Strengthening The Oversight Of Breast Implants

Author : Institute of Medicine,Committee on the Safety of Silicone Breast Implants
Publisher : National Academies Press
Page : 559 pages
File Size : 44,6 Mb
Release : 2000-01-06
Category : Medical
ISBN : 9780309132756

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Safety of Silicone Breast Implants by Institute of Medicine,Committee on the Safety of Silicone Breast Implants Pdf

The Dow Corning case raised serious questions about the safety of silicone breast implants and about larger issues of medical device testing and patient education. Safety of Silicone Breast Implants presents a well-documented, thoughtful exploration of the safety of these devices, drawing conclusions from the available research base and suggesting further questions to be answered. This book also examines the sensitive issues surrounding women's decisions about implants. In reaching conclusions, the committee reviews: The history of the silicone breast implant and the development of its chemistry. The wide variety of U.S.-made implants and their regulation by the Food and Drug Administration. Frequency and consequences of local complications from implants. The evidence for and against links between implants and autoimmune disorders, connective tissue disease, neurological problems, silicone in breast milk, or a proposed new syndrome. Evidence that implants may be associated with lower frequencies of breast cancer. Safety of Silicone Breast Implants provides a comprehensive, well-organized review of the science behind one of the most significant medical controversies of our time.

Author : Great Britain: Parliament: House of Commons: Health Committee
Publisher : The Stationery Office
Page : 60 pages
File Size : 52,5 Mb
Release : 2012-03-28
Category : Medical
ISBN : 0215043472

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PIP breast implants and regulation of cosmetic interventions by Great Britain: Parliament: House of Commons: Health Committee Pdf

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 : Great Britain: Parliament: House of Commons: Science and Technology Committee
Publisher : The Stationery Office
Page : 110 pages
File Size : 44,6 Mb
Release : 2012-11
Category : Medical
ISBN : 0215049748

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Regulation of Medical Implants in the EU and UK by Great Britain: Parliament: House of Commons: Science and Technology Committee Pdf

EU regulations on the safety of medical implants-such as metal-on-metal hip replacements-must be urgently tightened in response to evidence that manufacturers are seeking approval for devices in Member States with the least stringent regulatory regimes. Much greater transparency is needed about the approval process so patients and doctors can have full confidence in the implants they are using. Manufacturers and regulators must also publish more rigorous clinical data on the safety of new implants and be subject to greater scrutiny. The clinical data requirements for high-risk medical devices to be sold on the European Market are much less stringent than for new medicines. There appears to be reliance on equivalence-similarity to an existing implant-rather than clinical investigations of the implant being approved. The Committee calls for all clinical data used in the approval of a medical implant to be published without identifying patients or clinical trial participants. For products currently on the market, such data should be published immediately. There should also be a public record of every approach from a manufacturer to any notified body in the EU so that 'forum shopping' can be identified. UK regulatory body the Medicines and Healthcare products Regulatory Agency (MHRA) is criticised for its slow reaction to reports of problems with metal-on-metal hip replacements in Australia. The withdrawal of PIP breast implants also highlights the need for frequent and unannounced spot-checks of medical implant manufacturers to identify and prevent similar problems. The Committee is supportive of the proposed legislative changes from the European Commission to improve transparency

Author : Nichola Rumsey,Diana Harcourt
Publisher : Oxford University Press
Page : 736 pages
File Size : 51,7 Mb
Release : 2014
Category : Medical
ISBN : 9780198723226

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The Oxford Handbook of the Psychology of Appearance by Nichola Rumsey,Diana Harcourt Pdf

We live in a society in which messages associating physical attractiveness with success and happiness are pervasive. This text gives an account of research, policy, and practice in psychological aspects of appearance, including the role of the media in shaping people's attitudes.

Author : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions. Subcommittee on Public Health
Publisher : Unknown
Page : 88 pages
File Size : 45,6 Mb
Release : 2003
Category : Women
ISBN : PURD:32754074679840

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Addressing Unmet Needs in Women's Health by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions. Subcommittee on Public Health Pdf

Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher : Unknown
Page : 48 pages
File Size : 42,6 Mb
Release : 2002
Category : Medical
ISBN : PSU:000048685924

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Raising Health Awareness Through Examining Benign Brain Tumor Cancer, Alpha One, and Breast Implant Issues by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Pdf

Author : United States. Congress. House. Committee on Government Reform
Publisher : Unknown
Page : 296 pages
File Size : 49,7 Mb
Release : 2003
Category : Legislative oversight
ISBN : PURD:32754082299656

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Oversight Plans for All House Committees by United States. Congress. House. Committee on Government Reform Pdf

Author : United States. Congress. House. Committee on Oversight and Government Reform
Publisher : Unknown
Page : 296 pages
File Size : 40,5 Mb
Release : 2003
Category : Legislative oversight
ISBN : UCR:31210016345710

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Oversight Plans for All House Committees, with Accompanying Recommendations by United States. Congress. House. Committee on Oversight and Government Reform Pdf

Author : Mislav Mataija
Publisher : Oxford University Press
Page : 321 pages
File Size : 52,5 Mb
Release : 2016
Category : Law
ISBN : 9780198746652

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Private Regulation and the Internal Market by Mislav Mataija Pdf

How does EU internal market law, in particular the rules on free movement and competition, apply to private regulation? Through a close analysis of three case studies (sports, the legal profession, and standard-setting) this book studies how internal market law is used as a control mechanism over private regulators.

