Use of prepectoral polyurethane coated implants in the setting of radiotherapy: the OPBC-09 PRExRT retrospective cohort study

BACKGROUND: Radiotherapy (RT) increases the risk of capsular contracture after mastectomy with implant-based breast reconstruction (IBBR). The present study assessed the association between the use of polyurethane coated versus non-polyurethane coated implants and the likelihood of surgical revision due to capsular contracture after RT. METHODS: The international multicenter retrospective PRExRT cohort study included patients with breast cancer treated at 26 sites in 15 countries between January 2016 and December 2024. Eligible patients underwent prepectoral IBBR with either polyurethane coated or non-polyurethane coated implants and received RT. Primary endpoint was surgical revision due to capsular contracture and was analyzed using Cox regression models. RESULTS: Among 1455 patients, 475 (32.6%) received polyurethane coated implants and 980 (67.3%) non-polyurethane coated implants. The use of polyurethane coated implants was associated with less frequent use of synthetic or biologic mesh (1.6% vs. 42.8%, p < 0.001), and less frequent two-stage IBBR (8.4% vs. 21.5%, p < 0.001). Compared to IBBR with non-polyurethane coated implants, use of polyurethane coated implants was independently associated with a lower rate of surgical revision due to capsular contracture (9.3% vs. 25.7%; HR 0.2, 95%CI 0.1-0.5, p < 0.001). The risk of major infection (OR 0.3, 95%CI 0.2-0.6, p < 0.001), implant loss (OR 0.2, 95%CI 0.09-0.4, p < 0.001), reoperation (OR 0.3, 95%CI 0.2-0.6, p = 0.001) and implant rotation (OR 0.05, 95%CI 0.004-0.7, p = 0.02) was also lower in the polyurethane group. CONCLUSIONS: In the setting of RT, the use of prepectoral polyurethane coated implants was associated with a lower likelihood of surgical revision due to capsular contracture compared to non-polyurethane coated implants. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT06747065.