, Volume 33, Issue 3, pp 430-436,
Open Access This content is freely available online to anyone, anywhere at any time.
Date: 13 May 2009

Long-Term Safety and Effectiveness of Style 410 Highly Cohesive Silicone Breast Implants

Abstract

Background

In 2006, a single-center Swedish study demonstrated a low rupture rate and high patient satisfaction with the Style 410 shaped, form-stable gel implant. The current study aimed to validate the accuracy of the previously published results across multiple European sites.

Methods

A total of 163 subjects (~70% had augmentation [n = 112], 15% had reconstruction [n = 25], and 15% had revision [n = 26]) underwent a physical examination followed by breast magnetic resonance imaging (MRI) for rupture detection. These subjects had been implanted for 5 to 11 years with at least one Style 410 shaped gel breast implant before examination. The secondary end points included lactation, reproductive and breast disease history before and after implantation, and quality-of-life measurements and complications after implantation.

Results

The implant rupture rate was 1.7% a median of 8 years after implantation. Capsular contracture was the most common complication noted at the physical examination, occurring for 5.3% of implants, and there were no cases of grade 4 capsular contracture. The postimplantation rates for lactation and reproductive problems and breast disease were lower than the preimplantation rates. Breast implantation surgery was considered advantageous by 91% of the subjects, demonstrating high patient satisfaction.

Conclusions

The Style 410 anatomically shaped, form-stable gel breast implants demonstrated long-term safety and effectiveness.

Presented as a poster at the 19th Congress of the International Society of Aesthetic Plastic Surgery, Melbourne, Australia, 10–13 February 2008.