RESUMEN
PURPOSE: To describe an experimental surgical model in rats using a dual-plane technique for evaluation of biomaterials in an in-vivo silicone implant coverage. METHODS: This study was developed following the ISO 10993-6 standard. In this study, 40 male Wistar rats weighing between 250 and 350 g were used, distributed into two groups: experimental, biomaterial superimposed on the minimammary prosthesis (MP); and control, MP without implantation of the biomaterial, with eight animals at each biological point: 1, 2, 4, 12, and 26 weeks. Thus, at the end of biological points (1, 2, 4, 12, and 26 weeks; n = 8 animals per week), the tissue specimens achieved were fixed in buffered formalin and stained with hematoxylin-eosin. RESULTS: Macroscopically, throughout the study, no postoperative complications were apparent. In the histological analysis, it was possible to observe the evolution of the inflammatory response, tissue repair, and fibrous capsule during the biological points. CONCLUSIONS: The experimental model described in this study proved to be suitable for evaluating the biomaterial used in the coverage of breast silicone implants.
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Materiales Biocompatibles , Implantes de Mama , Ratas Wistar , Geles de Silicona , Animales , Masculino , Ratas , Ensayo de Materiales , Modelos Animales , Siliconas , Factores de TiempoRESUMEN
Los implantes de silicona recubiertos con poliuretano vulcanizado han reducido signifi cativamente la incidencia de contractura capsular. La FDA suspendió la venta temporalmente en EE.UU. de estos implantes por estudios que sugerían que el 2,4-TDA, metabolito del poliuretano, podría ser cancerígeno. En el año 1995, y por falta de evidencia que sustentara lo anterior, la FDA autorizó nuevamente su uso, pero aún genera controversias. Es nuestro objetivo demostrar cuál es el grado de reabsorción que sufre el poliuretano en relación con el tiempo de colocado el implante en forma experimental con ratas de laboratorio. Material y métodos. Trabajo prospectivo, experimental y a triple ciego. Se colocó en 18 ratas de laboratorio implantes de gel de silicona recubierto con poliuretano de 2 cc marca Silimed. Se realizó la extracción del implante en bloque a los 3, 6, 12, 18 y 24 meses. Se evaluó el nivel de contractura capsular, el espesor macroscópico de la cápsula y el análisis microscópico de la misma. Resultados. En ninguna de las ratas se objetivó contractura capsular. El espesor promedio de la cápsula fue de 1.88 mm (rango 1,8 a 1,92 mm, n: 18, p<0,5) siendo no signifi cativa en comparación con los 2 mm de recubierta original. A nivel microscópico se objetivó una reacción infl amatoria prolongada, reacción de células gigantes y macrófagos próximos a la cubierta, lo que forma una contractura no lineal. También se observo partículas de poliuretano grandes, rodeadas y ancladas a los macrófagos. Este hallazgo muestra que el poliuretano pasa a formar parte de la cápsula y que no se degrada en forma signifi cativa al menos a los 24 meses de haber sido implantados en ratas. Conclusión. Los hallazgos macroscópicos y microscópicos demuestran que el poliuretano pasa a formar parte de la cápsula y no a degradarse y volcarse a la circulación general como así también la formación de una capsula blanda, cuya correlación clínica, es el menor índice de contractura capsular de este tipo de implante
Polyurethane-covered silicone implants have signifi cantly reduced the incidence of capsular contracture. FDA temporarily suspended this product in EE UU due to studies that suggested 2,4-TDA, polyurethane`s metabolite, may be carcinogenic. In 1995, for lack of evidence to support this, its use was authorize by the FDA again, but still generates controversy. It is our objective to demonstrate wich is the degree of resorption of polyurethane cover, regarding the time the implant is placed, in an experimental laboratory rats. Material and methods: Prospective, experimental and triple blind study. It was placed on 18 laboratory rats 2 cc Polyurethane-covered silicone implants manufactured by Silimed. Implants removal was performed in block at 3, 6, 12, 18 and 24 months. It was evaluated the grade of capsular contracture, the macroscopic thickness of the capsule and the microscopic analysis of it. Results: None of the rats evidenced capsular contracture. The average thickness of the capsule was 1.88 mm (range 1.8 to 1.92 mm, n = 18, p <0.5) being not signifi cant compared