Clinical trial NCT05987475: Prospective Observational Clinical Follow-up of Euromi Biosciences Pre-filled Silicone Gel Breast Implants
Official title: Prospective Observational Clinical Follow-up of Euromi Biosciences Pre-filled Silicone Gel Breast Implants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Implant Rupture
Breast Implant; Complications
Lead sponsor: Euromi Biosciences
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 177
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two groups of participants will be distinguished:

* Group 1: Insertion of an implant in the event of a breast augmentation (for aesthetic reasons)
* Group 2: Insertion of an implant in the event of a breast reconstruction (eg.. following breast cancer)

Brief summary: Prospective observational clinical follow-up of Euromi Biosciences silicone gel-filled breast implants - Post-market clinical investigation - ELEGANT


Eligibility criteria: Inclusion Criteria:

* Female;
* 18 years old and above, and under 60 years old;
* has approved and signed the informed consent form;
* eligible to receive at least one EUROMI Biosciences implant during breast reconstruction following a mastectomy or during aesthetic breast surgery;
* Willing to be followed up for a period of 10 years.

Exclusion Criteria:

* Informed pregnancy or breastfeeding at the time of inclusion
* Known hypersensitivity and / or allergy to silicone;
* Not understanding or not accepting the risks of further surgeries during follow-up;
* Body mass index \> 40 kg/m²;
* Diabetes
* HbA1c levels \> 7,5%;
* History of repeated failure with the implantation of similar implants;
* Tissue or fat insufficiency;
* Progressive breast cancer large tumours (\>5 cm), late cancer stage and deep tumours;
* Grossly positive axillary involvement / or chest wall involvement;
* High risk of cancer recurrence;
* Tissue damage in the implant area due to irradiation of the thoracic wall;
* Pre-existing pathology in the implant area;
* General infection or infection in the implant area;
* Medical condition (poor physiological condition, psychological instability, severe smoking, obesity, coagulopathy, diabetes, severe cardiovascular or pulmonary disease, etc.) Which may, according to the judgement of the surgeon, entail excessive risk and/or post-surgical complications;
* History or presence of an autoimmune disease;
* Immunocompromised;
* History or current treatment using radiation with lower-pole scarring and thin, poorly vascularized skin/tissue / microwave diathermy / or steroids;
* Medical condition likely to interfere with her capacity to understand the follow-up requirements, to participate in the follow-up or to give her informed consent;
* Concomitantly part of another interventional clinical trial.
* Under supervision or legal guardianship
* Deprived of liberty by a judicial or administrative decision
* Not affiliated to health insurance system or is a beneficiary of such coverage

Primary outcomes:
measure: Rate of capsular contracture
timeFrame: From implantation to end of study (10-year)
measure: Post-surgery rupture
timeFrame: From implantation to end of study (10-year)
Secondary outcomes:
measure: Participant's QoL
timeFrame: From implantation to end of study (10-year)
measure: Breast implant survival rate.
timeFrame: From implantation to end of study (10-year)
measure: Frequency of occurrence of other adverse events and complications
timeFrame: From implantation to end of study (10-year)
measure: Participant's and investigator's satisfaction regarding the aesthetic result
timeFrame: From implantation to end of study (10-year)
measure: Reoperation rate
timeFrame: From implantation to end of study (10-year)
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
Study officials:
References: