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

Study Overview
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Brief Summary
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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
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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

Official Title
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Evaluation of the Safety and Performance of SYMATESE AESTHETICS ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the Breast Augmentation and Reconstruction - EMMIE Study

Conditions
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Breast Augmentation, Breast Reconstruction

Intervention / Treatment
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* Device: ESTYME® MATRIX Breast Implants


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient will be included if all of the following criteria are met: Subject of between 18 and 65 years old 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) 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: Local or systemic infection or abscess anywhere in the body Existing carcinoma or pre-carcinoma of the breast without treatment or mastectomy treatment without appropriate wash out period for chemotherapy at the surgeon discretion Subject with previous tissue expansion Diagnosis of active cancer of any type for augmentation procedure subject Pregnant subject or intending to become pregnant within three (3) months of the implant procedure Subject who had nursed within three (3) months of implant surgery, or still breastfeeding 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) Previously implanted subject with a silicone implant or History of failure following cosmetic augmentation or subcutaneous mastectomy History of autoimmune disease such as but not limited to: lupus, scleroderma … 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 …) Anatomic or physiologic abnormality which could result to significant post-operative complications History of sensitivity of foreign materials or known allergy to any component of the ESTYME® MATRIX Silicone Gel-Filled Breast Implant Subject known for alcohol abuse/history Underlying disease (HIV positive Subject, HF (heart Failure), renal insufficiency, diabetes, hypertension, …) Subject with implanted metal or metal devices, history of claustrophobia, or other condition that would make a MRI scan prohibitive Unwilling to undergo any further surgery for revision Subject with willingness that are unrealistic/unreasonable with the risks involved with the surgical procedure Participating into any other clinical study or had participated into a clinical study without appropriate wash out period at the surgeon discretion Subject who has sociological, cultural or geographical factors which could interfere with evaluation or completion of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESTYME MATRIX<br>Participants who meet the requirements for breast augmentation or breast reconstruction surgeries and have been implanted with one or two ESTYME® MATRIX Breast Implant(s) | Device: ESTYME® MATRIX Breast Implants<br>* Breast implant surgery in breast reconstruction or breast augmentation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local complications | 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. | 3 months | 
| Satisfaction of the patient and the surgeon | 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) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local complications | 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 | 1 year and 2 years | 
| Satisfaction of the patient and the surgeon | 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 | 1 year and 2 years |