PIP breast implants and regulation of cosmetic interventions

PIP breast implants and regulation of cosmetic interventions PDF Author: Great Britain: Parliament: House of Commons: Health Committee
Publisher: The Stationery Office
ISBN: 9780215043474
Category : Medical
Languages : en
Pages : 60

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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.

PIP breast implants and regulation of cosmetic interventions

PIP breast implants and regulation of cosmetic interventions PDF Author: Great Britain: Parliament: House of Commons: Health Committee
Publisher: The Stationery Office
ISBN: 9780215043474
Category : Medical
Languages : en
Pages : 60

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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.

PIP Breast Implants

PIP Breast Implants PDF Author: Antonia Mariconda
Publisher: Need2Know
ISBN: 9781861442611
Category : Self-Help
Languages : en
Pages : 116

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Book Description
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.

Scientific Advice on Evaluation of the Availability of New Scientific Information on the Safety of PIP Breast Implants

Scientific Advice on Evaluation of the Availability of New Scientific Information on the Safety of PIP Breast Implants PDF Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 25

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Book Description
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.

The Safety of Poly Implants Prothèse (PIP) Silicone Breast Implants

The Safety of Poly Implants Prothèse (PIP) Silicone Breast Implants PDF Author:
Publisher:
ISBN: 9789279301049
Category :
Languages : en
Pages : 95

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Book Description
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.

PIP breast implants

PIP breast implants PDF Author: Great Britain: Parliament: House of Commons: Health Committee
Publisher: The Stationery Office
ISBN: 9780215046062
Category : Medical
Languages : en
Pages : 32

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Book Description
In February 2012 the Health Committee undertook an inquiry into 'PIP Breast implants and regulation of cosmetic interventions' (HC 1816, 16th report session 2010-12, ISBN 9780215043474). The Government response to that report (Cm. 8351, ISBN 9780101835121) is not commented upon here. This report follows on from the earlier conclusion that all possible evidence, including patient-reported experiences, must be gathered and analysed in order to inform the policy response to the issue. The timescale of the earlier inquiry did not allow evidence to be taken directly from those women affected. The Committee therefore established a web forum where women with PIP implants could explain how they had learned about the issues; what they had been told about their implants when they were provided; their experiences with their private providers once they had discovered they had PIP implants; and the support they received privately or from the NHS in having the implants removed or replaced. The web forum was open for comments during May 2012. By the time the forum closed to new comments on 31 may 2012, 194 women had registered with the forum and left 279 posts. By 24 June 2012 the forum had received over 4, 230 page views. This report summarises the responses received on the forum.

The Safety of Poly Implants Prothèse (PIP) Silicone Breast Implants

The Safety of Poly Implants Prothèse (PIP) Silicone Breast Implants PDF Author:
Publisher:
ISBN: 9789279263095
Category :
Languages : en
Pages : 74

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Book Description
Breast implants can fail, regardless of manufacturer, and the probability of failure increases with time since implantation. This phenomenon is true for all types of implants used in humans. In most cases, breast implant failure appears to be without identifiable health consequences for the patient with the exception of possible local complications. The question asked of the SCENIHR is: Are the breast implants manufactured by Poly Implant Prothèse (PIP) more prone to failure than those of other manufacturers, and what are the consequences to health, if any, from PIP implant failures? In view of the nature and reliability of the available data on breast implants overall and the urgency of an Opinion from the SCENIHR on PIP silicone breast implants in particular, the focus of attention in this initial response is on the following aspects: Physical and chemical properties of the PIP silicone breast implants, where accessible; Findings of the effects of PIP implant contents in the required safety tests, where available; Reports of incidents of PIP implant failures, where available.

The Role of the Therapeutic Goods Administration Regarding Medical Devices, Particularly Poly Implant Prothese (PIP) Breast Implants

The Role of the Therapeutic Goods Administration Regarding Medical Devices, Particularly Poly Implant Prothese (PIP) Breast Implants PDF Author: Australia. Parliament. Senate. Community Affairs References Committee
Publisher:
ISBN: 9781742296456
Category : Breast implants
Languages : en
Pages : 112

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Book Description


Safety & Imaging of Modern Silicone Breast Implants

Safety & Imaging of Modern Silicone Breast Implants PDF Author:
Publisher:
ISBN: 9789461086525
Category :
Languages : en
Pages :

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Book Description


Breast Implants

Breast Implants PDF Author: Nancy Bruning
Publisher: Turner Publishing Company
ISBN: 163026881X
Category : Health & Fitness
Languages : en
Pages : 210

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Book Description
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.

Silicone-Gel Breast Implants: Health and Regulatory Update 2000

Silicone-Gel Breast Implants: Health and Regulatory Update 2000 PDF Author:
Publisher: Am Cncl on Science, Health
ISBN:
Category : Breast implants
Languages : en
Pages : 52

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Book Description