to the original 2mm coated. The microscopic study evidenced a large infl ammatory reaction, giant cells reaction and macrophages near the coat which makes a nonlinear contracture. Large Polyurethane particles was also observed, surrounded and anchored to macrophages. These fi ndings show that the polyurethane becomes part of the capsule and does not is degraded signifi cantly at least 24 months after being implanted in rats. Conclusion: Macroscopic and microscopic fi ndings demonstrate that the polyurethane coat becomes part of the capsule and is not degraded to go to the general circulation, as well as the formation of a soft capsule, nonlineal, whose clinical correlation, is a lower rate of capsular contracture of this implant
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Ratas , Poliuretanos , Ratas Endogámicas , Implantes de Mama , Geles de SiliconaRESUMEN
INTRODUCTION: Implant-based breast augmentations and reconstructions are one of the most common surgical procedures performed by plastic surgeons in the United States, which has rapidly increased in popularity since the 2000s. Silicone lymphadenopathy (SL) is a complication of breast implants that involves migration of silicone to nearby soft tissue/lymph nodes. Data on its clinical features and management is scarce. METHODS: SL-related search terms were used to find articles in 3 databases. Of 598 articles, 101 studies met the inclusion criteria. Demographics, clinical presentation, workup, and management data were analyzed. RESULTS: Of 279 cases of SL and 107 with information on initial diagnosis, 35 (33%) were incidental. The most common symptom was painless lymphadenopathy, followed by painful lymphadenopathy. 251 (95%) and 13 (5%) patients had silicone and saline implants, respectively. 149 (68%) patients had implant rupture. Axillary lymphadenopathy was the most affected region (136 cases, 72%), followed by internal mammary (40 cases, 21%), cervical/supraclavicular (36 cases, 19%), and mediastinal (24 cases, 13%) regions. 25% of patients underwent fine-needle aspiration, 12% core needle biopsy, and 59% excisional biopsy. 32% of cases underwent explantation and/or implant exchange. The most common indication for surgery was implant rupture. Histology showed multinucleated giant cells, large histiocytes, and silicone accumulation. CONCLUSIONS: SL is a complication associated with breast implants. The majority of patients are asymptomatic, and most cases are managed conservatively. Minority need a biopsy and surgical interventions due to abnormal imaging, persistent symptoms, and/or implant rupture. Workup and management should be tailored to the patient.
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Implantes de Mama , Linfadenopatía , Geles de Silicona , Femenino , Humanos , Implantación de Mama/efectos adversos , Implantación de Mama/métodos , Implantes de Mama/efectos adversos , Linfadenopatía/etiología , Prevalencia , Geles de Silicona/efectos adversosRESUMEN
Antecedentes. Se solicita a los fabricantes que garanticen los estándares de calidad actuales, actualicen el plan de investigación del dispositivo y actualicen los informes de eficacia/seguridad. El objetivo de este estudio es estimar la seguridad y eficacia de los implantes mamarios de Silimed disponibles para la venta. Métodos. Este es un ensayo de fase IV, abierto, no aleatorizado, realizado en Río de Janeiro/Brasil. Los participantes se seleccionaron consecutivamente. Los principales criterios de elegibilidad son: recibir los implantes mamarios de Silimed para el aumento estético hasta 21 días antes de la visita de inclusión; no tener condiciones que aumenten el riesgo de eventos adversos a corto plazo. Las intervenciones son los implantes mamarios de poliuretano de Silimed. Los resultados de seguridad se consideran eventos adversos y el plan de análisis es estimar la incidencia de eventos adversos de Kaplan-Meier. Resultados. Se analizaron un total de 213 con seguimiento hasta 36 meses. La edad media era de 33,04 años. El riesgo de extracción del implante fue del 0,0% a los 36 meses. La estimación del riesgo de Kaplan-Meier para el seroma fue del 1,3%, no hubo casos de contractura capsular clínicamente relevante (Backer III/ IV), reintervención, infección y ruptura del implante. Conclusiones. Las tasas de eventos se consideraron prometedoras. Los informes futuros del estudio en curso mejorarán la interpretación de los datos actuales. Identificador de ClinicalTrials.gov: NCT03356132.
