating the implant from a subcutaneous position to a submuscular one.

In the submuscular placement technique, the implant is positioned beneath the pectoralis major muscle without releasing its lower attachment. While this approach overcomes the soft-tissue coverage limitations seen in subcutaneous placement, it can lead to unnatural-looking breasts, pain due to muscle contractions, and “animation deformity”, where the implant shifted upwards and outwards when the pectoralis muscle contracted forcefully, causing a noticeable distortion of the breast shape. Additionally, this technique restricted lower pole expansion, resulting in poor breast projection and definition (5-8).

To overcome the limitations of full muscle coverage in breast reconstruction, the partial muscle coverage or dual-plane technique was introduced. In this method, the implant is partially covered by the pectoralis major muscle on its upper side and partially by the mastectomy flap on its lower side (5). However, the downside of this technique is that there is a risk of the implant becoming visible and palpable in the lower lateral part of the breast because this area is not adequately covered by the pectoralis major muscle (9).

In attempt to solve the issue of insufficient lower pole coverage in breast reconstruction, an ADM was introduced in 2006. This technique, which is a popular modification of the partial muscle coverage approach, involves suturing ADM at the lower pole of the breast implant to provide additional support. This method minimized complications related to subcutaneous coverage while allowing for better lower pole expansion (8). The introduction of ADM in combination with sub-pectoral reconstruction has led to improvements, such as better lower pole expansion, reduced post-operative pain, and a decrease in complications like capsular contracture and implant mispositioning (10-12). Additionally, there is less need for implant replacement for functional and aesthetic reasons (11,13).

In recent years, pre-pectoral implant-based breast reconstructions using ADM have become more popular. Advances in ADM and implant technology have made PPBR an appealing choice for reconstruction. ADM is associated with lower rates of capsular contracture, a more natural and aesthetically pleasing breast shape, and an improved success rate by adding an extra layer of soft tissue coverage between the implant and mastectomy skin flaps. Additionally, newer generation cohesive silicone implants help reduce issues like implant rippling and visibility (14). Pre-pectoral implant-based reconstruction with ADM offers clinical and aesthetic advantages over sub-pectoral placement, including the elimination of animation deformities and reduced patient discomfort (5,15-18). It is particularly suitable for patients with small to medium-sized breasts and minimal to moderate ptosis, as it carries a lower risk of post-operative complications (5,19).

In 2012, Braxon^® ADM pioneered the development of a preshaped biological matrix designed to fully encase breast implants (20,21). This innovation aimed to establish a complete biological interface between the implant and the patient’s tissues, potentially reducing fibrotic reactions and facilitating the placement of implants in a pre-pectoral position (21). Research by Berna et al. and over 50 subsequent scientific publications have provided substantial evidence supporting the clinical effectiveness of Braxon ADM. Numerous studies have confirmed the feasibility, safety, and benefits of this approach in breast implant procedures (22,23).

A new three-dimensional ADM called BRAXON^®Fast is a technological advancement from the classic BRAXON^® ADM. It’s a pre-shaped, ultra-thin (0.6 mm), unperforated porcine collagen membrane designed for wrapping around implants before implantation. Requiring only four stitches to secure the implant within it, this 3D design aims to accelerate the implant wrapping process, creating a comprehensive biological interface between the implant and the patient’s tissues, saving time in the process (24). Furthermore, its teardrop shape recreates the natural ptosis of the breast and allows for housing a round or anatomical breast implant of up to 600 g.

In our institution, BRAXON^®Fast, an ADM, is solely utilized for immediate pre-pectoral implant-based breast reconstruction. This study details our institution’s experience with this reconstruction technique using Motiva^® Ergonomix^® Implants alongside BRAXON^®Fast ADM. We present this article in accordance with the STROBE reporting checklist (available at https://abs.amegroups.com/article/view/10.21037/abs-23-78/rc).

