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

Launched by SILIMED INDUSTRIA DE IMPLANTES LTDA · May 13, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a specific type of breast tissue expander made by Silimed®, which is used in breast reconstruction for women. The study aims to find out how safe the expander is by collecting reports from patients about any problems they may experience after it is implanted. Additionally, doctors will assess how well the tissue quality is after implantation and how satisfied patients are with the results.

To participate in this study, women must be at least 18 years old, have a plan for breast reconstruction that includes using the Silimed® tissue expander, and be able to provide written consent to join the trial. However, certain criteria will exclude individuals, such as those currently pregnant, those with specific medical conditions like uncontrolled diabetes or active infections, or those who have had certain previous treatments. If eligible, participants can expect regular follow-ups to check on their health and the performance of the tissue expander, contributing valuable information for future breast reconstruction procedures.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. provide written informed consent
• • 2. female sex at birth;
• • 3. be 18 years of age or older;
• • 4. have an indication for reconstruction with breast expander + breast implant(s);
• • 5. have a plan to receive an expander with a textured surface from the Silimed® brand + implant breast with textured surface from the Silimed® brand;
• • 6. ability to comply with the protocol throughout the follow-up period.
• Exclusion Criteria:
• • 1. breast augmentation without reconstruction in at least one breast;
• • 2. neoplasia of any type (except breast neoplasia), not yet treated or under treatment, or requiring surgical removal at the time of implantation;
• • 3. pregnancy or breastfeeding at the time of implantation;
• • 4. smoking, uncontrolled diabetes, obesity (from grade 2) and ASA III/IV;
• • 5. active infection not yet treated or being treated at any site at the time of implantation;
• • 6. report or record of adverse reactions or intolerance to silicone prior to implantation;
• • 7. immune diseases that affect connective tissue in activity or under treatment (e.g. lupus erythematosus, discoid lupus, scleroderma, etc.) at the time of implantation;
• • 8. record or report of use of illicit drugs or medications that increase the risk of immediate post-surgical complications (eg, medications that interfere with coagulation);
• • 9. high surgical risk or complications in the immediate post-surgery period, estimated before the implantation;
• • 10. evidence or report of tissue characteristics that are clinically inconsistent with a successful implantation (eg tissues with excessive fibrosis or compromised vascularization);
• • 11. may not have participated in another clinical study up to 6 months before placement of the expander, unless the researcher deems it to be good for the participant and not impact the study;
• • 12. previous treatment with radiotherapy;
• • 13. any other condition that, based on the opinion of the researcher or designee, may prevent the provision of informed consent, make study participation unsafe, compromise adherence to the protocol, complicate the interpretation of study outcome data or otherwise interfere with the achievement of the study objectives.