Silimed® Breast Implants for Breast Augmentation

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

Recruiting Observational Study
Breast Implant; Complications Quality of Life Satisfaction Safety and Performance
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part. No Study Drug Researchers observe your health over time — no experimental treatment is given.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Female
Study type
Observational
Participants needed
384 (estimated)
Sponsor
Silimed Industria de Implantes Ltda · Industry
Who this trial is looking for

This trial is looking for women who want breast augmentation with Silimed® smooth surface implants. Participants will be followed for 10 years to evaluate safety and satisfaction after the procedure.

Are You a Good Fit for This Trial?
Rules you out Lupus erythematosusScleroderma

You may be able to join if

  • I am female at birth
  • I am 18 years or older
  • I have a complaint of hypomastia
  • I need breast augmentation with silicone implants
  • I can provide written consent
  • I can follow the study protocol for the entire follow-up period

You may not be able to join if

  • I have had a breast implant replaced due to a complication
  • I have had breast reconstruction in at least one breast
  • I am pregnant or breastfeeding
  • I have breast changes or lumps rated BI-RADS 3 or higher
  • I have advanced fibrocystic disease
  • I have untreated neoplasia
  • I have an active infection that is untreated
  • I have a record of adverse reactions to silicone

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial
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 …
Trial Locations
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Eligibility 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: * …
Contacts

Ludmila C Donato

+552198399-0573

Pesquisaclinica@silimed.com.br

CONTACT

Julia Maria V Roberto

+55212784 - 2772

pesquisa.clinica@silimed.com.br

CONTACT