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

Symatese Aesthetics

Status: Active, not recruiting

Conditions: Bilateral Breast Augmentation

Treatments: Device: ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants

Study type: Interventional

Funder types: Industry

Identifiers

NCT05336526

CLIN PMI-004

Details and patient eligibility

About

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).

Enrollment: 88 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Aged between 18 and 65 years

2. Eligible for bilateral breast augmentation in primary intention

   1. general breast enlargement for cosmetic purposes
   2. 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)

3. Signature of Patient Information Consent (PIC) & willingness to comply with the protocol assessments and follow up visits

4. 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 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)
7. Has breastfed within three (3) months the implant surgery, or is still breastfeeding
8. 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)
9. Has been previously implanted with a silicone implant or history of failure following 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 the investigator, may constitute an unwarranted surgical risk (e.g. severe lung or cardiac disease, unstable medical conditions, anaesthesia allergy, heavy smokers...)
12. Anatomic or physiologic abnormality which could result to significant post-operative complications
13. History of sensitivity to foreign materials or known allergy to any component of the ESTYME® 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 that would 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 previous clinical study as determined by the investigator
21. Has sociological, cultural or geographical factors which could interfere with evaluation or completion of the study

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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88 participants in 1 patient group

ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants

Experimental group

Description:

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

Treatment:

Device: ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants