Breast implant-associated anaplastic large cell lymphoma: two distinct clinicopathological variants with different outcomes.

BACKGROUND: ALK-negative anaplastic large cell lymphoma associated with breast implant (i-ALCL) has been recently recognized as a distinct entity. Among 43 830 lymphomas registered in the French Lymphopath network since 2010, 300 breast lymphomas comprising 25 peripheral T-cell lymphomas (PTCL) were reviewed. Among PTCL, ALK-negative ALCL was the most frequent and all of them were associated with breast implants. PATIENTS AND METHODS: Since 2010, all i-ALCL cases were collected from different institutions through Lymphopath. Immuno-morphologic features, molecular data and clinical outcome of 19 i-ALCLs have been retrospectively analyzed. RESULTS: The median age of the patients was 61 years and the median length between breast implant and i-ALCL was 9 years. Most implants were silicone-filled and textured. Implant removal was performed in 17 out of 19 patients with additional treatment based on mostly CHOP or CHOP-like chemotherapy regimens (n = 10/19) or irradiation (n = 1/19). CHOP alone or ABVD following radiation without implant removal have been given in two patients. The two clinical presentations, i.e. effusion and less frequently tumor mass correlated with distinct histopathologic features: in situ i-ALCL (anaplastic cell proliferation confined to the fibrous capsule) and infiltrative i-ALCL (pleomorphic cells massively infiltrating adjacent tissue with eosinophils and sometimes Reed-Sternberg-like cells mimicking Hodgkin lymphoma). Malignant cells were CD30-positive, showed a variable staining for EMA and were ALK negative. Most cases had a cytotoxic T-cell immunophenotype with variable T-cell antigen loss and pSTAT3 nuclear expression. T-cell receptor genes were clonally rearranged in 13 out of 13 tested cases. After 18 months of median follow-up, the 2-year overall survival for in situ and infiltrative i-ALCL was 100% and 52.5%, respectively. CONCLUSIONS: In situ i-ALCLs have an indolent clinical course and generally remain free of disease after implant removal. However, infiltrative i-ALCLs could have a more aggressive clinical course that might require additional therapy to implant removal.

Systemic Inflammatory Reaction After Silicone Breast Implant

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

Breast Implants Information for women considering breast implants

Breast Implants Information for women considering breast implants The information in this booklet is being provided for women considering the option of breast implant surgery. The aim of the booklet is to assist women in making an informed choice about breast implants before opting for surgery. The information has been compiled by a subcommittee of the Advisory Committee for Medical Devices at the Irish Medicines Board and has included consultation with health professionals and representatives of interested organisations.  Download the PDF

Optimizing the nipple-areola sparing mastectomy with double concentric periareolar incision and biodimensional expander-implant reconstruction: Aesthetic and technical refinements

Although the biodimensional anatomical expander-implant system (BEIS) is a reliable technique, little information has been available regarding outcome following nipple-areola sparing mastectomy (NSM). To perform the resection of glandular tissue, while improving the surgical access and maintaining the nipple-areola vascularization we have developed a new approach for NSM based on the double concentric periareolar incision (DCPI). The purpose of this study is to analyze the feasibility, surgical planning and its outcome following NSM. 18 patients underwent NSM reconstructions. Mean time of follow-up was 29 months. The technique was indicated in patients with small/moderate volume breasts. Flap complications were evaluated and information on aesthetic results and patient satisfaction were collected. 83.3% had tumors measuring 2 cm or less (T1) and 72.1% were stage 0 and 1. All patients presented peripherally tumors located (at least 5 cm from the nipple). Skin complications occurred in 11.1%. One patient (5.5%) presented small skin necrosis and a wound dehiscence was observed in one patient (5.5%). The aesthetic result was good/very good in 94.4 percent and the majority of patients were very satisfied/satisfied. No local recurrences were observed. All complications except one were treated by a conservative approach. DCPI-BEIS is a simple and reliable technique for NSM reconstruction. The success depends on patient selection, coordinated planning with the oncologic surgeon and careful intra-operative and post-operative management. (C) 2009 Elsevier Ltd. All rights reserved.

