Analysis of outcomes for women with Silimed® smooth surface breast implants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.