An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants
Recruiting
Observational Study
Breast Implant; Complications
Quality of Life
Satisfaction
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.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Observational
- Participants needed
- 632 (estimated)
- Sponsor
- Silimed Industria de Implantes Ltda · Industry
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About This Trial
The study investigates the safety and performance of Silimed® silicone gel breast implants with a textured surface and Silimed® silicone gel breast implants with polyurethane coated surface. Female patients who underwent primary or secondary breast augmentation using Silimed® breast implants will be followed-up through 10 years. The safety of each type of Silimed® breast implant is going to be ass…
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 received breast implant(s) for indication of primary or secondary augmentation until 21 days before (including the visit window)
* having received a breast implant with a textured surface …
Contacts