Abstract
<sec> <title>UNSTRUCTURED</title> <p>Background Medical device fraud extends beyond regulatory non-compliance, resulting in substantial erosion of public trust, disruption of healthcare systems, and long-term challenges to corporate legitimacy. While product recalls and regulatory sanctions have been extensively investigated, considerably less attention has been paid to how manufacturers attempt to restore public confidence following regulatory crises. In recent years, brand repositioning has emerged as a common commercial strategy after product-related scandals. However, whether rebranding alone can restore social trust and social sustainability remains unclear. Objective This perspective examines the relationship between medical device fraud, brand repositioning, and social sustainability using the Korean breast implant industry as a representative case. It further proposes a conceptual framework distinguishing commercial brand recovery from the broader process of rebuilding social trust. Methods Relevant literature concerning medical device regulation, breast implant safety, post-market surveillance, corporate governance, social sustainability, and healthcare ethics was reviewed. Publicly available regulatory documents, judicial decisions, scientific publications, and industry reports were analyzed to illustrate the evolution of the Korean breast implant industry following a major regulatory crisis. Results Brand repositioning may facilitate commercial recovery by creating a renewed market identity; however, sustainable recovery requires substantially more than changes in product names or marketing strategies. Restoration of social trust depends upon transparent governance, regulatory compliance, long-term clinical evidence, continuous post-market surveillance, corporate accountability, and meaningful engagement with healthcare professionals and patients. The transition from BellaGel to Bouns illustrates the distinction between commercial repositioning and social trust recovery. Conclusions Medical device manufacturers recovering from regulatory crises should recognize that successful commercialization does not necessarily indicate restored public confidence. We propose that rebuilding social trust, rather than merely repositioning brands, should become the primary objective of post-crisis corporate governance. This concept may provide a practical framework for evaluating the long-term social sustainability of high-risk implantable medical devices.</p> </sec>