Background. Manufacturers are requested to ensure the current quality standards, update the device's investigation plan and update efficacy/safety reports. The aim of this study is to estimate the safety and efficacy of Silimed's breast implants available for sale. Methods: This is a phase IV, open label, non-randomized trial, performed at Rio de Janeiro/Brazil. Participants were selected consecutively. Main eligibility criteria are: received Silimed's breast implant(s) for aesthetic augmentation up to 21 days before the inclusion visit; not having conditions that increases adverse event short term risk. Interventions are Silimed's polyurethanebreast implants. Safety outcomes are considered adverse events and the analysis plan is to estimate Kaplan-Meier incidence of adverse events. Results. A total of 213 were analyzed with follow-up up to 36 months. The average age was 33.04 years. The risk for implant removal was 0.0% at 36 months. The Kaplan-Meier risk estimate for seroma was 1.3%, there were no cases of clinically relevant capsular contracture (Backer III/IV), reoperation, infection and implant rupture. Conclusions. Rates of events were considered promising. Future reports from the ongoing study will improve the interpretation of current data. Clinical Trials. gov Identifier: NCT03356132.
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Humanos , Femenino , Adulto , Persona de Mediana Edad , Poliuretanos , Implantación de Mama/efectos adversos , Geles de Silicona/efectos adversos , Estimación de Kaplan-MeierRESUMEN
BACKGROUND: Hypertrophic and keloid scars are common skin conditions resulting from abnormal wound healing. They can cause itching, pain and have a negative physical and psychological impact on patients' lives. Different approaches are used aiming to improve these scars, including intralesional corticosteroids, surgery and more recently, laser therapy. Since laser therapy is expensive and may have adverse effects, it is critical to evaluate the potential benefits and harms of this therapy for treating hypertrophic and keloid scars. OBJECTIVES: To assess the effects of laser therapy for treating hypertrophic and keloid scars. SEARCH METHODS: In March 2021 we searched the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL EBSCO Plus and LILACS. To identify additional studies, we also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses, and health technology reports. There were no restrictions with respect to language, date of publication, or study setting. SELECTION CRITERIA: We included randomised controlled trials (RCTs) for treating hypertrophic or keloid scars (or both), comparing laser therapy with placebo, no intervention or another intervention. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, extracted the data, assessed the risk of bias of included studies and carried out GRADE assessments to assess the certainty of evidence. A third review author arbitrated if there were disagreements. MAIN RESULTS: We included 15 RCTs, involving 604 participants (children and adults) with study sample sizes ranging from 10 to 120 participants (mean 40.27). Where studies randomised different parts of the same scar, each scar segment was the unit of analysis (906 scar segments). The length of participant follow-up varied from 12 weeks to 12 months. All included trials had a high risk of bias for at least one domain: all studies were deemed at high risk of bias due to lack of blinding of participants and personnel. The variability of intervention types, controls, follow-up periods and limitations with report data meant we pooled data for one comparison (and only two outcomes within this). Several review secondary outcomes - cosmesis, tolerance, preference for different modes of treatment, adherence, and change in quality of life - were not reported in any of the included studies. Laser versus no treatment: We found low-certainty evidence suggesting there may be more hypertrophic and keloid scar improvement (that is scars are less severe) in 585-nm pulsed-dye laser (PDL) -treated scars compared with no treatment (risk ratio (RR) 1.96; 95% confidence interval (CI): 1.11 to 3.45; two studies, 60 scar segments). It is unclear whether non-ablative fractional laser (NAFL) impacts on hypertrophic scar severity when compared with no treatment (very low-certainty evidence). It is unclear whether fractional carbon dioxide (CO2) laser impacts on hypertrophic and keloid scar severity compared with no treatment (very low-certainty evidence). Eight studies reported treatment-related adverse effects but did not provide enough data for further analyses. Laser versus other treatments: We are uncertain whether treatment with 585-nm PDL impacts on hypertrophic and keloid scar severity compared with intralesional corticosteroid triamcinolone acetonide (TAC), intralesional Fluorouracil (5-FU) or combined use of TAC plus 5-FU (very low-certainty evidence). It is also uncertain whether erbium