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Multicenter Post-marketing Su...

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

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

908 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2027-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Implant; Complications

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes