Complication, Prosthesis Durability
Conditions
Brief summary
This study is part of the clinical evaluation of SEBBIN silicone gel-filled testicular implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.
Interventions
None listed
Sponsors
Groupe SEBBIN
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* The patient is an adult or a child at the time of implant placement with SEBBIN implant. * The patient is candidate to a unilateral or bilateral testicular implant placement with SEBBIN implant. * The patient has been informed of the study, has read the patient information letter and -provided oral consent.
Exclusion criteria
* The patient has silicone implants somewhere else than in the scrotal sac. * 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. * Custom-designed implants are used for surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complication rate | At 10 years of follow-up |
Countries
Belgium, France
Outcome results
None listed