Silicone Leakage From Breast Implants and Its Association With Capsular Contracture in 657 Patients.

[BACKGROUND] Capsular contracture is a common complication following breast reconstruction and augmentation, but there is limited evidence for the association between silicone leaking from the implant and capsular contracture.

[OBJECTIVES] To determine the association between silicone leaking into the surrounding fibrous capsule and the risk of capsular contracture.

[METHODS] This multicenter cross-sectional study included patients undergoing revisional surgery for any indication following breast reconstruction or augmentation with silicone implants. Silicone in the fibrous capsule was quantified using histopathological analysis, and capsular contracture was diagnosed using the Baker classification. Multivariable logistic regression was used to assess the association between the amount of silicone leakage and the predicted risk of capsular contracture. The association was tested in a sensitivity analysis excluding potential confounders and misclassifications.

[RESULTS] Among 657 included patients (1147 breasts), 272 patients (346 breasts) had either unilateral or bilateral capsular contracture. Capsular contracture was significantly associated with the amount of silicone in the fibrous capsule (P < .001), independent from the time of implantation (P < .001). The excess risk of capsular contracture increased rapidly by 12% (95% CI, 5.0-18), going from 0.00 mL (0-32nd percentile) to 0.26 mL (60th percentile) of silicone in the fibrous capsule. The association was confirmed in the sensitivity analysis of 421 patients (654 breasts) with intact implants.

[CONCLUSIONS] Even small amounts of silicone leakage are associated with a significantly increased risk of capsular contracture. This highlights the importance of using breast implants with low silicone leakage rates, such as highly cohesive implants, to prevent capsular contracture.