laser impacts on hypertrophic scar severity when compared with TAC (very low-certainty evidence). Other comparisons included 585-nm PDL versus silicone gel sheeting, fractional CO2 laser versus TAC and fractional CO2 laser versus verapamil. However, the authors did not report enough data regarding the severity of scars to compare the interventions. As only very low-certainty evidence is available on treatment-related adverse effects, including pain, charring (skin burning so that the surface becomes blackened), telangiectasia (a condition in which tiny blood vessels cause thread-like red lines on the skin), skin atrophy (skin thinning), purpuric discolorations, hypopigmentation (skin colour becomes lighter), and erosion (loss of part of the top layer of skin, leaving a denuded surface) secondary to blistering, we are not able to draw conclusions as to how these treatments compare. Laser plus other treatment versus other treatment: It is unclear whether 585-nm PDL plus TAC plus 5-FU leads to a higher percentage of good to excellent improvement in hypertrophic and keloid scar severity compared with TAC plus 5-FU, as the certainty of evidence has been assessed as very low. Due to very low-certainty evidence, it is also uncertain whether CO2 laser plus TAC impacts on keloid scar severity compared with cryosurgery plus TAC. The evidence is also very uncertain about the effect of neodymium-doped yttrium aluminium garnet (Nd:YAG) laser plus intralesional corticosteroid diprospan plus 5-FU on scar severity compared with diprospan plus 5-FU and about the effect of helium-neon (He-Ne) laser plus decamethyltetrasiloxane, polydimethylsiloxane and cyclopentasiloxane cream on scar severity compared with decamethyltetrasiloxane, polydimethylsiloxane and cyclopentasiloxane cream. Only very low-certainty evidence is available on treatment-related adverse effects, including pain, atrophy, erythema, telangiectasia, hypopigmentation, regrowth, hyperpigmentation (skin colour becomes darker), and depigmentation (loss of colour from the skin). Therefore, we are not able to draw conclusions as to how these treatments compare. AUTHORS' CONCLUSIONS: There is insufficient evidence to support or refute the effectiveness of laser therapy for treating hypertrophic and keloid scars. The available information is also insufficient to perform a more accurate analysis on treatment-related adverse effects related to laser therapy. Due to the heterogeneity of the studies, conflicting results, study design issues and small sample sizes, further high-quality trials, with validated scales and core outcome sets should be developed. These trials should take into consideration the consumers' opinion and values, the need for long-term follow-up and the necessity of reporting the rate of recurrence of scars to determine whether lasers may achieve superior results when compared with other therapies for treating hypertrophic and keloid scars.
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Cicatriz Hipertrófica , Hipopigmentación , Queloide , Terapia por Láser , Telangiectasia , Corticoesteroides/uso terapéutico , Adulto , Aluminio , Atrofia , Dióxido de Carbono , Niño , Cicatriz Hipertrófica/etiología , Cicatriz Hipertrófica/radioterapia , Dimetilpolisiloxanos , Erbio , Fluorouracilo , Helio , Humanos , Hipertrofia , Hipopigmentación/etiología , Queloide/etiología , Queloide/radioterapia , Terapia por Láser/efectos adversos , Neodimio , Neón , Dolor/etiología , Geles de Silicona , Telangiectasia/etiología , Triamcinolona Acetonida , Verapamilo , Cicatrización de Heridas , ItrioRESUMEN
BACKGROUND/AIM: The aim of this study was to investigate cytotoxicity, inflammatory response, and angiogenesis induced by silicone gel breast implants with different textured surfaces in vitro and in vivo. MATERIALS AND METHODS: In the in vitro study, murine fibroblast cells (L929) were cultured for 1, 3, and 5 days with silicone membranes of three different textures: nanotextured, microtextured, and silicone foam. In the in vivo study, a total of 30 male rats (Rattus, norvegicus, albinos, Wistar) were distributed into three groups (10 animals per group), with 2 implants in each rat: nanotextured silicone gel breast implants group, microtextured silicone gel breast implants group, and silicone gel breast foam implants group. RESULTS: The Alamar Blue assay detected higher viability of cells cultured in the presence of nanotextured silicone surface for 1 and 3 days. The MTT assay showed higher cytotoxicity of silicone foam after 1 and 3 days of exposure. Nanotextured silicone breast implants induced a more prolonged inflammatory response, denoting a delay in the healing process and subsequent organization of the fibrous capsule as depicted by the collagen fiber types found. VEGF expression did not differ between experimental groups. CONCLUSION: Gel foam breast implants are more biocompatible when compared to micro- or nano-textured silicone breast implants.
