An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants

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 augmentationuntil 21 days before (including the visit window)

• having received a breast implant with a textured surface or a breast implant with asurface coated with Silimed® polyurethane foam

• ability to comply with the protocol throughout the follow-up period.

Exclusion Criteria:

• mammary reconstruction in at least one breast or augmentation after previousreconstruction,

• 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 ofimplantation,

• reporting or recording of adverse reactions or intolerance to polyurethane orsilicone prior to implantation,

• immune diseases affecting active connective tissue or (eg, 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 immediate postoperative complications due to use of illicit drugsor medications,

• Increased risk of immediate post-surgical complications caused by illicit drug useor medication use,

• have participated in another clinical study up to 6 months prior to the placement ofthe implant,

• any other condition which, based on the opinion of the investigator or designee, mayprevent the provision of informed consent, renders participation in the study isunsafe, compromises adherence to the protocol, complicates the interpretation ofdata from the study outcome, or otherwise interferes with the achievement of studyobjectives.