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

Background: The practice of pre-pectoral implant-based breast reconstruction, particularly using biological meshes, has become more popular. Despite its increased use, there is a shortage of high-quality evidence regarding the safety and effectiveness of immediate implant-based breast reconstruction. This study presents an institutional experience and outcomes of performing the procedure using BRAXON (R) Fast acellular dermal matrix (ADM) exclusively in conjunction with Motiva (R) Ergonomix (R) breast implant. Methods: The study retrospectively collected data from November 2020 to October 2023 at Neath Port Talbot Hospital, Cwm Taf Morgannwg University Health Board in Wales. The data included information on patients who underwent immediate implant reconstruction with ADM. Parameters such as age, body mass index (BMI), implant size, mastectomy weight and risk factors for post-operative complications were examined. Risk factors considered were neo-adjuvant chemotherapy, radiotherapy, tobacco use, immunosuppression therapy, diabetes mellitus, and breast size. The analysis focused on early complications, encompassing infection, tissue necrosis, seroma, hematoma, and implant loss. Additionally, the study recorded the time needed to wrap the implant within the BRAXON (R) Fast ADM. Results: In this study with 55 patients (64 breasts), two oncoplastic breast surgeons performed skin-reducing or skin/nipple sparing mastectomies. Immediate pre-pectoral implant-based breast reconstruction using 3D BRAXON (R) Fast ADM and Motiva (R) Ergonomix (R) implants was performed in all patients. The average implant volume was 385 cc, and the average patient age was 47 (+/- 9.4) years. The BMI was greater than 30 kg/m(2) in 25% of patients. 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. In the study, the overall complication rate was 18.7%. Infections, comprising 10.9%, led to two cases requiring a return to the operating room and resulting in implant loss. Skin necrosis, either full thickness or superficial, occurred in 12.5% of cases, with full thickness necrosis causing an additional two implant losses, totalling 4 (6.2%) implant losses. Seroma occurred in only 1 (1.6%) of patient, and there were 10.9% re-admissions and returns to the operating room. The average time needed to encapsulate the implant within BRAXON (R) Fast was 3.26 minutes, with a range from 2.43 to 4.38 minutes. Conclusions: Immediate pre-pectoral implant-based reconstruction with BRAXON (R) Fast is safe for patients undergoing mastectomy, whether for therapeutic or prophylactic reasons. The use of tear-shaped, pre-made BRAXON (R) Fast aids in rapid encapsulation of the implant, potentially reducing exposure to the external environment. While factors like BMI, neoadjuvant chemotherapy, and radiotherapy did not significantly impact complication rates, it is crucial to engage in comprehensive discussions with each patient regarding surgical risks and potential quality-of-life benefits. Special attention should be given to individual risk factors such as immunosuppression therapy and smoking status to facilitate informed decision-making for breast reconstruction.