Breast Augmentation, Breast Reconstruction
Conditions
Brief summary
The study will evaluate the safety and performance of the ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the breast augmentation and reconstruction.
Detailed description
The study will evaluate the safety and performance of the ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the breast augmentation and reconstruction at 3 months, 1 year and 2 years post-procedure
Interventions
DEVICEESTYME® MATRIX Breast Implants
Breast implant surgery in breast reconstruction or breast augmentation
Sponsors
MedPass International
Symatese Aesthetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Patient will be included if all of the following criteria are met: 1. Subject of between 18 and 65 years old 2. Candidate eligible for : a. unilateral or bilateral breast augmentation i. general breast enlargement: cosmetic purposes, providing symmetry to opposite breast in case of unilateral surgery ii. surgical correction of various congenital or acquired anomalies such as amastia, aplasia, hypomastia, hypoplasia, asymmetries, Poland's syndrome, ptosis … b. or immediate or delayed unilateral or bilateral breast reconstruction (for cancer, trauma, surgical loss of breast) 3. Patient signs PIC (Patient Informed Consent) & willing to comply with the protocol assessments and visits follow up
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local complications | 3 months | Evaluation of the safety 3 months post-implantation. Procedure-related adverse events/complications at 3 months post implant. Main foreseen complications: infection, haematoma, wound healing complication, fluid accumulation, early capsular contracture, rupture, extrusion. |
| Satisfaction of the patient and the surgeon | 3 months | Evaluation of the performance, 3 months post-implantation Performance endpoint will be assessed by implant procedure success at 3 months defined as follows: * satisfactory procedure duration for the surgeon * satisfactory size of the incision for the surgeon * implant correct placement (absence of visible deformation of the gel, absence of rotation for anatomical implants) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local complications | 1 year and 2 years | Evaluation of the safety, 1 year and two years post-implantation. Safety endpoint: incidence of all Adverse Events (AE)/Serious Adverse Events (SAEs) @ 1 year and two years post procedure |
| Satisfaction of the patient and the surgeon | 1 year and 2 years | Performance endpoints are as follows: * global surgeon satisfaction post-procedure assessed by the usability of the device during the procedure (current implant procedure): surgeon comfort level for the insertion/implantation of the prosthesis, * global patient and surgeon satisfaction @ 1 year and 2 years post-procedure |
Countries
France
Outcome results
None listed