RESUMEN
BACKGROUND: Although silicone breast implants have been available for over 60 years, their safety and efficacy continue to be assessed via long-term clinical and vigilance studies. Complications often associated with breast implant surgery include but are not limited to capsular contracture and rupture. OBJECTIVE: The authors investigate and evaluate the safety and performance of Eurosilicone's (Eurosilicone S.A.S, Apt Cedex, France) Cristalline Paragel breast implants at least 10 years postimplantation. METHODS: Nine hundred and ninety-five of Eurosilicone's textured mammary implants were implanted in 526 women undergoing primary (423 patients) and revision surgery (103 patients) at 17 centers throughout France. Complications were recorded at 3 months and annually thereafter for 10 years. Descriptive statistics were used and the Kaplan-Meier method was utilized to analyze key complications. RESULTS: Seventy-four women (98 implants) experienced capsular contracture across all cohorts. The Kaplan-Meier 10-year cumulative risk of capsular contracture (Baker Grade III/IV) per implant was 11.5% in the primary augmentation cohort and 25.2% in the primary reconstruction cohort. Sixteen implant ruptures were observed by surgeon examination giving a Kaplan-Meier risk of 3.8% per patient and 3.5% per implant. Surgical re-intervention (explantation/exchange) was reported 80 times resulting in a Kaplan-Meier cumulative risk of 13.3% and 31.6% for primary augmentation and primary reconstruction, respectively, per patient. Local complication rates including infection and seroma were low with risk rates of 0.6% and 0.2% by subject. CONCLUSIONS: This multicenter clinical study demonstrates the long-term safety and efficacy profile through 10 years for Eurosilicone round and anatomical silicone gel breast implants.
RESUMEN
BACKGROUND: The safety and efficacy of all medical devices, including breast implants, is important and consistent performance is best shown by undertaking long-term clinical and vigilance studies. Local complications such as capsular contracture and rupture are risks often associated with breast implant surgery. OBJECTIVES: The authors investigate and evaluate the safety and performance of Eurosilicone's (Eurosilicone S.A.S, Apt Cedex, France) Cristalline Paragel breast implants at 8 years postimplantation. METHODS: In this prospective clinical study, 995 Eurosilicone textured cohesive Cristalline Paragel mammary implants were implanted in 526 women undergoing augmentation and reconstructive surgery at 17 centers across France. Complications were recorded at 3 months and annually thereafter for 8 years. Descriptive statistics were used and key complications were analysed using the Kaplan-Meier method. RESULTS: Capsular contracture was reported in 8.5% of implants across all cohorts through 8 years. The Kaplan-Meier risk of capsular contracture (Baker Grade III/IV) per implant was 8.4% in the primary augmentation cohort and 18.0% in the primary reconstruction cohort. Eight implant ruptures were identified by surgeon examination during this follow-up period. The Kaplan-Meier risk of rupture occurring within 8 years postimplantation, across all cohorts, was 1.4% per patient and 0.9% per implant. Actual implant removal rate (explantation/exchange) was 6.0% and 13.8% for primary augmentation and primary reconstruction, respectively. Actual rates of local complications including infection and seroma were low with risk rates of 0.6% and 0.2% by subject. CONCLUSIONS: This multicenter clinical study involving Eurosilicone's silicone gel breast implants in both round and shaped profiles demonstrates an excellent safety and efficacy profile through 8 years.