Eight-Year Safety Data for Round and Anatomical Silicone Gel Breast Implants.

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.