DOCSLIB.ORG

Preliminary Opinion on the Safety of Breast Implants in Relation To

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Preliminary Opinion on the Safety of Breast Implants in Relation To Breast implant safety and Anaplastic Large Cell Lymphoma Preliminary Opinion 1 2 3 4 5 6 7 8 Scientific Committee on Health, Environmental and Emerging Risks 9 (SCHEER) 10 11 12 13 14 15 Preliminary Opinion 16 on the safety of breast implants 17 in relation to anaplastic large cell lymphoma 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 The SCHEER adopted this Opinion at its plenary meeting on 8 October 2020 33 34 Breast implants safety and Anaplastic Large Cell Lymphoma Preliminary Opinion _________________________________________________________________________________________ 1 2 ABSTRACT 3 4 The SCHEER was requested by the European Commission to provide a scientific opinion on 5 the safety of breast implants in relation to anaplastic large cell lymphoma (ALCL). 6 7 Literature searches were carried out using PubMed and Find-eR. The publication period 8 covered was from 1 September 2016 to 31 August 2019, and an additional search was 9 performed early in 2020 covering the period from 1 September 2019 to 30 April 2020. In 10 addition, relevant sources and literature beyond this period was considered as well. After 11 excluding all irrelevant papers and duplicate papers, a total of 605 papers remained and 12 were evaluated for this Scientific Opinion. 13 14 BIA-ALCL is the occurrence of ALCL adjacent to a breast implant. Diagnosis of BIA-ALCL is 15 achieved by analysis of seroma fluid or if a mass, core needle, incisional or excisional tissue 16 biopsy. Radical en bloc surgical resection (i.e. implant including seroma and intact capsule) 17 with safe margins, including healthy tissue, is recommended as the standard of care 18 treatment, with a very good prognosis. The incidence of BIA-ALCL is considered low, varies 19 by implant type, and is mainly associated with textured implants. However, estimates of 20 incidence have significant limitations related to the frequent use of ad hoc reporting of 21 cases compared with systematic reporting, and the use of sales data provided by 22 manufacturers. Surface textures of breast implants are not all manufactured in the same 23 way. Overall there is a moderate level of evidence for a causal relationship between 24 textured breast implants and ALCL; however, the pathogenic mechanisms are not well 25 understood; current hypotheses include genetic predisposition, bacterial contamination 26 resulting in chronic inflammation, shell shedding of particulates resulting in chronic 27 inflammation, shell surface characteristics leading to friction resulting in inflammation, and 28 implant associated reactive compounds. The disease latency varies between a few to 20 29 or even more years. There are several alternatives to breast implants that involve plastic 30 surgery techniques, either using autologous flap tissue or autologous fat transfer. 31 32 There is a need for further research to better understand the aetiology and pathogenesis 33 of BIA-ALCL. Reporting of new BIA-ALCL cases by the relevant registries is also of major 34 importance to obtain a better estimate of the risk of BIA-ALCL for patients with a breast 35 implant. 36 37 Keywords: breast implants, anaplastic large cell lymphoma, cancer, BIA-ALCL 38 39 Opinion to be cited as: 40 41 SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), Scientific 42 Opinion on the safety of breast implants in relation to anaplastic large cell lymphoma, 8 43 October 2020 44 _________________________________________________________________________________________ 2 Breast implants safety and Anaplastic Large Cell Lymphoma Preliminary Opinion _________________________________________________________________________________________ 1 2 ACKNOWLEDGMENTS 3 4 5 Members of the Working Group are acknowledged for their valuable contribution to this 6 scientific advice. The members of the Working Group are: 7 8 9 The SCHEER members: 10 11 Roberto Bertollini 12 Wim H De Jong (Chair) 13 Demosthenes Panagiotakos (Rapporteur) 14 Ana Proykova 15 Theodoros Samaras 16 17 18 The external experts: 19 20 Mark Clemens (The University of Texas MD Anderson Cancer Center, Houston, USA) 21 Daphne De Jong (Amsterdam UMC, VU University Medical Center, Amsterdam, The 22 Netherlands) 23 Ingrid Hopper (Monash University, Melbourne, Australia) 24 Hinne Rakhorst (Medisch Spectrum Twente, Enschede, The Netherlands) 25 Fabio Santanelli di Pompeo (Sapienza University of