Analysis of outcomes for women with Silimed® smooth surface breast implants
Post-market Monitoring and Control of Safety and Efficacy of Silimed® Breast Implants With Smooth Surface (STEPS S)
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 384 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Silimed Industria de Implantes Ltda Industry-sponsored |
| Locations | 1 site (Santo André, São Paulo) |
| Trial ID | NCT05345821 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and performance of Silimed® brand smooth surface breast implants in women undergoing primary and secondary breast augmentation. It will follow participants for 10 years to assess both known and unexpected adverse events through patient reports. Additionally, the study will measure satisfaction and quality of life outcomes post-implantation. The observational nature of the study allows for real-world data collection on the implants' long-term effects.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a complaint of hypomastia and an indication for breast augmentation using silicone implants.
Not a fit: Patients who have had complications requiring breast implant replacement or those with active infections or untreated neoplasia will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and satisfaction associated with Silimed® breast implants, guiding future patients in their augmentation decisions.
How similar studies have performed: While there have been studies on breast implants, this specific analysis of Silimed® smooth surface implants is novel and focuses on long-term outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provide written informed consent * Female at birth * Be 18 years of age or older * Have a complaint of hypomastia * Have an indication for breast augmentation with silicone implants * Ability to comply with the protocol throughout the follow-up period. Exclusion Criteria: * Replacement of breast implants due to a complication * Breast reconstruction in at least one breast * Informed pregnancy or breastfeeding at the time of inclusion * Sequelae of mastopexy * Ptosis requiring mastopexy * Breast changes or lumps rated BI-RADS 3 or higher on preoperative ultrasound or mammograms * Advanced fibrocystic disease at the time of implantation * Neoplasia of any type not yet treated or undergoing treatment at the time of implantation, - Active infection not yet treated or undergoing treatment at any site at the time of implantation * Report or record of adverse reactions or intolerance to silicone prior to implantation * Report or record of immune diseases affecting the active or undergoing treatment (e.g. lupus erythematosus, discoid lupus, scleroderma, etc.) at the time of implantation * Signs of inflammation of the breast or implant site at the time of implantation * Increased risk of post-implantation complications -immediate surgical complications caused by illicit drug use or medication use * Having participated in another clinical trial within 6 months prior to implant placement * Any other condition which, based on the opinion of the investigator or designee, may prevent the provision of informed consent, make study participation unsafe, compromise protocol adherence, complicate the interpretation of study outcome data, or otherwise interfere with the achievement of study objectives
Where this trial is running
Santo André, São Paulo
- Fundação do ABC - Centro universitário FMABC — Santo André, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: André Luiz P de Freitas — Fundação do ABC - Centro Universitário FMABC
- Study coordinator: Ludmila C Donato
- Email: Pesquisaclinica@silimed.com.br
- Phone: +552198399-0573
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.