The BellaGel Case: Regulatory Non-Compliance and Strategic Limitations in Reintroducing Breast Implants (Preprint)

<sec> <title>UNSTRUCTURED</title> <p>Even if BellaGel is successfully reintroduced into the market, its global repositioning as a premium breast implant is structurally constrained by prior regulatory violations identified by the Korean Ministry of Food and Drug Safety and its historical association with the Poly Implant Prothèse fraud scandal. Accordingly, large-scale re-entry into advanced markets is likely to remain limited, and the most plausible commercial scenario involves restricted export activity focused on China and selected emerging markets rather than a full recovery of global market presence.</p> </sec>