Rome, Rome, Italy) 26 Suzanne Turner (University of Cambridge, UK) 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 All Declarations of Working Group members are available at the following webpage: 43 Register of Commission expert groups and other similar entities 44 45 46 47 48 49 50 51 52 53 54 _________________________________________________________________________________________ 3 Breast implants safety and Anaplastic Large Cell Lymphoma Preliminary Opinion _________________________________________________________________________________________ 1 2 About the Scientific Committees (2016-2021) 3 Two independent non-food Scientific Committees provide the Commission with the 4 scientific advice it needs when preparing policy and proposals relating to consumer safety, 5 public health and the environment. The Committees also draw the Commission's attention 6 to the new or emerging problems, which may pose an actual or potential threat. 7 These committees are the Scientific Committee on Consumer Safety (SCCS) and the 8 Scientific Committee on Health, Environmental and Emerging Risks (SCHEER), both of 9 which are composed of scientists appointed in their personal capacity. 10 In addition, the Commission relies upon the work of other Union bodies, such as the 11 European Food Safety Authority (EFSA), the European Medicines Agency (EMA), the 12 European Centre for Disease Prevention and Control (ECDC) and the European Chemicals 13 Agency (ECHA). 14 15 SCHEER 16 This Committee, on request of Commission services, provides Opinions on questions 17 concerning health, environmental and emerging risks. The Committees addresses 18 questions on: 19 - health and environmental risks related to pollutants in the environmental media and other 20 biological and physical factors in relation to air quality, water, waste and soils. 21 22 - complex or multidisciplinary issues requiring a comprehensive assessment of risks to 23 consumer safety or public health, for example antimicrobial resistance, nanotechnologies, 24 medical devices and physical hazards such as noise and electromagnetic fields. 25 26 SCHEER members 27 Roberto Bertollini, Teresa Borges, Wim de Jong, Pim de Voogt, Raquel Duarte-Davidson, 28 Peter Hoet, Rodica Mariana Ion, Renate Kraetke, Demosthenes Panagiotakos, Ana 29 Proykova, Theodoros Samaras, Marian Scott, Emanuela Testai, Theo Vermeire, Marco 30 Vighi, Sergej Zacharov 31 32 Contact 33 European Commission 34 Health and Food Safety 35 Directorate C: Public Health 36 Unit C2: Health information and integration in all policies 37 L-2920 Luxembourg 38 [email protected] 39 40 ©European Union, 2020 41 42 PDF ISBN xxx-xx-xx-xxxxx-x ISSN xxxx-xxxx doi:10.xxxx/xx...x xx-xx-xx-xxx-xx-x 43 44 Luxembourg: Publications Office of the European Union, 45 46 47 The Opinions of the Scientific Committees present the views of the independent 48 scientists who are members of the committees. They do not necessarily reflect the 49 views of the European Commission. The Opinions are published by the European 50 Commission in their original language only. 51 52 http://ec.europa.eu/health/scientific_committees/policy/index_en.htm 53 54 55 _________________________________________________________________________________________ 4 Breast implants safety and Anaplastic Large Cell Lymphoma Preliminary Opinion _________________________________________________________________________________________ 1 2 TABLE OF CONTENTS 3 4 ABSTRACT .......................................................................................................... 2 5 ACKNOWLEDGMENTS ........................................................................................... 3 6 1. MANDATE FROM THE EU COMMISSION SERVICES ............................................ 6 7 1.1 Background ................................................................................................ 6 8 1.2 Terms of Reference ..................................................................................... 7 9 2. CONCLUSIONS ................................................................................................. 8 10 2.1 Answers to the Terms of References .................................................................. 9 11 3. MINORITY OPINION ........................................................................................ 12 12 4. INTRODUCTION ............................................................................................. 13 13 4.1 Use of breast implants ................................................................................... 13 14 4.2 Types of breast implants ................................................................................ 14 15 4.3 Alternatives to breast implants ....................................................................... 15 16 4.4 Breast Implant Associated - Anaplastic Large Cell Lymphoma .............................. 17 17 4.4.1. Anaplastic Large Cell Lymphoma (ALCL) ....................................................... 17 18 4.4.2. Breast Implant Associated – Anaplastic Large Cell Lymphoma (BIA-ALCL) ......... 18 19 4.5 Treatment and prognosis of Breast Implant Associated - Anaplastic
