Abstract
<sec> <title>UNSTRUCTURED</title> <p>Background: Commercial rebranding is frequently adopted by manufacturers seeking to restore market confidence following regulatory enforcement or product-related controversies. However, for high-risk implantable medical devices, a change in product name does not necessarily constitute a new regulatory identity. The BellaGel breast implant case in South Korea provides a unique opportunity to examine the relationship between commercial rebranding and regulatory continuity after significant regulatory violations and subsequent market re-entry. Objective: This study examines the BellaGel regulatory violation, subsequent recall, judicial outcomes, and commercial rebranding as BOUNS. It further proposes a conceptual framework explaining why commercial rebranding does not eliminate accumulated regulatory obligations, regulatory history, or international market challenges associated with Class III implantable medical devices. Methods: A narrative regulatory science review was conducted using publicly available regulatory documents, judicial decisions, governmental reports, scientific literature, and published evidence regarding the BellaGel case, international breast implant regulations, and post-market governance. Regulatory approaches adopted by the Korean Ministry of Food and Drug Safety (KMFDS), the U.S. Food and Drug Administration (FDA), the European Union Medical Device Regulation (EU MDR), and China's National Medical Products Administration (NMPA) were comparatively evaluated. Results: The BellaGel case represents more than an isolated manufacturing violation. It illustrates how regulatory enforcement, criminal proceedings, civil litigation, and extensive media investigations collectively influence the long-term regulatory profile of a high-risk implantable medical device. Although commercial rebranding may alter market perception, regulatory approval history, manufacturing records, quality management documentation, post-market surveillance obligations, and accumulated regulatory evidence remain continuously associated with the device. Based on this observation, this study introduces three conceptual frameworks: Regulatory Identity, Regulatory Continuity, and Regulatory Memory. Together, these concepts explain why commercial rebranding alone is insufficient to establish regulatory renewal for implantable medical devices. Conclusions: The BellaGel–BOUNS case demonstrates that commercial identity and regulatory identity should be considered distinct concepts within modern medical device regulation. For Class III implantable medical devices, regulatory trust is accumulated through long-term compliance, transparent manufacturing practices, and continuous post-market surveillance rather than through commercial branding. The proposed framework may assist regulators, manufacturers, clinicians, and policymakers in evaluating future market re-entry strategies involving previously recalled or sanctioned implantable medical devices.</p> </sec>