Vascular postpneumonectomy syndrome: inferior vena cava and pulmonary vein compression as unusual cause for platypnea-orthodeoxia following pneumonectomy

Background: Excessive mediastinal shift into the vacated thoracic cavity after pneumonectomy can result in dyspnea without hypoxemia by compression of the tracheobronchial tree, a phenomenon called postpneumonectomy syndrome. More rarely hypoxemia in upright position (platypnea-orthodeoxia syndrome, POS) after pneumonectomy can result from re-opening of an atrial right-to-left shunt through a patent foramen ovale (PFO) due to mediastinal distorsion. Review of literature also shows a unique report of pulmonary veins stenosis resulting in POS without intracardiac shunt after pneumonectomy. Methods: We report the case of a 32-year-old woman who presented POS 6 months after right pneumonectomy for destroyed lung post tuberculosis. Results: The patient described severe dyspnea disappearing when lying. SpO2 decreased from 94% when lying to 60% sitting. Transthoracic echocardiography (TTE) suspected a possible PFO. We first tried to highlight clinical repercussions of PFO by noninvasive exams. Hyperoxia shunt quantification was not tolerated because of increased dyspnea in sitting position. Contrast bubbles TTE was difficult because of the important mediastinal shift but identified only rare left heart bubbles with/without Valsalva both in lying and sitting position, excluding a significant right-to-left shunt. A lung perfusion scintigraphy (injection while sitting) confirmed the absence of systemic isotope uptake. Computed tomographic pulmonary angiography (angio-CT) revealed a stretched but not stenosed left main bronchus, while the shift of the heart into the right cavity was major. Pulmonary angiography did not show embolism but revealed compression of the inferior vena cava (IVC) with impaired venous return to the right heart, as well as compression of the left pulmonary veins. There was no arteriovenous shunt. Cardiac MRI showed torsion of IVC at the level of the diaphragm, and strong atrial contraction contributing to a passive filling of the RV, while the right ventricle was normal. Right catheterism showed major hemodynamic disturbances with negative diastolic pressure in right heart cavities (atrium -12 mm Hg ventricle pressure -7 mm Hg). SaO2 measured in the pulmonary artery decreased from 58% when lying to 45% sitting. Conclusion: We described here an exceedingly rare and complex mechanism explaining POS after right pneumonectomy. Mediastinal repositioning with a silicone breast implant of appropriate size has been scheduled.

Se_nos gener@ mujeres La construcción discursiva del pecho femenino en el ámbito médico

El objetivo de este artículo es reflexionar sobre el impacto de los mandatos de género en los cuerpos de las mujeres en el contexto biomédico. Exploramos cómo se construye discursivamente la mamoplastia en tres grupos de mujeres: que han padecido cáncer de pecho, trans y que se intervienen por motivos estéticos. Mediante el análisis del discurso estudiamos cómo profesionales de la salud especialistas en los tres casos elaboran la distinción entre ellos, cómo otorgan diferentes grados de legitimidad a la demanda y cómo justifican si su coste se debe cubrir públicamente. Resultado de este análisis detectamos que se establecen dos fronteras entre los cuerpos susceptibles de recibir esta intervención: una relativa a la necesidad y otra a la legitimidad de la demanda.

Managing the risks of medical technology: Do hazard surveillance systems provide an early warning of medical device problems?

