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Author: Sonia Macleod Publisher: Bloomsbury Publishing ISBN: 1509916725 Category : Law Languages : en Pages : 321
Book Description
This book examines how regulatory and liability mechanisms have impacted upon product safety decisions in the pharmaceutical and medical devices sectors in Europe, the USA and beyond since the 1950s. Thirty-five case studies illustrate the interplay between the regulatory regimes and litigation. Observations from medical practice have been the overwhelming means of identifying post-marketing safety issues. Drug and device safety decisions have increasingly been taken by public regulators and companies within the framework of the comprehensive regulatory structure that has developed since the 1960s. In general, product liability cases have not identified or defined safety issues, and function merely as compensation mechanisms. This is unsurprising as the thresholds for these two systems differ considerably; regulatory action can be triggered by the possibility that a product might be harmful, whereas establishing liability in litigation requires proving that the product was actually harmful. As litigation normally post-dates regulatory implementation, the 'private enforcement' of public law has generally not occurred in these sectors. This has profound implications for the design of sectoral regulatory and liability regimes, including associated features such as extended liability law, class actions and contingency fees. This book forms a major contribution to the academic debate on the comparative utility of regulatory and liability systems, on public versus private enforcement, and on mechanisms of behaviour control.
Author: Sonia Macleod Publisher: Bloomsbury Publishing ISBN: 1509916725 Category : Law Languages : en Pages : 321
Book Description
This book examines how regulatory and liability mechanisms have impacted upon product safety decisions in the pharmaceutical and medical devices sectors in Europe, the USA and beyond since the 1950s. Thirty-five case studies illustrate the interplay between the regulatory regimes and litigation. Observations from medical practice have been the overwhelming means of identifying post-marketing safety issues. Drug and device safety decisions have increasingly been taken by public regulators and companies within the framework of the comprehensive regulatory structure that has developed since the 1960s. In general, product liability cases have not identified or defined safety issues, and function merely as compensation mechanisms. This is unsurprising as the thresholds for these two systems differ considerably; regulatory action can be triggered by the possibility that a product might be harmful, whereas establishing liability in litigation requires proving that the product was actually harmful. As litigation normally post-dates regulatory implementation, the 'private enforcement' of public law has generally not occurred in these sectors. This has profound implications for the design of sectoral regulatory and liability regimes, including associated features such as extended liability law, class actions and contingency fees. This book forms a major contribution to the academic debate on the comparative utility of regulatory and liability systems, on public versus private enforcement, and on mechanisms of behaviour control.
Author: Great Britain: Parliament: House of Commons: Health Committee Publisher: The Stationery Office ISBN: 9780215043474 Category : Medical Languages : en Pages : 60
Book Description
The Health Committee welcomes the Government's decision to commission two reviews following public concern about breast implant surgery, following the decision of the French authorities to recommend removal of implants sourced from PIP. The first, led by Sir Bruce Keogh, is tasked with assessing the regulation of cosmetic interventions in general. The second, led by Earl Howe, is tasked with analysing the policy reaction, in particular by MHRA and DoH, to the announcement by the French authorities in March 2010 that PIP products did not comply with the requirements of their CE registration. Sir Bruce 's preliminary report concluded that there is no evidence of likely long term negative health effects attributable to PIP implants, though the quality of evidence available does not allow definitive conclusions to be drawn. The Committee welcomes the Government's undertaking that the NHS will remove and replace any NHS implant which has failed, and agrees with the Government that all other care providers should make the same offer. The cost of all care provided in respect of non-NHS implants should be recovered, where possible, from the original care provider, or their insurers. Earl Howe's review should focus on key policy issues: the quality of information available about devices that have been implanted into patients; evidence that MRHA notices withdrawing CE registration from individual products do not require any positive response from non-NHS users of those products; evidence that some patients may have received implants without being fully aware of the medium and long term consequences.
