Evaluation of the Safety and Performance of SYMATESE AESTHETICS ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants in the Breast Augmentation

Exclusion Criteria

• •1. Local or systemic infection or abscess anywhere in the body
• •2. Existing carcinoma or pre-carcinoma of the breast with or without treatment
• •3. History of subcutaneous mastectomy
• •4. Subject with previous tissue expansion
• •5. Diagnosis of active cancer of any type
• •6. Pregnant subject or intending to become pregnant within three (3) months after the implant procedure (women of childbearing potential must use effective contraception from 1 month before the implantation procedure until 3 months after the implantation procedure)
• •7. Has breastfed within three (3) months the implant surgery, or is still breastfeeding
• •8. Tissue characteristics determined as clinically inadequate or unsuitable by the surgeon (i.e. tissue damage resulting from radiation, inadequate tissue or compromised vascularity, known wound healing complications)
• •9. Has been previously implanted with a silicone implant or history of failure following cosmetic augmentation
• •10. History of autoimmune disease such as, but not limited to, lupus and scleroderma
• •11. Any condition or treatment for any condition which, in the opinion of the investigator, may constitute an unwarranted surgical risk (e.g. severe lung or cardiac disease, unstable medical conditions, anaesthesia allergy, heavy smokers…)
• •12. Anatomic or physiologic abnormality which could result to significant post-operative complications
• •13. History of sensitivity to foreign materials or known allergy to any component of the ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implant
• •14. Known alcohol abuse or history of alcohol abuse
• •15. Psychological instability
• •16. Underlying disease (HIV-positive, heart failure, renal insufficiency, diabetes, hypertension)
• •17. Implanted metal or metal devices, history of claustrophobia, or other condition that would make a magnetic resonance imaging (MRI) scan prohibitive
• •18. Unwilling to undergo any further surgery for revision
• •19. Unrealistic/unreasonable expectations that entail a risk for the surgical procedure
• •20. Participating in another clinical study or within exclusion period of a previous clinical study as determined by the investigator
• •21. Has sociological, cultural or geographical factors which could interfere with evaluation or completion of the study