Dissertations / Theses on the topic 'Breast implants'

The Breast Implant Lifetime Study at Virginia Tech, on which this thesis is based, seeks to develop methods and data for predicting the lifetime of saline-filled implants. This research developed Finite Element Analysis (FEA) models to evaluate the stresses that are present in the silicone breast implant material under different loading situations. The FEA work was completed using the commercial codes PATRAN and ABAQUS. PATRAN was used for pre- and post-processing, while ABAQUS was used for the actual analysis and to add fluid and contact elements not supported by PATRAN. Many different loading situations and constraints were applied to these models, as well as variations in the material and model properties. Varying the Poisson's ratio of the implant material from 0.45 to 0.49 did not make a significant difference in the results. Changing the elastic modulus of the implant material from the modulus of a Smooth implant to the modulus of a Siltex implant had a noticeable effect on the stress results, increasing the maximum stresses by almost 8%. Changing the modulus of the surrounding tissue had marked effects as well, with stiffer tissue (E=300 psi) decreasing the implant's stresses by about 60% as compared to softer tissue (E=100 psi). A ten percent decrease in implant thickness yielded a 17% average increase in stress experienced by the implant. For both the 2.5" radius and the 4" radius tissue models, using CAX4 elements produced higher overall stresses in the tissue with the same loading conditions. However, in the 2.5" tissue model, the implant itself experienced less stress with the CAX4 tissue than the CAX3 tissue. In the 4" tissue model, the implant experienced more stress when surrounded by the CAX4 tissue elements. These models will be combined with implant fatigue data to develop a life prediction method for the implant membrane.
Master of Science

This project aimed to explore various opportunities of using the unique properties of nanoscale carbon materials to enhance mechanical strength and cell-surface compatibility of breast implants. The thesis focused on the synthesis of advanced nanocarbon-reinforced silicone composites and revealed that they have similar flexibility yet improved safety profile compared to the currently available implants. The project outcomes have led to international collaboration directly funded by one of the major industry players in the implant manufacturing market.

The purpose of this research is to examine through sociological and psychological theories how women make sense of the desire and attainment of breast implants for graduation. The study used a qualitative approach and focused on women ages 18-35 in the state of Texas who have received breast implants for graduation. The sample size in this study included 10 high-school graduates receiving implants as a gift and their 10 mothers. Seven theoretical paradigms provided a better understanding for why the daughters asked for breast implants and why the parent(s) paid for them. Symbolic interaction theory explained why the daughters wished to replace their "fake" cotton padded self with their augmented self, to become the most authentic woman possible. Social construction of reality theory explained why both mothers and daughters wanted to conform to the social construction of gender, and to accomplish their gender well. Conspicuous consumption theory demonstrated how cosmetic surgery practices allow women to appear wealthy, gain status, and "flash" their assets. Feminist theory explained why some women were motivated to capture the attention of men and others altered the body out of empowerment. Reference group and social comparison theories explained how the women in this study were influenced to undergo cosmetic surgery by ranking themselves in attractiveness against real friends and media icons. Lastly, self-discrepancy theory showed how the daughters in this study felt they needed surgery to fix a discrepancy between their real and ideal self. The majority of respondents expressed complete comfort with their gifting and receiving of breast implants for graduation, claiming it was a great decision. They also agreed surgery was worth any risk to increase their daughter's confidence. Most of the mothers expressed that they were comfortable with their decision to gift surgery to their daughters, despite knowing that their gift of augmentation would ultimately result in more surgery in the future.

Thirty-two silicone breast implant patients scored in the mild to moderate range of impairment on the Halstead-Reitan Neuropsychological Battery. An unusual number of patients had positive tests for antinuclear antibody on immunological testing and a high incidence of EEG abnormalities were found. Personality testing revealed an MMPI profile which is typical for neuropsychologically impaired subjects but components were consistent with extreme emotional distress. None of the subjects were near the cutoff score for malingering or faking bad on the F-K index of the MMPI. There was no apparent relationship between length of exposure and the severity of neurological impairment. Also, explanted subjects performance was not improved when compared to subjects whose implants were still in place.

Bilateral breast augmentation is one of the most common cosmetic surgical procedures carried out on women in the western world. Breast augmentation involves increasing the volume of a woman‘s breasts through surgery by placing a silicone implant in the subglandular or subpectoral cavity. Although a capsule forms inevitably around breast implants as a natural part of healing, it can cause significant morbidity if the capsule becomes firm and contracted, a condition known as breast capsular contracture (BCC). The aetiology of BCC remains unknown however it is characterised by dense fibrocollagenous connective tissue with a local inflammatory response. Host response is influenced by several factors including implant surface texture, chemistry and interactions between cells and the extracellular matrix. Texturing holds the implant in place, thus preventing micromotion at the host prosthesis interface. While in smooth surfaces, the implant moves inside the breast, making the fibroblasts repeatedly produce collagen in response to this host-prosthesis shearing motion. In this thesis, the effect of surface characteristics and specific coatings on the cell-surface interaction has been examined on smooth compared to textured surfaces using commercially available breast implants. The properties of breast implants shells have been characterised using confocal laser microscopy, contact angle measurements, confocal Raman spectroscopy and tensile testing. Confocal laser microscopy was used to evaluate the topographical features and surface roughness of the implant surfaces. Contact angle measurements were carried out to determine the hydrophobicity of the implant surfaces. Chemical characterisation was carried out recording Raman images and spectra of the implants using confocal Raman spectrometer. The mechanical properties of the breast implant shells were measured via tensile testing. Adhesive interactions of breast-derived fibroblasts with breast implant surfaces were examined in-vitro. For this purpose, the effect of four molecule coatings (aggrecan, collagen I, fibronectin, and hyaluronic acid) was evaluated on fibroblast attachment, proliferation, fibroblast morphology, spreading, cytotoxicity and gene expression. Results from in-vitro assays demonstrated cell susceptibility to topography and protein coatings and further showed cytoskeletal re-organisation and modification with specific cell adhesion patterns. Combination of diverse topographies and specific coatings induced differential regulation of the expression of adhesion related genes, such as focal adhesion kinase, paxillin, vinculin, and α-actinin on breast fibroblasts. In conclusion, this thesis has demonstrated the extent and strength of cell adhesion and subsequent cell proliferation and differentiation. This is based on the physical interactions between cells and the extracellular environment in the form of topography and on the chemical interactions mediated by specific coatings. Precise characterisation of the silicone breast implant surfaces was achieved. This may play an important role in the development of improved breast implant surfaces with improved qualities leading the development of surfaces that may be less prone to capsular contracture.

Echocardiography is one of the most important diagnostic testing in cardiology. The presence of a breast implant overlying heart can cause significant impairment of the echocardiographic acoustic window. Breast implants are increasing in popularity in the USA and the Federal Drug and Food Administration (FDA) just approved silicone implants again. In this review, the impact of silicone breast implant on the echocardiographic image acquisition and interpretation is discussed.

PONTIFÍCIA UNIVERSIDADE CATÓLICA DO RIO DE JANEIRO
COORDENAÇÃO DE APERFEIÇOAMENTO DO PESSOAL DE ENSINO SUPERIOR
PROGRAMA DE SUPORTE À PÓS-GRADUAÇÃO DE INSTS. DE ENSINO
O implante de prótese mamária de silicone a que meninas adolescentes se submetem na atualidade se tornou um fenômeno cultural sem precedentes. Baseado em tal fenômeno, este trabalho pretende investigar o que move meninas adolescentes a se submeterem ao referido procedimento cirúrgico, a partir da noção de corpo representado para a psicanálise em articulação com o campo da cultura. O campo de pesquisa foi estabelecido a partir de declarações de meninas adolescentes que se submeteram ou iriam se submeter ao implante de prótese mamária de silicone, coletadas na mídia, através da internet com seus blogs, redes sociais e artigos jornalísticos. As considerações finais deste trabalho ressaltam que, diante da chamada crise da adolescência, o implante de prótese mamária de silicone a que meninas adolescentes se submetem remete ao projeto de alcançar um padrão de beleza imaginário que funcionaria como suporte subjetivo para tal crise.
The silicone breast implants that adolescent girls undergo nowadays have become an unprecedented cultural phenomenon. Based on this phenomenon, it is intended to investigate what makes adolescent girls undergo such procedure from the idea of body representation for psychoanalysis interrelated with the idea of body for medicine and the field of culture. The research field was based on statements of adolescent girls who had or would have the silicone breast implants surgery, as well as media search, through the internet, with its blogs, social networks and journalistic articles. Results highlight that, facing with the so called adolescent crisis, the silicone breast implants which adolescent girls undergo take them to the project of reaching an imaginary standard of beauty that would work as a subjective support for such crisis.

Globally, Breast cancer accounts for about 23% of all cancers. PDMS or silicone breast implant is used in the breast reconstruction surgery to recreate the original shape and size of the breast post mastectomy. However, the safety of silicone based implantable medical devices has been a challenge since their introduction. The common clinical problems associated with silicone implants are autoimmune diseases, capsular contracture, biofilm formation, allergic reaction and recently there is also a presence of a rare type of cancer. Coating the surface of biomedical implants is a promising strategy to reduce the failure rate of implants. In this work, we coat the surface of silicone implant using a biocompatible natural protein polymer silk fibroin (SF). The PDMS surfaces have been modified using oxygen plasma treatment and 3-amino-propyl-triethoxy-silane (APTES) treatment. Interestingly, testing of the coated samples using a bulk technique such as tensile and bending deformation showed that the SF nano-coating exhibits improved crack resistance when the PDMS surface has been modified using APTES treatment as compared to oxygen plasma treatment. These results were validated at the microscopic and mesoscopic length scales through nano-scratch and nano-indentation measurements. Further, the work demonstrates that a novel process combining conventional dip coating with electrospinning results in the formation of a crack-resistant coating. The coating was also further functionalized using a green biomolecule – glycomonoterpene prepared using citronellal and glucose. These functional compounds are being touted as the next generation antibiofilm molecules on account of quorum sensing inhibitory activity. Also, we report functional coatings of silk fibroin and its blends with biopolymers and the effect of molecular weight of PEO on mechanical properties and aqueous stability of SF/PEO blend coatings on PDMS surface. Further, SF coatings have also been developed by blending with a novel polymers such as recombinantly produced elastin-like peptide (ELP), a class of polypeptide obtained from the primary sequence of mammalian elastin with a repeat unit of (GVGVP). The SF-ELP coatings were characterized for their physio-chemical and mechanical properties and their properties were compared with a selected molecular weight of PEO used for blending. The mechanical stability of SF-ELP blends shows more stable coatings than SF-PEO blends. The biological evaluation of these SF blends was performed by doing protein adsorption, accelerated degradation and cytotoxicity studies. Thus, this study shows various material science strategies that can be used to mitigate the risk of silicone implant failure.
Department of Biotechnology, India CSIR - HRDG
AcSIR

Introduction:One of the most common complications of the use of foreign material, both in reconstructive and cosmetic breast surgery, which often leads to re-intervention, is capsular contracture. It consists in pathological hardening of the fibrous shell developing around a breast prosthesis.The development of connective tissue around any foreign body is physiological, but progression into a thick and firm capsule, as around breast implants, is responsible for varying degrees of local inflammation, dislocation, and deformation of the prosthesis. Infection, hematoma, and granulomatous response to free silicone, as well as many other conditions, have been considered possible causes of capsules formation and pathological progression around some breast implants. the goal of the present thesis is to investigate the effects of omega-3 supplements on capsule contraction, evaluating the thickness, and tgfb expression on sample of capsule collected in a rat living model. Materials and Methods:32 Wild-type C57BL/6 knockout mice were bred and maintained in a university vivarium.The animals were divided in two groups: Omega3/control. Mice were operated on at 8 weeks of age and following implant surgery.After 12 weeks, mice were euthanized using a carbon dioxide inhalation and implant and all tissues surrounding implants were harvested in one piece.Histology (Capsular Thickness) and PCR Analysis (tgfb2/COL1A2) were performed to evaluate the grade of fibrosis. Results.:Capsular thickness and tgfb2/COL1A2 gene expression were significantly lower in treatment group. Discussion:This study s results suggest that Omega 3 supplement seems to be effective in reducing capsular formation occurrence. The main role in Omega 3 fatty acids in inflammation and fibrosis reduction around the implant is their inhibition of TGF-B pathway and thus impairment of collagen deposit. We believe that omega 3 supplement is a simple and promising method that could be used to prevent capsular contracture after silicone implant surgery. This therapy could have a high impact considering the number of patients who every year undergoes to breast reconstruction or to aesthetic mammoplasty. Furthermore Omega fatty acids 3 are dietary supplement with minimal side effects, normally used worldwide for multiple purposes. Nevertheless, further clinical studies are warranted to examine their therapeutic applicability and additional studies should be conducted to attempt a decrease in capsular contracture occurrence.

Esta dissertação trata da construção dos valores acerca do corpo que transforma aspectos estéticos em problemas de saúde física. Com base na pressuposição do compromisso de aliviar o sofrimento o cirurgião plástico busca, dentro do campo da saúde, justificativas para sua atuação. Por outro lado, na aspiração por modelos de beleza socialmente prestigiados há também a procura pela transformação pessoal com a construção e afirmação de papéis sociais, o que contribui para a maior aceitação das intervenções cirúrgicas com finalidade estética. Seguindo tendências estéticas sempre em mutação, observa-se, na atualidade, uma grande demanda por cirurgia plástica para colocação de implantes de silicone com objetivo de aumento mamário. Tomando como recorte a utilização de tais implantes, buscou-se analisar a construção médica e social da beleza e compreender como a procura e a prática da cirurgia plástica estão ligadas a valores controversamente aceitos ou criticados na sociedade contemporânea.
This study treats the construction of values concerning the body which transform aesthetic appearance into physical health troubles. Based on the presupposition of the commitment of relieving the suffering, the plastic surgeon searches for inside the health field to justify his acts. On the other hand, in aspiration for beautiful socially well-known models looking for personal transformation also occurs, with the construction and affirmation of social roles which contributes to the wider acceptance of operations with aesthetic purpose. Following aesthetics trends always in mutations, it was observed in present times a great demand for cosmetics breast augmentation with silicone implants. It was searched to analyze the medical and social constructions of beauty and understand how the search and the practice of plastic surgery are binding to values controversially accepted or criticized in the contemporaries societies.

Os implantes mamários de silicone têm sido empregados, tanto nas cirurgias de aumento das mamas, quanto na reconstrução do tecido mamário após mastectomia. A segurança biológica dos implantes de silicone merece estudo relacionado aos processos de esterilização empregados, pois podem constituir-se em fator de comprometimento da estrutura química do polímero e, conseqüentemente, da biocompatibilidade. Este estudo consistiu na avaliação da biocompatibilidade de implantes mamários de silicone após terem sido submetidos aos processos de esterilização por calor seco, radiação gama e óxido de etileno. O parâmetro avaliado foi a viabilidade celular, empregando o método de difusão em agar e de captura do vermelho neutro. As amostras compreenderam implantes de silicone gel lisos, texturizados e revestidos com poliuretano e implantes texturizados pré-cheios com solução salina. Também foi realizado o teste de endotoxinas bacterianas pelo método do LAL e determinação da taxa de migração do gel de silicone (teste de bleed). Os três métodos de esterilização mostraram-se igualmente eficientes pela comprovação da condição de esterilidade dos implantes através de metodologia descrita na Farmacopéia Americana 27 edição. Os níveis de endotoxinas bacterianas dos implantes, também atenderam aos requisitos dos compêndios oficiais. Na avaliação da biocompatibilidade todos os implantes, independente dos processos de esterilização utilizados, apresentaram ausência de citotoxicidade. Os resultados do teste de bleed mostraram uma maior taxa de migração de gel para os implantes de superfície lisa em comparação com os implantes de superfície texturizada e revestida com poliuretano, quando esterilizados por calor seco. Ao comparar a taxa de migração do gel para os implantes de superfície lisa esterilizados por calor seco e óxido de etileno, obteve-se uma maior taxa de migração para aqueles implantes esterilizados por óxido de etileno. As diferentes avaliações realizadas neste estudo abrangeram aspectos biológicos, químicos e físicos relevantes para garantir um produto de boa qualidade e que, por assegurar a manutenção da característica de biocompatibilidade, resulta na segurança biológica deste tipo de implante.
Silicone breast implants have been widely used for mammary augmentation and reconstruction surgery. Biological safety of these implants can be damaged by sterilization methods. This study consisted of the biocompatibility assessment of breast implants through cell viability, employing the agar diffusion test and neutral red uptake. Four silicone breast implants were tested: smooth, textured, polyurethane covered silicone gel breast implant and textured saline-filled breast implant. Sterilization methods comprised dry-heat, ethylene oxide and γ-radiation. Detection of bacterial endotoxins employing LAL test and gel bleed was also performed. The three methods of sterilization revealed equally efficacious, through the sterility confirmation of implants employing methodology described in 27th edition of United States Pharmacopeia. At the same way the leveis of bacterial endotoxins of implants accorded with the pharmacopeial requirements. In theevaluation of biocompatibility ali the implants, independently of the sterilization process used, showed no cytotoxicity signals. The results of gel bleed revealed a higher migration rate from the smooth implants in comparison with the textured and polyurethane-covered implants sterilized by dry-heat. When was compared the gel migration of smooth implants sterilized by dry-heat and ethylene oxide, was obtained a higher rate of gel bleed of those implants sterilized by ethylene oxide. The different evaluations performed in this study comprised biological, chemical and physical aspects, that are relevant to assure a good quality product and by having maintained the characteristics of biocompatibility, resulted in the biological safety on this kind of implant.

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Os implantes mamários caracterizam-se como dispositivos médicos que são usados para aumentar o tamanho dos seios ou para reconstruir a mama após mastectomia ou corrigir uma anomalia congênita. Sabe-se que desvio no processo produtivo de implantes mamários e o tempo de uso podem reduzir as propriedades do produto final e favorecer risco de agravos à saúde da população. Desta forma, este trabalho objetivou avaliar as propriedades físicas, químicas, biológicas e mecânicas de próteses mamárias de silicone explantadas. Os parâmetros de avaliação basearam-se na norma NBR 14 760 – 2001. Foram analisadas nove amostras de próteses mamárias de silicone texturizadas, com diferentes tempos de uso e os ensaios foram realizados em triplicata. Os ensaios de caracterização utilizados foram Microscopia Óptica - MO, Espectroscopia na Região do Infravermelho com Transformada de Fourier (FTIR), Coesividade do Gel, Ensaio Mecânico (Resistência a Tração) e Citotoxicidade. No ensaio de MO verificou-se padrões diversos de texturizações para as próteses, mas não foram observadas alterações significativas que comprometesse a qualidade das próteses mamárias, bem como nos espectros de FTIR. Baseado nos resultado obtidos no ensaio de coesividade do gel pode-se afirmar que apenas a amostra C não se encontra em conformidade com a norma International Standard ISO 14607. Nos resultados do Ensaio Mecânico, as amostras A, B, F, G e H encontraram-se em não conformidade com a norma. Os testes de citotoxicidade mostraram que as próteses analisadas estão em conformidade com a norma. Desta forma conclui-se que as amostras A, B, C, F, G e H estão fora dos parâmetros exigidos pelas normas vigentes e que o tempo de uso destas pode ter influenciado nestes resultados, sugerindo-se a continuidade de estudos considerando essa variável.
Breast implants are characterized as medical devices that are used to increase the size of breasts or to reconstruct the breast after mastectomy or to correct a congenital anomaly. It is known that deviations in the production process of breast implants and the use of time can reduce the properties of the final product and favor risk of harm to health. Thus, this study aimed to evaluate the physical, chemical, biological and mechanical properties of silicone breast implants explanted. The evaluation criteria were based on NBR 14 760 - 2001 were analyzed nine samples of textured silicone breast implants with different operating times and the assays were performed in triplicate. Characterization tests used were Microscopy Optica - MO, Infrared Spectroscopy in the Region Fourier Transform (FTIR), cohesiveness gel, Mechanical Test (Tensile Strength) and cytotoxicity. In the MO of study there are several standards for texturing the prosthesis, but no significant changes were observed that could compromise the quality of breast implants, as well as in FTIR spectra. Based on the results obtained in the gel assay cohesiveness, it can be stated that only sample C is not in accordance with International Standard ISO 14607.Nos results of mechanical testing, samples A, B, F, G and H found in noncompliance with the standard. Cytotoxicity tests showed that the prostheses are analyzed in accordance with the standard. Thus it is concluded that the samples A, B, C, F, G and H are out of the parameters required by current standards and that the time of use these may have influenced these results, suggesting continuing studies considering this variable .

A partir de um alerta internacional emitido pelas autoridades sanitárias francesas no ano de 2010 com respeito a altas taxas de ruptura de implantes mamários da marca Poly Implant Prothèse (PIP), a Agência de Vigilância Sanitária brasileira (ANVISA) suspendeu a importação, distribuição, comércio e uso destes implantes no país. Visando manter a qualidade destes produtos no mercado brasileiro, a partir de março de 2012 – conforme publicado pelo Instituto Nacional de Metrologia (INMETRO) – foi instituída a certificação compulsória dos implantes mamários e em seguida definidos os ensaios através dos quais os implantes mamários devem ter sua conformidade avaliada, sendo esses ensaios mecânicos e químicos. Este trabalho apresenta o desenvolvimento de equipamentos e metodologia para avaliação da conformidade de dois ensaios mecânicos em implantes mamários: ensaio de fadiga e ensaio de resistência ao impacto. Duas normas foram utilizadas para o processo de acreditação: ISO 14607 – Non - active surgical implants – Mammary implants – Particular Requirements, e ABNT NBR ISO 14607 – Implantes cirúrgicos não ativos – Implantes mamários – Requisitos particulares. Os equipamentos utilizados foram desenvolvidos e construídos ao longo do desenvolvimento deste estudo e os testes foram realizados em implantes mamários da marca PIP obtidos junto a ANVISA. A primeira etapa consistiu em organizar os documentos necessários para acreditação junto ao INMETRO e, após, ensaios os ensaios foram realizados. Ao todo trinta e cinco implantes foram ensaiados – 31 na primeira parte do trabalho e 04 na segunda – e analisados em lupa para verificação de defeitos causados pelos testes como: fraturas, cortes, alteração de forma, entre outros. Os equipamentos e metodologia desenvolvida atendem os requisitos de ambas as normas e permitem avaliação de conformidade de próteses mamárias comercializadas no país, no que diz respeito ao ensaio de fadiga e resistência ao impacto.
Due an international alert issued by French authorities in 2010 regarding high rupture rate of breast implants related to Poly Implant Prothèse (PIP), the Brazilian Health Surveillance Agency has suspended the importation, distribution, commercialization and use of these implants into Brazil. In order to maintain the quality of these products in Brazilian market, on March 2012 – according published by National Institute of Metrology – it has been decided for compulsory certification of breast implants and then defined the tests through which these products have to be submitted for its conformity assessment, being these mechanical and chemical tests. This dissertation evaluates the development and methodology for conformity assessment of two mechanical tests on breast implants: fatigue and impact resistance test. The process was based on two standards: ISO 14607 and ABNT NBR ISO – Non - active surgical implants – Mammary implants – Particular Requirements. The equipment used was developed in the laboratory during the realization of this study and the tests were performed on implants produced by PIP provided by National Sanitary Surveillance Agency. It started with the organization of the documents to be sent to National Institute of Metrology, in order to ask the accreditation and then tests were performed. Thirty five implants were tested – 31 on first part of the work and 04 on the second one – and then analyzed to detect any anomaly that could be considered a defect such as: rupture, cuts, shape alteration, etc. The equipment and methodology has met the requirements from both standards and enable conformity assessment of breast implants commercialized in Brazil, regarding to fatigue and impact resistance tests.