Methods

A single institution’s electronic database was used to identify patients who underwent mastectomy and immediate pre-pectoral implant-based reconstruction with ADM from November 2020 to October 2023 at Neath Port Talbot Hospital, Cwm Taf Morgannwg University Health Board in Wales. Motiva^® Ergonomix^® Implants along with BRAXON^®Fast, a 3D ADM was used exclusively for pre-pectoral implant reconstructions. Mastectomies were performed for both therapeutic and prophylactic reasons, including patients with positive genetic mutations.

The study collected data on various factors, including patients’ age, body mass index (BMI), and risk factors for post-operative complications such as diabetes, smoking status, previous radiotherapy and neoadjuvant chemotherapy, and immunosuppressive therapy, and mastectomy weight. The analysis focused on early complications such as infection, tissue loss, seroma, hematoma, and implant loss. The time to infection and its impact on the initiation of scheduled adjuvant chemotherapy were also documented. Additionally, the time required to wrap the implant within the BRAXON^®Fast ADM was recorded.

Infections in the reconstructions were categorized as major (requiring surgical intervention) and minor (successfully treated with oral antibiotics). Minor infections were identified through clinical observation of erythema and cellulitis, while major infections were diagnosed by the presence of an open wound and drainage from the incision, coupled with skin erythema and/or cellulitis. Tissue loss was categorized as full-thickness skin necrosis or superficial epidermolysis. Seroma complications were clinically diagnosed and confirmed by ultrasound, with only cases requiring drainage included in the study.

Patients were advised to wear a surgical bra continuously for 14 days and maintain dressing integrity and dryness. They received two sets of exercises: one for use while the drain was in, and another for after drain removal. Exercise initiation occurred on the day following the operation, including backward shoulder rolls and limited abduction and flexion to 90 degrees. After drain removal, exercises progressed to extend the range of motion beyond 90 degrees. Patients were cautioned against lifting heavy objects, pushing, and pulling for at least 2 weeks. Physical exercise was to be avoided until the wound had healed and the surgeon had provided clearance.

The minimum follow-up period was 2 months. Patients were instructed to report any concerns or complications during clinic visits. Four patients were lost to follow up and were not included in the study. Complication rates were determined by assessing the total number of breasts that underwent mastectomy and pre-pectoral reconstruction.

Statistical analysis

SPSS 25.0 software (IBM Corp., Armonk, NY, USA) was used to complete our statistical analysis. We describe quantitative continuous variables as mean ± standard deviation (SD) and range. The missing data was addressed by reporting valid percent value only.

Patient selection

This retrospective study included all patients who underwent mastectomy and immediate pre-pectoral implant-based reconstruction using BRAXON^®Fast ADM, irrespective of co-morbidities such as BMI, neoadjuvant chemotherapy, radiotherapy, or immunosuppression therapy. Patients currently smoking or vaping were generally discouraged from opting for immediate breast reconstruction. However, 4 such patients were included in the study, considering their specific circumstances, and were extensively counselled on potential post-operative complications related to their smoking status. The procedure was offered to both breast cancer patients and individuals at high risk of breast cancer undergoing risk-reducing mastectomies. Patients undergoing delayed implant-based pre-pectoral reconstruction were not included in the study.

Surgical technique

A skin/nipple sparing or skin reducing mastectomy was performed depending on the size of the breast, ptosis, and nipple areolar complex involvement in breast cancer. Pre-pectoral implant reconstruction using Motiva^® Ergonomix^®, a 360° smooth nanosurface implant, and BRAXON^®Fast ADM, was conducted by two oncoplastic and reconstructive breast surgeons. Intravenous antibiotic (cefuroxime 1.5 g) was administered pre-operatively. The mastectomy was conducted using standard techniques, employing either a central elliptical, omega, (Figure 1A-1C), batwing, peri areolar incision with lateral extension, or a Wise pattern incision in the case of skin-reducing mastectomy. In instances of skin-reducing mastectomy, the preservation of the nipple-areolar complex was not undertaken (Figure 1D). Preservation of superficial circulation was emphasized through careful dissection at the superficial breast fascia level. Intraoperative clinical evaluation confirmed satisfactory skin flap viability. The newly formed cavity was washed with betadine wash. BRAXON 3D ADM was rehydrated in a warm saline bath for 10 minutes, and implants were placed into it directly from sterile packaging. The implant was then secured within the ADM envelope using four 3-0 polydioxanone (PDS) suture and fixed to the chest wall at 2 and 10 o’clock positions. In cases of skin reducing mastectomy using wise pattern, dermal sling was deepithelialized and developed, and then secured to the ADM using PDS suture. A HandyVac TM drain (10 ch) was inserted in the inferior subcutaneous space. and kept in place until drainage output was less than 30 cc in 24 hours for two consecutive days. Patients were either discharged with a doxycycline 200mg loading dose followed by 100 mg per day until drain removal, or no postoperative antibiotics, based on the surgeon’s preference.

Figure 1 Mastectomies followed by immediate pre-pectoral implant-based reconstruction using Braxon ADM and Motiva^® Ergonomix^® Implants. (A) Left skin and nipple sparing mastectomy and immediate pre-pectoral implant reconstruction; Omega incision post-operative day 8. (B) Right skin sparing, nipple sacrificing mastectomy and immediate pre-pectoral implant reconstruction; Elliptical incision post-operative day 8. (C) Left skin and nipple sparing mastectomy and immediate pre-pectoral implant reconstruction; Omega incision post-operative day 15. (D) Bilateral skin reducing, nipple sacrificing mastectomy and immediate pre-pectoral implant reconstruction; Wise pattern post-operative day 28.

Ethical consideration

The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013). This study was approved by the ethics committee of Cwm Taf Morgannwg University Health Board and individual consent for this retrospective analysis was waived. We worked with matrices that have been used in our breast unit for the last 3 years, all of which have been Conformité Européenne (CE) marked. Pre-pectoral implant-based breast reconstruction using BRAXON^®Fast ADM is an existing technique.

Results

In the study, 64 mastectomies were performed in 55 patients, followed by immediate pre-pectoral implant-based reconstruction. Out of the total, 9 reconstructions (14%) were performed after risk-reducing mastectomy, while 55 reconstructions (85.9%) were carried out following therapeutic mastectomy. The patients had an age range of 32 to 71, with a median age of 47 (±9.4) years. Sixteen (25%) patients had a BMI greater than 30 kg/m², placing them in the obese range. Five (7.8%) patients were active tobacco/electronic cigarette users, and 12 (18.7%) were ex-smokers. Fifteen (23.4%) patients underwent neoadjuvant, and 22 (34.4%) adjuvant chemotherapy, with 4 (6.2%) patients completing radiotherapy to ipsilateral side prior to their breast reconstruction. The average implant volume of 384 [170–525] cc, and he average follow up was 14.6 (±9) [2–37] months. Out of the total cases, 26 (41.3%) underwent nipple-sparing mastectomies, while 37 (58.7%) had skin-sparing and nipple-sacrificing mastectomies, with an average breast weight of 384 (±100.2) g (Table 1).

As summarised in Table 2, major infections requiring re-operation occurred in 2 (3.1%) patients, one of which was on immunosuppressant treatment prior to her reconstruction with implant size of 525 cc. This patient was also noted to have superficial epidermolysis. Both cases resulted in implant loss.

All patients were given pre-operative intravenous cefalexin. Post-surgery, 48 patients (75%) were discharged with prophylactic oral doxycycline until drain removal, while 16 patients (25%) did not receive post-operative prophylaxis. The study found no significant difference in overall infection occurrence between the two groups. However, both patients who experienced implant loss due to infections were taking Doxycycline post-operatively.

