Risk factors and complication predictors in prepectoral breast reconstruction using ADM and smooth round implants: An observational cohort study

Background: Prepectoral implant-based reconstruction using acellular dermal matrices (ADMs) has emerged as a viable option for immediate breast reconstruction (IBR) following mastectomy. This multicenter, prospective observational cohort study evaluated the outcomes of prepectoral reconstruction using Braxon® ADMs and smooth round implants across two specialized Italian cancer centers. Methods: From April 2019 to December 2024, 140 female patients (221 breasts) underwent skin- or nipple-sparing mastectomy followed by immediate prepectoral reconstruction with either Braxon® Regular or Braxon® Fast ADM and Motiva® or Mentor® implants. Comprehensive demographic, surgical, and postoperative data were collected. Complications were classified as mastectomy-related (e.g., bleeding and mastectomy skin flap necrosis) or reconstruction-related (e.g., seroma, infection, and red breast syndrome). Binary logistic regression identified predictors of complications. Results: The mean patient age was 48.6 years, with a BMI of 22.7 kg/m². A total of 96 complications (43.4%) were recorded: 64 were mastectomy-related (29.0%) and 32 were reconstruction-related (14.4%). Reoperation was required in 14.9% of the cases. Mastectomy flap necrosis (6.9%) and infection (3.6%) were the most frequent complications leading to implant removal in 7.4% of the cases. Logistic regression identified neoadjuvant chemotherapy (OR=18.8; p=0.026), Braxon® Fast compared to Braxon® Regular (OR=0.092; p=0.013), and extended antibiotic prophylaxis (OR=0.013; p=0.004) as predictors of reconstruction-related complications. Conclusions: Prepectoral IBR with Braxon® ADMs demonstrated acceptable complication rates. No predictors were associated with mastectomy-related outcomes. Braxon® Fast and prolonged antibiotics were protective against reconstruction-related events, while neoadjuvant chemotherapy increased the risk. These findings highlight the importance of patient selection and perioperative strategies, particularly in high-risk subgroups such as those receiving neoadjuvant chemotherapy.