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Evaluation of the Performance and Safety of the Monobloc® - Silicone SoftOne® Breast Implants at 10 Years
Sponsor: Laboratoires ARION
Summary
The aim of this observational, Post-market, Retro-prospective, open, non-randomized, non-comparative, multicentric, European study is to evaluate the safety and performance of the Monobloc® - Silicone SoftOne® breast implants at 10 years. The primary objective is to evaluate the rate of women who had at least one re-intervention within the 10 years of follow-up. the secondary objectives are To evaluate the safety and performance outcomes of women who underwent breast augmentation and/or breast reconstruction using the Monobloc® - Silicone SoftOne® breast implants at 10 years Participants will have one follow-up visit during which data will be retrospectively documented at the following time points: preoperative visit, operative visit, follow-up 10 years
Official title: Evaluation of the Performance and Safety of the Monobloc® - Silicone SoftOne® Breast Implants at 10 Years: Post-marketing Clinical Follow-up Study
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
630
Start Date
2023-09-07
Completion Date
2027-01-07
Last Updated
2026-10-29
Healthy Volunteers
No
Conditions
Interventions
Breast augmentation
Breast augmentation with implants
Breast reconstruction
Breast reconstruction with implants
Locations (5)
Academia Aesthetica
Bordeaux, France
Cabinet de chirurgie esthétique de Marseille
Marseille, France
Cabinet de chirurgie esthétique de Paris
Paris, France
Cabinet Médical Esthétique Paris 7
Paris, France
CHU de Toulouse
Toulouse, France