Multicenter Post-marketing Survey of SEBBIN Group Silicone Gel-filled Breast Implants
Active, not recruiting
- Conditions
- Breast Implant; Complications
- Registration Number
- NCT04968457
- Lead Sponsor
- Groupe SEBBIN
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 908
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complication At 10 years of follow-up complication rate
- Secondary Outcome Measures
Name Time Method