NCT06981481

Post-marketing Clinical Monitoring of Safety and Performance of Breast Tissue Expander for Breast Reconstruction

Post-marketing Clinical Monitoring of Safety and Performance of the Silimed® Brand Breast Tissue Expander for Breast Reconstruction

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 152 (estimated)
• Sponsor: Silimed Industria de Implantes Ltda · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study investigates the safety and performance of Silimed® brand breast tissue expander in women born with indication for breast reconstruction. The safety of the breast tissue expander will be evaluated by estimating known and unexpected adverse event rates through patient reports of adverse events after implantation. The performance of using Silimed® brand breast tissue expander will be evaluated by evaluating the assessment of tissue quality and satisfaction by the evaluating physician after implantation.

Conditions

• Safety and Performance
• Breast Tissue Expander

Interventions

Type	Name	Description
DEVICE	Breast tissue expander	Silimed brand breast tissue expander

Timeline

• Start date: 2025-08-06
• Primary completion: 2027-08-31
• Completion: 2027-11-30
• First posted: 2025-05-20
• Last updated: 2026-03-13

Locations

3 sites across 1 country: Brazil