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Implantación de Mama , Implantes de Mama , Animales , Implantes de Mama/efectos adversos , Femenino , Masculino , Ratones , Ratas , Ratas Wistar , Geles de Silicona/efectos adversos , Cicatrización de HeridasRESUMEN
BACKGROUND: SmoothSilk implants (SSI) are the first generation of implants to incorporate a radio-frequency identification device (RFID-M), a non-invasive traceability system. Although the RFID-M is considered compatible with magnetic resonance imaging (MRI), the size of the artifact and its influence on breast tissue vary. This prospective study assessed safety and MRI issues in a cohort of breast reconstruction patients. METHODS: Forty-four SSI were used for breast reconstruction in patients undergoing treatment for breast cancer. All patients were evaluated for magnetic field interactions, MRI-related heating and artifacts in a 1.5-T MRI unit using standard T1/T2-weighted sequences utilized in clinical assessment of breast tissue/implants. RESULTS: Mean patient age was 41.5 years (27-53ys) and body mass index was 28+-6.44 kg/m2. In 18/22 patients (81.8%), mastectomies were unilateral. No patients reported local heat/discomfort. All implants showed RFID-M-related artifacts with an estimated mean volume in T1 of 42.9cm3 (26.2-63.6cm3; SD±8.6 and 95% CI, 40.37-45.45) and in T2 of 60.5cm3 (35.4-97.2cm3; SD±14.7 and 95% CI, 56.29-65.01). Artifact volume was smaller in T1 than in T2, to a statistically significant degree (p <0.001). There were no statistically significant differences in artifact volume according to surgical indication, breast side or implant volume. There were 4/44 (9%) cases of minor rotation (<45°). In all cases, adequate analysis of the breast tissue was performed. CONCLUSIONS: The results demonstrate that SSI with RFID-M technology presented an artifact volume of 42.9cm3 and 60.5cm3 in T1 and T2 images, respectively. Our findings provide detailed information on the quality and location of MRI artifacts in a reconstructed cohort which can help guide clinical decision-making for patients. To our knowledge, this is the first time RFID-M breast implants have been prospectively evaluated for clinical and MRI issues in a cohort of reconstructive patients. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
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Implantación de Mama , Implantes de Mama , Mamoplastia , Dispositivo de Identificación por Radiofrecuencia , Adulto , Implantación de Mama/efectos adversos , Implantes de Mama/efectos adversos , Estudios de Cohortes , Estudios de Seguimiento , Humanos , Imagen por Resonancia Magnética , Mamoplastia/efectos adversos , Estudios Prospectivos , Geles de Silicona , Resultado del TratamientoRESUMEN
BACKGROUND: Breast parenchyma interacts dynamically with an inserted implant, which may lead to local atrophy and sensory involvement, changes in vascular tissue and lactation, and volume reduction over time. The inversely proportional relationship between pressure and volume cannot be stated with certainty; that is, the larger implants having more local pressure would lead to compression, thus leading to atrophy of parenchyma more intensely compared with smaller implants. The objective of this study was to assess and list breast parenchyma volume changes with different pressure levels due to silicone implants of several sizes. OBJECTIVES: The authors sought to list the pressure exerted by silicone implants and the atrophy caused in the breast tissue. METHODS: Thirty-six women were placed in 3 groups (nâ =â 12) and subjected to augmentation mammoplasty in the subglandular plane. The measurement of pressure in millimeters of mercury was conducted with help of molds with the same base and projection of implants introduced posteriorly. MRI was conducted in all participants in the preoperative period and at 6 and 12 months after surgery. RESULTS: Twelve months after breast implant insertion, the groups had a significant glandular volume reduction (mean, 12.97% in the right breast and 12.42% in the left breast). There was a statistically significant difference in the proportions of volume reduction and the pressure levels measured. CONCLUSIONS: A reduction in breast volume was verified. This reduction was also related to the level of pressure exerted on the implant.
