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Multicenter Study
. 2015 Feb;35(2):145-55.
doi: 10.1093/asj/sju084.

Ten-year results from the Natrelle 410 anatomical form-stable silicone breast implant core study

G Patrick Maxwell  1 , Bruce W Van Natta  1 , Bradley P Bengtson  1 , Diane K Murphy  1
Affiliations
Multicenter Study

Ten-year results from the Natrelle 410 anatomical form-stable silicone breast implant core study

G Patrick Maxwell et al. Aesthet Surg J. 2015 Feb.

Erratum in

Abstract

Background: Silicone breast implants have long been used for breast augmentation and reconstruction. During this time, these medical devices have gone through a number of modifications to improve their safety, quality, and clinical outcome performance.

Objectives: The authors conducted a 10-year study to determine the safety and effectiveness of Natrelle 410 silicone breast implants.

Methods: This prospective, multicenter study enrolled 941 subjects who were undergoing either augmentation, augmentation revision, reconstruction, or reconstruction revision. Data on complications, reoperations, explantations, and subject satisfaction were collected at annual clinic visits, and one-third of subjects underwent biennial magnetic resonance imaging (MRI) to screen for implant rupture. The authors used the Kaplan-Meier estimator to calculate risk rates for local complications, reoperations, and explantations.

Results: Capsular contracture rates increased approximately 1% per year from the previously reported 6-year rates. The rates were significantly lower than those from the Natrelle round gel core study. The overall rate of confirmed ruptured implants in subjects who underwent MRI was 5.7%. Eleven late seromas were reported. The most common reason for explantation was a subject requesting a size or style change. Satisfaction rates remained high through 10 years, with most subjects saying they were somewhat or definitely satisfied with their implants.

Conclusions: This 10-year prospective trial demonstrated the long-term safety and effectiveness of Natrelle 410 anatomical form-stable implants. The complication rates were low and the satisfaction rates were high. LEVEL OF EVIDENCE 1: Therapeutic.

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Figures

Figure 1.
Figure 1.
These Kaplan-Meier curves show the risk of capsular contracture through 10 years.
Figure 2.
Figure 2.
These Kaplan-Meier curves show the risk of implant rupture through 10 years. MRI, magnetic resonance imaging.
Figure 3.
Figure 3.
This 33-year-old woman is shown before (A, C) and 10 years (B, D) after breast augmentation with 255-cc Natrelle 410 moderate height, full projection implants.
Figure 4.
Figure 4.
Magnetic resonance imaging scan taken 10 years after breast augmentation with 255-cc Natrelle 410 moderate height, full projection implants in the 33-year-old woman shown in Figure 3.
Figure 5.
Figure 5.
This 36-year-old woman is shown before (A, C) and 10 years after (B, D) breast reconstruction with a bilateral neopectoral pocket conversion and placement of 255-cc Natrelle 410 full height, full projection implants.
Figure 6.
Figure 6.
Magnetic resonance imaging scan taken 10 years after breast reconstruction with a bilateral neopectoral pocket conversion and placement of 255-cc Natrelle 410 full height, full projection implants in the 36-year-old woman shown in Figure 5.
See this image and copyright information in PMC

Comment in

References

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    1. Bengtson BP, Van Natta BW, Murphy DK, Slicton A, Maxwell GP for the Style 410 U.S. Core Clinical Study Group. Style 410 highly cohesive silicone breast implant core study results at 3 years. Plast Reconstr Surg. 2007;120(7 Suppl 1):40S–48S. - PubMed
    1. Maxwell GP, Van Natta BW, Murphy DK, Slicton A, Bengtson BP. Natrelle Style 410 form-stable silicone breast implants: core study results at 6 years. Aesthet Surg J. 2012;32(6):709–717. - PubMed
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    1. Maxwell GP, Hartley W. Breast augmentation. In: Mathes SJ, Hentz VR, editors. Plastic Surgery. 2nd ed. Amsterdam: Elsevier; 2006. pp. 1–33.

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