High-Resolution Ultrasound in the Detection of Silicone Gel Breast Implant Shell Failure: Background, In Vitro Studies, and Early Clinical Results

Abstract

Preliminary results with a variety of base and transducer systems demonstrated that HRUS provides excellent visualization of current fourth- and fifth-generation silicone gel implants both in the in vitro and ex vivo scanning models. In vivo surgeon-performed HRUS accurately identified implant status and correlated with radiologist-performed HRUS, MRI, and surgical findings. An ongoing Phase 4 prospective study is under way to help define the sensitivity and specificity of HRUS technologies in the evaluation of current implant designs. However, the relative affordability, accessibility, availability, and dynamic real-time visualization provided by HRUS represent significant potential advantages of HRUS over MRI in both the screening and future diagnosis of breast implant shell failure.