A Comparison of Outcomes Involving Highly Cohesive, Form-Stable Breast Implants From Two Manufacturers in Patients Undergoing Primary Breast Augmentation

Jewell, Mark L.; Jewell, James L.

doi:10.1177/1090820x09360700

Cited by 75 publications

(23 citation statements)

References 25 publications

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“…These data corroborated previously published data, which demonstrated that the Natrelle 410 implants have low rates of wrinkling compared with othershaped implants. Indeed, in a comparative study, Jewell and Jewell 29 reported a 5-fold higher rate of rippling in the CPG implant group compared with the 410 implant group. In a separate study of the 410 implant, wrinkling was reported in 5% of subjects after a mean of 8 years.…”

Section: Discussionmentioning

confidence: 99%

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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Section: Discussionmentioning

confidence: 99%

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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“…The lessons that I learned in these studies demonstrated that the process of breast augmentation would fit into a standardized planning and quality program similar to the Toyota Production System. 13,16 The results of this outcomes analysis/improvement process in my own clinic have been very gratifying in terms of yielding low reoperation rates and extremely high patient satisfaction. Reoperation must be minimized because any reoperation implies that there was a problem with the outcome.…”

Section: Improving Augmentation Outcomesmentioning

confidence: 96%

“…[11][12][13] These devices represent an opportunity for surgeons to produce better long-term outcomes with lower incidences of adverse events, typical of the studies published for round, smooth implants.…”

Section: : the Anatomically Shaped Form-stable Eramentioning

confidence: 99%

“…The evolution of the process for the use of breast implants also mirrors movements in aviation and manufacturing, where dramatically improved outcomes are associated with process engineering and planning systems. [13][14][15][16] The days are long gone of both "seat-of-their-pants" aviators and the "artistic" plastic surgeon's approach to breast augmentation, due to excessive variation in results.…”

Section: : the Anatomically Shaped Form-stable Eramentioning

confidence: 99%

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Silicone Gel Breast Implants at 50: The State of the Science

Jewell

2012

Aesthetic Surgery Journal

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“…This led to high re-intervention rates for patient's dissatisfaction with implant size and other post-operative complications (3)(4)(5).…”

Section: Introductionmentioning

confidence: 99%

Decisional pathways in breast augmentation: how to improve outcomes through accurate pre-operative planning

Nava

Rocco

Tunesi³

et al. 2017

Gland Surg.

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Breast augmentation is the most commonly performed surgical procedure in aesthetic plastic surgery. Accurate pre-operative planning is crucial to obtain the best outcomes. We present our planning method deriving from a more than 30-year experience in aesthetic breast surgery, matching together patients tissues' characteristics and patients' wishes. We schematized our planning method in an easy-to-use flow diagram to help the decisional process in breast augmentation.

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A Comparison of Outcomes Involving Highly Cohesive, Form-Stable Breast Implants From Two Manufacturers in Patients Undergoing Primary Breast Augmentation

Cited by 75 publications

References 25 publications

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

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

Silicone Gel Breast Implants at 50: The State of the Science

Decisional pathways in breast augmentation: how to improve outcomes through accurate pre-operative planning

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