The First Korean Case of a Medical Device Fraud, BellaGel Breast Implant Scandal, and Its Significance from Global Perspectives (Preprint)

UNSTRUCTURED Breast implants play a pivotal role in augmentation mammaplasty and reconstructive breast surgery, with ongoing technological advancements aimed at improving safety, durability and aesthetic outcomes. Of silicone gel-filled breast implants (SGBIs), surface characteristics, shell integrity and gel cohesiveness are key determinants of clinical performance. BellaGel® (HansBiomed Co. Ltd., Seoul, Korea) is the only breast implant product developed by a Korean manufacturer and has been designed based on anatomical and anthropometric characteristics of Korean women. Since its initial development in 2005, BellaGel® has undergone continuous evolution. Then, the manufacturer has commercialized BellaGel® SmoothFine, a nanotextured implant characterized by refined surface topography, high viscoelastic cohesive silicone gel and a multi-layered shell structure with an internal barrier layer. Marketing defective breast implants despite knowledge or reasonable cause to believe that the device is defective has been recently found in Korea, thus termed as the BellaGel breast implant scandal. Evidence suggests that HansBiomed Co. Ltd. previously participated in the Poly Implant Prothèse (PIP) fraud in Europe. It would therefore be mandatory to consider long-term safety outcomes of victims of the BellaGel breast implant scandal. BellaGel SmoothFine is the only fifth-generation of an SGBI from a Korean manufacturer. 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.