RecruitingNCT03356132

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

Post-market Monitoring and Control of Safety and Efficacy of Silimed® Breast Implants With Textured Surface and Polyurethane Foam-coated Surface


Sponsor

Silimed Industria de Implantes Ltda

Enrollment

632 participants

Start Date

Jul 31, 2018

Study Type

OBSERVATIONAL

Conditions

Summary

The study investigates the safety and performance of Silimed® silicone gel breast implants with a textured surface and Silimed® silicone gel breast implants with polyurethane coated surface. Female patients who underwent primary or secondary breast augmentation using Silimed® breast implants will be followed-up through 10 years. The safety of each type of Silimed® breast implant is going to be assessed by estimating the known and unexpected short- and long-term risk / adverse event rates. The performance of each type of Silimed® breast implant is going to be assesses by estimating the satisfaction and quality of life after implantation.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting long-term safety and satisfaction data from women who have received Silimed brand breast implants for augmentation (enlargement). The goal is to track complications, outcomes, and how satisfied patients are over time with textured or polyurethane foam-coated implants. You may be eligible if: - You were assigned female at birth - You are 18 years or older - You received a Silimed breast implant for primary or secondary breast augmentation within the past 21 days - Your implant has a textured surface or is coated with Silimed polyurethane foam - You are able to attend follow-up visits You may NOT be eligible if: - You had a breast reconstruction (not augmentation) - You were pregnant or breastfeeding at the time of implant placement - You had advanced fibrocystic breast disease at time of implantation - You had untreated cancer or active infection at time of implantation - You have a known allergy or intolerance to polyurethane or silicone - You have an active immune or connective tissue disorder (e.g., lupus, scleroderma) - You participated in another clinical study within 6 months before implant 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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Interventions

DEVICESilimed® Textured Silicone Gel-Filled Breast Implant

Women undergoing primary and secondary breast augmentation using Silimed® Textured Silicone Gel-Filled Breast Implant.

DEVICESilimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant

Women undergoing primary and secondary breast augmentation using Silimed® silicone gel-filled breast implants with polyurethane foam covered surface.


Locations(1)

Perfektua Serviços Médicos Ltda

Niterói, Rio de Janeiro, Brazil

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NCT03356132


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