The average time to infection (minor and major) was 27 (±11) days.

Four (6.2%) patients in total experienced implant loss. Two losses were due to infection as discussed above, and two had full thickness necrosis which led to implant loss. Delay in initiating adjuvant chemotherapy in this group was observed in 2 (3.1%) patients.

Five (7.8%) patients experienced a minor infection, associated with a superficial epidermolysis in one of these patients and resolving with oral antibiotics.

Five patients (7.8%) had full-thickness skin necrosis, with an average BMI of 27 kg/m² and average implant size 430 (±43) cc. Of the 5 patients, one was ex-smoker and vaping at the time of the surgery, and another 2 were ex-smokers.

Minor complications included superficial epidermolysis in 4.7% of patients, all of which healed in time without complications. Other minor complications comprised of 1 (1.6%) seroma requiring ultrasound-guided aspiration. No hematomas were recorded.

In the group of patients who experienced infection (both major and minor), the average mastectomy weight was 379.5 g. Conversely, patients with skin necrosis (comprising full thickness and superficial epidermolysis) had a higher mastectomy weight of 545 g, as indicated in Table 2.

The time required to wrap an implant with the BRAXON^®Fast matrix, using 4 PDS sutures positioned at 10, 2, 4, and 8 o’clock, was measured. On average, the wrapping process took 3.26 minutes, with a range from 2.43 to 4.38 minutes.

In the study, there were no significant difference in the size of the implant (P=0.84), BMI, or smoking status between patients who experienced complications and those who did not.

Discussion

Pre-pectoral implant reconstruction is a widely accepted technique that can offer better clinical and aesthetic results compared to the traditional sub-pectoral approach. This method has demonstrated advantages in avoiding issues like animation deformity, shoulder dysfunction, disruption of pectoral muscle function, and window shading, resulting in reduced post-operative pain (25). The incorporation of ADM in pre-pectoral reconstruction has further decreased the occurrence of capsular contraction by minimizing myofibroblast levels in ADM capsules compared to submuscular capsules (26). Moreover, the use of ADM has played a crucial role in enabling a single-stage direct-to-implant reconstruction, eliminating the requirement for a second procedure. This advancement brings significant benefits for both patients and healthcare providers (27).

In a meta-analysis conducted by Mangialardi and colleagues, involving 1,425 patients and 2,270 breasts undergoing immediate or delayed prepectoral implant-based reconstruction with various human ADM types, the primary objective was to evaluate complication rates associated with the procedure (28). The overall complication rate was 19%. The most frequent complications were infection (7.9%), seroma (4.8%), and mastectomy flap necrosis (3.4%). The incidence of implant loss was noted to be 2.8%, while capsular contracture was rare, affecting less than 1% of patients.

In 2019, a prospective multicentre cohort study called iBRA was conducted to address the lack of high-quality evidence regarding the safety and effectiveness of immediate implant-based breast reconstruction. The study included 2,108 patients (2,655 mastectomies) across 81 units in the UK. The main goal of the study was to assess the short-term safety of immediate implant-based breast reconstruction, both with and without the use of mesh. This research aimed to provide insights into the feasibility of conducting a future randomized clinical trial that would compare various reconstructive techniques (27).

The findings revealed that 9% of patients undergoing mastectomy and immediate implant-based reconstructions experienced implant loss, 18% required hospital readmission, and 18% underwent additional surgeries within three months of the initial procedure. Furthermore, 25% of patients needed treatment for infections, whether it be surgical intervention or treatment with antibiotics. The study concluded that the rate of complications following immediate implant-based breast reconstruction exceeded the national standards (<5% for re-operation, re-admission, and implant loss, and <10% for infection). The results highlighted the necessity for a randomized clinical trial to establish the optimal approach to immediate implant-based breast reconstruction (27).

