Select Committee on Health Minutes of Evidence

Memorandum by the Medical Devices Agency (B 1)


  Executive Summary



  Action Taken

  Table 1: Chronology of Key Events

  Response to Scientific and Clinical Questions

  Guidance to Healthcare Professionals

  Table 2: Summary of Information given to Healthcare Professionals

  Provision of Information to the Public

  Direct Communication with the Public

  Regulatory Initiatives by MDA

  Appendix 1: IRG Conclusions and Recommendations


  1.  The first priority of the Medical Devices Agency (MDA) is to protect public health and safeguard the interests of patients by ensuring the safety of medical devices. MDA has responded comprehensively to concerns over the safety of breast implants by:

    —  from 1988, assessing the risk of cancer arising from silicone gel breast implants. The risk was considered remote and these implants remain available;

    —  from 1991, assessing the risk of cancer arising from the breakdown of the polyurethane coating applied to some implants. MDA issued two Advisory Notices informing clinicians that these implants should not be used;

    —  from 1991, assessing evidence for a link between silicone gel breast implants and autoimmune disease or other associated health problems. These issues were addressed in a series of major scientific reviews, two by MDA and an Independent Expert Advisory Group, in 1992 and 1994, and a third by an Independent Review Group (IRG). The IRG concluded, in 1998, that risks from silicone gel breast implants are no greater than for any other type of implant;

    —  from 1998, assessing the safety of lipid-filed breast implants. These implants were withdrawn from use in the UK in 1999 and MDA gave advice in 2000 that women should consider having them removed;

    —  from 1999, assessing the safety of two types of hydrogel-filled breast implants. These implants were withdrawn from use in the UK in 2000.

  2.  The provision of reliable information to clinicians and via them to patients is the key element of MDA's risk communication strategy. MDA maintains close contact with relevant specialists and professional bodies to ensure that the advice it gives is appropriate and that both clinicians and their patients are fully informed. In addition to the reports mentioned above, which were widely distributed, relevant information has been communicated through:

    —  6 MDA Advisory Notices distributed to the Health Service;

    —  2 letters to all doctors from the Chief Medical Officer (CMO);

    —  4 articles in CMO's Update, sent to all doctors.

  3.  The provision of reliable information to patients has been achieved by:

    —  appending information for women to 4 of MDA's Advisory Notices;

    —  publication of an information booklet for women considering breast implants. This was in response to the IRG's concern that some women had been poorly informed about the potential risks associated with breast implant surgery;

    —  updates on the Internet, press releases and help-lines, when appropriate;

    —  direct responses by MDA or Ministers to the many hundreds of letters from patients, their advocacy groups and MPs.

  4.  MDA has called for and secured a review of the operation of the European Medical Devices Directives, which should lead to more stringent pre-market assessment procedures for breast implants and improved performance of assessment bodies. MDA has assisted the European Commission in specifying particular requirements applicable to the assessment of regulatory conformity for breast implants.


  5.  Silicone gel breast implants were first introduced in around 1962, when there were no specific statutory regulations in place to control the marketing and use of medical devices, either in the USA or Europe. Since then, the use of breast implants has increased gradually and it is now estimated that over 10,000 women receive breast implants each year in the UK, 80 per cent of those opting for silicone gel.


  6.  Several concerns have been voiced by clinicians and patients, over the last 10 years or so, related to the safety of breast implants. The MDA has responded to these by evaluating the potential long-term side effects associated with breast implants. The concerns have included the possibility of cancer, the incidence of local complications and the nature of the advice given to people considering surgery. The potential hazard that has given risen to the greatest concern has been the possibility of connective tissue (or autoimmune) disease.


  7.  The MDA has been responding to concerns raised about breast implants since 1988, when it examined data, highlighted by an American consumer interest group, showing that silicone gel-filled implants caused cancer in rats. The Government expert Committee on Carcinogenicity considered this risk to be remote.

  8.  In 1991, the MDA started to look into the risk of cancer arising from the breakdown of the polyurethane coating applied to some implants and into the growing concern that silicone gel breast implants could cause autoimmune effects. This latter issue has been a substantial part of the MDA's work ever since, involving staff in writing two major scientific reviews and assisting an Independent Review Group with a third, as well as responding directly to the public.

  9.  Between 1998 and 2000, MDA responded to concerns raised by plastic surgeons by reviewing safety data relating to lipid- and hydrogel-filled breast implants. Lipid-filled implants were withdrawn from use in UK hospitals in 1999 and, in 2000, women were advised to consider having them removed. Also in 2000, two types of hydrogel-filled breast implant were withdrawn from use in the UK. As a result of the MDA's investigations, the only breast implants currently available in the UK are filled with silicone gel or saline.

  10.  A brief chronology of MDA's response to key events is presented in Table 1.

Table 1


MDA reviews carcinogenicity data on silicone gel and refers it to DH Committee on Carcinogenicity (COC), who conclude that the risk to humans is remote.
1991MDA reviews carcinogenicity of polyurethane coating applied to some breast implants and refers paper to COC, who conclude that risk is theoretical but low. MDA advisory notices issued in 1994 and 1996.

