Breast implant capsule-associated squamous cell carcinoma: A systematic review and individual patient data meta-analysis.

[INTRODUCTION] New concerns have been raised by the US Food and Drug Administration regarding breast implant capsule-associated squamous cell carcinoma (BICA-SCC) but very little is known about this emerging topic. To gain a better understanding of the disease, a systematic review and individual patient data meta-analysis of patients with BICA-SCC were performed.

[METHODS] PubMed, Embase, and Cochrane were searched from inception to 26th February 2023 for studies including patients with BICA-SCC. Individual patient data were extracted and pooled. Risk of bias was assessed using the Joanna Briggs Institute critical appraisal tool.

[RESULTS] A total of 16 studies reported 19 patients with BICA-SCC, commonly presented with swelling (84.2%), pain (73.7%), and erythema (21.1%). The median age at SCC diagnosis was 52.0 (interquartile range [IQR] 46.0-60.0) years. The median time from breast augmentation to SCC diagnosis was 20.0 (IQR 15.0-35.0) years. The majority of patients (68.4%) were found to have extracapsular spread at SCC diagnosis. All patients with breast implants in situ underwent implant removal with at least 60.0% of patients undergoing capsulectomy. The mean follow-up period was 17.6 months with 1-year overall survival of 80.8% and 1-year disease-free survival of 53.0%.

[CONCLUSION] While rare, surgeons should counsel patients on the risks of malignancy including BICA-SCC before breast implantation and consider the possibility of BICA-SCC when treating patients with late-onset peri-implant changes. A centralized registry is needed to better understand and improve outcomes in patients with BICA-SCC.