Comparing International Revision Incidence of Commonly Used Breast Implants.

Importance: Despite the widespread use of breast implants, to date, no large-scale international studies on long-term revision incidence of different implant types have been conducted.

Objective: To determine whether international data could be combined using a harmonized dataset to increase power and investigate clinically relevant differences in complication-related revision incidence between breast implant types.

Design, Setting, And Participants: This multicenter, population-based cohort study used data from the Australian Breast Device Registry and the Dutch Breast Implant Registry from 2016 to 2021. Time-to-event analysis was performed using a frailty Cox proportional hazards regression model with pooled data. The study included all permanent breast implants that were inserted for primary postmastectomy or benign breast reconstruction or cosmetic augmentation. Data were analyzed from January 1, 2016, through December 31, 2021.

Exposure: Permanent breast implants grouped based on implant shape, shell, and fill.

Main Outcomes And Measures: Complication-related revision incidence between breast implant types.

Results: Data exchange between registries was successful. In total, 21 115 reconstructive and 129 854 cosmetic breast implants inserted in patients with a median (IQR) age of 47 (38-55) years and 31 (25-38) years, respectively, were included. Overall complication-related revision was 6.3% for reconstructive and 1.2% for cosmetic implants. For reconstructive implants, hazard ratios (HRs) for implant types showed no significant differences compared with anatomical textured-silicone implants. For cosmetic implants, anatomical polyurethane-silicone implants showed a lower risk of revision (HR, 0.38; 95% CI, 0.22-0.64) compared with anatomical-textured-silicone implants. At 5 years, no significant differences in cumulative revision incidence were observed between implant types for either reconstructive or cosmetic implants.

Conclusions And Relevance: This study showed that international datasets can be pooled to assess real-world incidence of breast implant revision, which is anticipated to generate a foundation on which future breast implant studies can be based.