Author : Institute of Medicine,Food and Nutrition Board,Board on Health Sciences Policy,Board on Health Care Services,Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease
Publisher : National Academies Press
Page : 335 pages
File Size : 49,7 Mb
Release : 2010-06-25
Category : Medical
ISBN : 9780309157278

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Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease by Institute of Medicine,Food and Nutrition Board,Board on Health Sciences Policy,Board on Health Care Services,Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease Pdf

Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.

Author : Madeleine de Cock Buning,Linda Senden
Publisher : Bloomsbury Publishing
Page : 599 pages
File Size : 41,7 Mb
Release : 2020-06-25
Category : Law
ISBN : 9781509919536

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Private Regulation and Enforcement in the EU by Madeleine de Cock Buning,Linda Senden Pdf

Globalisation and technological innovation have been fuelling the need for increasing levels of trust in private actors, such as companies or special interest groups, to regulate and enforce significant aspects of people's daily lives: from environmental and social protection to the areas of food safety, advertising and financial markets. This book investigates the trust vested in private actors from the perspective of European citizens. It answers the question of whether private actors live up to citizens' expectations or whether more should be done as to the safeguarding of citizens' interests. Several cross-cutting studies explore how private regulation and enforcement are embedded in EU law. The book offers an innovative approach to private regulation and enforcement by focusing on the specific EU context which, unlike the national and transnational ones, has not yet been widely explored. This context merits a stand-alone analysis because of the unique normative framework of the EU, as a particular polity itself but also in relation to its Member States. With an overall analysis of the main aspects of private regulation and enforcement across different policy fields of the EU, the book adds a missing tile to the mosaic of public–private governance studies.

Author : Nancy Bruning
Publisher : Hunter House
Page : 258 pages
File Size : 40,7 Mb
Release : 2002
Category : Family & Relationships
ISBN : 0897933710

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Breast Implants by Nancy Bruning Pdf

This edition discusses current research on the relationship between breast implants and disease; hardening, leaking, and rupture of implants; and relevant court decisions. The author also discusses the newest implant techniques and guidelines for having implants removed or replaced.

Author : Melanie Latham,Jean V. McHale
Publisher : Routledge
Page : 212 pages
File Size : 49,5 Mb
Release : 2020-04-30
Category : Health & Fitness
ISBN : 9780429489693

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The Regulation of Cosmetic Procedures by Melanie Latham,Jean V. McHale Pdf

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 : Monika Steffen
Publisher : Routledge
Page : 232 pages
File Size : 54,8 Mb
Release : 2005-11-28
Category : Political Science
ISBN : 9781134219551

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Health Governance in Europe by Monika Steffen Pdf

Health constitutes a core element of welfare states and a vital nerve in the trust relation between citizen and their governments. Focusing on the health sector, this book analyzes the closely interwoven relationship between the European Union and Member States. The authors explore the dynamic and multi-fold process of de-nationalizing health policies and illustrate how European policies develop in a sector that still appears to be under exclusively national competence. They describe the multiple forms and ways the Europeanization process takes, driven by market integration, public health crises and politics of consumer protection. The authors also provide a detailed analysis of key topics: the pharmaceutical sector, market regulation of medical goods and devices, food safety, the blood provision and plasma industry, European politics on bioethics, and risk reduction in the field of drug abuse. Providing a comprehensive and informed assessment of the Europeanization process in the field of health policies, this book will be of interest to students and scholars of health, European integration and policy-making.

Author : Daisy Fancourt,Saoirse Finn
Publisher : Unknown
Page : 142 pages
File Size : 43,9 Mb
Release : 2019-06
Category : Electronic
ISBN : 9289054557

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What Is the Evidence on the Role of the Arts in Improving Health and Well-Being by Daisy Fancourt,Saoirse Finn Pdf

Over the past two decades, there has been a major increase in research into the effects of the arts on health and well-being, alongside developments in practice and policy activities in different countries across the WHO European Region and further afield. This report synthesizes the global evidence on the role of the arts in improving health and well-being, with a specific focus on the WHO European Region. Results from over 3000 studies identified a major role for the arts in the prevention of ill health, promotion of health, and management and treatment of illness across the lifespan. The reviewed evidence included study designs such as uncontrolled pilot studies, case studies, small-scale cross-sectional surveys, nationally representative longitudinal cohort studies, community-wide ethnographies and randomized controlled trials from diverse disciplines. The beneficial impact of the arts could be furthered through acknowledging and acting on the growing evidence base; promoting arts engagement at the individual, local and national levels; and supporting cross-sectoral collaboration.