Image

Characterization of Capsule Inflammation in Patients Exposed to Silicone Breast Implants

Characterization of Capsule Inflammation in Patients Exposed to Silicone Breast Implants

Recruiting
18-99 years
Female
Phase N/A

Powered by AI

Overview

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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".

Study details
    Breast Implant; Complications
    Breast Expansion Prosthesis

NCT06414785

Centre Hospitalier Universitaire de Besancon

27 May 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.