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Implantación de Mama , Implantes de Mama , Mamoplastia , Atrofia , Mama/diagnóstico por imagen , Mama/cirugía , Implantes de Mama/efectos adversos , Femenino , Humanos , Mamoplastia/efectos adversos , Geles de Silicona/efectos adversosRESUMEN
BACKGROUND: Simultaneous application of the axillary approach (AA) with the subfascial pocket (SF) has been proposed for breast augmentation (BA) surgery. New silicone implant technology and recent improvements in autologous fat grafting (AFG) have ushered in a new era for BA. OBJECTIVES: The aim of this study was to present the combined subfascial ergonomic axillary hybrid (SEAH) method and evaluate its aesthetic benefits after primary/secondary BA. METHODS: In total, 42 patients (84 breasts) underwent BA with the SEAH technique; this approach was indicated when the overlying tissue was insufficient to adequately cover the implant. RESULTS: Mean patient age was 34.6 years (range, 28-56 years), mean BMI was 18.8 kg/m2 (range, 14.4-26.1 kg/m2). The most common implant (Motiva SmoothSilk surface Ergonomix style) volume was 255 cc (range, 175-355 cc), patients received a mean fat volume of 96 mL (range, 60-145 mL) per breast in the subcutaneous tissue. The average lower pole stretch value was 40.5% (21.75 mm) and 13.1% (9.9 mm) for preoperative to 10 days postprocedure and 10 days to 18 months postprocedure, respectively. Postoperative complications included subcutaneous banding in the axilla (nâ =â 3, 7.1%), small wound dehiscence (nâ =â 1, 2.3%), and hypertrophic scarring (nâ =â 1, 2.3%). No rippling, implant malposition, infection, or fat necrosis was observed during a mean follow-up of 18 months (range, 6-32 months). CONCLUSIONS: SEAH is a useful and versatile technique combining the benefits of AFG and implant-based augmentation, particularly with regard to soft tissue coverage, and avoids the limitations of the submuscular position. The combination of ergonomic gel implants and a SF pocket can yield satisfactory aesthetic outcomes.
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Implantación de Mama , Implantes de Mama , Mamoplastia , Adulto , Axila/cirugía , Implantación de Mama/efectos adversos , Implantes de Mama/efectos adversos , Ergonomía , Humanos , Mamoplastia/efectos adversos , Persona de Mediana Edad , Geles de Silicona/efectos adversosAsunto(s)
Contorneado Corporal/efectos adversos , Nalgas/patología , Granuloma de Cuerpo Extraño/diagnóstico , Turismo Médico , Geles de Silicona/efectos adversos , Adalimumab/administración & dosificación , Administración Oral , Adulto , Antibacterianos/administración & dosificación , Betametasona/administración & dosificación , Biopsia , Nalgas/diagnóstico por imagen , República Dominicana , Quimioterapia Combinada/métodos , Femenino , Granuloma de Cuerpo Extraño/tratamiento farmacológico , Granuloma de Cuerpo Extraño/etiología , Granuloma de Cuerpo Extraño/patología , Humanos , Hidroxicloroquina/administración & dosificación , Tomografía Computarizada por Rayos X , Resultado del Tratamiento , Estados UnidosRESUMEN
Silicone dressings have been used to treat hypertrophic scars and keloids since 1983. This treatment modality is considered to be safe and efficacious, leading to a progressive improvement in scar color, size, erythema, pliability, pain, and itching. Its mechanism of action is due to the hydration of the skin corneal layer; and modulating the cell signaling between fibroblasts and keratinocytes, mediated by cytokines. Silicone dressings are considered first line treatments for hypertrophic scars and keloids. Silicone gels were developed later, in order to help treating those scars in areas such as the scalp or joints, where fixing the silicone sheets would be a more difficult task, or on the face, where a silicone dressing would be cosmetically undesirable to most. Similar to silicone sheets, silicone gels have also proved to help treating and preventing hypertrophic scars and keloids. A new silicone gel combined with hypochlorous acid has recently been developed to help in treating scars. Hypochlorous acid acts as a biocide and anti-inflammatory agent, therefore, it has also been used in post procedure, on recent traumatic scars or on nonepithelized skin. This manuscript reviews the use of silicone dressings, silicone gels, and combined gels to treat scars.
