Multicenter Post-marketing Survey of SEBBIN Group Silicone Gel-filled Breast Implants (IM02)

March 5, 2024 updated by: Groupe SEBBIN
The aim of the study is to allow Groupe SEBBIN to communicate to competent authorities and to the scientific community data relative to the safety and effectiveness of SEBBIN silicone gel-filled breast implants.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

908

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Enrollment in the study was proposed to women over 18-year who were scheduled for a breast augmentation or breast reconstruction with SEBBIN silicone gel-filled breast implants.

Description

Inclusion Criteria:

  • The patient is at least 18-year-old.
  • The patient is genetically a woman.
  • The patient is candidate to a breast augmentation or breast reconstruction with silicone gel-filled breast implants.
  • The patient gets all information regarding the study and signs the informed consent relative to the use of her personal data.

Exclusion Criteria:

  • The patient is pregnant or breastfeeding.
  • The patient has silicone implants somewhere else than in the breast.

  • The patient was diagnosed with one of the following pathologies:

    • Systemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease.
    • Rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease.
    • Arthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease.
  • The patient has a pathology that could delay healing (does not apply to the reconstruction group).
  • The patient has cancer (does not apply to the reconstruction group).
  • The patient has anatomical or physiological conditions that could lead to postoperative complications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication
Time Frame: At 10 years of follow-up
complication rate
At 10 years of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe SEBBIN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

July 19, 2021

First Posted (Actual)

July 20, 2021

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • PEC 15-10-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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