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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital de câncer HCIII (INCA)
  Rio de Janeiro, Rio de Janeiro, Brazil Recruiting
• Irmandade Santa Casa de Misericórdia de São Paulo
  São Paulo, São Paulo, Brazil Recruiting
• Fundação do ABC - Centro universitário FMABC
  Santo André, São Paulo, Brazil Not yet recruiting

Study contacts

• Principal investigator: Marcelo A Bello — Hospital de câncer - HCIII (INCA)
• Study coordinator: Renata R M Figueira
• Email: pesquisaclinica@silimed.com.br
• Phone: +55 21 2784-2669

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Analysis of outcomes for women with Silimed® smooth surface breast implants

  This study is testing how safe and effective Silimed® smooth surface breast implants are for women getting breast augmentation, while also looking at their satisfaction and quality of life over 10 years.

  Recruiting Silimed Industria de Implantes Ltda · Santo André, São Paulo · NCT05345821

• Mastectomy Expander-Based Reconstruction: Comparing Expander Options and Outcomes

  This study tests whether different prepectoral tissue expander approaches lead to better breast shape and fewer complications after mastectomy and reconstruction.

  Recruiting Medical University Innsbruck · Innsbruck, Tyrol · NCT07434648

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.