Load more

Recommended publications
  • NDA/BLA Multi-Disciplinary Review and Evaluation
    NDA/BLA Multi-disciplinary Review and Evaluation NDA 214154 Nextstellis (drospirenone and estetrol tablets) NDA/BLA Multi-Disciplinary Review and Evaluation Application Type NDA Application Number(s) NDA 214154 (IND 110682) Priority or Standard Standard Submit Date(s) April 15, 2020 Received Date(s) April 15, 2020 PDUFA Goal Date April 15, 2021 Division/Office Division of Urology, Obstetrics, and Gynecology (DUOG) / Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM) Review Completion Date April 15, 2021 Established/Proper Name drospirenone and estetrol tablets (Proposed) Trade Name Nextstellis Pharmacologic Class Combination hormonal contraceptive Applicant Mayne Pharma LLC Dosage form Tablet Applicant proposed Dosing x Take one tablet by mouth at the same time every day. Regimen x Take tablets in the order directed on the blister pack. Applicant Proposed For use by females of reproductive potential to prevent Indication(s)/Population(s) pregnancy Recommendation on Approval Regulatory Action Recommended For use by females of reproductive potential to prevent Indication(s)/Population(s) pregnancy (if applicable) Recommended Dosing x Take one pink tablet (drospirenone 3 mg, estetrol Regimen anhydrous 14.2 mg) by mouth at the same time every day for 24 days x Take one white inert tablet (placebo) by mouth at the same time every day for 4 days following the pink tablets x Take tablets in the order directed on the blister pack 1 Reference ID: 4778993 NDA/BLA Multi-disciplinary Review and Evaluation NDA 214154 Nextstellis (drospirenone and estetrol tablets) Table of Contents Table of Tables .................................................................................................................... 5 Table of Figures ................................................................................................................... 7 Reviewers of Multi-Disciplinary Review and Evaluation ...................................................
    [Show full text]
  • Breast Disorders in Girls and Adolescents. Is There a Need for a Specialized Service?
    Original Study Breast Disorders in Girls and Adolescents. Is There a Need for a Specialized Service? Lina Michala MRCOG, PhD *, Alexandra Tsigginou MD, PhD, Dimitris Zacharakis MD, Constantine Dimitrakakis MD, PhD 1stDepartment of Obstetrics and Gynaecology, University of Athens, Alexandra Hospital, Athens, Greece abstract Introduction: Minor breast concerns in childhood and adolescence are common and lead to increased anxiety among young patients and their families, particularly due to high correlation with breast cancer. However, most breast services aim at managing adults and triaging patients with breast cancer, whereas adolescent medicine specialists or pediatricians are usually not appropriately trained to identify and treat breast pathology. Methods: We reviewed hospital records of all patients attending a pediatric and adolescent gynecology or breast clinic of a tertiary referral hospital, with a breast related symptom, between January 2009 and December 2011. We collected information regarding age at presen- tation, age at menarche, diagnosis, management and outcome. Results: We identified 81 patients of which 11 presented with an abnormal nipple or areolar secretion, 33 had a palpable lump, 20 had mastitis, and 16 had unequal breast development. One patient presented with virginal breast hypertrophy. Three out of 11 of the patients with an abnormal secretion had a cyst identified on ultrasonography. Out of the palpable lumps 12 were fibroadenomas, 3 were phyllodes tumors, and 14 were cystic in nature. The phyllodes tumors and half of the fibroadenomas were removed. The remaining fibroadenomas remain under regular ultrasonographic follow-up. All cases of mastitis were treated conservatively and resolved with broad spectrum antibiotic treatment. Conclusion: In our series, no malignancies were identified.
    [Show full text]
  • Cirugía De La Mama
    25,5 mm 15 GUÍAS CLÍNICAS DE LA ASOCIACIÓN ESPAÑOLA DE CIRUJANOS 15 CIRUGÍA DE LA MAMA Fernando Domínguez Cunchillos Sapiña Juan Blas Ballester Parga Gonzalo de Castro Fernando Domínguez Cunchillos Juan Blas Ballester Sapiña Gonzalo de Castro Parga CIRUGÍA DE LA MAMA CIRUGÍA SECCIÓN DE PATOLOGÍA DE LA MAMA Portada AEC Cirugia de la mama.indd 1 17/10/17 17:47 Guías Clínicas de la Asociación Española de Cirujanos CIRUGÍA DE LA MAMA EDITORES Fernando Domínguez Cunchillos Juan Blas Ballester Sapiña Gonzalo de Castro Parga SECCIÓN DE PATOLOGÍA DE LA MAMA © Copyright 2017. Fernando Domínguez Cunchillos, Juan Blas Ballester Sapiña, Gonzalo de Castro Parga. © Copyright 2017. Asociación Española de Cirujanos. © Copyright 2017. Arán Ediciones, S.L. Castelló, 128, 1.º - 28006 Madrid e-mail: [email protected] http://www.grupoaran.com Reservados todos los derechos. Esta publicación no puede ser reproducida o transmitida, total o parcialmente, por cualquier medio, electrónico o mecánico, ni por fotocopia, grabación u otro sistema de reproducción de información sin el permiso por escrito de los titulares del Copyright. El contenido de este libro es responsabilidad exclusiva de los autores. La Editorial declina toda responsabilidad sobre el mismo. ISBN 1.ª Edición: 978-84-95913-97-5 ISBN 2.ª Edición: 978-84-17046-18-7 Depósito Legal: M-27661-2017 Impreso en España Printed in Spain CIRUGÍA DE LA MAMA EDITORES F. Domínguez Cunchillos J. B. Ballester Sapiña G. de Castro Parga AUTORES A. Abascal Amo M. Fraile Vasallo B. Acea Nebril G. Freiría Barreiro J. Aguilar Jiménez C. A. Fuster Diana L.
    [Show full text]
  • Dicionario-Ilustrado-De-Saude.Pdf
    http://materialdeenfermagem.blogspot.com Aabcdefghijklmnopqrstuvwxyz A (1) em fisiologia, serve para representar o símbolo do ar alveolar; em física, é o símbolo do ampère. (2) em hematologia, o grupo sangüíneo A do ABO. (3) segundo som aórtico. a em fisiologia, é o símbolo do sangue arterial, ou ainda, serve para designar a abreviatura de artéria. a termo em obstetrícia, refere-se ao bebê nascido da 38a até a 41a semana de gestação. a-, an- prefixo de negação, afastamento de, não. A, fibra fibras nervosas mielínicas encontradas em nervos somáticos; conduzem impulsos nervosos a uma velocidade que varia de 6 a 120 m/s. aa ou ana- da expressão latina ana partes aequales. Nas receitas médicas, serve para designar a abreviação que é utilizada após duas ou mais substâncias para indicar que elas devem ser dadas em quantidades iguais. aania medo mórbido de perder a capacidade sexual. ab- palavra latina que significa “longe de”. É utilizada como um prefixo que in- dica distanciamento, afastamento, separação. Seu antônimo é o prefixo ad-. abacteriano que não contém bactérias. abacto aborto provocado. Abadie, sinal de espasmo do músculo elevador da pálpebra superior. abaixa-língua instrumento espatulado com que a língua é mantida abaixada para exame ou intervenção cirúrgica. Há vários tipos de abaixa-língua. abalienação distúrbio mental. aba-mordida, radiografia com filme tipo de radiografia que demonstra as co- roas e o terço superior das raízes dos dentes superiores e inferiores. Também denominada radiografia interproximal. abandônico criança ou adulto cujas dificuldades vitais estão centradas em tor- no do temor ou do sentimento, reais ou imaginários, de estar abandonado, de perder o amor de seus pais ou de seus próximos.
