Analysis of outcomes for women with Silimed breast implants
Post-market Monitoring and Control of Safety and Efficacy of Silimed® Breast Implants With Textured Surface and Polyurethane Foam-coated Surface
This study is testing how safe and effective Silimed silicone gel breast implants are for women who have had breast augmentation, while also looking at their satisfaction and quality of life over the next 10 years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 632 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Silimed Industria de Implantes Ltda Industry-sponsored |
| Locations | 1 site (Niterói, Rio de Janeiro) |
| Trial ID | NCT03356132 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and performance of Silimed® silicone gel breast implants, comparing textured and polyurethane-coated surfaces. Female patients who have undergone primary or secondary breast augmentation will be followed for up to 10 years to assess both known and unexpected adverse events. Additionally, the study will evaluate patient satisfaction and quality of life post-implantation. The goal is to provide a comprehensive understanding of the risks and benefits associated with these breast implants.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who have received Silimed breast implants for primary or secondary augmentation within the last 21 days.
Not a fit: Patients who have undergone breast reconstruction, are pregnant or breastfeeding, or have certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and satisfaction levels associated with Silimed breast implants, guiding future patients in their decisions.
How similar studies have performed: While there have been studies on breast implants, this specific analysis of Silimed implants and their long-term outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * provide written informed consent. * female at birth * be 18 years of age or older * have received breast implant(s) for indication of primary or secondary augmentation until 21 days before (including the visit window) * having received a breast implant with a textured surface or a breast implant with a surface coated with Silimed® polyurethane foam * ability to comply with the protocol throughout the follow-up period. Exclusion Criteria: * mammary reconstruction in at least one breast or augmentation after previous reconstruction, * pregnancy informed or breastfeeding at the inclusion moment, * advanced fibrocystic disease at the time of implantation, * neoplasia of any type not yet treated or being treated at the time of implantation, infection in activity not yet treated or being treated at any site at the time of implantation, * reporting or recording of adverse reactions or intolerance to polyurethane or silicone prior to implantation, * immune diseases affecting active connective tissue or (eg, 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 immediate postoperative complications due to use of illicit drugs or medications, * Increased risk of immediate post-surgical complications caused by illicit drug use or medication use, * have participated in another clinical study up to 6 months prior to the placement of the implant, * any other condition which, based on the opinion of the investigator or designee, may prevent the provision of informed consent, renders participation in the study is unsafe, compromises adherence to the protocol, complicates the interpretation of data from the study outcome, or otherwise interferes with the achievement of study objectives.
Where this trial is running
Niterói, Rio de Janeiro
- Perfektua Serviços Médicos Ltda — Niterói, Rio de Janeiro, Brazil (Recruiting)
Study contacts
- Principal investigator: Celso EJ Boechat, MD — Perfektua Serviços Médicos Ltda
- 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.