The Food and Drug Administration (FDA) is responsible for risk assessment and risk management in the post-market surveillance of the U.S. medical device industry. One of the FDA regulatory mechanisms, the Medical Device Reporting System (MDR) is an adverse event reporting system intended to provide the FDA with advance warning of device problems. It includes voluntary reporting for individuals, and mandatory reporting for device manufacturers. ^ In a study of alleged breast implant safety problems, this research examines the organizational processes by which the FDA gathers data on adverse events and uses adverse event reporting systems to assess and manage risk. The research reviews the literature on problem recognition, risk perception, and organizational learning to understand the influence highly publicized events may have on adverse event reporting. Understanding the influence of an environmental factor, such as publicity, on adverse event reporting can provide insight into the question of whether the FDA's adverse event reporting system operates as an early warning system for medical device problems. ^ The research focuses on two main questions. The first question addresses the relationship between publicity and the voluntary and mandatory reporting of adverse events. The second question examines whether government agencies make use of these adverse event reports. ^ Using quantitative and qualitative methods, a longitudinal study was conducted of the number and content of adverse event reports regarding breast implants filed with the FDA's medical device reporting system during 1985–1991. To assess variation in publicity over time, the print media were analyzed to identify articles related to breast implant failures. ^ The exploratory findings suggest that an increase in media activity is related to an increase in voluntary reporting, especially following periods of intense media coverage of the FDA. However, a similar relationship was not found between media activity and manufacturers' mandatory adverse event reporting. A review of government committee and agency reports on the FDA published during 1976–1996 produced little evidence to suggest that publicity or MDR information contributed to problem recognition, agenda setting, or the formulation of policy recommendations. ^ The research findings suggest that the reporting of breast implant problems to FDA may reflect the perceptions and concerns of the reporting groups, a barometer of the volume and content of media attention. ^

Segurança biológica de implantes mamários de silicone: interrelação entre processos esterilizantes e biocompatibilidade

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.

Breast phantom with silicone implant for evaluation in conventional mammography

With the increased incidence of cancer and a similarly increased number of surgeries for insertion of silicone breast implants, it is necessary to assess the effect of such material within the breast tissue, particularly in mammography, because of the reduction in the power of breast cancer diagnosis. In this work, we introduce a breast phantom with silicone implants in order to evaluate the influence of the implant on the visibility of the main mammographic findings: fibers, microcalcifications and tumor masses. In this proposed phantom, the breast tissue was simulated using gel paraffin. In the optical density of phantom mammograms with implants, a reduction in breast tissue visibility was seen corresponding to 23% when compared to a phantom without silicone implants. This poor visibility was due to the X-ray beam scattering on silicone material; this effect produced a loss of visibility in the areas adjacent to the implant. It is expected that the proposed phantom model may be used as a device for the establishment of a technical standard for these types of procedures.

Applying scanning electron microscopy for the ultrastructural and clinical analysis of periprosthetic capsules in implant-based breast reconstruction

La reconstruction en deux étapes par expanseur et implant est la technique la plus répandue pour la reconstruction mammmaire post mastectomie. La formation d’une capsule périprothétique est une réponse physiologique universelle à tout corps étranger présent dans le corps humain; par contre, la formation d’une capsule pathologique mène souvent à des complications et par conséquent à des résultats esthétiques sous-optimaux. Le microscope électronique à balayage (MEB) est un outil puissant qui permet d’effectuer une évaluation sans pareille de la topographie ultrastructurelle de spécimens. Le premier objectif de cette thèse est de comparer le MEB conventionnel (Hi-Vac) à une technologie plus récente, soit le MEB environnemental (ESEM), afin de déterminer si cette dernière mène à une évaluation supérieure des tissus capsulaires du sein. Le deuxième objectif est d‘appliquer la modalité de MEB supérieure et d’étudier les modifications ultrastructurelles des capsules périprothétiques chez les femmes subissant différents protocoles d’expansion de tissus dans le contexte de reconstruction mammaire prothétique. Deux études prospectives ont été réalisées afin de répondre à nos objectifs de recherche. Dix patientes ont été incluses dans la première, et 48 dans la seconde. La modalité Hi-Vac s’est avérée supérieure pour l’analyse compréhensive de tissus capsulaires mammaires. En employant le mode Hi-Vac dans notre protocole de recherche établi, un relief 3-D plus prononcé à été observé autour des expanseurs BIOCELL® dans le groupe d’approche d’intervention retardée (6 semaines). Des changements significatifs n’ont pas été observés au niveau des capsules SILTEX® dans les groupes d’approche d’intervention précoce (2 semaines) ni retardée.

