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 Parameters
Brief Summary
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
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 ac