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

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 o...

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Autores principales: Hedén, Per, Bronz, Giorgio, Elberg, Jens Jorgen, Deraemaecker, Rika, Murphy, Diane K., Slicton, Araceli, Brenner, R. James, Svarvar, Catarina, van Tetering, Joost, van der Weij, Leo Peter
Formato: Texto
Lenguaje:English
Publicado: Springer-Verlag 2009
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2693778/
https://www.ncbi.nlm.nih.gov/pubmed/19437071
http://dx.doi.org/10.1007/s00266-009-9360-x
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author Hedén, Per
Bronz, Giorgio
Elberg, Jens Jorgen
Deraemaecker, Rika
Murphy, Diane K.
Slicton, Araceli
Brenner, R. James
Svarvar, Catarina
van Tetering, Joost
van der Weij, Leo Peter
author_facet Hedén, Per
Bronz, Giorgio
Elberg, Jens Jorgen
Deraemaecker, Rika
Murphy, Diane K.
Slicton, Araceli
Brenner, R. James
Svarvar, Catarina
van Tetering, Joost
van der Weij, Leo Peter
author_sort Hedén, Per
collection PubMed
description 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.
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spelling pubmed-26937782009-06-09 Long-Term Safety and Effectiveness of Style 410 Highly Cohesive Silicone Breast Implants Hedén, Per Bronz, Giorgio Elberg, Jens Jorgen Deraemaecker, Rika Murphy, Diane K. Slicton, Araceli Brenner, R. James Svarvar, Catarina van Tetering, Joost van der Weij, Leo Peter Aesthetic Plast Surg Original Article 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. Springer-Verlag 2009-05-13 2009-05 /pmc/articles/PMC2693778/ /pubmed/19437071 http://dx.doi.org/10.1007/s00266-009-9360-x Text en © The Author(s) 2009
spellingShingle Original Article
Hedén, Per
Bronz, Giorgio
Elberg, Jens Jorgen
Deraemaecker, Rika
Murphy, Diane K.
Slicton, Araceli
Brenner, R. James
Svarvar, Catarina
van Tetering, Joost
van der Weij, Leo Peter
Long-Term Safety and Effectiveness of Style 410 Highly Cohesive Silicone Breast Implants
title Long-Term Safety and Effectiveness of Style 410 Highly Cohesive Silicone Breast Implants
title_full Long-Term Safety and Effectiveness of Style 410 Highly Cohesive Silicone Breast Implants
title_fullStr Long-Term Safety and Effectiveness of Style 410 Highly Cohesive Silicone Breast Implants
title_full_unstemmed Long-Term Safety and Effectiveness of Style 410 Highly Cohesive Silicone Breast Implants
title_short Long-Term Safety and Effectiveness of Style 410 Highly Cohesive Silicone Breast Implants
title_sort long-term safety and effectiveness of style 410 highly cohesive silicone breast implants
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2693778/
https://www.ncbi.nlm.nih.gov/pubmed/19437071
http://dx.doi.org/10.1007/s00266-009-9360-x
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