Examining Inflammation Around Silicone Breast Implants
INFLAMA : Histological and Molecular Characterization of Capsule Inflammation in Patients Exposed to Silicone Breast Implants
This study is testing how different types of breast implants affect inflammation and silicone movement in women who are getting their implants changed or expanded.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | Centre Hospitalier Universitaire de Besancon Academic / other |
| Locations | 1 site (Besançon) |
| Trial ID | NCT06414785 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on women who are undergoing a change of breast implants or breast expansion prosthesis. It aims to analyze samples of periprosthetic capsules collected during the procedure to understand the inflammatory reactions and silicone diffusion associated with breast implants. The study will investigate how the texture of the implants may influence the formation of these capsules and the potential release of silicone particles into surrounding tissues. By examining these factors, the research seeks to provide insights into the complications related to breast implants.
Who should consider this trial
Good fit: Ideal candidates are women over 18 years old who require a change of breast implants for cosmetic or reconstructive purposes.
Not a fit: Patients such as transgender men, pregnant or nursing women, and those unable to provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of breast implant complications and lead to improved safety and design of implants.
How similar studies have performed: While this study addresses a common issue with breast implants, similar observational studies have shown varying degrees of success in understanding implant-related complications.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women over the age of 18 years old * Requiring a change of unilateral/bilateral breast implants or breast expansion prosthesis for cosmetic surgery or breast reconstruction * Subject not objecting to the use of personal data and/or biological samples * Affiliation to or beneficiary of a French social security scheme. Exclusion Criteria: * Transgender men and patients * Pregnant women, and nursing mothers * Persons deprived of their liberty by a judicial or administrative decision; * Persons undergoing psychiatric care under duress; * Persons admitted to a health or social establishment for purposes other than research * Persons of full age who are subject to a legal protection measure or who cannot express their consent * Subject being in the period of exclusion from another study or foreseen by the "national volunteer file".
Where this trial is running
Besançon
- CHU de Besançon — Besançon, France (Recruiting)
Study contacts
- Principal investigator: Isabelle PLUVY — CHU de Besançon
- Study coordinator: Isabelle PLUVY, MD
- Email: i1pluvy@chu-besancon.fr
- Phone: +33381218988
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.