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Natrelle Style 410 Form-Stable Silicone Breast Implants: Core Study Results at 6 Years

G. Patrick Maxwell MD, Bruce W. Van Natta MD, Diane K. Murphy MBA, Araceli Slicton BA, Bradley P. Bengtson MD
DOI: http://dx.doi.org/10.1177/1090820X12452423 709-717 First published online: 1 August 2012

Abstract

Background: The Natrelle Style 410 shaped, form-stable silicone gel implant (Allergan, Inc; Irvine, California) has been the subject of a pivotal study that supports potential US Food and Drug Administration approval of the device. The 3-year results of this study were reported previously.

Objectives: The authors update the safety and effectiveness findings for the Natrelle Style 410 implants through 6 years of study.

Methods: This prospective, nonrandomized, multicenter study included 941 patients (492 primary augmentations, 156 revision-augmentations, 225 primary reconstructions, and 68 revision-reconstructions). Since the original 3-year report, follow-up visits have been conducted annually. Kaplan–Meier risk rates were calculated for local complications, reoperations, and explantations. One-third of the subjects were enrolled in the magnetic resonance imaging (MRI) cohort and underwent biannual MRI rupture screening. Effectiveness was measured by subject satisfaction on a 5-point scale.

Results: As expected after breast implantation, capsular contracture (CC) was one of the most common complications, with 6-year risk rates of 4.6% for augmentation, 6.9% for revision-augmentation, 10.7% for reconstruction, and 18.3% for revision-reconstruction. The rates for CC among augmentations and revision-augmentations were significantly lower with the Natrelle 410 implants than with other standard gel implants. The rupture rate (confirmed plus suspected) across all cohorts was 6.4% by subject and 3.8% by implant. The most common reasons for reoperation were style or size change (augmentation), implant malposition (revision-augmentation), scarring (reconstruction), and CC (revision-reconstruction). The satisfaction rate exceeded 80% in all cohorts.

Conclusions: These fifth-generation, form-stable implants represent another option to achieve desired aesthetic outcomes with minimal complications.

Level of Evidence: 2

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Keywords
  • breast implants
  • silicone gel
  • patient satisfaction
  • reoperation
  • cohesive gel implants
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