Toward Safer Regenerative, Functional, and Aesthetic Gynecology: A Clinical Governance Framework for Patient Safety

Regenerative, functional, and aesthetic gynecology has expanded rapidly, yet discussions about complications remain focused on individual technologies rather than the clinical decisions that determine procedural safety. This review proposes a multidimensional clinical governance framework for complication prevention in this subspecialty.

A narrative review was based on a structured search of PubMed/MEDLINE and Embase (January 2014-May 2026), supplemented by international guidelines, regulatory communications, and evidence syntheses. Forty-two sources were included in the final qualitative synthesis. Evidence was appraised by study design, methodological rigor, clinical relevance, consistency, and applicability. The preliminary framework underwent successive rounds of multidisciplinary expert review, substantive textual and conceptual revision, and approval by all authors.

Adverse outcomes arise from the convergence of 3 interdependent domains: patient-related factors (hormonal status, tissue quality, expectations, psychological context), clinician-related factors (diagnostic accuracy, anatomic expertise, endocrine competence, willingness to decline intervention), and procedural variables (technique, standardization, follow-up). When present, genitourinary syndrome of menopause represents a potentially modifiable biologic risk factor that should be identified and appropriately managed before restorative intervention is considered. A structured 5-component clinical evaluation framework integrating hormonal status, symptom profile, anatomic assessment, psychological context, and prior treatment history supports indication-based decision-making. Safety reflects both procedure-specific risk and patient-, clinician-, and protocol-related factors.

Complication prevention begins with clinical reasoning, not procedural selection. The credibility of this subspecialty will depend on rigorous patient selection, endocrine optimization when indicated, evidence-based indications, competency-based training, and robust clinical governance rather than on the continuous introduction of new technologies.