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 assessed by estimating the known and unexpected short- and long-term risk / adverse event rates. The performance of each type of Silimed® breast implant is going to be assesses by estimating the satisfaction and quality of life after implantation.
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)
mammary reconstruction in at least one breast or augmentation after previous reconstruction,
pregnancy informed or breastfeeding at the inclusion moment,
advanced fibrocystic disease at the time of implantation,
neoplasia of any type not yet treated or being treated at the time of implantation, infection in activity not yet treated or being treated at any site at the time of implantation,