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

U.S., May 21 -- ClinicalTrials.gov registry received information related to the study (NCT06981481) titled 'Post-marketing Clinical Monitoring of Safety and Performance of Breast Tissue Expander for Breast Reconstruction' on April 25.

Brief Summary: The study investigates the safety and performance of Silimed(R) 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(R) brand breast tissue expander will be evaluated by evaluating the assessment of tissue quality and satisfaction by the evaluating physicia...