xiv, 246 p. : ill. A print copy of this thesis is available through the UO Libraries. Search the library catalog for the location and call number.
This project is a critical and comparative investigation of Western and non-Western practices of body modification. Situated in the realm of feminist political theory, the project engages the literature and debates concerning embodiment, or the symbolic and concrete meanings of women's bodies. I specifically explore two examples of the physical construction of women's bodies: breast implantation in the United States and female genital cutting (FGC) in Senegal. I demonstrate that each of the practices molds bodies into preexisting naturalized forms. For this project, I conducted eighty in-depth, open-ended, and semi-structured interviews with women and men in twelve different locations in Senegal. Then, I carried out sixty-five in-depth, open-ended, and semi-structured interviews with American men and women from twenty-one different cities. I argue that the information that emerges from looking at body normalization comparatively allows me to make two important claims. The first is that the material that originates from interviews in this comparative study disrupts existing hegemonic discourse on sex-based body modifications. In particular, the comparative findings challenge the viewpoint that espouses a "Western women are free, African women are oppressed" binary. Second, examining FGC in Senegal alongside breast implantation in the US can uncover normalization that is invisible within social fields, or in the lives of women and men. Normalization is hard to see when in it, but easier to see if an individual steps outside of herself, her context, and her patriarchy. Thus, though many women do not recognize the normalizing structures within their own lives, they often are able to see these hegemonic structures in the lives of others. Women stepping outside of their own contexts can provide fresh, critical eyes that recognize embedded normalizations and oppression in other contexts. Further, this realization also can push them to return that critical gaze onto their own environment, which is the beginning of locating mechanisms of control within their own field. The construction of sex and the imprinting of gender norms upon bodies are manifestations of regulation and normalization that occur within socio-cultural contexts, and which individuals can potentially locate through a comparative conversation of this type.
Committee in charge: Dennis Galvan, Chairperson, Political Science; Julie Novkov, Member, Political Science; Leonard Feldman, Member, Political Science; Stephen Wooten, Outside Member, Anthropology

INTRODUÇÃO: Pacientes portadoras de obesidade mórbida submetidas a tratamento cirúrgico através de cirurgias disabsortivas-restritivas, após considerável perda ponderal, evoluem com dobras cutâneas ou dermogordurosas em várias regiões do corpo. As mamas são caracterizadas pela deficiência de volume, ptose acentuada, assimetria e medialização dos complexos aréolo-papilares. A mastopexia com inclusão de implantes mamários tem demonstrado ser solução cirúrgica eficaz para melhora da forma, volume e simetria das mamas. OBJETIVO: Avaliar a satisfação das pacientes e os resultados cirúrgicos obtidos após a mastopexia com inclusão de implantes mamários. MÉTODOS: Vinte pacientes do sexo feminino, com média etária de 39,9 anos, foram submetidas à mastopexia com inclusão de implantes mamários entre setembro de 2008 e abril de 2009. Foram aplicadas entrevistas psicológicas semidirigidas a todas as pacientes, nos períodos pré e pós-operatórios, cujas respostas foram tabuladas, divididas em categorias, e possibilitaram a avaliação da satisfação das pacientes. Foi realizada avaliação dos resultados cirúrgicos através da análise fotográfica por três cirurgiões plásticos independentes, nos períodos pré e pós-operatórios, onde foram atribuídas notas zero, um ou dois, para os seguintes itens: forma da mama, volume da mama, simetria entre as mamas, posicionamento do complexo aréolo-papilar e qualidade e extensão das cicatrizes. RESULTADOS: Dezenove pacientes (95%) referiram satisfação com o resultado cirúrgico obtido (p<0,001). Quatro pacientes (20%) relataram melhora da vida profissional; doze pacientes (60%), melhora da vida social; dez pacientes (50%), da vida afetiva; e dez pacientes (50%), da vida sexual. A média das somatórias das notas atribuídas pelos três cirurgiões, referentes a cada paciente, variou entre 4,7 e 10, sendo a média geral de 7,28. Os resultados foram considerados bom ou ótimo para 65% da amostra e pobre para 8,4%. CONCLUSÕES: Houve satisfação de 95% das pacientes com os resultados obtidos pela mastopexia com inclusão de implantes. A análise fotográfica dos resultados obteve nota média de 7,28, caracterizado como bom resultado, apesar da fraca concordância entre os avaliadores.
INTRODUCTION: Morbid obesity patients submitted to surgical treatment through disabsortive-restrictive procedures, and after considerable weight loss, develop skin or fatty tissue folds in many regions of the body. These changes in the breasts, in particular, are characterized by volume deficiency, marked ptosis, asymmetry and medialization of the nipple-areola complexes (NAC). Mastopexy associated with breast implant inclusion has shown to be an efficient solution to improve shape, volume and breast symmetry. OBJECTIVE: To evaluate patient satisfaction and surgical results obtained after mastopexy with breast implant inclusion. METHODS: Twenty female patients with a mean age of 39.9 years were submitted to mastopexy with breast implant inclusion between September 2008 and April 2009. All patients had semi-directed psychological evaluation in the pre- and postoperative periods. The answers to the evaluations were tabulated, categorized, and allowed patient satisfaction analysis. The surgical results evaluation was made through photographic analysis of three independent plastic surgeons, in the pre- and post-operative periods, when scores of zero, one or two, were attributed to the following items: breast shape, breast volume, symmetry of breasts, NAC position, scar quality and extent. RESULTS: Nineteen patients (95%) referred satisfaction with the surgical results attained (p<0,001). Four patients (20%) referred improvement in their professional lives; twelve patients (60%), improvement in their social lives; ten patients (50%), of their affective lives; and ten (50%) of their sexual lives. The mean sum of the scores attributed by the three surgeons, respective to each patient, varied between 4.7 and 10, with an overall mean of 7.28. The results were considered good or great for 65% of the sample and poor for 8.4%. CONCLUSIONS: There was a 95% satisfaction rate among patients with the results obtained through Mastopexy with breast implant inclusion. The photographic analysis of the results obtained a mean score of 7.28, considered as a good result, albeit the weak correlation among evaluators.

La première structuration de surface d’implants mammaires approuvée par l’agence sanitaire américaine Food and Drug Administration (FDA) est la texturation Biocell de l’Américain Allergan en 1987. La plupart des fabricants d’implants mammaires ont ensuite adopté des procédés permettant d’obtenir des texturations similaires pour la plupart. Un rapport de l’Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) a estimé que 85% des implants vendus en France entre 2007 et 2016 étaient texturés. En 2011, la FDA alerte sur une possible association entre les implants mammaires et une forme rare et spécifique de lymphome : le Lymphome Anaplasique à Grandes Cellules Associés aux Implants Mammaires (LAGC-AIM). Le nombre de cas de LAGC-AIM a explosé depuis 2014-2015, avec une sur-représentation de la texture Biocell dans les statistiques justifiant le retrait du marché français de ces prothèses par l’ANSM en avril 2019. Ces travaux de thèse ont pour but d’évaluer l’impact de la topographie de surface des implants mammaires sur les performances cliniques du dispositif. Premièrement, une étude comparative menée sur 3 techniques de mesure de surface, ainsi qu’une analyse statistique basée sur la décomposition multi-échelle des topographies, nous ont permis de proposer une méthodologie de mesure métrologiquement correcte prenant en compte la morphologie de surface et l’échelle et de jeter la lumière sur les faiblesses de la norme ISO relative aux implants mammaires (ISO 14607). Ensuite, une classification et une dénomination morphologiquement pertinente des texturations ont été proposées et validées par un protocole original d’analyse génétique sur tissus humains et par une analyse discriminante menée sur une large base de paramètres topographiques. Des analyses topographique et statistique similaires ont été également conduites sur prothèses retirées du corps humain (ou explant), afin de quantifier l’endommagement en fonction du type de texturation et de l’échelle. Ces études permettront au GROUPE SEBBIN de concevoir une nouvelle prothèse de forme anatomique, qui alliera à la fois accroche tissulaire et minimisation des processus d’inflammation et d’endommagement
The first breast implant surface pattern approved by the American Food and Drug Administration (FDA) is Biocell texture commercialized by the American company Allergan in 1987. Most breast implant manufacturers then adopted similar surface patterning process. A report from the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) estimated that 85% of implants sold in France between 2007 and 2016 were textured. In 2011, the FDA warned of a possible association between breast implants and a rare and specific form of lymphoma: Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). The number of cases of BIA-ALCL has exploded since 2014-2015, with an overrepresentation of the Biocell texture in the statistics, which justified the withdrawal of the French market of these prostheses by the ANSM in April 2019. This thesis aims to evaluate the impact of breast implant surface topography on the clinical performance of the device. Firstly, a comparative study carried out on 3 surface measurement techniques, as well as a statistical analysis based on the multi-scale decomposition of the topographies, allowed us to propose a metrologically-validated measurement methodology taking into account the surface morphology and the scale and to highlight the inconsistencies of the ISO standard related to breast implants (ISO 14607). Then, a classification and a morphologically-relevant designation of the textures were proposed and validated by an original protocol of genetic analysis on human tissues and by a discriminant analysis carried out on a large base of topographical parameters. Similar topographical and statistical analyzes were also conducted on prostheses removed from the human body (or explant) in order to quantify the damage according to the type of texture and to the scale. These studies will enable the GROUPE SEBBIN to design a new anatomically-shaped prosthesis, which will combine tissue anchoring and minimization of inflammation and damage processes

Capsular Contracture (CC) has been identified as the major cause of breast-implant failures and subsequent discomfort, pain and shape deformation following cosmetic breast implantation procedures. It has been documented that CC is primarily due to bacteria which are transmitted in the breast-cavity through conventional implantation. A 'no-touch' implant insertion technique has therefore been identified as the optimal method in potentially reducing CC rates. This describes an implant delivery without the implant ever touching: gloves (even during post-insertion implant orientation assessments), retractors or the patient's skin and breast-tissue; which is inherently unachievable with the traditional finger-manipulation method. To date, the most significant improvement in the insertion process has been a 'minimal-touch' technique, i.e. with the Keller-Funnel. This study was therefore in the design and development of a safe 'no-touch' insertion device for the delivery of silicone breast-implants. Parameters included a horizontal 45 mm incision, which can stretch up to a maximum vertical central distance of 35 mm. The proposed design featured a positive-displacement method with: (a) pressurized air as the insertion 'force', (b) an inverting-bag (partially inserted with the implant) to eliminate direct glove/implant contact, and (c) a built-in retractor with a breast-cavity air-removal path to reduce implant insertion resistance due to trapped air. The implant, in the device, remains closed to the environment and separated from the wound margin thus, eliminating skin/implant contact and further providing wound protection. Finally, the design employed an eccentric funnel shape for device use at the inframammary incision site with a suggested subpectoral or submuscular pocket placement, i.e. to eliminate breast-tissue/implant contact. Through experimentation with various implant sizes, device dimensions were suitable for implant-volumes up to 428.57 cm3. A 1 bar air supply was used to test the prototype and prove the concept on a silicone cast breast-model. Leverage of the built-in retractor efficiently opened the incision for device placement multiple times and, the successful insertions of the implants and inverting-bag into the breast-model indicated that a 'no-touch' technique was achievable. This was at a maximum insertion time of 4.2 seconds, amongst eight implants ranging from 242 to 428.57 cm3. However, the continued post-insertion air supply resulted in inflation of the inverted bag in the breast. This is at a high risk of developing a thoracic wall deformity and/or embolism. Suggestions were made to improve the design and eliminate this fault.

