Mean shell thickness of breast implants. Statistical comparisons were made separately among textured (A) and smooth (B) implants. Textured shaped implants are Allergan Natrelle 410, Mentor Cohesive III, and Sientra High-Strength Cohesive Plus. Values that do not share a letter are significantly different (P < 0.05). Error bars represent the standard deviation. HSC, high-strength cohesive; Prog., progressive; TF, TruForm.

Mean shell thickness of breast implants. Statistical comparisons were made separately among textured (A) and smooth (B) implants. Textured shaped implants are Allergan Natrelle 410, Mentor Cohesive III, and Sientra High-Strength Cohesive Plus. Values that do not share a letter are significantly different (P < 0.05). Error bars represent the standard deviation. HSC, high-strength cohesive; Prog., progressive; TF, TruForm.

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Background Surgical applications using breast implants are individualized operations to fill and shape the breast. Physical properties beyond shape, size, and surface texture are important considerations during implant selection. Objective Compare form stability, gel material properties, and shell thickness of textured shaped, textured round, and...

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... thickness was consistent across all Allergan textured implants, regardless of shape. Of the textured shaped devices, Allergan Natrelle 410 implants and Mentor MemoryShape implants had the same mean shell thickness (0.78 mm), both of which were significantly greater than that of the Sientra Textured Shaped implants (0.63 mm; P < 0.0001) ( Figure 6A). Of the textured round devices, the mean thickness of the Inspira implants containing ...

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... mm. 41,42 Additional steps may also be included as part of the fabrication process. For example, to produce silicone elastomer shells having a textured surface, the mandrel can be dipped into salt or sugar granules (of well-defined particle size) immediately or shortly after applying the final layer of silicone. ...
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... A 5 th generation of devices was introduced in 1993 with an anatomical teardrop or "gummy bear" shape and highly cohesive form-stable gel filler to maintain it, 42 combined with a rough outer surface of the shell (texturing) allowing for ingrowth and adherence with host tissues, necessary to stabilize implants in the correct position in the periprosthetic pocket. 43 Some brands as Allergan (BIOCELL surface), Eurosilicone, GC Aesthetics, Silimed and others, began producing the "salt-loss" texturization either by spraying, by dipping or sprinkling fine salt crystals onto the silicone shell before curing, and supposedly removed afterwards by rinsing with water without brushing. ...
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... 1,2 Moreover, a silicone gelfilled breast implant is characterized by a variability in its shell, gel, surface topography, and shape. 3 To date, plastic surgeons, manufacturers of a silicone gel-filled breast implant, and patients have experienced a transition from one device to another worldwide. 2,4 Extensive testing procedures are required to make a silicone gel-filled breast implant commercially available in the market; its efficacy and safety should be stringently assessed. ...
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... This may lead to fracture due to the increased fatigue [18,19]. It can therefore be inferred that women receiving anatomical implants are at increased risks of derangement in the integrity of a silicone gel and the resulting shape deformity [20,21]. In addition, a breast implant with a thick shell and a soft silicone gel reveals its disadvantages such as an insufficient level of tensile strength [22,23]. ...
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A major contributing factor to proton range uncertainty is the conversion of computed tomography (CT) Hounsfield Units (HU) to proton relative stopping power (RSP). This uncertainty is elevated with implanted devices, such as silicone breast implants when computed with single energy CT (SECT). In recent years, manufacturers have introduced implants with variations in gel cohesivity. Deriving the RSP for these implants from dual‐energy CT (DECT) can result in a marked reduction of the error associated with SECT. In this study, we investigate the validity of DECT calibration of HU to RSP on silicone breast implants of varying cohesivity levels. A DECT capable scanner was calibrated using the stoichiometric method of Bourque et al for SECT and DECT using a tissue substitute phantom. Three silicone breast implants of increasing gel cohesivity were measured in a proton beam of clinical energy to determine ground‐truth RSP and water equivalent thickness (WET). These were compared to SECT‐derived RSP at three CT spectrum energies and DECT with two energy pairs (80/140 kVp and 100/140 kVp) as obtained from scans with and without an anthropomorphic phantom. The RSP derived from parameters estimates from CT vendor‐specific software (syngo.via) was compared. The WET estimates from SECT deviated from MLIC ground truth approximately +11%–19%, which would result in overpenetration if used clinically. Both the Bourque calibration and syngo.via WET estimates from DECT yielded error ≤0.5% from ground truth; no significant difference was found between models of varying gel cohesivity levels. WET estimates without the anthropomorphic phantom were significantly different than ground truth for the Bourque calibration. From these results, gel cohesivity had no effect on proton RSP. User‐generated DECT calibration can yield comparably accurate RSP estimates for silicone breast implants to vendor software methods. However, care must be taken to account for beam hardening effects.
