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Aesthetic Plast Surg. 2009 May;33(3):430-6; discussion 437-8. doi: 10.1007/s00266-009-9360-x. Epub 2009 May 13.

Long-term safety and effectiveness of style 410 highly cohesive silicone breast implants.

Author information

1
Akademikliniken, Stockholm, Sweden. per.heden@ak.se

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 (approximately 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.

PMID:
19437071
PMCID:
PMC2693778
DOI:
10.1007/s00266-009-9360-x
[Indexed for MEDLINE]
Free PMC Article

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