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Cicatriz Hipertrófica , Queloide , Cicatriz Hipertrófica/terapia , Geles , Humanos , Queloide/terapia , Geles de Silicona/efectos adversos , PielRESUMEN
Purpose To evaluate whether silicone foam implants have a different evolution pattern compared to conventional texture implants. Methods Fifty-eight female patients underwent surgery. They were divided into two groups (silicone foam Lifesil® and microtexturized silicone Lifesil®). The evolution was analyzed in postoperative consultations, with physical examination, photographic documentation and filling in a satisfaction questionnaire, in the postoperative period of one month, four months, one year and then annually, up to a maximum of 3 years of follow-up. Results There were no statistically significant differences in presence of rippling, stretch marks, breast ptosis, capsular contracture and quality of scars. There was a higher rate of patients who were very satisfied with the outcome 360 days after surgery in the group receiving silicone foam implants (p = 0.036). Conclusion In short time, silicone foam envelope implants proved to be as reliable as textured silicone envelope implants, making them an option for augmentation mammoplasty.(AU)
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Humanos , Femenino , Benchmarking , Implantación de Mama/métodos , Geles de Silicona/administración & dosificación , Mamoplastia/métodosRESUMEN
BACKGROUND: Changes in breast tissue thickness and in implant projection 5 years after augmentation with high- and extra-high-profile round implants were measured through MRI with a DICOM standard viewer. METHODS: Twenty-four females with small-volume breast asymmetry without hypertrophy or ptosis underwent subfascial breast augmentation for cosmetic purposes, by using micro-textured soft cohesive silicone gel-filled round implants, from a single manufacturer. MRI measured the linear antero-posterior dimension of breast tissue thickness and projection of the implants. Statistical analysis of data was performed by Pearson correlation coefficient, line graph, and scatter diagram. RESULTS: The "r" of Pearson for right and left breasts indicated a significant correlation between the breast tissue thickness before and 5 years after augmentation. Closeness of the lines displayed in the line graph indicated strong linear positive correlation between the breast tissue thicknesses. The "r" values for projection of right and left implants indicated a significant correlation between the projection standardized by the manufacturer and that encountered 5 years after augmentation with high- and extra-high-profile round implants. A scatter diagram of data indicated a strong positive correlation between implant projection standardized by the manufacturer and that encountered 5 years after augmentation, on both breasts. CONCLUSION: Soft cohesive silicone gel-filled high- and extra-high-profile round implants supported breast tissue compressing without significant loss of the implant projection. Despite the consistency of the soft cohesive silicone gel, the implant softness and flexibility were preserved, resulting in low-pressure gradient over the mammary parenchyma without significant changes of the breast tissue thickness. EBM LEVEL IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.
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Implantación de Mama , Implantes de Mama , Mamoplastia , Implantación de Mama/efectos adversos , Femenino , Humanos , Imagen por Resonancia Magnética , Geles de SiliconaAsunto(s)
Implantación de Mama , Implantes de Mama/efectos adversos , Mama , Granuloma de Cuerpo Extraño , Geles de Silicona/efectos adversos , Adulto , Mama/diagnóstico por imagen , Mama/patología , Implantación de Mama/efectos adversos , Implantación de Mama/instrumentación , Análisis de Falla de Equipo , Femenino , Granuloma de Cuerpo Extraño/diagnóstico , Granuloma de Cuerpo Extraño/etiología , Humanos , Aumento de la Imagen/métodos , Imagen por Resonancia Magnética/métodos , Tamaño de los ÓrganosRESUMEN
Durante muchos años, el gel de silicona ha tenido un rol primario en el tratamiento y la prevención de cicatrices anómalas en forma de cicatrices hipertróficas y queloides luego de la epitelización. Los autores publican los hallazgos preliminares sobre el uso de un novedoso apósito de gel de silicona grado médico que forma una película y que fue aprobado para ser usado en heridas abiertas y en lesiones de la piel como único tratamiento y en combinación con otros tratamientos previos a la reepitelización. Un estudio observacional de 105 pacientes analizó la efectividad del gel de silicona en la estimulación de la epitelización acelerada, la reducción de la respuesta inflamatoria y la prevención de la formación de cicatrices. El estudio se realizó en una variedad de intervenciones quirúrgicas dermatológicas. Las observaciones de los autores confirmaron el rol de la silicona en la aceleración de la cicatrización de heridas, la prevención de la formación de cicatrices y la utilidad de este nuevo apósito de silicona que forma una película cuando se lo combina con otras modalidades de tratamiento. (SKINmed. 2012; 10:S1- S7).
