The FDA's Regulation of Silicone Breast Implants PDF Download
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Author:
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 64
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Book Description
Author:
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 64
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Book Description
Author: Marcia Angell
Publisher: W. W. Norton & Company
ISBN: 9780393316728
Category : Business & Economics
Languages : en
Pages : 276
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Book Description
In the early 1990s, sympathetic juries awarded huge damages to women claiming injury from silicone breast implants, leading to a $4.25 billion class-action settlement that still wasn't large enough to cover all the claims. Shockingly, rigorous scientific studies of breast implants have now shown that there is no significant link between breast implants and disease. Why were the courts and the public so certain that breast implants were dangerous when medical researchers were not? The answer to this question reveals important differences in the way science, the law, and the public regard evidence--and not just in the breast implant controversy.
Author: W Peters
Publisher: Elsevier
ISBN: 0857096419
Category : Technology & Engineering
Languages : en
Pages : 244
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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: United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources and Intergovernmental Relations
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 214
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Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212421
Category : Medical
Languages : en
Pages : 318
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Book Description
Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Author: Ioannis Koutroulis
Publisher: John Wiley & Sons
ISBN: 1119262925
Category : Medical
Languages : en
Pages : 48
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Book Description
EMERGENCY MANAGEMENT OF THE HI-TECH PATIENT IN ACUTE AND CRITICAL CARE Emergency Management of the Hi-Tech Patient in Acute and Critical Care helps practitioners stabilize and care for pediatric and adult patients who have specialized medical devices such as prosthetic valves, cochlear transplants, insulin pumps, orthopedic hardware, and ventriculoperitoneal (VP) shunts. Using a step-by-step approach to acute presentations of patients with clinical hardware, this concise yet comprehensive guide provides specific instructions for the initial evaluation and management of numerous clinical scenarios including device malfunctions, infections, trauma, surgical complications, and more. Encompassing management of both the patient and the device, the guide enables emergency and critical care clinicians to rapidly make appropriate treatment decisions without the immediate need for extensive research, extended discussions with subspecialists, or recalling complex diagnostic and therapeutic algorithms. Clear, concise, and easy-to-follow chapters—written by a panel of highly experienced experts across specialties—include numerous algorithms, figures, tables, diagrams, and color illustrations and clinical images. An invaluable resource for improving the quality of care for the unique hi-tech patient population, this advanced practical manual: Provides algorithms for the most common clinical scenarios of device malfunction and related complications Covers management of patients who have undergone major operations such as organ transplantation or complex congenital heart disease repair Presents detailed management plans for a wide range of hardware types and medical conditions Offers expert guidance to practitioners in settings where not all specialties are readily available, such as rural and remote areas or community hospitals Features contributions from a team of experts in various areas of adult and pediatric emergency and critical care medicine Emergency Management of the Hi-Tech Patient in Acute and Critical Care is a must-have clinical reference and guide for pediatric and adult emergency medicine physicians, general pediatricians, internists, general practitioners, critical care specialists, and allied health practitioners.
Author: Oscar M. Ramirez
Publisher: Springer Science & Business Media
ISBN: 1461223288
Category : Medical
Languages : en
Pages : 339
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Book Description
Endoscopic Techniques in Plastic and Aesthetic Surgery comprehensively addresses both the aesthetic and reconstructive aspects of endoscopic surgery as applied to plastic surgery. The editors, renowned pioneers of these techniques, have assembled a group of distinguished contributors to present, step-by-step, the operative strategies for incorporation of endoscopic procedures to the armamentarium of the practicing plastic surgeon. The procedures are precisely and exquisitely rendered by 721 illustrations, including over 300 full color endoscopic views and operative photographs. This book is the essential, definitive source for mastery of these state-of-the-art techniques.
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 256
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Book Description
Author:
Publisher:
ISBN:
Category : Cancer
Languages : en
Pages : 980
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Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309175658
Category : Medical
Languages : en
Pages : 534
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Book Description
The "contraceptive revolution" of the 1960s and 1970s introduced totally new contraceptive options and launched an era of research and product development. Yet by the late 1980s, conditions had changed and improvements in contraceptive products, while very important in relation to improved oral contraceptives, IUDs, implants, and injectables, had become primarily incremental. Is it time for a second contraceptive revolution and how might it happen? Contraceptive Research and Development explores the frontiers of science where the contraceptives of the future are likely to be found and lays out criteria for deciding where to make the next R&D investments. The book comprehensively examines today's contraceptive needs, identifies "niches" in those needs that seem most readily translatable into market terms, and scrutinizes issues that shape the market: method side effects and contraceptive failure, the challenge of HIV/AIDS and other sexually transmitted diseases, and the implications of the "women's agenda." Contraceptive Research and Development analyzes the response of the pharmaceutical industry to current dynamics in regulation, liability, public opinion, and the economics of the health sector and offers an integrated set of recommendations for public- and private-sector action to meet a whole new generation of demand.
