Five | 合法醫療器材資訊網

由FDuteille著作·2014·被引用20次—CentredesBrûlés,ImmeubleJeanMonnet,CHU,Nantes,France;CabinetMedical,Tours,France;EurosiliconeS.A.S.,ZIdelaPeyrolière,BP68, ...

Background: Multicenter prospective studies assessing the safety and efficacy of silicone gel breast implants are relatively rare. Eurosilicone S.A.S. present their safety and efficacy data herein for the largest European silicone gel breast implant study published to date.

Methods: One thousand and ten of Eurosilicones textured cohesive Cristalline Paragel range of mammary implants was implanted in women undergoing augmentation and reconstructive surgery at 17 centers throughout France. Physical examinations and complications were recorded by physicians at 3 months and annually thereafter until 10 years postimplantation. Descriptive statistics were used and key complications were analyzed using the Kaplan-Meier analysis method.

Results: Two ruptures were observed within 5 years postimplantation, one of which was subject to mechanical trauma during reoperation and the other was ...