Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414785
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-03
Brief Title:
Characterization of Capsule Inflammation in Patients Exposed to Silicone Breast Implants
Sponsor:
Centre Hospitalier Universitaire de Besancon
Organization:
Centre Hospitalier Universitaire de Besancon
Study Overview
Official Title:
INFLAMA Histological and Molecular Characterization of Capsule Inflammation in Patients Exposed to Silicone Breast Implants
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INFLAMA
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None