The Manufacturer’s Deliberate Modification of the Shell Structure of the BellaGel® SmoothFine in Violation of the Regulatory Requirement

The BellaGel® SmoothFine (HansBiomed Co. Ltd., Seoul, Korea) is the only fifth-generation of a silicone gel-filled breast implant from a Korean manufacturer. The BellaGel® SmoothFine with a 5-layered shell structure was approved for clinical use, but the manufacturer deliberately modified the shell structure in violation of the regulatory requirement of the Korean Ministry of Food and Drug Safety. This was hidden by both plastic surgeons and the manufacturer. With the use of high-resolution ultrasound, however, we confirmed that both 4-layered and 5-layered devices were circulated in the Korean market. Further investigations are warranted to disclose a relationship between plastic surgeons and the manufacturer.