Five-year Safety Data for Eurosilicone's Round and Anatomical Silicone Gel Breast Implants.

[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 Eurosilicone's 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 identified during routine screening. Capsular contracture, one of the most common complications associated with breast implants, was reported in 6.6% implants across all indications through 5 years. The Kaplan-Meier risk of capsular contracture (Baker III/IV) was 10.7% (95% confidence interval, 7.2-14.2%) and 17.2% (95% confidence interval, 5.4-29%) in the primary augmentation and primary reconstruction patient cohorts, respectively. Implant removal (explantation/exchange) was 8.5% and 16.5% for primary augmentation and primary reconstruction cohorts, respectively. Rates of local complications including infection and seroma were low with risk rates of 0.6% and 0.2% by subject.

[CONCLUSIONS] Eurosilicone S.A.S. prospective study involving 1010 Eurosilicone silicone gel breast implants in both round and shaped profiles demonstrated a low rupture rate and an excellent safety profile through 5 years.