... This may lead to fracture due to the increased fatigue [20,21]. It can therefore be inferred that women receiving anatomical implants are at increased risks of derangement in the integrity of a silicone gel and the resulting shape deformity [22,23]. In addition, a breast implant with a thick shell and a soft silicone gel reveals its disadvantages such as an insufficient level of tensile strength [24,25]. ...
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Background In this study, we describe our clinical experience with the fifth-generation of a breast implant with a smooth, fine surface from a Korean manufacturer (BellaGelÒ SmoothFine; HansBiomed Co. Ltd., Seoul, Korea) in Asian women. Methods We analyzed 223 women (mean age=35.28±9.45 years and mean follow-up period=12.03±2.48 months), comprising 118 bilateral cases and 109 unilateral ones, who received breast augmentation using the BellaGelÒ SmoothFine at our hospital between June 4, 2018 and February 28, 2019. For safety assessment, we analyzed frequencies of postoperative complications and overall survival of the BellaGelÒ SmoothFine. Results Postoperatively, complications (12 cases, 5.38%) include asymmetry (3 cases, 1.35%), hematoma (2 cases, 0.90%), hypertrophic scars (2 cases, 0.90%), wound disruption (2 cases, 0.90%), rippling (1 case, 0.45%), capsular contracture (1 case, 0.45%), stretch deformities with skin excess (1 case, 0.45%). In addition, time-to-events were calculated as 10.94±0.64 months (95% CI 9.69-12.19). Conclusions Here, we describe our clinical experience with the BellaGelÒ SmoothFine. Our results are of significance in that this is the first report about the fifth-generation of a breast implant with a smooth, fine surface from a Korean manufacturer in Asian women.
... Similarly, an understanding of the physical characteristics of various breast implant silicone gels used for breast augmentation affects the outcome in terms of breast shape. 20 It behooves plastic surgeons to take the time to understand the importance of these physical concepts when performing cosmetic injectables or selecting the optimal silicone gel formulation based on physical characteristics suited to the intended outcome. ...
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Safe injection practices regarding cosmetic injectable tissue fillers, both synthetic and autologous, offer patients optimal results with the least risk of adverse events (AEs). There is a range of AEs from ecchymosis to the most severe type of accidental intra-arterial injection that can produce tissue necrosis or vision loss. Even the most experienced injector can recall situations of moderate to severe ecchymosis that in retrospect was most likely caused by perforating a branch of the facial artery, yet filler material was not injected into the arterial lumen in any appreciable amount to cause harm. The bottom line here is that any agent, drug, or cosmetic injectable that is injected into the body has the potential to produce an adverse outcome. The importance of safe injection practices is paramount. Given the sheer number of tissue filler injections performed, the incidence of accidental needle/cannula perforation through facial arteries is probably large (ecchymosis); fortunately, the accidental intra-arterial injection of tissue filler material is rare (catastrophic outcome). Although most of the published reports involve hyaluronic acid (HA) or fat, there is a single report of vision loss from an off-label neurotoxin injection into the masseter with a 30-gauge needle that was attributed to an ischemic retinopathy.¹ This apparently involved a bolus injection of neurotoxin (25 units).