In 2022, Giorgio Berna et al. reported their experience using BRAXON^®Fast in select 23 patients (27 breast), who underwent a nipple-sparing mastectomy and PPBR. Patients undergoing a preoperative selection process were chosen based on specific criteria. These criteria included having small to moderate ptosis, a pinch test measuring at least 1 cm on the upper pole, no history of radiotherapy to the breast, and being non-smokers. The overall complication rate in the study was 11.1%. Specific complications included a minor seroma in 3.7% of cases, necrosis in 3.7% of cases, and one instance of implant removal due to infection (24). In this study, the preparation time for implants within the BRAXON^®Fast system was compared to the classic BRAXON^® matrix. The classic matrix required 15 minutes and 25–30 stitches, while BRAXON^®Fast took only 6 minutes with 7–10 stitches. The study concluded that BRAXON^®Fast significantly reduces the overall exposure time for implant preparation, offering an optimal safety profile.

In our institution, mastectomy with an immediate pre-pectoral implant reconstruction combined with the use of BRAXON^®Fast ADM, is the preferred technique, and it is used exclusively in the reconstruction after skin/nipple sparing or skin reducing mastectomy for both breast cancer patients and individuals at high risk of breast cancer who chose risk-reducing mastectomies. Consistent with Berna and colleagues’ findings, this study observed that preparing the implant within a pre-made tear-drop-shaped ADM resulted in a rapid and efficient encapsulation process, requiring only four stitches, and averaging 3.26 minutes. The use of 4 stitches, in contrast to the 7–10 stitches reported by Berna, may have contributed to the slightly quicker preparation time in this study. Faster preparation process may reduce implant exposure to the external environment potentially enhancing the safety profile.

In this series of 64 immediate PPBRs using ADM, we identified a major infection in 2 (3.1%) patients, one of which occurred in a patient who was on immunosuppressant therapy prior to the surgery. Immunosuppression therapy has been shown to impair the wound healing process (26). The average BMI of these patients was 24 kg/m², and implant size 355 cc and were not considered contributing factors to the infections. Both cases of major infection resulted in an implant loss.

Two additional implant losses, resulting in a total of 4 (6.2%), were attributed to full-thickness skin necrosis. Among these losses, one was due to nipple-areolar complex (NAC) necrosis, marking the sole instance of NAC loss. The patient, with a BMI of 27, had received neoadjuvant chemotherapy before undergoing mastectomy and implant reconstruction. It was observed that the mastectomy flap in this case was thin, likely attributable to the patient’s body habitus. In the absence of infection, another 3 patients with full thickness necrosis required a return to the theatre for debridement of skin edges, where implants were salvaged.

We know from the literature that nicotine in cigarette smoke acts as a direct cutaneous vasoconstrictor causing tissue ischemia and impaired healing. Post-operative complications such as flap necrosis, hematoma, and fat necrosis occur significantly more frequently in smokers than in non-smokers (29-31). Liu D et al. reported that former smokers exhibit a 33% higher likelihood of experiencing healing problems after surgery compared to those who never smoked, although statistical significance was not established in sensitivity analysis. This suggests a lasting adverse effect of past smoking on postoperative healing, indicating a potentially lifelong increased risk for former smokers (32).

In our series, 8 (12.5%) of patients encountered either full-thickness skin breakdown or superficial epidermolysis. Out of these cases, 2 (25%) were ex-smokers, 1 (12.5%) was a current vaper, 2 (25%) were on immunosuppressants before surgery, and 1 (12.5%) underwent two re-excisions of margins before opting for a mastectomy. The impaired wound healing in this case was likely due to suboptimal skin flap quality resulting from breast oedema following multiple surgeries. This was also the only patient who developed seroma post-operatively.

The overall complications rate was 18.7%, with re-operation and re-admissions rates at 10.9%, which are lower than the national, multicentre iBRA study’s reported rates of 19% and 18% respectively. The combined rate of infection (major and minor) was 10.9%, and implant loss was at 6.2%, aligning with national standards. The elevated complication rate in our study, in contrast to a comparable study by Giorgio Berna et al., may be linked to differences in patient selection.