INTRODUÇÃO: Os enxertos de gordura tem se mostrado como uma poderosa técnica cirúrgica em reconstrução mamaria secundária e os enxertos enriquecidos com células-tronco, além de suas ações parácrinas, vem apresentando resultados encorajadores no que tange a persistência volumétrica. OBJETIVO: Este estudo clínico teve como objetivo analisar comparativamente quantitativa e qualitativamente enxertos de gordura enriquecidos com células da fração vásculoestromal em reconstrução mamária secundária e a incidência de complicações. MÉTODO: Nós desenvolvemos um método que produz enxertos de gordura, na sala de cirurgia, em uma taxa de enriquecimento maior que os já publicados (2:1). Este estudo clínico prospectivo e controlado analisou qualitativa e quantitativamente enxertos de gordura com (GT - grupo tronco) e sem (GC - grupo controle) adição das células da fração vásculo-estromal fresca em reconstrução mamária secundária; através de volumetria mamária por RNM de mamas, imunofenotipagem e contagem celular. Também foram estudados os resultados estéticos, a satisfação das pacientes e as complicações. RESULTADOS: A persistência volumétrica no GT foi 78,9% e 51,4% no GC, entretanto não houve diferença estatisticamente significativa entre os grupos. CD90 foi o marcador mais expresso e que alcançou diferença significante e ao mesmo tempo apresentou correlação positiva entre a sua expressão e a persistência volumétrica (r=0.651, p=0.03). Necrose gordurosa ocorreu, isoladamente em 4 pacientes do GT submetidas à radioterapia e nenhuma paciente do GC apresentou este evento. Desta forma, pacientes do GC mostraram tendência de estar mais satisfeitas com o enxerto de gordura. Nos dois grupos, os resultados estéticos foram iguais e não foram observadas recidivas loco-regionais. CONCLUSÃO: Os resultados do enriquecimento em uma taxa maior que as já publicadas são encorajadores, apesar de a persistência volumétrica não ter alcançado diferença estatisticamente significante entre os grupos. Enxertos de gordura enriquecidos na proporção 2:1 podem não ser indicados para pacientes submetidas à radioterapia apesar de terem se mostrados seguros num tempo de seguimento de 3 anos
BACKGROUND: Fat grafting is a tremendous tool in secondary breast reconstruction. Stromal vascular fraction (SVF) enriched fat grafts have been presenting promising results regarding volume maintenance. OBJECTIVE: The main purpose of this study was to analyze comparatively SVF-enriched fat grafts in secondary breast reconstruction: volumetric persistence, expression of surface markers and complications. METHODS: We developed a method that produces a superior SVF enrichment rate (2:1) in the operating theatre. This prospective and controlled trial analyzed quantitatively and qualitatively fat grafts with (stem cells group - SG) and without (control group - CG) SVF enrichment in secondary breast reconstruction, through MRI-based volumetry, immunophenotyping and cell counting. Also, patient satisfaction, aesthetic outcomes and complications were analyzed. RESULTS: Volumetric persistence in the SG was 78,9% and 51,4% in the CG, however it did not reach statistical significant difference. CD90 was the only marker highly expressed in the SG and showed a positive correlation with volumetric persistence (r=0.651, p=0.03). Fat necrosis occurred in 4 patients in the SG and in none in the CG. Patients in the CG showed a trend to be more satisfied. Considering aesthetics, both groups presented improvements. No locoregional recurrences were observed. CONCLUSIONS: Results are encouraging despite the fact that SVF enrichment in a higher supplementation rate did not improve, with statistical significance, fat graft volumetric persistence. Enriched fat grafts have proven to be safe in a 3-years follow up, however they do not seem suitable for patients that received radiotherapy

Submitted by Emanuel Varela Cardoso (emanuel.varela@ufcg.edu.br) on 2018-07-26T22:44:22Z No. of bitstreams: 1 CRISTIANE AGRA PIMENTEL – DISSERTAÇÃO (UAEMa) 2016.pdf: 1843438 bytes, checksum: 753df6133976145dbe21cffc31c69065 (MD5)
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Os biomateriais produzidos para serem aplicados como dispositivos médicos devem atender a exigências de qualidade, segurança e eficácia. Dentre estes, se inclui as próteses mamárias. A padronização de processos em laboratórios de ensaios responsáveis pela certificação destes biomateriais a partir da implantação de normas específicas tem impacto importante na segurança e qualidade do processo e no desempenho estratégico dos laboratórios. Neste contexto, este trabalho tem como objetivo realizar um diagnóstico no processo de acreditação do Laboratório CERTBIO na norma NBR ISO/IEC 17025:2005 para avaliação das próteses mamárias. Também será realizado um estudo detalhado do ensaio de determinação da matéria volátil quanto ao desempenho dos fornecedores e validação do método de ensaio. Em termos metodológicos foi realizado um estudo de caso de natureza descritiva e exploratória. Os resultados demonstram que a implantação da norma supracitada associada a um sistema de gestão no processo de certificação de próteses mamárias no CERTBIO, promoveu a redução no prazo de entrega dos resultados de ensaio, maior padronização dos processos, maior satisfação do cliente externo e melhor controle no processo de aquisição de suprimentos. Além disso, nos estudos da parte técnica, comprovou-se que apesar de todos os fornecedores terem atendido à especificação do ensaio de determinação de matéria volátil, o de número 1 foi extremamente melhor quanto à performance nos resultados. Enquanto que na validação de método, recomendou-se continuar analisando gel e membrana. Dessa forma, pôde-se comprovar que após o processo de acreditação o laboratório CERTBIO se tornou uma referência internacional em biomateriais, além da excelência em qualidade e confiabilidade nos serviços executados.
Biomaterials produced to be applied as medical devices must attend the requirements of quality, safety and efficacy. In this context includes breast implants. The standardization processes in laboratories responsible for the certification of these biomaterials through the implementation of specific rules have major impact on process quality and safety and strategic performance of laboratories. Thus, this study aims to conduct a diagnosis at CERTBIO Laboratory to have an accreditation process on breast implants in the standard ISO / IEC 17025: 2005. An addition study at technical part was conducted to see the performance of suppliers at volatile material determination and validation the method of this test. In terms of methodology we conducted a case study of descriptive and exploratory nature. The results demonstrate that the implementation of the above requirement associated with a management system in the certification process of breast implants in CERTBIO, promoted the reduction in the delivery performance, greater standardization of processes, greater customer satisfaction and better control the supply procurement process. Moreover, in the part of technical studies, it was shown that all suppliers have attended to the determination of volatile matter test specification, but the number 1 was extremely better performance as to the results; however it did not see any difference between these variances. While the validated test of this method, recommended to continue analyzing gel and membrane. Thus, it could be proved that after accreditation process, the CERTBIO laboratory has become an international reference in biomaterials , as well as excellence in quality and reliability of the services performed.

Three-dimensional printing has broad potential for the medical landscape as demonstrated in the two projects that comprise this thesis. Project one encompasses three-dimensional scanning of healthy volunteers to create equations that enable prediction of breast dimensions and volume directly from torso landmarks and measurements. Future development may streamline the creation of custom computer modelled breast implant scaffolds for three-dimensional printing and improve aesthetic outcomes. Project two outlines the creation, bioprinting and assessment of a new biological ink with components generally found in breast tumours. These techniques may be used in the future to create customised models for drug testing.

El texto completo de este trabajo no está disponible en el Repositorio Académico UPC por restricciones de la casa editorial donde ha sido publicado.
Breast implant-associated anaplastic large cell lymphoma is a newly recognized provisional entity in the 2017 revision of the World Health Organization Classification of Tumors of Hematopoietic and Lymphoid Tissues. It is an uncommon, slow growing T-cell lymphoma with morphology and immunophenotype similar to anaplastic lymphoma kinase-negative anaplastic large cell lymphoma. However, the presentation and treatment are unique. Breast implant-associated anaplastic large cell lymphoma often presents as a unilateral effusion confined to the capsule of a textured-surface breast implant, a median time of 9 years after the initial implants have been placed. Although it follows an indolent clinical course, breast implant-associated anaplastic large cell lymphoma has the potential to form a mass, to invade locally through the capsule into breast parenchyma or soft tissue and/or to spread to regional lymph nodes. In most cases, an explantation with a complete capsulectomy removing all disease, without chemotherapy is considered to be curative and confers an excellent event free and overall survival. Here we provide a comprehensive review of breast implant-associated anaplastic large cell lymphoma, including history, epidemiology, clinical features, imaging and pathology findings, pathologic handling, pathogenic mechanisms, model for progression, therapy and outcomes as well as an analysis of causality between breast implants and anaplastic large cell lymphoma.
Revisión por pares

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Os implantes mamários são dispositivos médicos, empregados para aumentar, reconstrutir ou corrigir anomalis congênitas mamárias. Normalmente, são preenchidas por gel de silicone e/ou solução salina. Atualmente, têm sido utilizados com frequência implantes mamários com a superfície externa da membrana texturizada, por apresentar maior seguraça e reduzir complicações pós-operatórias como as contraturas capsulares. Desta forma, este trabalho teve como objetivo avaliar as propriedades físicas, químicas e biológicas de implantes mamários com membrana texturizada e preenchidas com gel de silicone. Portanto foram analisados quatro implantes mamários, de dois diferentes fabricantes, sendo uma marca nacional e outra importada. Os ensaios de caracterização foram realizados no lado da membrana interno que fica em contado com o gel e no lado externo que fica em contato com o meio biológico, através das seguintes técnicas: Microscopia Óptica – MO, Microscopia Eletrônica de Varredura – MEV, Espectroscopia por Energia Dispersiva de Raios X - EDS, Retilineidade, Ensaios Dimensionais - Espessura, Ensaio Mecânico - Tração, Citotoxicidade e Coesividade do Gel. Nos resultados do ensaio de avaliação morfológica (MO e MEV) foi observado que a superfície das membranas em contato com o gel apresenta-se com textura lisa e uniforme já o lado externo da membrana observou-se presença de poros com tamanhos e formas bastante distintas. Em relação aos ensaios mecânicos, todas as amostras atenderam aos requisitos normativos, porém uma das amostras apresentou valor muito próximo do limite de aprovação. Observou-se que a texturização das superfícies influencia nos desempenhos mecânicos das membranas. Os resultados do ensaio de coesividade do gel de preenchimento, citotoxicidade e de elementos químicos contaminantes foram semelhantes em todas as amostras e estão de acordo com as normas de certificação, sendo X2 muito próximo ao limite de aprovação.
Silicone breast implants are medical devices used to increase, reconstruct or correct mammary congenital deformities. Typically, they are filled with silicone gel and / or saline solutions. Currently, there is often used breast implants with the outer surface of the textured membrane to present maximum security and reduce post-operative complications such as capsular contracture. Thus, this study aimed to evaluate the physical, chemical and biological properties of textured silicone gel breast implants. Four breast implants were analyzed, two different manufacturers. The characterization tests were performed on the inner side of the membrane which is in contact with the gel, and the external side, in contact with the biological environment, through the following techniques: optical microscopy - MO, Scanning Electron Microscopy - SEM, Spectroscopy Energy Dispersive X-ray - EDS, Straightness, Dimensional Testing - Thickness, Mechanical Testing - Traction, Cytotoxicity and cohesiveness gel. The results of the morphological evaluation test (OM and SEM) it was observed that the surface of the membrane in contact with the gel appears with smooth and uniform texture, however, the external side of the membrane was observed pores with very different sizes and shapes . Regarding the mechanical tests, all samples met the regulatory requirements, but one of the samples showed a value close to approval limit. It was observed that the texturing of suferfícies influences the mechanical performances of the membranes. The cohesiveness filling gel test, cytotoxicity and chemical contaminants were similar in all samples and comply with certification regulations.

This master's thesis concerns the increasing popularity of cosmetic breast augmentation in America in recent years. Specifically, statistics indicate that between 1992 and 1998 there has been a 306% rise in the number of breast augmentation surgeries in the U.S. (ASPRS, 1999). Why do women elect a surgery to cosmetically augment their breasts? Taking a postmodern theoretical approach, this research offers a meta-theory for women's desires and ultimately their decisions for cosmetic breast augmentation. It entails examining a multiplicity of converging micro- and macro-level social forces, subject to historical, cultural, economic, and religious and philosophical interpretation. Supplementary interviews provide additional theoretical support and direction, engaging the discourse of women in response to one, open-ended question, "Why is it that a woman would desire and ultimately decide to have cosmetic breast augmentation or enhancement?" Together these women's personal narratives reveal a metadiscourse on the politics of a postmodern gendered body in America.

