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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorSilimed Industria de Implantes Ltda

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

384 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Silimed Industria de Implantes Ltda

Lead sponsor

Centro Universitário Saúde ABC

Collaborator