An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants With Smooth Surface
Recruiting
Observational Study
Breast Implant; ComplicationsQuality of LifeSatisfactionSafety and Performance
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Observational
Participants needed
384 (estimated)
Sponsor
Silimed Industria de Implantes Ltda · Industry
Who this trial is looking for
This trial is looking for women who want breast augmentation with Silimed® smooth surface implants. Participants will be followed for 10 years to evaluate safety and satisfaction after the procedure.
Are You a Good Fit for This Trial?
Rules you outLupus erythematosusScleroderma
You may be able to join if
I am female at birth
I am 18 years or older
I have a complaint of hypomastia
I need breast augmentation with silicone implants
I can provide written consent
I can follow the study protocol for the entire follow-up period
You may not be able to join if
I have had a breast implant replaced due to a complication
I have had breast reconstruction in at least one breast
I am pregnant or breastfeeding
I have breast changes or lumps rated BI-RADS 3 or higher
I have advanced fibrocystic disease
I have untreated neoplasia
I have an active infection that is untreated
I have a record of adverse reactions to silicone
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
Trial Locations
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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:
* …
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
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