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

Inclusion Criteria:

1. Aged between 18 and 65 years

2. Eligible for bilateral breast augmentation in primary intention

3. general breast enlargement for cosmetic purposes

4. surgical correction of various congenital or acquired anomalies such asamastia, aplasia, hypomastia, hypoplasia, asymmetries*, Poland's syndrome*,ptosis ... * correction of asymmetries and Poland's Syndrome with concomitantaugmentation of the second breast (bilateral implantation)

5. Signature of Patient Information Consent (PIC) & willingness to comply with theprotocol assessments and follow up visits

6. 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 theimplant procedure (women of childbearing potential must use effective contraceptionfrom 1 month before the implantation procedure until 3 months after the implantationprocedure)

7. Has breastfed within three (3) months the implant surgery, or is still breastfeeding

8. Tissue characteristics determined as clinically inadequate or unsuitable by thesurgeon (i.e. tissue damage resulting from radiation, inadequate tissue orcompromised vascularity, known wound healing complications)

9. Has been previously implanted with a silicone implant or history of failurefollowing 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 theinvestigator, may constitute an unwarranted surgical risk (e.g. severe lung orcardiac disease, unstable medical conditions, anaesthesia allergy, heavy smokers...)

12. Anatomic or physiologic abnormality which could result to significant post-operativecomplications

13. History of sensitivity to foreign materials or known allergy to any component of theESTYME® 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 thatwould 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 previousclinical study as determined by the investigator

21. Has sociological, cultural or geographical factors which could interfere withevaluation or completion of the study