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

Jewell, Mark L.

doi:10.1177/1090820x12461649

Cited by 21 publications

(11 citation statements)

References 14 publications

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“…1 During this time, these medical devices have gone through a number of modifications to improve their safety, quality, and clinical outcome performance. The most objective clinical assessment of these outcome parameters in the United States was obtained from investigational device exemption studies that were approved by the US Food and Drug Administration (FDA).…”

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confidence: 99%

Ten-Year Results From the Natrelle 410 Anatomical Form-Stable Silicone Breast Implant Core Study

Maxwell

Natta

Bengtson

et al. 2015

Aesthetic Surgery Journal

190

107

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BackgroundSilicone 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.ObjectivesThe authors conducted a 10-year study to determine the safety and effectiveness of Natrelle 410 silicone breast implants.MethodsThis 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.ResultsCapsular 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.ConclusionsThis 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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mentioning

confidence: 99%

Ten-Year Results From the Natrelle 410 Anatomical Form-Stable Silicone Breast Implant Core Study

Maxwell

Natta

Bengtson

et al. 2015

Aesthetic Surgery Journal

190

107

View full text Add to dashboard Cite

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“…This study reveals the importance of accurate measurements of width and height of the breast, with weight having lesser importance. This may entail a shift from round implants, where volume was the optimal measure, to anatomical implants, where shape and size can vary greatly despite similar volume [15]. Width is the focal point of every implant choice for reconstruction [9,10].…”

Section: Discussionmentioning

confidence: 99%

Predictability of anthropomorphic measurements in implant selection for breast reconstruction: a retrospective cohort study

et al. 2017

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Background Preoperative implant planning for breast reconstruction is often at risk of being changed perioperatively. This study examined which factors are associated with a change of implant selection. Methods Women who had unilateral two-stage breast reconstruction between 2002 and 2007 were studied. Inclusion criteria were photographic evidence of preoperative skin markings indicating breast dimensions and a selected implant model. Multivariable logistic regression was used to identify variables associated with a changed selection. Results Among the 496 women studied, 308 preoperative implant choices (62.1%) were changed during surgery. A change in plan was significantly associated with symmetrization surgery involving contralateral reduction mammaplasty (OR = 1.92; 95% CI, 1.12 to 3.29) and contralateral mastopexy (OR = 2.26; 95% CI, 1.29 to 3.96), but not with BMI. The required implant width changed more than 0.5 cm in 70 cases (14.1%) while height changed more than 0.5 cm in 215 cases (43.2%). The likelihood of a change was high for large preoperative widths (OR = 9.66 for 15.5 cm) and small preoperative heights (OR = 2.97 for 10.5 cm). At a mean follow-up of 16.6 months, patient satisfaction was good or average in 92.1% of cases and 5.9% of implants had been replaced with another model, indicating that the perioperative implant selection was usually appropriate. Conclusions This study documents the frequency with which implant choices, despite accurate preoperative planning, are changed perioperatively as a result of relatively small differences in anthropomorphic measurements. Perioperative recalculation of breast dimensions may have an advantage in terms of patient reoperation rates. Changes in width were less frequent than changes in height and projection. Contralateral surgery, large width, and small height were the most influential factors. Level of Evidence: Level IV, risk / prognostic study.

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“…For this work, semi‐IPNs based on a linear SPU was selected to allow for full use of their attractive characteristics without sacrificing key mechanical properties. A crosslinked silicone network was selected as the second component of the semi‐IPN given the prevalence of the material class in biomedical devices and demonstrated biostability . Previous research has explored employing an SPU coupled with a poly(dimethylsiloxane) (PDMS)‐based macromer to improve the compliance of a vascular graft .…”

Section: Introductionmentioning

confidence: 99%

High Compliance Vascular Grafts Based on Semi-Interpenetrating Networks

Dempsey

Nezarati

Mackey

et al. 2014

Macromol. Mater. Eng.

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Current synthetic vascular grafts have poor patency rates in small diameter applications (<6 mm) due to intimal hyperplasia arising from a compliance mismatch between the graft and native vasculature. Enormous efforts have focused on improving biomechanical properties; however, polymeric grafts are often constrained by an inverse relationship between burst pressure and compliance. We have developed a new, semi-interpenetrating network (semi-IPN) approach to improve compliance without sacrificing burst pressure. The effects of heat treatment on graft morphology, fiber architecture, and resultant biomechanical properties are presented. In addition, biomechanical properties after equilibration at physiological temperature were investigated in relation to polyurethane microstructure to better predict in vivo performance. Compliance values as high as 9.2 ± 2.7 %/mmHg x 10−4 were observed for the semi-IPN graft while also maintaining high burst pressure, 1780 ± 230 mm Hg. The high compliance of these heat-treated poly(carbonate urethane) (PCU) and semi-IPN grafts is expected to improve long-term patency rates beyond even saphenous vein autografts by preventing intimal hyperplasia. The fundamental structure-property relationships gained from this work may also be utilized to advance biomedical device designs based on thermoplastic polyurethanes.

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

Cited by 21 publications

References 14 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

Predictability of anthropomorphic measurements in implant selection for breast reconstruction: a retrospective cohort study

High Compliance Vascular Grafts Based on Semi-Interpenetrating Networks

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