Follow-up on Euromi silicone gel breast implants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHRU Nancy
  Nancy, France Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Predictors of Breast Implant Rupture in Women with Aesthetic Silicone Implants

  This study follows women with silicone breast implants over time to see which implant details and surgical choices are linked to rupture.

  Recruiting Research Inc · Medellín · NCT07810205

• Implant-based breast reconstruction after bariatric (weight-loss) surgery

  This registry-based project will use national data to see how common breast implants are and whether women who've had bariatric weight-loss surgery have different complication rates after implant-based breast augmentation or reconstruction.

  Recruiting Vastra Gotaland Region · Gothenburg · NCT07059104

• Long-term follow-up of Motiva silicone breast implants

  This project sees if Motiva silicone breast implants are safe and work well over up to 10 years for adult women having primary or revision breast augmentation.

  Recruiting at 33 sites Motiva USA LLC · Beverly Hills, California and 32 other locations · NCT06938399

• Identifying risk factors for seroma formation after breast surgery

  This study is trying to find out which patients are more likely to develop fluid buildup after breast surgery so that doctors can give better advice and care to prevent it.

  Recruiting University Hospital Augsburg · Augsburg, Bavaria · NCT05899387

• Investigating bacterial biofilms in breast implant complications

  This study is trying to see if bacteria that form biofilms are linked to problems some people have with breast implants, especially those experiencing Breast Implant Illness.

  Recruiting at 3 sites Indiana University · Carmel, Indiana and 2 other locations · NCT05736354

• Analysis of outcomes for women with Silimed® smooth surface breast implants

  This study is testing how safe and effective Silimed® smooth surface breast implants are for women getting breast augmentation, while also looking at their satisfaction and quality of life over 10 years.

  Recruiting Silimed Industria de Implantes Ltda · Santo André, São Paulo · NCT05345821

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.