An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants With Smooth Surface
Breast Implant; ComplicationsQuality of LifeSatisfactionSafety and Performance
Study 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
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Expected Adverse Events — Every three years over the 10-year duration of the study Estimate the known short-term and long-term risk / adverse event rate for breast implant with smooth surface Silimed®
Unexpected Adverse Events — Every three years over the 10-year duration of the study Estimate the unknown short-term and long-term risk / adverse event rate for breast implant with smooth surface Silimed®
Trial sites (1)
Facility
City
Region
Status
Fundação do ABC - Centro universitário FMABC
Santo André
São Paulo
Recruiting
More Silimed Industria de Implantes Ltda trials in Brazil
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.