Evaluation of the Safety and Performance of ESTYME® MATRIX Round and Anatomical Breast Implants - EMMIE Study

Exclusion Criteria

• •Patient will not be included if any of the following conditions exists:
• •1. Local or systemic infection or abscess anywhere in the body
• •2. Existing carcinoma or pre-carcinoma of the breast without treatment or mastectomy treatment without appropriate wash out period for chemotherapy at the surgeon discretion
• •3. Subject with previous tissue expansion
• •4. Diagnosis of active cancer of any type for augmentation procedure subject
• •5. Pregnant subject or intending to become pregnant within three (3) months of the implant procedure
• •6. Subject who had nursed within three (3) months of implant surgery, or still breastfeeding
• •7. Tissue characteristics determined clinically inadequate or unsuitable by the surgeon (i.e. tissue damage resulting from radiation, inadequate tissue or compromised vascularity, know complication wound healing)
• •8. Previously implanted subject with a silicone implant or History of failure following cosmetic augmentation or subcutaneous mastectomy
• •9. History of autoimmune disease such as but not limited to: lupus, scleroderma …
• •10. Any condition or treatment for any condition which, in the opinion of the physician, may constitute an unwarranted surgical risk (e.g. anaesthesia allergy, high consumption smoking subject …)
• •11. Anatomic or physiologic abnormality which could result to significant post-operative complications
• •12. History of sensitivity of foreign materials or known allergy to any component of the ESTYME® MATRIX Silicone Gel-Filled Breast Implant
• •13. Subject known for alcohol abuse/history
• •14. Underlying disease (HIV positive Subject, HF (heart Failure), renal insufficiency, diabetes, hypertension, …)
• •15. Subject with implanted metal or metal devices, history of claustrophobia, or other condition that would make a MRI scan prohibitive
• •16. Unwilling to undergo any further surgery for revision
• •17. Subject with willingness that are unrealistic/unreasonable with the risks involved with the surgical procedure
• •18. Participating into any other clinical study or had participated into a clinical study without appropriate wash out period at the surgeon discretion
• •19. Subject who has sociological, cultural or geographical factors which could interfere with evaluation or completion of the study