    [Show full text]
  • Scaffold in the Ptotic Breast: a Multicenter [email protected] DOI: 10.1093/Asj/Sjy022 Clinical Study
    Breast Surgery Aesthetic Surgery Journal 2018, Vol 38(5) 502–518 The Use of Poly-4-Hydroxybutyrate (P4HB) © 2018 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: Scaffold in the Ptotic Breast: A Multicenter [email protected] DOI: 10.1093/asj/sjy022 Clinical Study www.aestheticsurgeryjournal.com William P. Adams, Jr, MD; Richard Baxter, MD; Caroline Glicksman, MD; Bruce A. Mast, MD; Michael Tantillo, MD; and Bruce W. Van Natta, MD Abstract Background: Mastopexy and reduction mammaplasty are often limited by the patient’s poor native soft tissue quality, resulting in ptosis recurrence and loss of rejuvenated surgical results. Surgical scaffolds and acellular dermal matrices are used in these procedures to provide physical and mechanical stabilization of weakened or compromised tissue. GalaFLEX scaffold, made from poly-4-hydroxybutyrate (P4HB), is a next-generation product for soft tissue reinforcement that resorbs gradually while aiding tissue regeneration to achieve excellent outcomes. Objectives: To assess the clinical performance of GalaFLEX scaffold in soft tissue reinforcement during elective mastopexy and reduction mammaplasty. Methods: This multicenter, single-arm, observational study assessed product performance and outcomes of GalaFLEX scaffold when used in breast surgery. Outcomes included ptosis correction and maintenance, associated adverse events, patient and surgeon satisfaction, and mammographic and ultrasound imaging evaluation. Results: At 6 centers in the US, 62 of 69 enrolled patients were treated. Of this population, 89.7% had successful ptosis correction and maintenance at 1 year, with high patient and surgeon satisfaction for breast shape, droop/sag of the breast, and maintenance of results at 1 year.
    [Show full text]
  • Breast Augmentation Surgery Using an Inframammary
    Breast augmentation surgery using an inframammary fold incision in Southeast Asian Original Article women: Patient-reported outcomes Charles Randquist1, Yong Chen Por2,3, Vincent Yeow2,3, Joy Maglambayan4, Susan Simonyi4 1Victoriakliniken, Saltsjöbaden, Sweden; 2DREAM Aesthetics & Plastic Surgery, Singapore; 3KK Women’s and Children’s Hospital, Singapore; 4Allergan Singapore Pte Ltd, Singapore Background This analysis presents patient-reported outcomes of breast augmentation pro- Correspondence: Charles Randquist cedures performed in Singapore using an inframammary fold incision and the “5 Ps” best Victoriakliniken, Rosundavagen 4, SE-133 36 Saltsjöbaden, Sweden practice principles for breast augmentation. These data are the first of their kind in Southeast Tel: +46-853021000 Asian patients. Fax: +46-853021009 Methods Through a retrospective chart review, patients who underwent primary breast aug- E-mail: charles.randquist@ mentation with anatomical form-stable silicone gel breast implants using an inframammary victoriakliniken.com fold incision were followed for ≥ 6 months postoperatively. The BREAST-Q Augmentation Module (scores standardized to 0 [worst] – 100 [best]) and Patient and Observer Scar Assess- ment Scale (POSAS; 1 [normal skin] to 10 [worst scar imaginable]) were administered. Re- sponses were summarized using descriptive statistics. Patient-reported events were collected. Results Twenty-two Southeast Asian patients (mean age, 35.1 years) completed ≥ 1 post- operative BREAST-Q and POSAS assessment and were assessed 11 months to 5.5 years post- operatively. The mean postoperative BREAST-Q satisfaction with breasts and psychosocial well-being scores were 69.2 and 84.0, respectively. The mean POSAS score for their overall opinion of the scar was 4.2; the mean scores for all scar characteristics ranged from 1.2 to 4.2.
