Safety and performance monitoring of Silimed textured breast tissue expanders for reconstruction

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

This project will see if Silimed textured breast tissue expanders are safe and work well for adult women having breast reconstruction.

Quick facts

• Study type: Observational
• Enrollment: 152 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Silimed Industria de Implantes Ltda (Industry-sponsored)
• Locations: 3 sites (Rio de Janeiro, Rio de Janeiro and 2 other locations)
• Trial ID: NCT06981481 on ClinicalTrials.gov

What this trial studies

This is an observational post‑marketing program that follows adult women who receive Silimed textured breast tissue expanders and implants at participating Brazilian hospitals. Safety is tracked through patient-reported adverse events after implantation to estimate known and unexpected complication rates. Performance is documented by physician assessments of tissue quality and satisfaction with the reconstruction. Standard inclusion and exclusion criteria apply to ensure participants are appropriate surgical candidates and able to complete follow-up visits.

Who should consider this trial

Good fit: Adult women (18+) planning breast reconstruction with Silimed textured expanders and implants who can provide informed consent and attend follow-up at the participating centers.

Not a fit: People seeking cosmetic augmentation without reconstruction, pregnant or breastfeeding women, and those with active infection, uncontrolled diabetes, severe obesity, silicone intolerance, or significant immune disease are excluded and unlikely to benefit.

Why it matters

Potential benefit: If results show low complication rates and adequate performance, patients and surgeons may gain clearer safety and performance information to guide implant choices.

How similar studies have performed: Post‑marketing observational monitoring of breast implants and expanders is a common, established approach that has previously identified known complications (for example capsular contracture and rare BIA‑ALCL), though device-specific outcomes vary.

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.

Where this trial is running

Rio de Janeiro, Rio de Janeiro and 2 other locations

• Hospital de câncer HCIII (INCA) — Rio de Janeiro, Rio de Janeiro, Brazil (Recruiting)
• Fundação do ABC - Centro universitário FMABC — Santo André, São Paulo, Brazil (Not_yet_recruiting)
• Irmandade Santa Casa de Misericórdia de São Paulo — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Principal investigator: Marcelo A Bello — Hospital de câncer - HCIII (INCA)
• Study coordinator: Renata R M Figueira

Conditions Safety and Performance; Breast Tissue Expander; post-market; safety; performance; Breast tissue expander; breast reconstruction