Breast Implant; Complications
Conditions
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.
Interventions
None listed
Sponsors
Groupe SEBBIN
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication | At 10 years of follow-up | complication rate |
Outcome results
None listed