    [Show full text]
  • Anisomastia Como Trastorno De Asimetría En La Patología Mamaria
    REV. SENOLOGIA Y PATOL. MAM., 5, 2 (83-91), 1992 L. C. Tejerizo López*, Anisomastia como J. L. Lanchares Pérez*, R. Morales Lugo**, A. García Iglesias*, trastorno de asimetría en J. A. González Pérez*, J. M. Jorge Mendoza**, la patología mamaria M.• J. Velasco Martín* M.a J. Doyague Sánchez* infantojuvenil SUMMARY Complejo Hospitalario. Hospital Clínico. Departamento de Anisomastia is to be considered today as a not infrequent possibility in Obstetricia y Ginecología the disorders of mammary pathology in infancy and adolescence. Three (J. L. Lanchares Pérez, cases of constitutional anisomastia in youths are studied in the present L. C. Tejerizo López). work without anisothelia and without any pathological process either Salamanca*. Hospital General de Lanzarote. concomitant or subjacent. Servicio de Obstetricia y Ginecología (R. Morales Lugo). Arrecife de Lanzarote**. Palabras clave Trastornos desarrollo mamario, Asimetría mamaria, Anisomastia. Correspondencia: Dr. L. C. Tejerizo López. Keywords Varillas, 16-18, 1.° C. 37001 Salamanca. Disorders in mammary development, Mammary asymetry, Anisomastia. INTRODUCCION desarrollo, los procesos inflamatorios, la displasia o mastopatía fibroquística y los tumores. Fernández-Cid, 1 al establecer la clasificación de la Señalan Capraro y Dewhurst 3 que es tal la varie­ patología mamaria infantojuvenil, incluye los trastor­ dad de padecimientos que afectan a la mama duran­ nos del desarrollo, los trastornos funcionales, los pro­ te la infancia y adolescencia, que sus lesiones no co­ cesos inflamatorios, las displasias mamarias (masto­ rresponden a una sola especialidad y algunas de patías), los traumatismos y dermatosis y los tumores. ellas, sobre todo las relacionadas con el desarrollo, Al considerar específicamente a los trastornos del de­ pueden incluirse entre las que suscitan el interés del sarrollo refiere 7 formas de presentarse los mismos ginecólogo.
    [Show full text]
  • Comments Received During the Public Consultation on the SCHEER
    Comments received during the public consultation on the SCHEER preliminary opinion on "The safety of breast implants in relation to anaplastic large cell lymphoma (BIA-ALCL)" Name of at Table of individual/ DJ ta SCHEER's response contents organisation ch 1 Geertsma Robert, ABSTRACT Abstract, lines 23-24 SCHEER agrees with this comment and has adapted the text of the RIVM - National The statement “Overall there is a moderate level of evidence for a Opinion for further clarification. Institute for causal relationship between textured breast implants and ALCL” implies Public Health and that a causal relationship exists between ALCL and all types of textured Modified text: the Environment, implants. As can be concluded from multiple statements in the body of Netherlands the Opinion, stratification between the relative risks of various types of “Overall SCHEER considers that there is a moderate weight of textures (including no texture) is currently not possible. In order to evidence for a causal relationship between textured breast implants provide an honest and complete picture of current knowledge, this and BIA-ALCL, particularly in relation to implants with an intermediate should be explained carefully in the Opinion, and certainly also in the to high surface roughness. Abstract, which is likely to undergo a much broader dissemination than the entire report. Furthermore, it is important also to point out that At this point it should be noted that i) there are several types of implants with different surface textures may also have different textured implants ii) surface textures of breast implants are not all benefits, so in order to draw conclusions, a full benefit-risk evaluation manufactured in the same way, and iii) implants with diverse surface should be made.
    [Show full text]
  • Breast Disorders in Girls and Adolescents. Is There a Need for a Specialized Service?
