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

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.

NCT Number	NCT06981481
Lead Sponsor	Silimed Industria de Implantes Ltda
Conditions	Safety and Performance, Breast Tissue Expander
Enrollment	152 participants
Start Date	2025-08-06
Primary Completion	2027-08-31 (estimated)
Study Completion	2027-11-30 (estimated)
Updated on ClinicalTrials.gov	2026-03-13