Clinical trial NCT06414785: Characterization of Capsule Inflammation in Patients Exposed to Silicone Breast Implants
Official title: INFLAMA : Histological and Molecular Characterization of Capsule Inflammation in Patients Exposed to Silicone Breast Implants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Implant; Complications
Breast Expansion Prosthesis
Keywords: type of texturing of implants
periprosthetic capsule fragment
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Institut de Science des Matériaux de Mulhouse IS2M
name: NOVOTEC labs (lyon)
First posted: 2024-05-16
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women Requiring a change of unilateral/bilateral breast implants or breast expansion prosthesis

Brief 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.


Eligibility 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".

Primary outcomes:
measure: characteristics of inflammation according to the importance of silicone exposure
timeFrame: immediately after surgery
Secondary outcomes:
measure: characteristics of inflammation according to the type of texturing of implants
timeFrame: immediately after surgery
measure: Characterize the inflammatory reaction within the periprosthetic capsule histologically, depending on the importance of silicone exposure.
timeFrame: immediately after surgery
measure: Characterize the inflammatory reaction within the periprosthetic capsule histologically, according to texturation.
timeFrame: immediately after surgery
measure: Identify a possible relationship between the characteristics of inflammation and the presence of a clinical shell.
timeFrame: immediately after surgery
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
affiliation: CHU de Besançon
name: Isabelle PLUVY
role: PRINCIPAL_INVESTIGATOR
References: