Status: Recruiting
A Post-market Prospective Clinical Study of Eurosilicone Luna Mammary Implants
The goal of this observational, non-comparative study is to determine the frequency and rate of rupture and capsular contracture Baker III-IV of Eurosilicone Luna range of breast implants, over a 10-year period following surgical implantation in female population between 18 and 65 years old undergoing primary or revision of breast augmentation or breast reconstruction.
Participants needed: 650
Trial details
Age: 18-65Biological sex: FemaleType: ObservationalSponsor: GCA (Eurosilicone)Updated: Jul 1, 2026Locations: 2
Eligibility criteria
The target population includes subjects undergoing augmentation or reconstructiv... [+1]
Subjects with a BMI >35. [+11]