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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU de Besançon
RECRUITING
Besançon
Contact Information
Primary
Isabelle PLUVY, MD
i1pluvy@chu-besancon.fr
+33381218988
Backup
astrid pozet
apozet@chu-besancon.fr
Time Frame
Start Date: 2024-05-03
Estimated Completion Date: 2025-05-31
Participants
Target number of participants: 100
Sponsors
Leads: Centre Hospitalier Universitaire de Besancon
Collaborators: NOVOTEC labs (lyon), Institut de Science des Matériaux de Mulhouse IS2M

This content was sourced from clinicaltrials.gov