In the literature, mastectomy weight is recognized as a significant risk factor for flap necrosis. Chattha and colleagues, in a review of 704 patients and 1,041 mastectomy surgeries, observed a higher rate of overall post-operative complications associated with increased mastectomy weights. The review categorized patients into three groups based on mastectomy weight: <500, 500–1,000, and >1,000 g. The study revealed statistically significant complication rates of 14.0%, 17.6%, and 25.7%, respectively, among these weight categories (33). In our retrospective study, with an average mastectomy weight of 540 g, patients experiencing post-operative complications had an average weight of 512 g, suggesting that mastectomy weight did not significantly contribute to complications. Nine patients had a mastectomy weight exceeding 1,000 g, and there were no observed complications within this specific group. Notably, the study’s small patient cohort may limit its generalizability.

Similar to the findings of Jones and colleagues in their study of 73 pre-pectoral single-stage implant-based reconstructions using anterior AlloDerm ADM (34), we observed that factors such as BMI, smoking, and large mastectomy weight, did not appear to significantly influence complication rates. In our study, this was also observed for factors such as neo-adjuvant chemotherapy and radiotherapy. However, given the small size of our patient cohort, caution is warranted in interpreting these results. Existing literature suggests that obese patients, particularly those who are morbidly obese, and individuals undergoing neo-adjuvant chemotherapy and radiotherapy, tend to have higher post-operative complication rates (35,36). In contrast to our study, Jones and colleagues did not report any instances of full-thickness skin necrosis (34). This difference may be attributed to their use of intraoperative indocyanine green fluorescence perfusion assessment, whereas our study relied solely on clinical assessment of the mastectomy flap.

Conclusions

Immediate pre-pectoral implant reconstruction with BRAXON^®Fast can be safely performed irrespective of breast size and shape. With an average BMI of 27 (±5.6) kg/m² ranging from 18 to 43 kg/m², and 26% of patients with BMI >30 kg/m², it was not shown to be a risk factor in this series. Furthermore, neo-adjuvant chemotherapy, and radiotherapy did not appear to significantly influence complication rates. Contrary to our observations, the existing bodies of literature states that obese patients, especially those who are morbidly obese, as well as individuals undergoing neo-adjuvant chemotherapy and radiotherapy, tend to experience higher post-operative complication rates. These factors are widely recognised risk factors for post-operative complications. It is, therefore, recommended that surgical risks and potential quality-of-life benefits be thoroughly discussed with each patient, considering specific risk factors like immunosuppression therapy and smoking status. This comprehensive approach optimizes the decision-making process for breast reconstruction.

The use of tear-shaped, pre-made BRAXON^®Fast allowed for rapid encapsulation of the implant, potentially reducing exposure to the external environment. This approach involved only four stitches for complete coverage within the ADM, contributing to a quick preparation time.

This retrospective study, conducted at a single medical canter with a small patient cohort, has inherent limitations common to retrospective designs. While offering valuable insights, the results should be interpreted cautiously. The study underscores the need for future research with larger sample sizes, prospective methodologies, and longer follow-up durations to enhance the comprehensiveness of findings in this area.

Acknowledgments

Funding: None.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://abs.amegroups.com/article/view/10.21037/abs-23-78/rc

Data Sharing Statement: Available at https://abs.amegroups.com/article/view/10.21037/abs-23-78/dss

Peer Review File: Available at https://abs.amegroups.com/article/view/10.21037/abs-23-78/prf

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://abs.amegroups.com/article/view/10.21037/abs-23-78/coif). Z.B. attended a conference and gave a presentation paid by Raise Healthcare. 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. The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013). This study was approved by the ethics committee of Cwm Taf Morgannwg University Health Board and individual consent for this retrospective analysis was waived.

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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