Analysis of outcomes for women with Silimed 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 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.

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 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 it's running

• 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

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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.