Clinical Research Directory

Inclusion Criteria: 1. Aged between 18 and 65 years 2. Eligible for bilateral breast augmentation in primary intention 1. general breast enlargement for cosmetic purposes 2. surgical correction of various congenital or acquired anomalies such as amastia, aplasia, hypomastia, hypoplasia, asymmetries\*, Poland's syndrome\*, ptosis … \* correction of asymmetries and Poland's Syndrome with concomitant augmentation of the second breast (bilateral implantation) 3. Signature of Patient Information Consent (PIC) \& willingness to comply with the protocol assessments and follow up visits 4. Affiliation to the social security regime 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