RecruitingNCT05345821

An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants With Smooth Surface

Post-market Monitoring and Control of Safety and Efficacy of Silimed® Breast Implants With Smooth Surface (STEPS S)


Sponsor

Silimed Industria de Implantes Ltda

Enrollment

384 participants

Start Date

Oct 5, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

The study investigates the safety and performance of Silimed® brand smooth surface breast implants in women born with indication for primary and secondary (revision) augmentation to be followed up for 10 years. The safety of the smooth-surfaced Silimed® implant will be evaluated by estimating known and unexpected short-term and long-term risk/adverse event rates through patient reports of adverse events after implantation. The performance of using Silimed® brand smooth surface breast implants will be evaluated by evaluating satisfaction and quality of life after implantation.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is analyzing outcomes and patient satisfaction in women who received breast augmentation using smooth-surface Silimed® silicone implants, either for the first time (primary augmentation) or to replace previous implants (secondary augmentation). It aims to understand the long-term safety and satisfaction with these implants. You may be eligible if... - You were female at birth and are 18 or older - You had a breast augmentation using Silimed® smooth-surface implants for underdeveloped breasts (hypomastia) - You are able to comply with follow-up visits You may NOT be eligible if... - You had implants replaced due to a complication - You had breast reconstruction in at least one breast - You were pregnant or breastfeeding at the time of the procedure - You had breast abnormalities rated BI-RADS 3 or higher before surgery - You had active cancer, infection, or autoimmune disease at the time of implantation - You have a known reaction or intolerance to silicone - You have signs of inflammation at the implant site Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Fundação do ABC - Centro universitário FMABC

Santo André, São Paulo, Brazil

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NCT05345821


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