Characterization of Capsule Inflammation in Patients Exposed to Silicone Breast Implants

NCT06414785 | Recruiting

• 1 other identifier: 2024/870
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Implant; Complications; Breast Expansion Prosthesis

Keywords

type of texturing of implants; periprosthetic capsule fragment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• characteristics of inflammation according to the type of texturing of implants

  immediately after surgery

• Characterize the inflammatory reaction within the periprosthetic capsule histologically, depending on the importance of silicone exposure.

  immediately after surgery

• Characterize the inflammatory reaction within the periprosthetic capsule histologically, according to texturation.

  immediately after surgery

• Identify a possible relationship between the characteristics of inflammation and the presence of a clinical shell.

  immediately after surgery

Interventions

analysis of samples of periprosthetic capsules taken during breast implant change procedure OTHER

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women Requiring a change of unilateral/bilateral breast implants or breast expansion prosthesis

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Institut de Science des Matériaux de Mulhouse IS2M: collaborator
• NOVOTEC labs (lyon): collaborator

Study Sites (1)

CHU de Besançon

Besançon, 25030, France

RECRUITING

Study Officials

• Isabelle PLUVY

  CHU de Besançon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle PLUVY, MD

CONTACT

+33381218988; i1pluvy@chu-besancon.fr

astrid pozet

CONTACT

apozet@chu-besancon.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 16, 2024
• Study Start: May 3, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)