Evaluation of the biocompatibility of silicone gel implants - histomorphometric study

Breast implants are medical devices that are used to augment breast size or to reconstruct the breast following mastectomy or to correct a congenital abnormality. Breast implants consist of a silicone outer shell and a filler (most commonly silicone gel or saline). Approximately 5 to 10 million women worldwide have breast implants. Histomorphometric study to evaluate the biological tissue compatibility of silicone implants suitable for plastic surgery and the adverse effects and risks of this material. Thirty Wistar white rats received subcutaneous implants and the revestiment of silicone gel Silimed ®®, and randomized into six groups of five animals each, according to the type of implanted material and the time of sacrifice. Eight areas of 60.11mm2 corresponding to the obtained surgical pieces were analyzed, counting mesenchymal cells, eosinophils, and foreign body giant cells, observing an acceptable biocompatibility in all implants, for subsequent statistical analysis by Tukey test. Silicone gel showed inflammation slightly greater than for other groups, with tissue reactions varying from light to moderate, whose result was the formation of a fibrous capsule around the material, recognized by the organism as a foreign body. Despite frequent local complications and adverse outcomes, this research showed that the silicone and top layer presented an acceptable chronic inflammatory reaction, which did not significantly differ from the control group. In general, it is possible to affirm that silicone gel had acceptable levels of biocompatibility, confirmed the rare presence of foreign body giant cells, and when of the rupture, formed a fibrous capsule around the material, separating the material of the organism. © AVICENA 2013.

Evaluation of the Shore A Hardness of Silicone for Facial Prosthesis as to the Effect of Storage Period and Chemical Disinfection

The failure of facial prostheses is caused by limitations in the properties of existing materials, especially flexibility and durability. Therefore, this study evaluated the Shore A hardness of silicone used for fabrication of facial prostheses, Silastic MDX4-4210, according to the influence of storage period, daily disinfection, and 2 types of pigmentation. Thirty specimens were fabricated and divided in 3 groups: colorless, pigmented with makeup, and pigmented with iron oxide. Analysis of results was assessed on a Shore A hardness meter immediately, 6 months, and 1 year after fabrication of specimens, following the guidelines of the American Society for Testing and Materials. The hardness values were statistically analyzed by the Tukey test. The silicone exhibited an increase in hardness with time. However, the hardness was stable from 6 months to 1 year. It was concluded that the silicone is within the values of Shore A hardness reported in the literature, regardless of the storage period, pigmentation, and chemical disinfection.

Marginal deterioration of the silicone for facial prosthesis with pigments after effect of storage period and chemical disinfection

The failure of facial prostheses is caused by limitations in the properties of existing materials, especially flexibility and durability. Therefore, this study evaluated the marginal deterioration of a silicone used for fabrication of facial prostheses (Silastic MDX4-4210, Dow Corning Corporation, Midland, MI, USA) according to the influence of artificial aging, daily disinfection, and 2 types of pigmentation. Thirty specimens were fabricated and subdivided in 6 groups: without pigmentation, pigmented with make-up powder and iron oxide, and evaluated with and without the action of the disinfectant. Analysis of marginal deterioration was performed on a scanning electron microscope (magnification, ×5000) immediately 6 months and 1 year after fabrication of specimens, following the guidelines of ASTM International. After visual analysis of the photomicrographs, it was noticed that all groups presented marginal deterioration and alterations in surface texture with time. The use of disinfection did not contribute to the marginal deterioration of polymer (silicone), regardless of the pigmentation and artificial aging.

Avaliação volumétrica e funcional do músculo glúteo máximo submetido a gluteoplastia de aumento com implantes de silicone

A operação para aumento de glúteos com implantes teve início no fim da década de 1960, entretanto a técnica intramuscular, considerada padrão atualmente, foi descrita cerca de 30 anos depois. Cirurgiões e pacientes apresentam crescente interesse na realização do aumento de glúteos haja vista que sua frequência apresenta aumento nos últimos anos. A utilização de implantes intramusculares que superam o volume do músculo em mais de cinquenta por cento configura uma situação nova que deve ser estudada. O tecido muscular estriado esquelético apresenta grande suscetibilidade para atrofia secundariamente à compressão, e sendo o glúteo máximo um músculo importante na manutenção da postura ereta, deambulação, corrida e salto, é necessário pesquisar possíveis alterações musculares decorrentes da operação. O objetivo deste estudo é avaliar o volume e força do músculo glúteo máximo ao longo de 12 meses após a introdução de implantes intramusculares, o posicionamento destes implantes no interior da musculatura e mudanças antropométricas obtidas com a operação. Foram selecionadas 48 mulheres, 24 candidatas a gluteoplastia de aumento com implantes compuseram o grupo de estudo e 24 candidatas a mamoplastia de aumento compuseram o grupo controle de acordo com os critérios de inclusão e exclusão. As pacientes foram avaliadas em quatro momentos diferentes: pré-operatório e após três, seis e 12 meses da operação. Em todas as etapas foi realizada avaliação clínica nutricional, tomografia computadorizada com reconstrução 3D e teste isocinético. Todas as pacientes permaneceram afastadas de atividades físicas durante três meses após a operação. Foram utilizados implantes glúteos em gel coesivo de base oval e superfície lisa com volumes de 350 cm3 e 400 cm3. O nível de significância estatística foi mantido em 5%. As pacientes candidatas a gluteoplastia apresentaram valores da relação entre as medidas da cintura e do quadril maiores que aquelas do grupo controle. A operação de aumento glúteo com implantes demonstrou eficácia na melhora desta relação. Os implantes apresentaram posição obliqua com inclinação semelhante à das fibras musculares após três meses da operação, independente da posição em que foram inseridos. As pacientes do grupo de estudo apresentaram atrofia muscular após 12 meses em 6,14% à esquerda e 6,43% à direita, as pacientes do grupo controle não apresentaram atrofia. A força muscular apresentou redução do valor de torque máximo durante a flexão do quadril a 30 /s em ambos os grupos e aumento do torque máximo durante a adução a 60 /s apenas no grupo de estudo. Concluímos que a introdução de implante de silicone no interior do músculo glúteo máximo causa atrofia muscular após 12 meses. As variações na força deste músculo nesse período não podem ser atribuídas primariamente à operação ou à presença dos implantes em seu interior. Os implantes permaneceram em posição obliqua. O aumento de glúteos com implantes gera mudanças antropométricas nas mulheres submetidas a esta operação.

Systemic Inflammatory Reaction After Silicone Breast Implant

Systemic inflammation after augmentation mammaplasty with modern silicone implants is not currently recognized. In a prospective controlled study, C-reactive protein and other variables were monitored, aiming to test this hypothesis in a young cohort of patients. Females (18-30 years old, BMI = 18.5-30 kg/m(2), N = 52) were consecutively recruited for breast implant (n = 24, Group I) and for abdominal liposuction (n = 28, Group II/Controls). Patients were interviewed at baseline and followed until 6 months after operation. Variables included demographic and clinical information, surgical outcome, inflammatory markers and autoantibodies. Operations were well tolerated, without surgical or infectious complications. Mean prosthesis size was 258 +/- A 21 ml (range = 220-280) and mean aspirate of liposuction was 1972 +/- A 499 ml (range = 1200-3000). Preoperative, 2-month, and 6-month C-reactive protein concentrations for breast implant patients were 1.3 +/- A 1.2, 4.8 +/- A 3.0, and 4.3 +/- A 6.4 mg/l and for liposuction 3.5 +/- A 2.7, 3.5 +/- A 2.1, and 2.2 +/- A 2.2 mg/l, respectively. Change at 2 months was significant (p = 0.001). Autoantibody investigation failed to reveal remarkable aberrations, except for anticardiolipin elevation, which was nearly symmetrical in the two groups. C-reactive protein levels increased after operation and correlated with proinflammatory and procoagulatory indices. A mild increase in anticardiolipin IgM occurred but differences between populations were lacking. Despite excellent cosmetic outcomes and lack of complications, acute phase reaction could signal ongoing immunogenicity of silicone and long-term monitoring is recommended.

Implant-retained thumb prosthesis with anti-rotational attachment for a geriatric patient

This report presents the use of a dental implant with an anti-rotational attachment for the retention of a thumb prosthesis. A retention system was manufactured with an attachment (UCLA) screwed into the implant with a two-bar system that was cast in metallic silver palladium. A substructure made from heat-cured acrylic resin was joined to the retention system by clips to join the thumb to the finger (bar clip) in the cast with implant rejoinder. The silicone material, Silastic-MDX 44210, was used to achieve function and aesthetics. Following osseointegration, no skin problems were observed. Whilst the implant-retained digital prosthesis presented some motor limitations, it allowed the patient to return to entertainment and achieve social conviviality.

Prosthesis Auricular With Osseointegrated Implants and Quality of Life

Implants in craniofacial reconstructions improve prostheses retention and stability, comfort, and safety for the patient. According to biomechanical principles, the treatment success regarding osseointegration maintenance depends on an adequate surgery technique associated to a retention system that provides favorable tension distribution to implants. Implants in the mastoid area are a very important aid for retention of auricular prostheses. Color stability of resin and silicone is an important factor for longevity of auricular prostheses, and the high degree of satisfaction of patients with head and neck defects receiving epithesial reconstruction in the maxillofacial region is demonstrated.

Rehabilitation with ear prosthesis linked to osseointegrated implants

Background: The absence of an ear, which can be the result of a congenital malformation, surgical tumour resection or traumatic injury, is a significant aesthetic problem. Attachment of ear prostheses with adhesives can cause local irritation for the wearer and affect the colour of the prostheses. Use of implants in craniofacial reconstruction can improve the retention and stability of prostheses giving to patient greater comfort and security relative to adhesive attachment.Objective: The aim of this report was to present a clinical case of a mutilated patient who was rehabilitated by means of installing an ear prosthesis fixed through osseointegrated implants.Materials and methods: The patient had two implants installed in the mastoid region that were linked by a bar, and a clip-type system was used. The ear prosthesis was constructed from medical-use silicone, pigmented to match the patient's skin colour and linked to the retention system.Conclusion: The patient's rehabilitation was satisfactory from both a functional and an aesthetic point of view, making it possible for the patient to return to a normal social life and regain lost self-esteem.

Effect of Chemical Disinfection and Accelerated Aging on Color Stability of Maxillofacial Silicone with Opacifiers

Purpose: The purpose of this study was to evaluate the color stability of MDX4-4210 maxillofacial elastomer with opacifier addition submitted to chemical disinfection and accelerated aging.Materials and Methods: Ninety specimens were obtained from Silastic MDX4-4210 silicone. The specimens were divided into three groups (n = 30): Group I: colorless, Group II: barium sulfate opacifier, Group III: titanium dioxide opacifier. Specimens of each group (n = 10) were disinfected with effervescent tablets, neutral soap, or 4% chlorhexidine gluconate. Disinfection was conducted three times a week for 2 months. Afterward, the specimens were submitted to different periods of accelerated aging. Color evaluation was carried out after 60 days (disinfection period) and after 252, 504, and 1008 hours of accelerated aging, using a reflection spectrophotometer. Color alterations were calculated by the CIE L*a*b* system. Data were analyzed by three-way ANOVA and Tukey test (alpha = 0.05).Results: Group II exhibited the lowest color change, whereas Group III the highest (p < 0.05), regardless of the chemical disinfection and accelerated aging periods.Conclusion: Opacifier addition, chemical disinfection, and accelerated aging procedures affected the color stability of the maxillofacial silicone.

Bond strength between acrylic resin and maxillofacial silicone

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Influence of Pigments and Opacifiers on Color Stability of an Artificially Aged Facial Silicone

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Effect of Disinfection and Accelerated Aging on Color Stability of Colorless and Pigmented Facial Silicone

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Color Stability Comparison of Silicone Facial Prostheses Following Disinfection

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)