Characterization of Capsule Inflammation in Patients Exposed to Silicone Breast Implants

Breast Implant; Complications Clinical Trial

— INFLAMA  

Official title:

INFLAMA : Histological and Molecular Characterization of Capsule Inflammation in Patients Exposed to Silicone Breast Implants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06414785
• Other study ID #: 2024/870
• Status: Recruiting
• Start date: May 3, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Isabelle PLUVY, MD
• Phone: +33381218988
• Email: i1pluvy[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The use of breast implants, both in cosmetic and restorative surgery, is common. It is a device consisting of a silicone elastomer envelope and the container of which may be silicone gel or saline. They can be texturing carriers (roughness) on the surface of their envelope.

If silicone is considered inert and biocompatible, several phenomena should be noted:

• Implant placement results in the formation of a periprosthetic capsule which is the product of the inflammatory reaction and will isolate it from adjacent breast tissue

• The periprosthetic capsule and adjacent breast tissue are chronically exposed to implant silicone.

• Silicone in implants, even intact, has been shown to diffuse through the shell into the periprosthetic compartment and adjacent breast tissue

• There is a phenomenon of erosion of the surface of the implants, particularly textured, responsible for the release of silicone particles within the periprosthetic capsule

• The rupture of the prosthetic envelope is a dreaded complication, due to the alteration of the aesthetic result and the possibility of leakage of silicone gel

• Since 2016, macrotextured implants have been implicated in the occurrence of anaplastic large cell lymphoma associated with breast implants (LAC-AIM) The presence of silicone in contact with tissues seems to promote an inflammatory environment, and this phenomenon seems increased if the implant is textured.

Chronic inflammation induced by these devices can therefore have harmful consequences in the long term. INFLAMA study interested in the consequences of the presence of a silicone implant on local inflammatory phenomena within the periprosthetic capsule.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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".

Related Conditions & MeSH terms

• Breast Implant; Complications
• Inflammation

Intervention

Other:
• analysis of samples of periprosthetic capsules taken during breast implant change procedure
characteristics of inflammation and the importance of silicone exposure (intact implant, implant rupture in serum or silicone) at the genomic molecular level, by analyzing the level of expression of genes related to the extracellular matrix and inflammation within a periprosthetic capsule fragment

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Institut de Science des Matériaux de Mulhouse IS2M, NOVOTEC labs (lyon)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	characteristics of inflammation according to the importance of silicone exposure	Verify the existence of a relationship between the characteristics of inflammation and the importance of silicone exposure (intact implant, implant rupture in serum or silicone) at the genomic molecular level, by analyzing the level of expression of genes related to the extracellular matrix and inflammation within a periprosthetic capsule fragment	immediately after surgery
Secondary	characteristics of inflammation according to the type of texturing of implants	Check the existence of a relationship between the characteristics of inflammation and the type of texturing of implants (smooth, micro textured or macro textured), on the genomic molecular level, by analyzing the level of expression of genes related to the extracellular matrix and inflammation within a periprosthetic capsule fragment.	immediately after surgery
Secondary	Characterize the inflammatory reaction within the periprosthetic capsule histologically, depending on the importance of silicone exposure.		immediately after surgery
Secondary	Characterize the inflammatory reaction within the periprosthetic capsule histologically, according to texturation.		immediately after surgery
Secondary	Identify a possible relationship between the characteristics of inflammation and the presence of a clinical shell.		immediately after surgery