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The main test for early detection of breast cancer is mammography. In the last decade, there was a significant increase in the number of women undergoing mammography for screening of breast cancer and have breast implants. Despite the mammographic screening recommended for patients with implants, follow the same range as recommended for patients doesn’t have implants, routinely includes images with posterior displacement of the implant (ID), known as Eklund’s maneuver, adding four views in relation to who do not have it. This study aimed to evaluate the mammographic characteristics of the required views and the dose that these patients have received in the examination. Data collection was divided into two stages: the first, for radiological evaluation of images and the second for data collection of radiographic techniques for image production. The radiological evaluation was performed by radiologists, with experience in mammography reading, who independently answered a questionnaire about: 1) implant position, 2) overall improvement image, 3) amount of breast tissue seen in the maneuver in relation to the standard images, 4) if there were findings in the exams, e) which view these findings were seen. For the data of the mammographic techniques, from the records in the DICOM (Digital Imaging and Communications in Medicine) heading of each image were collected: voltage (kV) and current x time (mAs) emitted by the device, target/filter combination, breast thickness and mean glandular dose (DGM). The data were analyzed by means of statistical treatment. Regarding the radiological evaluation, the evaluators agreed that the amount of breast tissue in the in the ID views depends on the position of the implant and is smaller in the retroglandular position. There was a significant increase in the quality of the images with the displacement of the implant and there were no findings seen in the exams, which were not seen in those views. Regarding the radiation doses received by patients with implants, during the mammographic examination, the DGM exceeds the limit recommended by the agencies responsible for the protocols. This study suggests the need for continuity of the research, with an increase in the sample and optimization of the mammographic technique, in order to evaluate the risk benefit ratio of maintaining all views of augmentation mammograms.
O principal exame para detecção precoce do câncer de mama é a mamografia. Na última década, houve um crescimento expressivo do número de mulheres que realizam mamografia para o rastreamento do câncer de mama e possuem implantes mamários. Apesar do rastreamento mamográfico recomendado para as pacientes com implantes, seguir o mesmo intervalo que o preconizado para as pacientes que não possuem, inclui de rotina, imagens com deslocamento posterior do implante, conhecida como manobra de Eklund, adicionando-se quatro incidências em relação às que não possuem. Este trabalho propôs-se à avaliação das características mamográficas das incidências exigidas e da dose de radiação que estas pacientes têm recebido no exame. A coleta de dados foi dividida em duas etapas: a primeira, para avaliação radiológica das imagens e a segunda para levantamento dos dados das técnicas radiográficas para produção das imagens. A avaliação radiológica foi realizada por médicos radiologistas, com experiência em leitura de mamografias, que responderam de forma independente um questionário sobre: 1) posição do implante, 2) melhoria global em detalhe de imagem, 3) quantidade de tecido mamário visto na manobra de Eklund em relação as imagens padrões, 4) se houve alteração nos exames, e) em quais incidências estas alterações foram vistas. Para os dados das técnicas mamográficas, foram coletados, a partir dos registros no cabeçalho DICOM (Digital Imaging and Communications in Medicine) de cada imagem: tensão (kV) e corrente x tempo (mAs), combinação alvo/filtro, espessura da mama e dose glandular média (DGM). Os dados foram analisados por meio de tratamento estatístico. Em relação à avaliação radiológica, os avaliadores concordaram que a quantidade de tecido mamário nas imagens com deslocamento do implante, depende da posição em que o implante se encontra, sendo menor na posição retroglandular. Houve significativo aumento da qualidade das imagens com o deslocamento do implante e não houve nenhuma alteração vista nos exames, que não tenham sido visibilizadas nas imagens com a manobra. Quanto às doses de radiação recebidas pelas pacientes com implantes, durante o exame mamográfico, a DGM excede o limite preconizado pelas agências responsáveis pelos protocolos. Este estudo sugere a necessidade de continuidade da pesquisa, com incremento da amostra e otimização da técnica mamográfica, para que se possa avaliar, a relação benefício risco de se manter todas as incidências em mamografias de mulheres com implantes mamários.

Os implantes mamários de silicone constituem-se em biomateriais os quais têm sido amplamente utilizados em cirurgias para reconstituição da mama após ocorrência de câncer, acidentes, correção do tamanho dos seios quando há uma diferença de volume entre eles, ou até mesmo, para o aumento do tamanho da mama por motivos estéticos. Com o intuito de conferir segurança em sua aplicação, intimamente ligada à saúde dos pacientes, grande atenção tem sido dada aos processos de esterilização aplicados a biomateriais. Ao avaliar o processo produtivo de implantes mamários de silicone, um dos processos de esterilização mais comumente empregados é o calor seco, que necessita de elevadas temperaturas por longo tempo para o sucesso da esterilização. A exposição do implante a tais condições potencialmente pode ocasionar alterações de suas características. De outro lado, uma etapa preliminar do processo produtivo do implante é a vulcanização, que consiste no aquecimento do implante a temperaturas da ordem de 165 ± 5°C por aproximadamente 9 horas. Considerando tempo e temperatura empregados nesta etapa, o objetivo deste estudo foi avaliar a carga microbiana dos implantes mamários de silicone antes do processo de vulcanização, assim como o decaimento da carga microbiana neste processo e também confirmar a esterilidade do gel contido internamente à membrana. Desta forma, foi possível observar que o nível de contaminação microbiana dos implantes gelatinosos é relativamente baixo e que a vulcanização foi um processo que possibilitou a inativação de até 108 esporos, a concentração de esporos mais alta utilizada no estudo. Os resultados mostraram que a vulcanização possibilitou não só a redução da carga microbiana, mas também consiste em mecanismo para garantir a esterilidade do gel interno ao produto. Desta forma, o processo esterilizante final teve como contribuição elevar o Nível de Garantia de Esterilidade (SAL ou Sterility Assurance Level), condição interessante ao se considerar a tendência de adoção da liberação paramétrica, assim como o conceito de validação combinado bioburden/indicador biológico em vez de sobre-morte. Avaliação complementar foi feita ao quantificar endotoxina nos implantes antes e após o processo de esterilização (calor seco e óxido de etileno), verificando-se que os processos considerados não alteram significativamente a quantidade de endotoxina. Ainda assim, em todas as situações foram obtidos níveis aceitáveis, conforme USP 31.
Silicone breast implants consist of biomaterials widely used in breast reconstitution surgeries after the occurrence of cancer, accidents, breast size correction (in case of different volume between both breasts)or in mammary augmentation for esthetic reasons. With a view to confer security in its application, directly related to patients health, great attention has been given to sterilization processes applied to biomaterials. Among these, dry heat is one of the most often employed. For a successful sterilization, it requires high temperatures for a long period, what may give rise to alteration of the implant characteristics. On the other hand, a preliminary stage of the implant production process is vulcanization, which consists of heating the implant to 165 ± 5°C for approximately 9 hours. Taking into account the time and temperature used in this stage, the aim of this work was to evaluate the bioburden of silicone breast implants prior to the vulcanization process and the decline in bioburden due to this process, and to confirm the sterility of the gel contained in the membrane. This study led us to the conclusion that the level of microbial contamination of gel implants is relatively low, and that vulcanization allowed for the inactivation of up to 100 million spores, the highest concentration of spores used in this study. The results obtained showed that vulcanization enabled not only the reduction of the microbial load, but also guaranteed the sterility of the gel inside the product. Thus, the final sterilizing process contributed to an increase in the Sterility Assurance Level, an interesting phenomenon if we consider the tendency toward adoption of parametric release and the concept of a combined validation bioburden/biological indicator rather than overkill. Complement evaluation was made measuring endotoxins in the implants before and after the sterilization process (dry heat and ethylene oxide), verifying that the considered processes do not modify the amount of endotoxin significantly, as expectation. Still thus, in all the situations had been gotten acceptable levels, as USP 31.

