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

Study Overview
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Brief Summary
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The purpose of this study is to collect clinical data to evaluate the safety and performance of ESTYME® MATRIX Round microtextured breast implants in patients who receive these silicone gel-filled implants as part of their breast augmentation surgery in primary intention. This study also aims to measure patient and surgeon satisfaction. An initial study of all ESTYME® MATRIX implants was conducted between 2018 and 2021. The purpose of the current EMMA study is to complete the data from this first study on a larger number of implants, and only on the ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants range for primary intention breast augmentation, with a view to obtaining marketing authorization (CE marking).

Official Title
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Evaluation of the Safety and Performance of SYMATESE AESTHETICS ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants in the Breast Augmentation, Primary Intention (EMMA Study)

Conditions
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Bilateral Breast Augmentation

Intervention / Treatment
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* Device: ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18 and 65 years Eligible for bilateral breast augmentation in primary intention general breast enlargement for cosmetic purposes 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) Signature of Patient Information Consent (PIC) & willingness to comply with the protocol assessments and follow up visits Affiliation to the social security regime Exclusion Criteria: Local or systemic infection or abscess anywhere in the body Existing carcinoma or pre-carcinoma of the breast with or without treatment History of subcutaneous mastectomy Subject with previous tissue expansion Diagnosis of active cancer of any type 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) Has breastfed within three (3) months the implant surgery, or is still breastfeeding 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) Has been previously implanted with a silicone implant or history of failure following cosmetic augmentation History of autoimmune disease such as, but not limited to, lupus and scleroderma 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…) Anatomic or physiologic abnormality which could result to significant post-operative complications History of sensitivity to foreign materials or known allergy to any component of the ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implant Known alcohol abuse or history of alcohol abuse Psychological instability Underlying disease (HIV-positive, heart failure, renal insufficiency, diabetes, hypertension) Implanted metal or metal devices, history of claustrophobia, or other condition that would make a magnetic resonance imaging (MRI) scan prohibitive Unwilling to undergo any further surgery for revision Unrealistic/unreasonable expectations that entail a risk for the surgical procedure Participating in another clinical study or within exclusion period of a previous clinical study as determined by the investigator 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants<br>Participants who meet the requirements for bilateral breast augmentation in primary intention and have been implanted with ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants | Device: ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants<br>* Bilateral brest augmentation in primary intention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety : Incidence of implant and/or procedure-related adverse events/complications | Safety endpoint will be assessed by the incidence of implant and/or procedure-related adverse events/complications at 3 months post implant | 3 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety : Incidence of all AEs/SAEs | Safety endpoint will be assessed by the incidence of all AEs/SAEs at 1 year post-procedure | 1 year post-procedure | 
| Safety : Incidence of all AEs/SAEs | Safety endpoint will be assessed by the incidence of all AEs/SAEs at 2 years post-procedure | 2 years post-procedure | 
| Performance, Implant procedure Success: Surgeon comfort evaluation with procedure duration | Evaluation of surgeon 's satisfaction with procedure duration (5 options: Definitely satisfied, Satisfied, Somewhat satisfied, Somewhat dissatisfied, Definitely dissatisfied) | at the implant procedure | 
| Performance, Implant procedure Success: Surgeon comfort evaluation with size incision | Evaluation of surgeon 's satisfaction with size of incision (5 options: Definitely satisfied, Satisfied, Somewhat satisfied, Somewhat dissatisfied, Definitely dissatisfied) | at the implant procedure | 
| Performance, Implant procedure Success: Assessment of implant placement and deformation | Assessment of the implant correct placement (absence of visible deformation of the gel) at 3 months | 3 months post-procedure | 
| Performance :Surgeon comfort evaluation with comfort level for insertion/implantation of the prothesis | Evaluation of surgeon's satisfaction with the usability of the device during the procedure (current implant procedure), the comfort level for insertion/implantation of the prothesis (5 options: Definitely satisfied, Satisfied, Somewhat satisfied, Somewhat dissatisfied, Definitely dissatisfied) | Discharge Visit, an average of 24h | 
| Performance : number of steps of increase in bra cup size | Overall mean number of steps of increase in bra cup size at 3 months, 1 year and 2 years post-procedure | 3 months, 1 year and 2 years post-procedure | 
| Performance : change in chest circumference at the level of the breasts | Overall mean change in chest circumference at the level of the breasts following the implant procedure analyzed as change in thoracic measure at 3 months, 1 years and 2 years post-procedure | 3 months, 1 year and 2 years post-procedure | 
| Performance : satisfaction with the implant size choice | Suitability of the implant size choice at the time of the procedure analyzed as the difference between the final decision of the cup size for surgery and the cup size at 3 months, 1 year and 2 years | 3 months, 1 year and 2 years post-procedure | 
| Performance : global satisfaction of the patient | Evaluation of global patient satisfaction at 3 months, 1 year and 2 years post-procedure with the BREAST EVALUATION QUESTIONNAIRE (BEQ55) (5 options: 1 = Very dissatisfied, 2 = Somewhat dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Somewhat satisfied, 5 = Very satisfied) | 3 months, 1 year and 2 years post-procedure | 
| Performance : global satisfaction of the surgeon | Surgeon satisfaction at 3 months, 1 year and 2 years post-procedure evaluated as : degree of symmetry (4 options: NA, Good, Mediocre, Bad), degree of ptosis (3 options: Good, Mediocre, Bad), quality of contours (3 options: Good, Mediocre, Bad), implant placement (2 options: correct placement, visible deformation of the gel), global satisfaction (5 scoring options : definitely satisfied, satisfied, somewhat satisfied, somewhat dissatisfied and definitely dissatisfied). | 3 months, 1 year and 2 years post-procedure |