    Original Study Breast Disorders in Girls and Adolescents. Is There a Need for a Specialized Service? Lina Michala MRCOG, PhD *, Alexandra Tsigginou MD, PhD, Dimitris Zacharakis MD, Constantine Dimitrakakis MD, PhD 1stDepartment of Obstetrics and Gynaecology, University of Athens, Alexandra Hospital, Athens, Greece abstract Introduction: Minor breast concerns in childhood and adolescence are common and lead to increased anxiety among young patients and their families, particularly due to high correlation with breast cancer. However, most breast services aim at managing adults and triaging patients with breast cancer, whereas adolescent medicine specialists or pediatricians are usually not appropriately trained to identify and treat breast pathology. Methods: We reviewed hospital records of all patients attending a pediatric and adolescent gynecology or breast clinic of a tertiary referral hospital, with a breast related symptom, between January 2009 and December 2011. We collected information regarding age at presen- tation, age at menarche, diagnosis, management and outcome. Results: We identified 81 patients of which 11 presented with an abnormal nipple or areolar secretion, 33 had a palpable lump, 20 had mastitis, and 16 had unequal breast development. One patient presented with virginal breast hypertrophy. Three out of 11 of the patients with an abnormal secretion had a cyst identified on ultrasonography. Out of the palpable lumps 12 were fibroadenomas, 3 were phyllodes tumors, and 14 were cystic in nature. The phyllodes tumors and half of the fibroadenomas were removed. The remaining fibroadenomas remain under regular ultrasonographic follow-up. All cases of mastitis were treated conservatively and resolved with broad spectrum antibiotic treatment. Conclusion: In our series, no malignancies were identified.
    [Show full text]
  • Our 20-Year Institutional Experience with Surgical Approach for Breast Hamartomas
    Original Article Eur J Breast Health 2019; 15(3): 171-175 DOI: 10.5152/ejbh.2019.4624 Our 20-Year Institutional Experience with Surgical Approach for Breast Hamartomas Zeliha Türkyılmaz1 , Tahacan Aydın2 , Ravza Yılmaz3 , Semen Önder4 , Enver Özkurt5 , Mustafa Tükenmez5, Mahmut Müslümanoğlu5, Gülden Acunaş5, Abdullah İğci5, Vahit Özmen5, Ahmet Dinçağ5 , Neslihan Cabioğlu5 1Department of General Surgery, Trakya University School of Medicine, Edirne, Turkey 2İstanbul University, İstanbul School of Medicine, İstanbul, Turkey 3Department of Radiology, İstanbul University, İstanbul School of Medicine, İstanbul, Turkey 4Department of Pathology, İstanbul University, İstanbul School of Medicine, İstanbul, Turkey 5Department of General Surgery, İstanbul University, İstanbul School of Medicine, İstanbul, Turkey ABSTRACT Objective: Hamartomas are rare, slowly-growing breast tumours. Clinical, radiological and histopathological examination together increase the diagnostic accuracy. To evaluate the clinicopathologic features of hamartomas and outline our clinical approach to hamartomas in our 20-year experi- ence at our Breast Clinic. Materials and Methods: Between 1995 and 2015, 24 cases were retrospectively analyzed with a diagnosis of breast hamartoma at our Breast Clinic followed by excisional biopsy. Data was obtained on patient demographics, clinical examination, radiological findings and histopathological subtypes. Results: Of 1338 benign breast tumours excised from January 1995 to January 2015, 24 (1.8%) were identified as breast hamartoma. Median age of patients was 42 (range, 13-70), whereas the median tumour size was 5 cm (1-10 cm). On preoperative imaging, hamartoma was most commonly misdiagnosed as fibroadenoma. Pathological examination of the 24 biopsy specimens revealed 3 cases with pseudoangiomatous stromal hyperplasia, and another hamartoma associated with a radial scar within the centre of the lesion.
