Abstract
<sec> <title>UNSTRUCTURED</title> <p>Background: High-risk implantable medical devices are subject to stringent regulatory oversight due to their direct and long-term impact on patient safety. While product-related safety concerns have historically been addressed through recalls, post-market surveillance, and iterative innovation, regulatory non-compliance represents a qualitatively different challenge. The long-term implications of regulatory and ethical breaches on market re-entry and global access remain insufficiently examined. Objective: This study analyzes how regulatory non-compliance and historical governance failures affect the feasibility of product relaunch and international market access for high-risk implantable medical devices, using a breast implant case as an illustrative example. Methods: A narrative policy analysis was conducted based on publicly available regulatory actions, judicial records, academic literature, and international regulatory frameworks. The analysis distinguishes technical safety risks from compliance failures and examines their differential effects across regulatory jurisdictions, including the United States, the European Union, and China. Results: The findings indicate that while safety-related controversies may be mitigated through transparency and long-term surveillance, regulatory non-compliance produces persistent institutional distrust. This distrust materially constrains relaunch feasibility, prolongs approval timelines, and limits access to highly regulated markets. Jurisdictional differences reveal that pragmatic regulatory environments may allow limited market re-entry, whereas trust-based regulatory systems impose structural barriers. Conclusion: Regulatory non-compliance functions as a path-dependent constraint rather than a recoverable operational setback. For manufacturers of high-risk implantable devices, compliance failures fundamentally alter long-term strategic options, shifting viable pathways from global brand rehabilitation toward containment strategies such as OEM manufacturing or market exit.</p> </sec>