... Cohesive silicone gel-filled breast implants are characterized by a high degree of softness [11,12]. Their clinical use was approved by the Korean Ministry of Food and Drug Safety (KMFDS) in 2007. ...
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Background BellaGel® is the only cohesive silicone gel-filled breast implant from a Korean manufacturer, and it was first developed in 2005. It was approved by the CE in 2008, thus becoming the first Asian breast implant available in the EU. We conducted this study to assess the safety of BellaGel® in patients receiving augmentation mammaplasty. Methods We evaluated a consecutive series of 239 patients (478 breasts) who received esthetic augmentation mammaplasty using the BellaGel® (round smooth, round textured, round nanotextured, and anatomical textured types of implant) (HansBiomed Co. Ltd., Seoul, Korea) at three clinics in Korea (JW Plastic Surgery Center, BS The Body Plastic Surgery Clinic and Grace Plastic Surgery Clinic) during a period from December 1, 2015 to January 31, 2018. Results A total of 239 patients with a mean age of 33.1 ± 8.5 years old were followed up during a mean period of 399.58 ± 232.71 days, where there were no cases of capsular contracture in our clinical series of the patients. Other complications include one case (0.4%) of seroma, three cases (1.3%) of hematoma, and one case (0.4%) of infection. Moreover, there were no significant differences in the cumulative incidences of complications between the four types of the BellaGel® (χ² = 2.322, df = 3, P = 0.508). Furthermore, the cumulative Kaplan-Meier survival rate was estimated at 0.979 (95% CI 0.961–0.997). Conclusions Our results indicate that the BellaGel® is such a safe breast implant that surgeons might consider using it for esthetic augmentation mammaplasty. Level of evidence: Level III, risk/prognostic study.
... [3][4][5][6] Patients with a predominance of adipose tissue in the breasts, sagging skin with decreased breast consistency, and loss of the upper pole are the ideal candidates for the use of silicone implants. 26 Currently, technological advances have allowed the development of implants with less tissue reaction and with a proven benefit in reducing capsular contracture rates. 27 Breast implants were developed by Cronin and Gerow in 1963. ...
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Background Mastopexy combined with silicone implant placement is one of the most frequently performed plastic surgeries. Various techniques have been developed to increase the degree of patient satisfaction after surgery. The goal is to give the breasts a harmonious shape, generating the smallest scars possible. The Breast Evaluation Questionnaire (BEQ 55) was developed in 2006 as a tool for assessing the satisfaction and comfort of patients with the general appearance of the breasts. Objectives The objective of this study was to compare the degree of satisfaction of patients undergoing mastopexy using the inverted-T technique vs. the short-scar technique by the BEQ 55. Methods The BEQ 55 was administered in the pre- and postoperative periods to 200 patients who underwent mastopexy performed by the first author between October 2013, and September 2017. One hundred patients underwent the short-scar technique, and 100 patients underwent the inverted-T technique. Results The first analysis used descriptive statistics. Relative frequencies were used to track the responses corresponding to each technique. There was an increase in the level of patient comfort and satisfaction with breast appearance after surgery in both groups. The short-scar technique was shown to be superior, with statistical significance (p < 0.05) found for the questions evaluating comfort with overall appearance naked, comfort with breast appearance naked and satisfaction with breast appearance. Conclusions Both techniques improved the patients’ satisfaction and comfort with their breasts. When the short-scar technique was used, patients were more comfortable with their breast appearance and with their overall appearance naked.
... Nevertheless, it is essential to mention one more factor; each implant manufacturer manipulates the chemical structure of the silicone elastomer differently and provides unique characteristics to its product which allows them to differentiate themselves from others on the market; as demonstrated by Jewell et al. [9] and Formes et al., the latter author conducted a study in which they used NMR 1 H spectroscopy to study the chemical characteristics of silicone in the different implants of different brands, finding that there are differences in the structure of the silicone present in the different prostheses (10). This variable considered another stimulation factor for the immune response of the organism. ...