Condition: Breast Implant; Complications · Quality of Life · Satisfaction · Sponsor: Silimed Industria de Implantes Ltda
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.
This description comes directly from the study's public registry record.
Ludmila C Donato · +552198399-0573 · Pesquisaclinica@silimed.com.br
Julia Maria V Roberto · +55212784 - 2772 · pesquisa.clinica@silimed.com.br
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| Fundação do ABC - Centro universitário FMABC | Santo André, São Paulo, Brazil | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05345821