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 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 criteria
Qualifiers
Provide written informed consent
Female at birth
Be 18 years of age or older
Have a complaint of hypomastia
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Silimed Industria de Implantes Ltda
Lead sponsor
Centro Universitário Saúde ABC
Collaborator