Silicone Induced Granuloma of Breast Implant Capsule (SIGBIC) diagnosis: Breast Magnetic Resonance (BMR) sensitivity to detect silicone bleeding.

OBJECTIVE: To evaluate the sensitivity (S) of BMRI to detect silicone gel bleeding in a prospective observational study, including consecutive patients referred for BMRI scan. METHODS: From January 2017 to March 2018, we evaluated patients with breast implants referred for BMRI in a prospective observational study. For SIGBIC diagnosis, we adopted three new original imaging features: black drop signal; T2* hyper signal mass; and delayed contrast enhancement, considered as irrevocable signs to detect gel bleeding (GB). Histology confirmed the presence of a silicone corpuscle in breast implant capsular specimens. The accuracy of BMRI SIGBIC findings to predict GB was determined. We also compared SIGBIC diagnosis criteria to those features proposed by the BI-RADS léxicon, considered as equivocal findings. RESULTS: 208 patients had SIGBIC diagnosis at BMRI, and the histology confirmed GB in all cases. There were no false-positive results. Compared to the BI-RADS equivocal findings (S = 0.74), SIGBIC criteria had better sensitivity for GB diagnosis. CONCLUSION: SIGBIC diagnosis has high sensitivity to predict GB by the three irrevocable BMRI features described by the authors. We suppose GB is underdiagnosed in clinical practice by BI-RADS features. TRIAL CERTIFICATION: Study protocol: Plataforma Brasil CAAE: 77215317.0.0000.0072.