    [Show full text]
  • FINAL Opinion on the Safety of Breast Implants in Relation to Anaplastic Large Cell Lymphoma
    Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) FINAL Opinion on the safety of breast implants in relation to anaplastic large cell lymphoma The SCHEER adopted this Opinion by written procedure on 26 March 2021 Breast Implants Safety and Anaplastic Large Cell Lymphoma Final Opinion _________________________________________________________________________________________ ABSTRACT The SCHEER was requested by the European Commission to provide a scientific opinion on the safety of breast implants in relation to anaplastic large cell lymphoma (ALCL). Literature searches were carried out using PubMed and Find-eR. The publication period covered was from 1 September 2016 to 31 August 2019, and an additional search was performed early in 2020 covering the period from 1 September 2019 to 30 April 2020. In addition, relevant sources and literature beyond this period was considered as well. After excluding all irrelevant papers and duplicate papers, a total of 605 papers remained and were evaluated for this Scientific Opinion. BIA-ALCL is the occurrence of ALCL adjacent to a breast implant. Diagnosis of BIA-ALCL is achieved by analysis of seroma fluid or if a mass, core needle, incisional or excisional tissue biopsy. Radical en bloc surgical resection (i.e. implant including seroma and intact capsule) with safe margins, including healthy tissue, is recommended as the standard of care treatment, with a very good prognosis. The incidence of BIA-ALCL is considered low, varies by implant type, and is mainly associated with macro-textured implants. However, estimates of incidence have significant limitations related to the frequent use of ad hoc reporting of cases compared with systematic reporting, and the use of sales data provided by manufacturers.
    [Show full text]
  • I. Ulusal Meme Kanseri Konsensusu
    I. ULUSAL MEME KANSERİ KONSENSUSU I. ULUSAL MEME KANSERİ KONSENSUSU Editör Prof. Dr. Ayfer Haydaroğlu 1 I. ULUSAL MEME KANSERİ KONSENSUSU I. ULUSAL MEME KANSERİ KONSENSUSU Ağustos 2007 Prof. Dr. Ayfer HAYDAROĞLU Yazışma Adresi : Ege Üniversitesi Radyasyon Onkolojisi Anabilim Dalı, Bornova - İZMİR Telefon : 0 232 390 32 70 Fax : 0 232 388 86 00 E mail : [email protected] 15 - 19 KASIM 2006 TARİHLERİ ARASINDA, BODRUM’DA GERÇEKLEŞTİRİLEN, “I. ULUSAL MEME KANSERİ KONSENSUS TOPLANTISI”NDA TARTIŞILAN UZLAŞMA KONULARINI VE SONUÇLARINI İÇEREN BİR KİTAPTIR. Bu kitap Meme Dernekleri Koordinasyon Kurulu ve İzmir Meme Hastalıkları Derneği adına I. Ulusal Meme Kanseri Konsensusu Toplantısı Başkanı Prof. Dr. Ayfer HAYDAROĞLU’nun editörlüğünde derlenmiş ve 1000 adet basılmıştır. İSBN: 978-975-01491-0-8 Bu kitap Kongre Basımevi Matbaası’nda basılmıştır. Bu kitabın tamamı veya bir bölümü izin alınmadan kullanılamaz. Her türlü yayın hakkı İzmir Meme Hastalıkları Derneği ve Editöre aittir. 2 I. ULUSAL MEME KANSERİ KONSENSUSU Değerli Meslektaşlarımız , Kurulduğu günden beri pek çok ilke imzasını atan Meme Dernekleri Koordinasyon Kurulu (MDKK) 2006 Kasım ayında yeni bir girişime daha önder olmuştur. Türkiye‘ nin dört bir yanından gelen ve meme kanserini kendilerine uğraş alanı olarak seçen Genel Cerrah, Tıbbi Onkolog, Radyasyon Onkoloğu, Radyolog ve Patolog meslektaşlarımız Bodrum‘ da toplanarak bir ulusal uzlaşı metni oluşturmak için yoğun çaba harcadılar. Yurt dışında katıldığımız ve buruk bir şekilde izlediğimiz bu tip bir toplantıyı ülkemizde gerçekleştirmek kolay olmadı. Bu toplantı için yoğun uğraşlar verildi ve çabalar harcandı. Sonuçta hepimizin katkılarıyla ortaya bize ait olan ulusal bir ortak metin çıktı. Bu ortak metinin paylaşılması ve hayata geçirilmesi bundan sonra yapılacak uzlaşı toplantılarının önünü açacaktır.
    [Show full text]