Download or read book Scientific Advice on Evaluation of the Availability of New Scientific Information on the Safety of PIP Breast Implants written by and published by . This book was released on 2017 with total page 25 pages. Available in PDF, EPUB and Kindle. Book excerpt: Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) hereby provides an inventory of new information available on the safety of Poly Implant Prothèse (PIP) silicone breast implants to evaluate whether an update of the 2014 SCENIHR Opinion on the safety of the PIP breast implants (2014 Opinion) is warranted. In addition to conducting a literature review, a public call for scientific information was launched. The literature review showed that new information is available regarding the possible health effects of PIP breast implants, but this information is rather limited. Also, the public call for information did not result in the submission of scientific papers regarding health effects specific to PIP implants, but rather on breast implants in general. Therefore, on the basis of the new scientific information gathered, the SCHEER concludes that an update of the 2014 Opinion is not warranted. New scientific information was found relating to the early and increased PIP implant rupture risk, which suggested that the risk was probably due to the low quality of the implant's shell as already reported in 2014 Opinion. Based on new data, the rupture rate of PIP silicone breast implants was calculated to about 23%, which is similar to the 25% - 30% rupture rate indicated in the 2014 Opinion.

Download or read book The Safety of Poly Implants Proth se PIP Silicone Breast Implants written by and published by . This book was released on 2014 with total page 95 pages. Available in PDF, EPUB and Kindle. Book excerpt: PIP silicone gel filled breast implants (PIP implants) are reported to have a higher prevalence and incidence of implant ruptures than other silicone breast implants, and ruptures also tend to occur earlier in the implant life than is the case with other implants. These reports indicate that the shell/patch or the manufacturing process for a number of batches of PIP implants was of inferior quality, which may be a reflection of variations in the manufacturing process. The risk of implant rupture increases with implantation time. Quantifying the actual increase in failure rate is problematic because the failure rates of non-PIP implants are not well documented. The purpose of this Opinion is to update the previous SCENIHR opinion on PIP breast implants in February 2012, based on additional data which have become available since then. In the previous opinion the effects of both released polymeric and unpolymerised silicones in general were considered.^Since then several cyclic siloxanes (known as D4, D5 and D6) have been identified in PIP devices at higher concentrations than in other silicone breast implants. This has led to investigate the possible toxicological consequences of cyclic siloxanes release from damaged PIP implants. It has become apparent that these chemicals are commonly present in the bodies of women even without breast implants. This is a consequence of the widespread use of siloxanes in many domestic products. Cyclic siloxanes D4, D5 and D6 are non-toxic and not irritant in standard tests. In some cases, implant gel-bleed or rupture has been associated with an inflammatory reaction either locally or in regional lymph nodes. In other cases, ruptures were free of symptoms. There is no new evidence on the reasons for this variation in the response of individual recipients. Neither implant rupture, nor local inflammation, has been found to be associated with breast cancer or anaplastic large cell lymphoma.^While there are differences in rupture rates, there is no reliable evidence that ruptured PIP implants create a greater health risk than a ruptured silicone breast implant from another manufacturer. In the case of implant rupture, explantation is advised. Because of the widespread concern of undetected ruptures, there is a need for women with PIP breast implants to seek regular clinical examinations, and where deemed appropriate, individual counselling and imaging with ultrasonography or MRI. There is currently no convincing medical, toxicological or other data to justify routine removal of intact PIP implants. Implant removal in the absence of malfunction may be considered for women who are experiencing significant anxiety because they have a PIP breast implant. However, the decision to remove an intact PIP implant for this reason should be based on an individual assessment of the woman's condition by her surgeon or other treating physician after consultation.

Download or read book The FDA s Regulation of Silicone Breast Implants written by and published by . This book was released on 1993 with total page 66 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Silicone Gel Breast Implants Health and Regulatory Update 2000 written by and published by Am Cncl on Science, Health. This book was released on 2000 with total page 52 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book PIP Breast Implants written by Antonia Mariconda and published by Need2Know. This book was released on 2013-11 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt: Between 2001 and 2010 about 80,000 Poly Implant Prothese (PIP) implants representing some 40,000 women were sold in the UK. Implants are usually designed to last a minimum of ten years however, the lifespan of PIP implants was averaging at as little as three years. From about 2006 onwards, concerns began to emerge amongst cosmetic surgeons in the UK regarding the performance of PIP implants. The alarm was originally raised after many patients and surgeons reported premature rupturing. Breast Surgery and PIP Implants: The Essential Guide has been written with the purpose of assisting you and giving you factual advice and information on breast surgery and PIP implants. This book will provide you with reassurance and guidance.

Download or read book Silicone Chronicles written by Anabel M. Scaranelo and published by . This book was released on 2024-08-07 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the realm of medical science, the integrity and safety of breast implants have evolved into a critical area of study. 'Silicone Chronicles: Advanced Insights on Breast Implant Safety' encompasses a curated collection of peer-reviewed scientific articles that delve into the multifaceted aspects of breast implant complications, diagnostic methods, and patient outcomes. Through meticulous exploration, this book offers insights into the rupture rates, potential health complications, and the comparative efficacy of diagnostic tools such as MRI, ultrasound, and mammography. It addresses the longevity and durability concerns of older implants and spotlights the emergent IDEAL IMPLANT(R) technology, which seeks to mitigate rupture risks. Furthermore, this collection examines the regulatory oversight's impact, with a focus on the Poly Implant Prothèse (PIP) scandal. Bridging the gap between patient stories and rigorous clinical studies, 'Silicone Chronicles' serves as an essential resource for medical professionals and patients alike, striving for enhanced safety and informed decision-making in breast implant surgeries. Quality Research Publishing is dedicated to making knowledge more accessible to the general public by curating a topical compilation of the latest research on various subjects and providing plain language summaries. Each of the articles in this book is available individually and digitally without cost. However, we believe it is important for the contextualizing and sharing of educational and scientific work to curate this research in a way that is understandable and helpful to the average person seeking deeper knowledge of a particular subject. The research articles compiled for this book were published under a permissive Creative Commons license, are in the public domain, or have no copyright restrictions, permitting their use in this book. If you have questions about the licensing of any article, please visit qualityresearchpublishing.com.