For many years, silicone gel has played a primary role in the treatment of prevention of abnormal scars in the form of after epithelialization. The authors publish the pre-elimination findings use of a novel medical grade silicone gel dressing that form a film that was approved for use in open wounds and in skin as the only treatment and in combination with other treatments prior to re-epithelialization. An observational study of 105 patients analyzed the effectiveness of silicone gel in the stimulation of accelerated epithelialization, reducing the inflammatory response and preventing the formation of scars. The study was conducted on a variety of dermatological surgeries. The authors' observations confirmed the role of silicone in acceleration of wound healing, prevention of the formation of the usefulness of this new silicone dressing that forms a film it is combined with other forms of treatment.
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Humanos , Vendajes , Cicatrización de Heridas , Cicatriz Hipertrófica/terapia , Procedimientos de Cirugía Plástica , Geles de Silicona/uso terapéutico , Estudios Observacionales como Asunto , Procedimientos Quirúrgicos Dermatologicos/métodosRESUMEN
La silicona podría tener propiedades ideales para estimular la cicatrización de heridas abiertas. Se presentan cuatro casos de heridas en el cuero cabelludo que no cicatrizaban y en todas se observaba tejido de granulación abundante y falta de migración epidérmica. La aplicación de un gel a base de silicona (Stratamed, Stratpharma, Basilea, Suiza), que forma una película directamente sobre la herida, a modo de monoterapia se asoció con una mejor cicatrización de la herida
The silicone could have ideal properties to stimulate the healing of open wounds. We present four cases of wounds on the scalp that did not heal and in all of them there was abundant granulation tissue and lack of epidermal migration. The application as a monotherapy of a silicone-based gel (Stratamed, Stratpharma, Basel, Switzerland), which forms a film directly on the wound, was associated with better wound healing
Asunto(s)
Humanos , Anciano , Anciano de 80 o más Años , Cuero Cabelludo/lesiones , Cicatrización de Heridas , Heridas Penetrantes/terapia , Geles de Silicona/uso terapéutico , Tejido de GranulaciónRESUMEN
Resumen Objetivo: Describir las características clínicas, demográficas, resultados y complicaciones de una serie de pacientes operados de aumento de glúteo con implantes de silicona por medio de la técnica XYZ. Materiales y Método: Serie de casos retrospectiva de pacientes sometidos a gluteoplastía de aumento con implantes de silicona por medio de técnica intramuscular. Se describe la técnica quirúrgica, datos demográficos, antecedentes médico quirúrgicos y complicaciones posoperatorias. Resultados: Entre diciembre de 2014 y junio de 2017 se operaron 19 pacientes. La complicación más frecuente fue dehiscencia de herida operatoria, presentándose en 5 pacientes. Un paciente tuvo hematoma posoperatorio. Dos pacientes tuvieron seroma posoperatorio. Una paciente presentó rotación de un implante. Una paciente se perdió de seguimiento luego del control de retiro de puntos a la 6a semana. Una paciente necesitó reinternación para manejo del dolor. Ningún paciente necesitó reoperación. Ningún paciente presentó infección de herida operatoria. Ningún paciente presentó extrusión ni pérdida de implantes. Discusión: La técnica XYZ es un método efectivo para el tratamiento estético y reconstructivo de la región glútea especialmente en pacientes que no presentan zona dadora suficiente para injerto graso. Las complicaciones descritas son acordes a la literatura, por lo que se recomienda la técnica de gluteoplastía de aumento con prótesis de silicona intramuscular como una técnica reproducible y segura.
Objective: Describing the clinical features, demographics features, outcomes and complications from a serie of patients underwent buttock augmentation with silicone implants with XYZ technique. Material and Methods: Retrospective case series of patients underwent buttock augmentation with intramuscular technique. It Is described the surgical technique, demographics data, comorbidities and post operative complications. Results: Since December 2014 to June 2017 were operated 19 patients. The most frecuent complication was wound dehiscence, it was present in 5 patients. One patient had a postoperative hematoma. Two patients presented seroma. One patient presented implant rotation. One patient left controls after removal the suture in the sixth week. None of patients needed revisional procedures. None of patients presented wound infection. None of patients presented extrusión or implant removal. Discussion: The XYZ technique is a efective method to aesthetic and reconstructive treatment of buttock area, especially in patientes without a suficient donor area to fat graft. The complications described are accord with literatura, that is why buttock augmentation with intramuscular silicone implant is recomended as a reproducible and safe technique.