Comparing International Revision Incidence of Commonly Used Breast Implants.
Summary
In a pooled, multicountry registry cohort (Australia and Netherlands) including 150,969 breast implants, overall complication-related revision was 6.3% (reconstructive) and 1.2% (cosmetic). Cosmetic anatomical polyurethane–silicone implants had a lower revision risk vs anatomical textured–silicone (HR 0.38), while no significant 5-year cumulative differences were seen between types.
Key Findings
- Successful harmonization and pooling of Australian and Dutch implant registries enabled multinational time-to-event analysis.
- Overall complication-related revision incidence: 6.3% (reconstructive) vs 1.2% (cosmetic).
- Cosmetic anatomical polyurethane–silicone implants had lower revision risk vs anatomical textured–silicone (HR 0.38; 95% CI 0.22–0.64).
- No significant differences in 5-year cumulative revision incidence across implant types in both reconstructive and cosmetic indications.
Clinical Implications
For cosmetic augmentation, anatomical polyurethane–silicone implants may offer lower revision risk versus anatomical textured–silicone; however, 5-year cumulative differences are minimal across types. Shared decision-making should emphasize comparable medium-term outcomes and the value of continued registry participation.
Why It Matters
Demonstrates feasibility and value of harmonized international registries for real-world device safety, informing implant selection and future regulatory/clinical studies.
Limitations
- Observational design with potential residual confounding and unmeasured factors (e.g., surgical technique, surgeon experience).
- Five-year horizon may miss longer-term differences; registry capture depends on reporting completeness.
Future Directions
Expand harmonization to additional national registries, include manufacturer-level and surgical technique variables, and extend follow-up to assess long-term outcomes and rare events.
Study Information
- Study Type
- Cohort
- Research Domain
- Prognosis
- Evidence Level
- III - Multicenter observational cohort study using registry data with time-to-event analysis.
- Study Design
- OTHER