Prospective Observational Clinical Follow-up of Euromi Biosciences Pre-filled Silicone Gel Breast Implants

Inclusion Criteria:

• Female;
• 18 years old and above, and under 60 years old;
• has approved and signed the informed consent form;
• eligible to receive at least one EUROMI Biosciences implant during breastreconstruction following a mastectomy or during aesthetic breast surgery;
• Willing to be followed up for a period of 10 years.

Exclusion Criteria:

• Informed pregnancy or breastfeeding at the time of inclusion
• Known hypersensitivity and / or allergy to silicone;
• Not understanding or not accepting the risks of further surgeries during follow-up;
• Body mass index > 40 kg/m²;
• Diabetes
• HbA1c levels > 7,5%;
• History of repeated failure with the implantation of similar implants;
• Tissue or fat insufficiency;
• Progressive breast cancer large tumours (>5 cm), late cancer stage and deep tumours;
• Grossly positive axillary involvement / or chest wall involvement;
• High risk of cancer recurrence;
• Tissue damage in the implant area due to irradiation of the thoracic wall;
• Pre-existing pathology in the implant area;
• General infection or infection in the implant area;
• Medical condition (poor physiological condition, psychological instability, severesmoking, obesity, coagulopathy, diabetes, severe cardiovascular or pulmonary disease,etc.) Which may, according to the judgement of the surgeon, entail excessive riskand/or post-surgical complications;
• History or presence of an autoimmune disease;
• Immunocompromised;
• History or current treatment using radiation with lower-pole scarring and thin, poorlyvascularized skin/tissue / microwave diathermy / or steroids;
• Medical condition likely to interfere with her capacity to understand the follow-uprequirements, to participate in the follow-up or to give her informed consent;
• Concomitantly part of another interventional clinical trial.
• Under supervision or legal guardianship
• Deprived of liberty by a judicial or administrative decision
• Not affiliated to health insurance system or is a beneficiary of such coverage