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

Abstract

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

In vivo bioresponses to silk proteins

“…Indeed, it has recently been used in clinical trials including for breast reconstruction and tympanic membrane repair (84, 90). However, in order for silk to be used more extensively, more detailed analysis of its immune response including more extensive characterization of M1 verses M2 macrophage activation, locally released cytokines, and the time course of activation of the foreign body response are needed.…”

“…The number of breast implant surgeries performed annually is increasing for a number of reasons including an increasing number of mastectomies and improved surgical procedures(83). Silicone breast implants have been in use for over two decades but suffer from capsular contraction and rupture leading to 30–54% re-operation depending on the nature of original surgery(84). Silicone is not able to be remodeled and it was hypothesized that using a material capable of remodeling such as silk could improve long-term outcomes.…”

Risk Factor Analysis for Capsular Contracture, Malposition, and Late Seroma in Subjects Receiving Natrelle 410 Form-Stable Silicone Breast Implants

“…The long-term safety and effectiveness of Natrelle 410 implants are supported by results from a 10-year, prospective multicenter study. 5 At 10 years, satisfaction rates of subjects who received Natrelle 410 implants were 96 percent in primary augmentation, 93 percent in primary reconstruction, and more than 87 percent in revision procedures. 5 …”

Low Risk of Skin and Nipple Sensitivity and Lactation Issues After Primary Breast Augmentation with Form-Stable Silicone Implants: Follow-Up in 4927 Subjects

“…9,10 Long-term safety, effectiveness, and subject satisfaction are supported by results from a 10 year, multicenter prospective study. 11 …”

“…11 The study was conducted in compliance with the US Food and Drug Administration requirements. 12 Before enrolling subjects, an institutional review board (IRB) at each site approved the study protocol (the full list of approving IRBs is available online as Supplementary material, at ).…”