Author: Fay Bound Alberti Publisher: Oxford University Press ISBN: 0191036560 Category : History Languages : en Pages : 285
Book Description
To many people the idea that 'the body' has its own history might sound faintly ridiculous. The body and its experiences are usually seen as something that we share with people from the past. Like 'human nature', it represents the unchanging in a changing world. Bodies just are... But the body does have a history. The way that it moves, feels, breathes, and engages with the world has been viewed very differently across times and cultures. For centuries, 'we' were believed to be composed of souls that were part of the body and inseparable from it. Now we exist in our heads, and our bodies have become the vessels for that uncertain and elusive thing we call our 'true selves'. The way we understand the material structure of the body has also changed radically over the centuries. From the bones to the skin, from the senses to the organs of sexual reproduction, every part of the body has an ever-changing history, dependent on time, culture, and place. This Mortal Coil is an exploration of that history. Peeling away our assumptions about the unchanging nature of the human body, Fay Bound Alberti takes it apart in order to put it back anew, telling the cultural history of our key organs and systems from the inside out, from blood to guts, brains to sex organs. The understanding of the 'modern body' she reveals in the process is far removed from the 'eternal' or timeless object of common assumption. In fact, she argues, its roots go back no further than the sixteenth century at the earliest - and it has only truly existed in its current form since the nineteenth century.
Author: Lynda Wyld Publisher: Springer ISBN: 3319566733 Category : Medical Languages : en Pages : 713
Book Description
This textbook provides a comprehensive overview of the state of the art knowledge of breast cancer management for the modern breast surgeon. It covers all aspects of multidisciplinary care including primary breast and axillary surgery, reconstruction and oncoplastic techniques, external beam radiotherapy and newer techniques such as tomotherapy, intraoperative radiotherapy and brachytherapy. In addition, systemic therapies including chemotherapy, the latest biological targeted therapies and endocrine therapies are covered. Readers can find out about other important aspects of breast cancer such as genetics, screening, imaging and long-term health among others. Chapters take the reader through the basics up to the highest levels of knowledge in an easy to understand format with management algorithms to aid clinical care, generous referencing of the best literature and figures and photographs to illustrate each section. Published with the official approval of the European Society of Surgical Oncology (ESSO) and the European Society of Breast Cancer Specialists (EUSOMA), the book is written by a panel of recognised leaders in the field and is an indispensable guide for the practicing breast specialist and senior specialists in training, wishing to update their knowledge with the latest trends or polish off their training before accreditation.
Author: Renato Natal Jorge Publisher: CRC Press ISBN: 1317289560 Category : Health & Fitness Languages : en Pages : 285
Book Description
BioMedWomen 2015 - Clinical and BioEngineering for Women ́s Health contains all author contributions presented at BioMedWomen 2015 (Porto, Portugal, 20–23 June 2015). International contributions from countries worldwide provided comprehensive coverage of the current state-of-the-art on different topics: • Aging • Physical Activity and Sports • Physiotherapy • Aesthetic and Reconstructive Surgery • Urogynecology • Imaging • Biomechanics • Nutrition • Health Psychology • Assisted diagnosis and Treatment • Tissue Engineering • Medical Devices • Prosthesis • Dental care and Orthodontics BioMedWomen 2015 - Clinical and BioEngineering for Women ́s Health will be of interest to academics and to others interested and involved in clinical and engineering subjects related to women ́s health.
Author: W Peters Publisher: Elsevier ISBN: 0857096419 Category : Technology & Engineering Languages : en Pages : 244
Book Description
Employed for both cosmetic and reconstructive purposes, breast implants are one of the most widely-used and controversial prostheses available. The development of safe, reliable products is vital to the future of this important field of surgery. Biomaterials in plastic surgery reviews the history, materials and safety issues associated with breast implants.Beginning with an introduction to the history of biomaterials used for breast augmentation, Biomaterials in plastic surgery goes on to discuss development issues. It then discusses the chemistry and physical properties of biomedical silicones before reviewing cohesive gel and polyurethane foam implants. The book concludes by analysing the epidemiological evidence on the safety issues relating to breast implants, followed by a review of retrieval and analysis of breast implants emphasizing strength, durability and failure mechanisms.With its distinguished editors and international team of expert contributors, Biomaterials in plastic surgery is an important guide for surgeons, manufacturers and all those researching this important field. - Comprehensively examines the history, materials and safety issues associated with breast implants - Provides an overview of the history of biomaterials used for breast augmentation and goes on to discuss the development and chemical and physical properties of biomedical silicones - Reviews cohesive gel breast implants and polyurethane foam breast implants
Author: Sofia Brandão Publisher: Springer ISBN: 3319715747 Category : Science Languages : en Pages : 239
Book Description
This book focuses on particular mental and physical aspects of women’s health, presenting topics concerning the pelvis and pelvic floor dysfunction and the breast during a woman’s life, such as rehabilitation for pelvic and breast disorders, and the benefits of biomechanical analysis in treating these conditions. With each chapter providing a brief survey of a major research area related to the theme, the book offers an integrated overview of topics such as the bio-psycho-social model of women’s health, pelvic floor evaluation in sports, the breast, pregnancy and delivery. It is a valuable resource for a wide range of readers, including researchers, graduates and professionals.
Author: Barend Van Leeuwen Publisher: Bloomsbury Publishing ISBN: 1509908358 Category : Law Languages : en Pages : 332
Book Description
With the New Approach, the EU has incorporated European standardisation in its regulatory approach to improve the free movement of goods. Such a New Approach does not exist for services. Nevertheless, a significant number of European services standards have been made. This book focuses on European standardisation of services and its impact on private law. Two services sectors are analysed: the healthcare sector and the tourism sector. The core chapters of the book contain a number of case studies based on empirical research in these sectors. The first part discusses how European services standards interact with existing legal regulation at the European and national level. It is shown that, at the European level, there is no clear legal framework in which European services standards are adopted. This has an impact on their application in private law, which is the main theme of the second part of the book. Moreover, there is a real risk that European services standards create obstacles to free movement. This will prevent their successful application in private law.
Author: Monica Fawzy Publisher: CRC Press ISBN: 0429678584 Category : Medical Languages : en Pages : 439
Book Description
This is the first Q&A-based revision book specifically aimed at candidates sitting the viva component of the FRCS(Plast) examination. It provides a selection of common clinical scenarios presented in a realistic way and presents a guide to answering the FRCS (Plast) questions, as well as advice on how to approach the revision process itself. Crucially, this will help to prepare candidates to organise their thoughts, demonstrate higher order thinking and present a robust answer in the face of grey areas and controversies. The text covers all topics from the syllabus including Trauma, Burns, Facial and Soft Tissue Injuries, Acute Head and Neck Tumours, Cleft and Craniofacial, Congenital anomalies, Facial Palsy, Vascular anomalies, Trunk & Perineal, Skin Cancer, Basic Sciences, Aesthetic, Ethics & Medico-legal, and Consent. Candidates using this book will be able to realistically recreate the exam scenario either in private or in a group setting. This book is equally useful for candidates sitting plastic surgery post graduate exams with equivalent syllabuses to that of the FRCS(Plast) such as the EBOPRAS exam, as well as others. In addition, it also makes an excellent companion for trainees throughout the course of their six-year training rotation, allowing more junior plastic surgery trainees the opportunity to become acquainted with the format and content of the FRCS (Plast) exam. Lastly it may be helpful to consultants who are interested in coaching their trainees in topics other than their subspeciality.
Author: Melanie Latham Publisher: Routledge ISBN: 0429489692 Category : Health & Fitness Languages : en Pages : 222
Book Description
This book examines the legal, ethical and regulatory debates surrounding the rise of the cosmetic procedures industry. In the past, cosmetic procedures were often seen as limited to a small number of wealthy older women. Today, such procedures have gone mainstream, partly facilitated by the rise of ‘non-invasive’ techniques, such as the use of Botox and Dermal Fillers. While still a business dominated by the female consumer, there is also an increasing number of males undertaking cosmetic procedures as social expectations around appearance and ageing are challenged. At the same time, the rapid expansion of this business and the incoherent, diverse approach to its regulation have given rise to concern. It has been seen as a ‘Wild West’. If cosmetic procedures go wrong, such procedures give rise to real risks of harm. This book examines the historical backdrop, current practice and risks associated with cosmetic procedures. It discusses the ethical and regulatory challenges for this area. It also examines the current legal frameworks concerning people, practitioners and products in the UK. The book also draws lessons from regulatory approaches in other jurisdictions with particular reference to the United States, Brazil and France. It then sets out a legal and regulatory framework that might better protect and empower the cosmetic consumer, now and in the future. The book is likely to be of particular interest to those working in the areas of health and medical law, socio-legal studies and political science.
Author: Sonia Macleod
Author: Sonia Macleod
Author: Great Britain: Parliament: House of Commons: Health Committee
Author: Fay Bound Alberti
Author: Lynda Wyld
Author: Renato Natal Jorge
Author: W Peters
Author: Sofia Brandão
Author: Barend Van Leeuwen
Author: Monica Fawzy
Author: Melanie Latham