Download or read book Regulation of Medical Implants in the EU and UK written by Great Britain: Parliament: House of Commons: Science and Technology Committee and published by The Stationery Office. This book was released on 2012-11 with total page 110 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Final Opinion on the Safety of Breast Implants in Relation to Anaplastic Large Cell Lymphoma written by and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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. Overall SCHEER considers that there is a moderate weight of evidence for a causal relationship between textured breast implants and ALCL, particularly in relation to implants with an intermediate to high surface roughness. At this point it should be noted that i) there are several types of textured implants ii) surface textures of breast implants are not all manufactured in the same way, and iii) implants with diverse surface textures may also present different benefits. The magnitude of the risk per type of textured implant is difficult to establish due to the low incidence of the BIA-ALCL. Even with macro-textured implants, BIA-ALCL has a very low incidence. Therefore, risk assessments per implant type are needed. Furthermore, the risk should be weighed against the benefits. There is also a need for an unambiguous, clinically validated classification system for breast implants including more parameters than just "surface roughness". A history of textured breast implants/expanders appears to be necessary but not sufficient for the development of BIA-ALCL. The pathogenic mechanisms of the induction of BIA - ALCL are not well understood; current hypotheses include genetic predisposition, bacterial contamination resulting in chronic inflammation, shell shedding of particulates resulting in chronic inflammation, shell surface characteristics leading to friction resulting in inflammation, and implant associated reactive compounds. The disease latency varies between a few to 20 or even more years. There are several alternatives to breast implants that involve plastic surgery techniques, either using autologous flap tissue or autologous fat transfer. However, patients' characteristics may limit the application of these techniques. There is a need for further research to better understand the aetiology and pathogenesis of BIA-ALCL. Reporting of new BIA-ALCL cases by the relevant registries is also of major importance to obtain a better estimate of the risk of BIA-ALCL for patients with a breast implant.

Download or read book What Women Want to Know about Breast Implants written by Karen Berger and published by Quality Medical Publishing. This book was released on 1998 with total page 66 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Science on Trial written by Marcia Angell and published by W. W. Norton. This book was released on 1996-01-01 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: An expert in the medical field uses the breast implant controversy to discuss the consequences of society's increasing dependence on technology and the resulting confusion over what scientific evidence means in terms of health and justice.

Download or read book In My Quest for Beauty written by Fran Stiff and published by . This book was released on 2007-07 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book The Role of the Therapeutic Goods Administration Regarding Medical Devices Particularly Poly Implant Prothese PIP Breast Implants written by Australia. Parliament. Senate. Community Affairs References Committee and published by . This book was released on 2012 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book This Mortal Coil written by Fay Bound Alberti and published by Oxford University Press. This book was released on 2016-04-08 with total page 285 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Public Health Implications of Differences in US and European Union Regulatory Policies for Breast Implants written by Diane Zuckerman and published by . This book was released on 2013 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The recall of tens of thousands of defective breast implants in Europe in 2011-12 as well as new data on risks have raised questions about regulatory standards for these and other medical implants in the United States (US) and European Union (EU). In the US, breast implants are regulated as high-risk medical devices that must be proven reasonably safe and effective in clinical trials and subject to government inspection before they can be sold. In contrast, clinical trials and inspections have not been required for breast implants or other implanted devices in the EU; approval is based on other information. As a result of these differing standards, the PIP breast implants that were recalled across Europe had been removed from the market years earlier in the US than in the EU, a decision US government health agencies can point to with pride. Nevertheless, the FDA track record on post-marketing breast implant research indicates poorly implemented studies and little meaningful enforcement to ensure that studies have been conducted correctly or findings reported accurately or acted upon. In sum, neither the EU nor the US has used their regulatory authority to ensure the long-term safety of breast implants. However, in 2012 the EU announced regulatory changes that could improve that situation.

Download or read book Provision of Information by the Government Relating to the Safety of Breast Implants written by Great Britain. Parliament. House of Commons. Health Committee and published by . This book was released on 2001-04-05 with total page 78 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book EU Law written by Iyiola Solanke and published by Cambridge University Press. This book was released on 2022-07-14 with total page 703 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides up-to-date, accessible, and intellectually sophisticated insights on EU Law using real-life examples and current case studies.

Download or read book The Routledge History of Disease written by Mark Jackson and published by Routledge. This book was released on 2016-08-05 with total page 636 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Routledge History of Disease draws on innovative scholarship in the history of medicine to explore the challenges involved in writing about health and disease throughout the past and across the globe, presenting a varied range of case studies and perspectives on the patterns, technologies and narratives of disease that can be identified in the past and that continue to influence our present. Organized thematically, chapters examine particular forms and conceptualizations of disease, covering subjects from leprosy in medieval Europe and cancer screening practices in twentieth-century USA to the ayurvedic tradition in ancient India and the pioneering studies of mental illness that took place in nineteenth-century Paris, as well as discussing the various sources and methods that can be used to understand the social and cultural contexts of disease. Chapter 24 of this book is freely available as a downloadable Open Access PDF under a Creative Commons Attribution-Non Commercial-No Derivatives 3.0 license. https://www.routledgehandbooks.com/doi/10.4324/9781315543420.ch24