Najčešća komplikacija nakon ugradnje silikonskih implantata za dojku je kontraktura fibrozne kapsule (KK), koja se normalno stvara oko implantata u sklopu reakcije oko stranog tela. Najozbiljnija komplikacija nakon ugradnje silikonskih implantata za dojku je anaplastični krupnoćelijski limfom koji se javlja isključivo kod pacijentkinja koje imaju ugraĎene implantate (eng. Breast-implant associated anaplastic large cell lymphoma – BIA ALCL). Uzrok nastanka ovih komplikacija ostaje nepoznat. Ustanovljeno je da se KK manje javlja kod implantata koji imaju makroteksturisanu površinu i kod onih koji su presvučeni poliuretanskom penom. S druge strane, BIA-ALCL se češće dijagnostikuje kod pacijentkinja kojima su ugraĎeni upravo makroteksturisani implantati. Subklinička infekcija koja predstavlja odgovor organizma na postojanje biofilma na ugraĎenim implantatima, predstavlja jedan od najznačajnijih etioloških faktora za nastanak KK i BIA-ALCL. Biofilm je konglomerat mirkoorganizama uronjenih u matriks koji ih štiti od dejstva antibiotika i antiseptika. Kako je nemoguće delovati medikamentozno na eradikaciju biofilma, brojni autori daju razne preporuke u cilju izbegavanja kontaminacije implantata tokom operativnog zahvata, a time i formiranja biofilma. Pored brojnih mera, savetuje se i ispiranje džepa u koji će se plasirati proteza kao i same proteze, nekim od antiseptičkih ili antibiotskih rastvora. Do sada ne postoje prihvaćene jasne preporuke o načinu ispiranja različitih implantata, objavljena su samo lična iskustva raznih autora. Ciljevi ovog istraživanja su bili da se ustanovi mogućnost formiranja biofilma četiri različite bakterije (Staphylococcus epidermidis, Staphylococcus aureus, Pseudomonas aeruginosa i Ralstonia pickettii) na tri različito teksturisana silikonska implantata za dojku (sa porama veličine 70-150 μm, 50–900 μm i 13 μm) u in vitro uslovima; da se ispita da li ispiranje antisepticima (oktenidindihidrohloridom i povidon jodom), ili antibiotikom (cefuroksimom) ili istovremeno mešavinom povidon joda i antibiotika pre bakterijske kontaminacije sa četiri različite bakterije ima uticaja na formiranje biofilma na tri različito teksturisana implantata za dojke u in vitro uslovima; i da se ispita efekat antiseptika u odnosu na efekat antibiotika na formiranje bakterijskog biofilma na tri različito teksturisana silikonska implantata za dojku. Istraživanje je koncipirano kao prospektivna studija u vidu eksperimenta koji je izveden u Laboratoriji za mikrobiologiju, Instituta za javno zdravlje Vojvodine u Novom Sadu. Za izvoĎenje eksperimenta korišćeni su uzorci tri vrste silikonskih implantata za dojku sa različito teksturisanom površinom, odnosno porama različite veličine: 70-150 μm, 50–900 μm, i 13 μm. Od svakog od navedenih implantata su pravljeni uzorci, sečenjem kapsula implantata na komadiće veličine 1x1 cm. Ukupno je bilo 1440 uzoraka. Na osnovu teksture uzorci su podeljeni u tri grupe: Grupa 1 (pore veličine 70-150 μm), Grupa 2 (pore veličine 50–900 μm) i Grupa 3 (pore veličine 13 μm). Svaka od ovih grupa je dalje podeljena u jednu kontrolnu grupu i po četiri ispitivane grupe. Nakon sterilizacije uzoraka svaka kontrolna grupa je kontaminirana sa po 100μl bakterijskog bujona Staphylococcus epidermidis (n=30), Staphylococcus aureus (n=30), Pseudomonas aeruginosa (n=30) i Ralstonia pickettii (n=30). Ispitivane grupe se bile podeljene prema načinima ispiranja na one u kojima su uzorci prvo ispirani: oktenidin – dihidrohloridom ili povidon jodom ili cefuroksimom ili kombinacijom povidon joda i dva antibiotika, pa potom kontaminirani sa po 100μl bakterijskog bujona Staphylococcus epidermidis (n=30), Staphylococcus aureus (n=30), Pseudomonas aeruginosa (n=30) i Ralstonia pickettii (n=30). Po završenoj kontaminaciji, uzorci su se inkubirali na temperaturi od 37°C u trajanju od 96h, čime su stvoreni uslovi za formiranje biofilma. Nakon inkubacije, svaki pojedinačni uzorak je uronjen u sterilan tripton soja bujon, izlagan soničnoj energiji u trajanju od 1minuta i zatim vorteksiran 1 minut, čime je omogućeno odvajanje nastalog biofilma od implantata. Za ispitivanje sposobnosti formiranja biofilma korišćena je modifikovana tehnika sa mikrotitar pločom po Stepanoviću. Rezultati su pokazali da sve četiri ispitivane bakterije S. epidermidis, S. aureus, P. aeruginosa i Ralstonia pickettii statistički značajno više stvaraju biofilm na implantatima sa porama veličine 50–900 μm u odnosu na pore 70-150 μm i u odnosu na pore veličine 13 μm. Biofilm se statistički značajno više stvara na porama veličine 70-150 μm u odnosu na pore 13 μm. Jedini izuzetak je Pseudomonas aeruginosa kod kojeg ne postoji statistični značajna razlika u produkciji biofilma na teksturisanim implantatima sa porama veličine 70-150 μm u odnosu na one sa porama 13 μm. TakoĎe, sve četiri ispitivane bakterije statistički značajano manje stvaraju biofilm nakon ispiranja povidon jodom, oktenidin-dihidrohloridom ili rastvorom antibiotika u sve tri grupe implantata, u odnosu na površine koje nisu ispirane. Izuzetak je S. epidermidis u Grupi 3 kod kojeg nije utvrĎeno statistički značajno manje formiranje biofilma nakon ispiranja oktenidin dihidrohloridom u odnosu na neispiranje. Cefuroksim je bio efikasniji u sprečavanju formiranja biofilma sve četiri ispitivane bakterije u odnosu na neispiranje u Grupi 1, kao i za S. epidermidis i Ralstoniu Pickettii u Grupi 2. Cefuroksim se nije pokazao statistički značajno efikasnim u sprečavanju formiranja biofilma S. aureus i P. aeruginosa u Grupi 2, kao ni kod jedne bakterije u Grupi 3. Dalje je dokazano da su antiseptici (oktenidin-dihirohlorid i povidon jod) kao i mešavina povidon joda i dva antibiotika (cefuroksim i gentamicin), statistički značajno efikasnji od ispiranja samo antibiotikomcefuroksimom u smanjenju formiranja biofilma sve četiri ispitivane bakterije kod sva tri ispitivana, različito teksturisana silikonska implantata. Rezultati su pokazali da je ispiranje povidon jodom statistički značajno efikasnije u prevenciji stvaranja biofilma kod skoro svih ispitivanih bakterija od ispiranja oktenidin- dihidrohloridom u sve tri grupe implantata. Statistički značajna razlika nije utvrĎena u prevenciji stvaranja biofilma Staphylococcus aureusa kod sve tri grupe implantata prilikom ispiranja povidon jodom u odnosu na oktenidin- dihidrohlorid, kao i kod Ralsotnia pickettii u Grupi 2. Na osnovu rezultata ove studije, preporuka je da se koriste mikroteksturisani implantati kao i da se oni, pre ugradnje isperu povidon jodom ili mešavinom povidon jod i dva antibiotika (cefuroksim i gentamicin), u cilju prevencije stvaranja biofilma, a time i postoperativnih komplikacija koje mogu nastati nakon ugradnje implantata.
The most common complication after breast implant surgery is contracture of capsule, which is normally formed around implants as part of foreign body reaction. The most sincere complication after this kind of surgery is breast implant associated anaplastic large cell lymphoma (BIA-ALCL). The cause of these complications is still unknown. It is evident that capsular contracture (CC) is seen less frequently in patients with macro-textured implants and in those with implants covered with polyurethane foam. On the other hand, BIA-ALCL is diagnosed more frequently in patients with those, macro-textured implants. Subclinical infection, defined as an response of organism on presence of biofilm on the implant, is considered to be one of the most important etiologic factors for CC and BIA-ALCL. Biofilm is a conglomerate of microorganisms immersed into matrix, which protects them from influence of antibiotics and antiseptics. As it is impossible to eradicate biofilms with medicaments, many authors suggest different steps in order to avoid contamination of the implant during the operation and therefore, prevent the formation of biofilm. Among many tips, it is recommended to irrigate the pocket for breast implant and the implant itself, with some antiseptic or antibiotic solution. Up till now, there is no agreed consensus on the type of irrigation for different implants. Only personal experiences of a few authors have been published. Aims of this research were: to establish the possibility of biofilm formation of four different bacteria (Staphylococcus epidermidis, Staphylococcus aureus, Pseudomonas aeruginosa and Ralstonia pickettii) on three differently textured breast implants (with pore diameter of 70-150 μm, 50–900 μm and 13 μm) in vitro; to examine whether the irrigation of implant with antiseptics (povidone iodine and octenidine dihydrochloride), antibiotics (cefuroxime) or mixture of povidone iodine and two antibiotics, before the contamination with bacteria, has an influence on the incidence on biofilm formation on three differently textured implants; and to examine the effect of antiseptics in contrast to the effect of antibiotics on biofilm formation on three differently textured breast implants. The study was conducted as a prospective research that took place at the Laboratory for microbiology, at the Institute of public health of Vojvodina in Novi Sad. For the experiment, three types of silicone breast implants were used with different pore sizes: 70-150 μm, 50–900 μm and 13 μm. Samples were made by cutting each of these types of implants into pieces sized 1x1cm. There were 1440 samples in total. According to texture, samples were divided it three groups: Group 1 (pore size 70-150 μm), Group 2 (pore size 50–900 μm) and Group 3 (pore size 13 μm). Furthermore, each of these groups was divided in one control and four test groups. After sterilisation of samples, every control group was contaminated with 100μl of bacterial broth of Staphylococcus epidermidis (n=30), Staphylococcus aureus (n=30), Pseudomonas aeruginosa (n=30) and Ralstonia pickettii (n=30). Tested groups were divided according to type of irrigation into those where samples were firstly irrigated with either: octenidine dihydrochloride of povidone iodine or cefuroxime of mixture of povidone iodine with two antibiotics, and after the irrigation, contaminated with 100μl bacterial broth of Staphylococcus epidermidis (n=30), Staphylococcus aureus (n=30), Pseudomonas aeruginosa (n=30) and Ralstonia pickettii (n=30). After contamination, samples were incubated on 37°C for 96h, which created excellent conditions for biofilm formation. After incubation, each sample was dipped into sterile tripton soy broth, and then exposed to sonic energy for 1 minute and vortexed for 1 minute, which made biofilm separate from the implant. For testing the capability of biofilm formation, modified technique with microtitar plates described by Stepanović was used. Results show that all four examined bacteria S. epidermidis, S. aureus, P. aeruginosa and Ralstonia pickettii form more biofilm on implants with pore sizes 50–900 μm compared to implants with pore size 70-150 μm and those with 13 μm. Statistical significance was found in biofilm formation on implants with pores 70-150 μm compared to implants with pores 13 μm. Furthermore, all four examined bacteria form statistically less biofilm after the irrigation with any of used solutions: povidone iodine, octenidine dihydrochloride, antibiotic solution of mixture of povidone iodine and two antibiotics, in all three groups of implants compared to surfaces that were not irrigated. The exception is S. epidermidis in Group 3, where no statistical significance was found on biofilm formation after the irrigation with octenidine dihydrochloride compared to non-irrigation. Cefuroxime was more efficient in biofilm prevention for all four tested bacteria compared to non-irrigation in Group 1 and for S. epidermidis and Ralstonia pickettii in Group 2. There was no statistical significance found in prevention of S. aureus i P. aeruginosa biofilms when irrigating with cefuroxime in Group 2, as well as for all tested bacteria in Group 3. Furthermore, it was verified that antiseptics (octenidin dihydrochloride and povidone iodine) and mixture of povidone iodine and two antibiotics (cefuroxime and gentamycin), were statistically more efficient in biofilm prevention of all four examined bacteria in all groups of implants, compared to irrigation with antibiotic-cefuroxime alone. Results show that irrigation with povidone iodine is statistically more efficient in biofilm prevention of almost all examined bacteria compared to irrigation with octenidine dihydrochloride in all groups of implants. There was not found any statistical significance in prevention of Staphylococcus aureus biofilm when irrigating with povidone iodine compared to octenidine dihydrochloride in all groups of implants, and also in biofilm prevention of Ralsotnia pickettii in Group 2. According to results of this research, it is recommended to use micro-textured implants and to irrigate them with povidone iodine or mixture of povidone iodine and two antibiotics (cefuroxime and gentamycin) prior the implementation, in order to prevent biofilm formation which is most probable cause of postoperative complications after implant surgery.

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Este trabalho tem por objetivo avaliar membranas de silicone que envolve o implante mamário preenchido com gel de silicone, no intuito de verificar a conformidade das suas propriedades. Como estratégia utilizou-se das técnicas de caracterização para analisar os parâmetros físico-químicos em três lotes diferentes de implante mamário. Os resultados experimentais encontrados foram comparados com valores referenciados em padrões estabelecidos em norma ou na literatura. Com isso, foi possível analisar alguns atributos que influenciam na qualidade desses implantes. Os resultados de microscopia por MO e MEV não detectaram anomalias nas superfícies das amostras. Foram detectados pelo ensaio de espectroscopia por EDS os elementos carbono, silício e oxigênio, como também identificados os metais ferro, cálcio, níquel e cromo nas amostras ensaiadas. O teste de alongamento de duas amostras não atendeu o requisito normativo. Conclui-se, portanto, que a integridade das membranas de silicone foi comprometida, por conta do seu comportamento mecânico, em duas das três amostras ensaiadas.
This work aims to evaluate silicon membranes surrounding the breast implant filled with silicone gel, in order to verify the conformity of its properties. As a strategy, we used the characterization techniques to analyze the physicochemical parameters in three different batches of breast implant. The experimental results were compared with values referenced in standard or standards established in the literature. Thus, it was possible to analyze some attributes that influence the quality of these implants. The results of OM and SEM microscopy did not detect anomalies in the surfaces of the samples. Were detected by testing the EDS spectra of carbon, silicon and oxygen elements, also identified as metals iron, calcium, nickel and chromium in the test samples. The stretching test two samples did not meet the regulatory requirement. Therefore, it is concluded that the integrity of the silicone membranes was compromised, because its mechanical behavior, in two of the three samples tested.

Les patientes atteintes d’un cancer du sein bénéficient pour la plupart d’une mastectomie, qui consiste en une ablation du sein dans le but de retirer les cellules tumorales. Cet acte chirurgical entraîne une perte conséquente de tissu et peut être alors suivi d’une opération de reconstruction mammaire afin de combler le volume manquant. Il existe aujourd’hui un certain nombre de méthodes de reconstruction, cependant toutes présentent à la fois des avantages et des inconvénients. Les recherches actuelles sont orientées vers le développement de solutions de reconstruction innovantes à partir des propres tissus des patientes. Parmi elles, la reconstruction par chambre d’ingénierie tissulaire (TEC) semble prometteuse pour reconstruire des volumes plus importants.L’objectif de ce travail de thèse est de proposer une amélioration des TEC en ayant recourt à l’impression 3D de matériaux biorésorbables. L’utilisation de polymères thermoplastiques biorésorbables permet de ne pas avoir à réaliser une seconde chirurgie après la reconstruction qui consisterait en le retrait de l’implant. De plus, utiliser l’impression 3D comme moyen de fabrication permettra à terme de proposer aux patientes des implants sur-mesure adaptés à leur morphologie et donc d’améliorer l’aspect esthétique de la reconstruction.L’étude a d’abord porté sur le choix d’un procédé de fabrication additive et d’une méthode de stérilisation pour le développement de l’implant permettant de minimiser la dégradation des biomatériaux sélectionnés. La fabrication par dépôt de filament fondu ainsi que la stérilisation par oxyde d’éthylène ont été retenues comme moyen de production de l’implant final stérile. Une étude de dégradation in vitro a ensuite été réalisée dans le but de déterminer les profils de résorption des PLGA et PLCL. Enfin, une étude in vivo a été conduite sur un modèle rat qui nous a permis de valider le concept de TEC résorbable imprimée en 3D. Les deux biomatériaux résorbables sélectionnés se sont donc montrés compatibles avec le procédé de reconstruction par chambre d’ingénierie tissulaire et ont donc permis la croissance du lambeau graisseux au cours du temps au sein de la TEC
Mastectomy is one of the most common way to treat breast cancer, it consists in the removal of breast tissue to remove tumor cells. This surgical act causes a consequent loss of tissue and can then be followed by a breast reconstruction operation to fill in the missing volume. Implant based or autologous fat grafting (fat flap or lipofilling) are some of breast reconstruction method, however they all have advantages and drawbacks. Tissue engineering chamber (TEC) using fat flap from the patient’s own tissue could be a promising solution to restore large volume of mature and vascularized adipose tissue and a therapeutic alternative to current breast reconstruction techniques.The main objective of this thesis it to improve TEC by using additive manufacturing and bioabsorbable polymers. The use of bioresorbable thermoplastic polymers eliminates the need for a second surgery, which would consist of removing the implant after breast reconstruction. In addition, using 3D printing to manufacture the TEC will allow patients to be offered tailor-made implants adapted to their morphology and therefore improve the aesthetic aspect of the reconstruction.The study first focused on the choice of an additive manufacturing process and a sterilization method for the development of the implant to minimize the degradation of the selected biomaterials. Fused Filament Fabrication (FFF) as well as ethylene oxide sterilization were chosen as means of producing the final sterile device. An in vitro degradation study was then carried out to determine the resorption profiles of PLGA and PLCL. Finally, an in vivo study was carried out on a rat model which enabled us to validate the concept of 3D-printed bioabsorbable TEC. The two selected polymers were therefore shown to be compatible with the tissue engineering chamber reconstruction process and thus allowed the growth of the fat flap over time within the TEC

Breast implant capsular contracture (CC) formation is a significant clinical complication post augmentation/reconstruction, which often necessitates re-operation. CC, which occurs in over half of patients post augmentation, is the formation of a fibrous internal capsule which constricts around the prosthesis leading to firmness, deformity and pain. The pathoetiology of CC is poorly understood with minimal understanding of the triggers, signalling pathways or dysregulated genes implicated in its formation. Therefore, the first aim of the present thesis was to investigate biomarkers implicated in CC formation, through whole genome microarray, quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) and immunohistochemistry (IHC) on capsule samples ranging from normal capsules (Baker Grade 1) to severely contracted capsules (Baker Grade 4). After targeted enrichment analysis, microarray identified 6 genes which were significantly dysregulated in contracted capsules. After further genomic and proteomic validation, two potential diagnostic, prognostic or therapeutic biomarkers for CC, interleukin 8 (IL8) and tissue inhibitor of metalloproteinase 4 (TIMP 4), were identified as being significantly dysregulated in CC. However, the role of each of the multiple cell types which populate a contracted capsule has yet to be determined. Therefore, the role of capsular fibroblasts was investigated using immunocytochemistry, qRT-PCR, cytokine arrays and a fibroblast populated 3D collagen matrix. IL8 and TIMP were investigated, in addition to other pro-fibrotic and pro-inflammation related candidates, to identify the role of breast capsule fibroblasts in CC formation. Normal breast fibroblast populated collagen matrices were significantly more contracted after supplementation with contracted-capsule fibroblast conditioned media, in comparison to normal growth media. It was discovered that breast-derived fibroblasts were potentially instigating and/or perpetuating CC through the transformation of normal breast fibroblasts into contracted capsule fibroblast like cells, via a paracrine signalling mechanism. The results of this work on capsular fibroblasts, and the previous work on capsular tissue, increased our understanding of the cell types and signalling molecules which are dysregulated leading to CC formation. Therefore, a novel silicone implant surface potentially capable of averting CC formation could be fabricated. Acellular dermal matrix (ADM) has been used as an adjunct in breast implant augmentation/reconstruction resulting in reduced rates of CC formation. Therefore, the micro and nanoscale topography of ADM was reproduced in a silicone surface, through a novel fabrication technique utilising comprehensive characterisation of ADM with atomic force microscopy (AFM), maskless grayscale photolithography, modified deep reactive ion etching (DRIE) and replica moulding. The features of ADM were successfully re-created in silicone to within 5 nm (Sa) and 655 nm (Sz), at a length scale of 90x90 µm2. Biological evaluation revealed that ADM PDMS surfaces promoted cell adhesion, proliferation and survival when compared to commercially available implant surfaces while cell adhesion regulating genes were upregulated and pro-inflammatory/pro-fibrotic related genes were downregulated. A reduced inflammatory cytokine response was also observed. This study demonstrates that biomimetic prosthetic implant surfaces might significantly attenuate the acute in vitro foreign body reaction to silicone. In conclusion, the results of the present thesis have enhanced our knowledge and understanding of the pathological cellular and molecular mechanisms leading to CC, in addition to the design and development of a novel, biomimetic implant surface that is potentially capable of averting the identified pathological processes in vivo.

The first case of breast implant-associated anaplastic large cell lymphoma (breast implant ALCL) was described by John Keech and the late Brevator Creech in 1997. In the following 2 decades, much research has led to acceptance of breast implant ALCL as a specific clinicopathologic entity, a process that we bring up to life through the memories of 6 persons who were involved in this progress, although we acknowledge that many others also have contributed to the current state of the art of this disease. Dr. Keech recalls the events that led him and Creech to first report the disease. Ahmet Dogan and colleagues at the Mayo Clinic described a series of 4 patients with breast implant ALCL, and led to increased awareness of breast implant ALCL in the pathology community. Daphne de Jong and colleagues in the Netherlands were the first to provide epidemiologic evidence to support the association between breast implants and ALCL. Garry Brody was one of the first investigators to collect a large number of patients with the disease, present the spectrum of clinical findings, and alert the community of plastic surgeons. Roberto Miranda and L. Jeffrey Medeiros and colleagues studied the pathologic findings of a large number of cases of breast implant ALCL, and published the findings in 2 impactful studies in the medical oncology literature. The recognition and acceptance of this disease by surgeons, epidemiologists, and medical oncologists, working together, has led to subsequent studies on the pathogenesis and optimal therapy of this disease.
Revisión por pares

The establishment of specific equipment with the only purpose of evaluation the breast tissue has brought important improvement in mammary cancer detection. Presenting a huge variety in its characteristics, the female breasts varies in density and also in thickness, the mammographer it is useful in many occasions, including breast with artificial implants. The goal of this work is evaluate, using as main parameters the effective atomic number (Zef) and the total mass attenuation coefficient (ì/ñ), the mixture between paraffin gel and acrylic powder as breast simulator, as well as use the best proportion of these materials to analyze the interference of the silicone implant in images. Showing a rapid manufacture procedure, and requiring low cost materials, the simulator built with the proportion Paraffin+10%acrylic , which represents the addition of 10% of acrylic in the value of the paraffin, was the one that simulated best the mammary glands. The adipose tissue, which the proximity was greater, the percentage differences obtained to ì/ñ were approximately 32,9% for 10keV, 28,5% for 15 keV, 20,2% for 20 KeV, 11,1% for 30 keV e 5,4% for 40 keV. The evaluation in terms of implant interference showed that the scattered radiation produced by it has an approximated range of 5 mm to the built simulator which was introduced a 105 mL implant. Exposures with different compressions characteristics also were made, which was clear the influence in the image with quality and less time exposure
O estabelecimento de um equipamento especifico para avaliação da mama com uso da radiação X trouxe importantes beneficios na deteccao precoce do câncer mamário. Apresentando-se com diversas características, a mama feminina varia em relação tanto a densidade como em espessura, sendo o mamografo util em diversas analises, incluindo em mamas portadoras de implantes artificiais. O objetivo deste trabalho foi avaliar uma mistura entre parafina em gel e acrilico em po como simulador do tecido mamario, usando como parametros principais o numero atomico efetivo (Zef) e o coeficiente de atenuacao massico total ( Ê/ Ï), bem como utilizar a melhor proporcao destes para analisar a interferencia na imagem da presenca do implante de silicone. Empregando processo de confeccao rapido, e utilizando materiais de baixo valor monetario, o simulador construido com a proporcao eParafina + 10% acrilico f, que representa adicao de acrilico no valor de 10% do valor da parafina utilizado, foi aquele que melhor simulou a glandula mamaria. Em relacao ao tecido adiposo, no qual a proximidade de simulacao foi maior, as diferencas percentuais exibidas para Ê/ Ï foram de aproximadamente 32,9% para 10 keV, 28,5% para 15 keV, 20,2% para 20 keV, 11,1% para 30 keV e 5,4% para 40 keV. A avaliacao em termos da interferencia do implante de 105 mL mostrou que a radiacao espalhada por ele dentro do objeto simulador tinha um alcance aproximado de 5 mm. Exposicoes com diferentes caracteristicas de compressao tambem foram efetuadas e por meio da analise das imagens obtidas ficou evidente a influencia da compressao na obtencao de imagens com boa qualidade sendo necessario um menor tempo de exposição

Surface porous silicon based ceramics are a class of materials with excellent mechanical, physical and chemical properties and for this reason they are widely used in different fields of application. The resultant properties of these material are due principally to the combination of the chemical composition (coordination with the Si atom) and the specific geometry of the pattern. These parameters are able to influence phenomena such as the biological activity, the exposed surface area and the thermal, mechanical and chemical resistance. Techniques used nowadays to synthesize these ceramics with a specific patter are usually really complicated, expensive and time-consuming with limitations for the large-scale industrial application. The Breath Figure method is a new fast and highly controllable technique that allows to decorate the surface of polymer films with different porous patterns. A large variety of starting materials can be used to perform this process, obtaining porous films with different characteristics and with a specific control on the entire process. In this work we used a UV cross-linkable polysiloxane as precursor for the Breath Figure process in order to combine the pattern procedure with the polymer derived ceramic method. Initially, the effects of the process variables on the final surface porosity was evaluated, identifying the parameters which most influence the final material. After the patterning, materials with different characteristics were pyrolyzed under different atmospheres in order to induce simultaneously the ceramic conversion and the chemical modification of the silicone structure. Three different porous silicon-based ceramics were obtained using flowing air, nitrogen and ammonia during the heat treatments, respectively: silicon dioxide, silicon oxycarbide and silicon oxynitride. All these material have been proposed as implant coating for different body districts, but recent studies demonstrated the potential application of silicon oxynitrides as bone implant coatings due to the enhanced bioactivity and osteoinductivity of the ceramic. For this reason in the second part of this work we evaluated the potential bioactivity of surface porous silicon oxynitrides in terms of bioactive silicon ions release capability and effects of different porosity degrees on cells behavior. Four different surface pattern were applied on titanium alloy disks and used for an in vitro characterization using human Mesenchymal Stem Cells and compared with uncoated titanium. The results indicated that the silicon ions release from the coating surface leads to an increase of the cellular activity with the porous pattern influencing the hMSC initial adhesion and proliferation.

Surface porous silicon based ceramics are a class of materials with excellent mechanical, physical and chemical properties and for this reason they are widely used in different fields of application. The resultant properties of these material are due principally to the combination of the chemical composition (coordination with the Si atom) and the specific geometry of the pattern. These parameters are able to influence phenomena such as the biological activity, the exposed surface area and the thermal, mechanical and chemical resistance. Techniques used nowadays to synthesize these ceramics with a specific patter are usually really complicated, expensive and time-consuming with limitations for the large-scale industrial application. The Breath Figure method is a new fast and highly controllable technique that allows to decorate the surface of polymer films with different porous patterns. A large variety of starting materials can be used to perform this process, obtaining porous films with different characteristics and with a specific control on the entire process. In this work we used a UV cross-linkable polysiloxane as precursor for the Breath Figure process in order to combine the pattern procedure with the polymer derived ceramic method. Initially, the effects of the process variables on the final surface porosity was evaluated, identifying the parameters which most influence the final material. After the patterning, materials with different characteristics were pyrolyzed under different atmospheres in order to induce simultaneously the ceramic conversion and the chemical modification of the silicone structure. Three different porous silicon-based ceramics were obtained using flowing air, nitrogen and ammonia during the heat treatments, respectively: silicon dioxide, silicon oxycarbide and silicon oxynitride. All these material have been proposed as implant coating for different body districts, but recent studies demonstrated the potential application of silicon oxynitrides as bone implant coatings due to the enhanced bioactivity and osteoinductivity of the ceramic. For this reason in the second part of this work we evaluated the potential bioactivity of surface porous silicon oxynitrides in terms of bioactive silicon ions release capability and effects of different porosity degrees on cells behavior. Four different surface pattern were applied on titanium alloy disks and used for an in vitro characterization using human Mesenchymal Stem Cells and compared with uncoated titanium. The results indicated that the silicon ions release from the coating surface leads to an increase of the cellular activity with the porous pattern influencing the hMSC initial adhesion and proliferation.

