The Mentor Core Study on Silicone MemoryGel Breast Implants

Cunningham, Bruce L.

doi:10.1097/01.prs.0000286574.88752.04

Cited by 156 publications

(74 citation statements)

References 42 publications

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“…Apesar da queda nos índices de procedimentos de troca dos implantes, estes ainda ocorrem com uma frequência que não é desprezível, sendo relatados em torno de 27 a 29,1% de reoperações 11 . As principais causas descritas que levam as pacientes à troca de implantes são a ocorrência de contratura capsular sintomá-tica, índice que vem caindo com a evolução dos implantes, seguida da insatisfação das pacientes com a aparência estética das mamas 7,11,12 .…”

Section: Discussionunclassified

“…As principais causas descritas que levam as pacientes à troca de implantes são a ocorrência de contratura capsular sintomá-tica, índice que vem caindo com a evolução dos implantes, seguida da insatisfação das pacientes com a aparência estética das mamas 7,11,12 . A ocorrência de infecção na loja dos implantes, evento dramático e que necessita de uma troca imediata, ocorrência de ruptura dos implantes, evento que também vem caindo devido à evolução nos revestimentos dos implantes, e a presença de alguma condição clínica, como o diagnóstico de nódulos mamá-rios ou, até, de neoplasias mamárias, são motivos infrequentes que levam à necessidade da troca dos implantes 12 .…”

Section: Discussionunclassified

“…Somente 19,1% dos casos de reoperações ocorreram por este motivo, enquanto que a literatura nos mostra índices que variam de 11 a 81% 11,19,21 . No mesmo estudo, em 46,1% das pacientes submetidas a troca dos implantes, o revestimento do implante anterior era de poliuretano, em 30,7% dos casos, era texturizado, e em 23,2%, liso.…”

Section: Discussionunclassified

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Análise das trocas de implantes mamários nos últimos cinco anos na Clínica Ivo Pitanguy

Pitanguy¹,

Amorim²,

Ferreira³

et al. 2010

Rev. Bras. Cir. Plást. (Impr.)

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RESUMOIntrodução: A cirurgia de aumento mamário foi a cirurgia plástica mais realizada no Brasil, em 2008. Com a evolução da técnica e da qualidade dos implantes de silicone, a taxa de complicações tem diminuído progressivamente, tornando a cirurgia mais segura. Objetivo: Demonstrar o perfil das pacientes submetidas à troca de implante mamário, nos últimos cinco anos, na Clínica Ivo Pitanguy, analisando as características dos implantes de silicone e as causas que motivaram a troca. Método: Foram analisadas, retrospectivamente, todas as pacientes submetidas a procedimentos cirúrgicos de troca, retirada ou reinclusão de implantes mamários, nos últimos cinco anos, num total de 59 pacientes em 68 procedimentos e 129 mamas operadas. Resultados: O intervalo de tempo entre a colocação e a retirada dos implantes variou de 1 mês a 34 anos; 44 pacientes eram provenientes do nosso serviço e 24 de outros. Quarenta e três implantes eram, antes da troca, de poliuretano, 13 texturizados e seis lisos. O grande motivo de troca foi estético, com 50 casos, seguido por contratura capsular em 13 casos, e cinco casos de infecção, ruptura ou nódulo mamário. Conclusão: O principal motivo de troca de implantes foi estético, diferentemente da literatura. Os índices de contratura capsular e de infecção da loja do implante do presente estudo foram comparáveis aos apresentados em vários outros estudos.Descritores: Implante mamário. Reoperação. Próteses e implantes. ABSTRACT Background:The breast augmentation surgery was the most performed in Brazil in 2008. With the evolution of the technique and the quality of the implants, complications have diminished, leading to a more secure procedure. Objective: To assess the profile of patients submitted to implant exchange in the last five years at Ivo Pitanguy Clinic, analyzing the causes that led to implant removal. Methods: We have analyzed all patients submitted to exchange, removal or replacement of mammary implants in the last five years, at a total of 59 patients, 68 procedures and 129 breasts operated. Results: The time interval from the inclusion to the removal of the implants ranged from one month to 34 years; 44 patients have first operated at our service and 24 at other services. Forty three implants were, before the exchange, made of polyurethane, 13 texturized and six smooth. The major cause of the exchange was esthetic, with 50 cases, followed by capsular contracture, 13 cases and five cases of infection, rupture or breast nodule. Conclusion: The major reason of implants exchange was esthetic, differing from the literature. The capsular contracture and infection rates, at this study, were comparable to several others.

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Section: Discussionunclassified

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Análise das trocas de implantes mamários nos últimos cinco anos na Clínica Ivo Pitanguy

Pitanguy¹,

Amorim²,

Ferreira³

et al. 2010

Rev. Bras. Cir. Plást. (Impr.)

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“…The risk of this complication increases over time [9][10][11] and is reflected in the slightly increased capsular contracture rates reported herein from 6 years to 10 years. 3 However, the 10-year rates (9.2%, 11.9%, 14.5%, and 26.8% for the augmentation, augmentation revision, reconstruction, and reconstruction revision cohorts, respectively) are lower than those observed in the Natrelle round gel (fourth generation) core study, which included predominately smooth implants (56.2%).…”

Section: Discussionmentioning

confidence: 74%

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

Maxwell

Natta

Bengtson

et al. 2014

Journal of Plastic, Reconstructive & Aesthetic Surgery

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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.

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“…Furthermore, they were manufactured with improved quality control (20), and with a wider variety of surface textures and implant shapes. They are currently available from all three breast implant manufactures in the United States (Sientra, Allergan, and Mentor) (21)(22)(23)(24)(25).…”

Section: Evolution Of Silicone Implantsmentioning

confidence: 99%

Breast implant design

Maxwell¹,

Gabriel²

2017

Gland Surg.

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The Mentor Core Study on Silicone MemoryGel Breast Implants

Abstract: The data demonstrated safety and efficacy of the devices, but also indicate that a focus must be placed on better education and technique to improve clinical outcomes in the future.

Cited by 156 publications

References 42 publications

Análise das trocas de implantes mamários nos últimos cinco anos na Clínica Ivo Pitanguy

Análise das trocas de implantes mamários nos últimos cinco anos na Clínica Ivo Pitanguy

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

Breast implant design

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