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Comparing International Revision Incidence of Commonly Used Breast Implants.

JAMA surgery2025-02-19PubMed
Total: 75.5Innovation: 7Impact: 7Rigor: 8Citation: 8

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