Actively Recruiting
Characterization of Capsule Inflammation in Patients Exposed to Silicone Breast Implants
Led by Centre Hospitalier Universitaire de Besancon · Updated on 2024-05-16
100
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire de Besancon
Lead Sponsor
I
Institut de Science des Matériaux de Mulhouse IS2M
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Characterization of Capsule Inflammation in Patients Exposed to Silicone Breast Implants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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".
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU de Besançon
Besançon, France, 25030
Actively Recruiting
Research Team
I
Isabelle PLUVY, MD
CONTACT
A
astrid pozet
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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