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Characterization of Capsule Inflammation in Patients Exposed to Silicone Breast Implants

NCT06414785 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-05-16

No results posted yet for this study

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

Interventions

OTHER

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

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

Sponsors & Collaborators

  • Institut de Science des Matériaux de Mulhouse IS2M

    collaborator UNKNOWN

  • NOVOTEC labs (lyon)

    collaborator UNKNOWN

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Principal Investigators

  • Isabelle PLUVY · CHU de Besançon

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-03
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06414785 on ClinicalTrials.gov