Characterization of Capsule Inflammation in Patients Exposed to Silicone Breast Implants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-03

Study Completion Date

2025-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Implant; Complications Breast Expansion Prosthesis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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".

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No