Follow-up on Euromi silicone gel breast implants

Prospective Observational Clinical Follow-up of Euromi Biosciences Pre-filled Silicone Gel Breast Implants

This study is tracking patients with Euromi silicone gel breast implants for 10 years to see how safe and effective they are and to check for any problems like implant rupture.

Quick facts

• Study type: Observational
• Enrollment: 177 (estimated)
• Ages: 18 Years to 60 Years
• Sex: Female
• Sponsor: Euromi Biosciences (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Nancy)
• Trial ID: NCT05987475 on ClinicalTrials.gov

What this trial studies

This observational study aims to conduct a prospective clinical follow-up of patients receiving Euromi Biosciences silicone gel-filled breast implants. It focuses on monitoring the long-term outcomes and potential complications associated with these implants, particularly breast implant rupture. Participants will be followed for a period of 10 years to gather data on the safety and effectiveness of the implants in breast reconstruction and aesthetic surgery settings.

Who should consider this trial

Good fit: Ideal candidates for this study are females aged 18 to 60 who are undergoing breast reconstruction after mastectomy or aesthetic breast surgery and are willing to participate in a long-term follow-up.

Not a fit: Patients who are pregnant, breastfeeding, or have certain medical conditions such as diabetes or a high body mass index may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety and performance of silicone gel breast implants, improving patient outcomes.

How similar studies have performed: While observational studies on breast implants are common, the specific focus on Euromi Biosciences implants may provide novel insights, as similar studies have shown varying results in terms of safety and complications.

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

Where this trial is running

Nancy

• CHRU Nancy — Nancy, France (Recruiting)

Conditions Breast Implant Rupture; Breast Implant; Complications