The Expanding Role of High-Resolution Ultrasound in the Context of the First Korean Case of a Breast Implant Fraud and Its Implications for Medical Device Regulation: Case Report with a Review of Literatures (Preprint)

UNSTRUCTURED Silicone gel-filled breast implants (SGBIs) have undergone significant technological evolution, yet their safety continues to be challenged by complications, such as capsular contracture (CC), device rupture and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Korea has recently faced two major events affecting implant safety perception: three Korean cases of BIA-ALCL and the first Korean case of a breast implant fraud (BIF). High-resolution ultrasound (HRUS) has emerged as a reliable imaging modality capable of non-invasively characterizing implant features and detecting early complications. A 37-year-old Korean woman receiving a breast implant illegally manufactured with altered shell structures and non-approved silicone materials. An HRUS showed five hyperechoic shell layers on the left implant and four on the right, inconsistent with the manufacturer’s specifications. This case emphasizes the expanding application of HRUS for implant surveillance, particularly in the context of BIF.