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Após alerta sanitário emitido pela Agencia Francesa de Segurança Sanitária de Produtos de Saúde (AFFSAPS) de não conformidades no silicone utilizado para fabricação de próteses mamárias da empresa Poly Implant Prothese (PIP), a Agência Nacional de Vigilância Sanitária (ANVISA) publicou regulamentação estabelecendo a necessidade de certificação no âmbito do Sistema Brasileiro de Avaliação da Conformidade (SBAC) segundo parâmetros de Portaria do Instituto Nacional de Metrologia, Qualidade e Tecnologia (INMETRO) para avaliação de conformidade para Implantes Mamários. Dentre outros requisitos foi estabelecida a obrigatoriedade de observação das condições descritas na referida portaria. Neste trabalho foram avaliadas amostras de próteses mamárias de silicone de um mesmo fabricante, com as mesmas especificações, variando apenas o número dos lotes. Observaram-se as características macroscópicas das amostras como variáveis para a realização de ensaios normatizados. Foram comparadas características das amostras como rugosidade, cor, consistência, deformação, aderência ao elastômero, adesividade do gel e comportamento mecânico das membranas quando submetidas ao ensaio de tração. Embora tenham sido avaliadas próteses com as mesmas especificações de fabrica, foram observadas diferenças nas características macroscópicas das amostras e na resistência à tração. Quando avaliados em conjunto, os dados demonstram discrepâncias nas características das amostras e inconformidades com as normas estabelecidas.
After health alert issued by the French Agency for Sanitary Safety of Health Products (AFFSAPS) of non-compliance in the silicone used for the manufacture of breast implants the company Poly Implant Prothese (PIP), the Brazilian Health Surveillance Agency (ANVISA) has published regulations establishing certification requirement under the Brazilian System of Conformity Assessment (SBAC) within the parameters of Ordinance of the National Institute of Metrology, Quality and Technology (Inmetro) for conformity assessment to Breast Implants. Among other requirements the obligation to observe the conditions described in the said ordinance was established. In this work we were evaluated samples of silicone breast implants from the same manufacturer with the same specifications, varying only the number of lots. Were observed in the macroscopic characteristics of the samples as variable for performing standardized tests. Sample characteristics were compared as roughness, color, consistency, deformation, adhesion to the elastomer, gel adhesive and mechanical behavior of the membrane when subjected to tensile test. Although dentures have been evaluated with the same specifications of manufactures, differences were observed in macroscopic characteristics of the samples and tensile strength. When evaluated together, the data show differences in the characteristics of samples and noncompliance with established standards.

Background: The use of acellular dermal matrices has become increasingly popular in immediate and delayed tissue expander/implant–based breast reconstruction. However, it is unclear whether their use is associated with increased postoperative complication rates. Using the American College of Surgeons National Surgical Quality Improvement Program database, the authors assessed baseline differences in demographics and comorbidities with and without acellular dermal matrix and determined whether postoperative complication rates varied. Methods: Using the national surgical database (2005 to 2011), tissue expander/ implant–based breast reconstruction cases were extracted using Current Procedural Terminology codes. Differences in preoperative demographics and comorbidities were assessed using chi-square and t test analysis using SPSS. The authors analyzed variations in complication rates and determined whether demographics and comorbidities affected outcomes using multivariate logistical analysis. A post hoc power study was calculated. Results: Of 19,100 cases, 3301 involved acellular dermal matrix use. Overall complication rates were not statistically significant (acellular dermal matrix, 5.3 percent; non–acellular dermal matrix, 4.9 percent; p = 0.396). Several risk factors were statistically significant associated factors of complications. Higher body mass index was associated with wound complications in both cohorts. In the non–acellular dermal matrix group, body mass index, smoking, and diabetes were associated with major complications, and radiotherapy and steroid use with minor complications. Conclusions: Acellular dermal matrix use did not appear to increase complication rates in tissue expander/implant–based breast reconstruction in this survey of a national surgical database. There was no significant difference in complication rates between the acellular dermal matrix and non–acellular dermal matrix groups.

Since their discovery breast prostheses have been criticized for being responsible for triggering systemic autoimmune disease. The presence of breast implants causes a natural foreign body reaction characterized by the infiltration of macrophages and T-cells. In order to understand which immunological pathways could be responsible for giving rise to, and the development of, connective tissue disease such as systemic sclerosis, I considered the cells and cytokines involved, focusing on the relationship between tissue growth factor-β, interleukin (IL)-1, IL-6 and T helper 17 and/or T regulatory cells, and their effects on the different steps of capsular tissue formation. A disturbance in the modulation of these key cytokines may be responsible, in susceptible individuals, for a perpetuation of the inflammatory reaction which can locally lead to capsular contracture and at the systemic level may contribute to triggering autoimmune diseases
Sin dalla loro creazione le protesi mammarie sono state considerate responsabili della possibile insorgenza di malattie autoimmuni sistemiche. La presenza di protesi mammarie provoca una reazione naturale da corpo estraneo caratterizzata dall’infiltrazione di macrofagi e linfociti T. Al fine di capire i meccanismi immunologici che stanno alla base dell’insorgenza e dello sviluppo di malattie, come la sclerodermia, ho considerato le cellule e le citochine coinvolte, focalizzando l’attenzione sulla relazione tra il TGF-β, l’interleuchina (IL)-1, IL-6, i T helper 17 e/o le cellule T regolatrici, e il loro effetto sulle diverse fasi di formazione del tessuto capsulare. Un disturbo nella modulazione di queste citochine chiave può essere responsabile, in soggetti sensibili, di una cronicizzazione della reazione infiammatoria, che può localmente portare a contrattura capsulare e a livello sistemico può contribuire a innescare malattie autoimmuni

O objetivo desse trabalho foi estudar a viabilidade de adaptação do Implantador Iônico da Universidade de São Paulo para a técnica de Accelerator Mass Spectrometry (AMS), tendo em vista as baixas energias utilizadas por este acelerador de partículas. A técnica de AMS, amplamente utilizada para a análise de Carbono-14 no estudo de datação de fósseis, requer que algum componente do acelerador garanta a quebra de moléculas de massa 14, contaminantes no processo de medição dos átomos de carbono com massa 14. Com a utilização de energias da ordem de dezenas de keV no acelerador, o estudo do processo de quebra de moléculas para estas energias foi realizado através do projeto, construção e caracterização de um stripper gasoso. Para caracterizar o stripper implementado foram realizadas medidas de seção de choque para troca de carga do feixe e quebra molecular em função da pressão de gás injetado no stripper. Também investigou-se a influência do átomo utilizado como gás, através de três diferentes gases injetados no stripper: Hélio, Argônio e Xenônio. Alguns feixes posivos foram produzidos no Implantador para o estudo destas seções de choques: Ar+, Ar(2+), CO+, CO2(+) e O2(+). O projeto do stripper foi idealizado para minimizar a variação de pressão no interior do implantador, visando preservar as condições da fonte de íons. Curvas de perfil de pressão de gás dentro do tubo do stripper foram calculadas segundo as teorias da Tecnologia do Vácuo que permitiram tanto a estimativa desta variação quanto a quantidade de gás no interior do stripper. Também foram realizados estudos do perfil de pressão em stripper com outras geometrias (cônicas abertas e fechadas), buscando estimar a otimização da espessura do stripper em função da injeção de gás em sua base. Baseando-se nos resultados, foram apontadas mudanças necessárias no atual estágio de adaptação desse acelerador de partículas para que se torne possível a concepção de um sistema AMS em sua linha de pesquisa.
The present work aimed on studying the feasibility of adapting the Ion Implanter of University of Sao Paulo to the Accelerator Mass Spectrometry technique, taking into account the low energies employed by this type of particle accelerator. The AMS technique, largely applied to the Carbon-14 analysis for fossil dating, requires the breaking of molecules with mass 14 by some component in the accelerator, since these lead to interference on the Carbon-14 counting process. By employing energies on the level of keV in the accelerator, the study of the breaking process of the molecules for this energy was accomplished by means desiring, building and characterization of a gaseous stripper. In order to characterize the installed stripper, measurements were taken of the charge state exchange and molecular break up process as a function of the pressure of the gas injection into the stripper. The influence of the atom employed as gas was also investigated. The experiments were realized with the following different gases: Helium, Argon and Xenon. Some positive beams were produced on the implanter: Ar+, \\Ar(2+), CO+, CO2(+) and O2(+). The designed stripper was idealized to minimize the pressure variation on the inside of the implanter in order to preserve the conditions of the ion source. Pressure profiles of the gas inside the stripper were calculated according to the Vacuum Technology theory, which allowed estimating the quantity of gas inside the stripper. Studies on the pressure profile for different stripper geometries (open and closed conic forms) were also carried out to estimate the optimization of the stripper thickness as a function of the gas injection on its base. Based on the results, specifications for further work and changes on the current system were listed to make it possible to implement the AMS system.

碩士
元培醫事科技大學
醫學影像暨放射技術系碩士班
107
Introduction: According to the statistics of the Taiwan Ministry of Health and Welfare in 2017, breast cancer is the fourth largest cancer death in Taiwan and the first female cancer. Due to the rapid progress of medical beauty in recent years, the number of women with breast augmentation has increased. Many women suffer from rupture of the implant due to concerns about mammography screening, and the implant does not penetrate completely under X-rays to cover the breast lesions under the implant, increasing the difficulty of screening. However, most of today's mammography uses Automatic Exposure System (AEC) illumination, but breast implants are not easy to penetrate, and the required dose varies depending on the material, so it is necessary to manually adjust the dose. Compared with the actual clinical dose, the original recommended set value is too low to provide a diagnostic value image, and the original factory does not provide post-compression illumination parameters. Purpose: Simulated human breast tissue replaces the rigid prosthesis PMMA used by the product with Bolus and adds implants of different materials to evaluate images under various exposure conditions to construct an optimized breast implant image. These conditions will provide reference for radiologist when performing clinically photography. Materials and Methods: Bolus simulated breast tissue was sandwiched between silicone and saline bags and the fiber strips, calcifications and masses were simulated with fishing lines, fish bones, bone meal and pork slices. The images obtained by adding and subtracting the kVp and mAs parameters of the three ranges by manual adjustment are compared with the AEC image. The kVp manual setting mAs and the fixed mAs were manually measured to set the kVp dose values for the saline bag and the silicone implant thicknesses of 5, 6, 7, 8, 9, 10 and 11 cm, respectively. After being interpreted by two radiologists and five mammography screen radiologists technician, they were scored according to the image clarity. Results and Conclusions: The original recommended setting conditions and automatic detection and manual parameters change, the tissue thickness of 5cm, 6cm, 7cm, 8cm, 9cm, 10cm and 11cm, the thickness of the seven kinds of salt water bags and silicone implants, the average breast absorption dose is not significant difference. In the 8-10 cm aspect, the average glandular dose per 1 cm thickness of the saline bag and the silicone implant is about 0.13 ± 0.015 mGy, and the overall average dose of the saline bag will be higher than that of the silicone implant. After 11 cm, the saline bag will be higher than the silicone implant of 1.799 ± 0.008 mGy. The difference is so much because the kVp must be 33 or more after the salt bag exceeds 11cm to produce a more diagnostic image. If the thickness of the breast implant exceeds 8 cm, it is not recommended to use the factory setting reference value. The saline bag can be irradiated with an automatic exposure mode below 6 cm, and the silicone implant is preferably set by manual parameters.