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

Abstract

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.

Reoperation Rate After Primary Augmentation With Smooth, Textured, High Fill, Cohesive, Round Breast Implants (RANBI-I Study)

“…3 The primary reasons for reoperation in these longer-term studies were capsular contracture, mastopexy, scarring, and breast mass (the latter generally associated with the need for biopsy to assess potential malignancy). 12,13 In the Core study of Natrelle Classic round smooth and textured breast implants with TruForm 1 silicone gel, the reoperation rate was 28.0% and 36.1% at 6 and 10 years, respectively, and capsular contracture was the leading reason for reoperation. 14,15 In the 10-year data for Natrelle Style 410 shaped breast implants, the reoperation rate was 29.7% (95% CI: 25.6–34.3); patient request and capsular contracture were common reasons.…”

Preliminary 3-Year Evaluation of Experience With SilkSurface and VelvetSurface Motiva Silicone Breast Implants: A Single-Center Experience With 5813 Consecutive Breast Augmentation Cases

“…A second study reported an 8% rate of capsular contracture at 9 years following implantation of form-stable textured silicone implants. 18 These studies suggest somewhat improved risk for contracture with implants with textured surfaces, but many patients remained at risk for this adverse outcome.…”

Ten-Year Safety Data for Eurosilicone’s Round and Anatomical Silicone Gel Breast Implants

“…The risk of this complication increases over time as evidenced by the increase in capsular contracture rates over the period of this 10-year study. At 5 years 11 postimplantation, the Kaplan-Meier estimated cumulative risk rate for capsular contracture for the primary augmentation cohort was 10.7%, at 8 years 12 it had increased to 12.5% and at 10 years postimplantation the rate had increased further to 13.8%. The number of cases per year is provided in Figure 3 .…”