Applying scanning electron microscopy for the ultrastructural and clinical analysis of periprosthetic capsules in implant-based breast reconstruction

La reconstruction en deux étapes par expanseur et implant est la technique la plus répandue pour la reconstruction mammmaire post mastectomie. La formation d’une capsule périprothétique est une réponse physiologique universelle à tout corps étranger présent dans le corps humain; par contre, la formation d’une capsule pathologique mène souvent à des complications et par conséquent à des résultats esthétiques sous-optimaux. Le microscope électronique à balayage (MEB) est un outil puissant qui permet d’effectuer une évaluation sans pareille de la topographie ultrastructurelle de spécimens. Le premier objectif de cette thèse est de comparer le MEB conventionnel (Hi-Vac) à une technologie plus récente, soit le MEB environnemental (ESEM), afin de déterminer si cette dernière mène à une évaluation supérieure des tissus capsulaires du sein. Le deuxième objectif est d‘appliquer la modalité de MEB supérieure et d’étudier les modifications ultrastructurelles des capsules périprothétiques chez les femmes subissant différents protocoles d’expansion de tissus dans le contexte de reconstruction mammaire prothétique. Deux études prospectives ont été réalisées afin de répondre à nos objectifs de recherche. Dix patientes ont été incluses dans la première, et 48 dans la seconde. La modalité Hi-Vac s’est avérée supérieure pour l’analyse compréhensive de tissus capsulaires mammaires. En employant le mode Hi-Vac dans notre protocole de recherche établi, un relief 3-D plus prononcé à été observé autour des expanseurs BIOCELL® dans le groupe d’approche d’intervention retardée (6 semaines). Des changements significatifs n’ont pas été observés au niveau des capsules SILTEX® dans les groupes d’approche d’intervention précoce (2 semaines) ni retardée.

Sonication of removed breast implants for improved detection of subclinical infection.

BACKGROUND: Capsular fibrosis is a severe complication after breast implantation with an uncertain etiology. Microbial colonization of the prosthesis is hypothesized as a possible reason for the low-grade infection and subsequent capsular fibrosis. Current diagnostic tests consist of intraoperative swabs and tissue biopsies. Sonication of removed implants may improve the diagnosis of implant infection by detachment of biofilms from the implant surface. METHODS: Breast implants removed from patients with Baker grades 3 and 4 capsular contracture were analyzed by sonication, and the resulting sonication fluid was quantitatively cultured. RESULTS: This study investigated 22 breast implants (6 implants with Baker 3 and 16 implants with Baker 4 capsular fibrosis) from 13 patients. The mean age of the patients was 49 years (range, 31-76 years). The mean implant indwelling time was 10.4 years (range, 3 months to 30 years). Of the 22 implants, 12 were used for breast reconstruction and 10 for aesthetic procedures. The implants were located subglandularly (n = 12), submuscularly (n = 6), and subcutaneously (n = 4). Coagulase-negative staphylococci, Propionibacterium acnes, or both were detected in the sonication fluid cultures of nine implants (41%), eight of which grew significant numbers of microorganisms (>100 colonies/ml of sonication fluid). CONCLUSIONS: Sonication detected bacteria in 41% of removed breast implants. The identified bacteria belonged to normal skin flora. Further investigation is needed to determine any causal relation between biofilms and capsular fibrosis.

Propionibacterium acnes: An Underestimated Pathogen in Implant-Associated Infections.

The role of Propionibacterium acnes in acne and in a wide range of inflammatory diseases is well established. However, P. acnes is also responsible for infections involving implants. Prolonged aerobic and anaerobic agar cultures for 14 days and broth cultures increase the detection rate. In this paper, we review the pathogenic role of P. acnes in implant-associated infections such as prosthetic joints, cardiac devices, breast implants, intraocular lenses, neurosurgical devices, and spine implants. The management of severe infections caused by P. acnes involves a combination of antimicrobial and surgical treatment (often removal of the device). Intravenous penicillin G and ceftriaxone are the first choice for serious infections, with vancomycin and daptomycin as alternatives, and amoxicillin, rifampicin, clindamycin, tetracycline, and levofloxacin for oral treatment. Sonication of explanted prosthetic material improves the diagnosis of implant-associated infections. Molecular methods may further increase the sensitivity of P. acnes detection. Coating of implants with antimicrobial substances could avoid or limit colonization of the surface and thereby reduce the risk of biofilm formation during severe infections. Our understanding of the role of P. acnes in human diseases will likely continue to increase as new associations and pathogenic mechanisms are discovered.