Concern in medical literature about possible link between silicone gel breast implants and autoimmune disease. An Advisory Panel to the US Food and Drug Agency (FDA) recommend continued availability of silicone gel breast implants while safety and efficacy data are collected.

MDA commences review of relevant published literature and manufacturer's data.
1992FDA imposes a US moratorium on silicone gel breast implants. FDA Advisory Panel notes that new data are inconclusive, but FDA restricts implantation to clinical trials for defined categories of patient. CMO Letter issued to all UK doctors to explain situation.

MDA reviews scientific data on hypothesised link between silicone gel breast implants and autoimmune disease and refers report to specially convened Independent Expert Advisory Group (IEAG). IEAG conclude that there is no evidence to indicate a change in practice or policy, but recommends a registry to assist collection of relevant data.
1993National Breast Implant Registry set up by MDA in response to IEAG recommendation.
MDA report published; IEAG conclusions reported in CMO Letter and CMO's Update.
1994Escalating US legal claims culminate in proposal of $4.75B class action, leading to an increased level of public interest and concern over breast implant safety.

MDA reviews scientific data published since 1992 review. IEAG confirms lack of evidence of link with autoimmune disease. Report sent to all UK plastic surgeons; around 10,000 copies distributed worldwide. Conclusions reported in CMO's Update.

MDA issued a Safety Advice Bulletin on polyurethane-coated breast implants.
1996Manufacturer Dow Corning makes provision for bankruptcy; public concern heightens.
MDA issued a second Safety Notice on polyurethane-coated breast implants.
1997Incoming Minister responds to concern among implanted women by ordering the Independent Review Group (IRG) to be set up.

IRG collects and considers evidence, including that provided by implanted women.
1998IRG report concludes that silicone gel breast implants are safe but recommends controls on medical practice and better information for patients. IRG report sent to all UK plastic surgeons; findings reported in CMO's update. Website with report and additional information set up.
MDA co-ordinates implementation of IRG recommendations.

Plastic surgeons report concern over swelling around lipid-filled breast implants. MDA calls for and reviews manufacturer's technical data.
1999MDA's review of lipid-filled breast implants reveals serious concerns over long-term safety. MDA's conclusions confirmed by members of Committee on Toxicology (COT). Product withdrawn; MDA issues Advice Notice.
2000Department of Health booklet on Information for Women considering breast implant surgery published.

MDA sets up expert advisory group to review new data on breakdown of lipid filling. Group recommends removal of implants. MDA issues Hazard Notice.

As part of ongoing review of biological safety of all breast implants, MDA calls for and reviews manufacturers' safety data for two hydrogel-filled breast implants and concludes that there are serious concerns over long-term safety data. MDA's concerns confirmed by COT. Products withdrawn; MDA issues two Device Alerts.


  11.  Several safety reviews has been carried out by MDA scientific staff and/or independent expert groups. These have led variously to reassurance about safety or precautionary action. Information about these outcomes has been passed on to relevant clinicians and the wider public through a variety of routes.

Expert Advisory Groups

  12.  The MDA has approached two of the Government's standing committees[50] for advice on the cancer risks arising from silicone gel and polyurethane-coated breast implants, and the toxicological risks arising from lipid- and hydrogel-filled breast implants.

  13.  Two ad hoc groups were set up to advise the Department of Health on conclusions about risks and recommendations about clinical practice. The Independent Expert Advisory Group (IEAG) advised the Department of Health from 1992 until 1997 on the suspected link between silicone gel breast implants and autoimmune disease. A further group was set up to advise the MDA in 2000 about risks arising from the breakdown of the lipid filler present in some implants.

The Independent Review Group

  14.  In June 1997, the Chief Medical Officer set up an Independent Review Group (IRG). This was in response to concern by the Minister for Health, Baroness Jay, that women continued to complain of severe medical problems which they attributed to their implants and that many patients appeared to have been inadequately counselled prior to breast implantation.

  15.  The IRG's remit was to review the evidence relating to the possible health risks associated with silicone gel breast implants, to examine the issues relating to pre-operative patient information and to report on its conclusions.

  16.  The IRG published its findings in July 1998[51], confirming the lack of association between silicone implants and disease but highlighting problems relating to information given to patients prior to surgery. The IRG made several recommendations on how their concerns should be addressed. (Appendix 1 lists the IRG's conclusions and progress on its recommendations.)

  17.  The IRG continues to meet and review new evidence. In October 2000 they held an Open Day to give members of the public and other interested parties an opportunity to submit new evidence and put questions to the Group.[52]

The National Breast Implant Registry

  18.  The National Breast Implant Registry (NBIR) was set up in 1993 in response to a recommendation by the IEAG. The aim of the NBIR is to provide a comprehensive record of breast implant operations carried out in both the private and the NHS sectors in the UK. The MDA funds the NBIR and acts as secretariat of the NBIR Steering Group, which was set up in 1999 to advise the MDA on the management of the Registry and the use of the data. A pilot study using NBIR data, designed in the light of the IRG's recommendations, has been commissioned.

Adverse Incidents

  19.  The MDA processes around 7,000 reports of suspected problems by medical device users each year, and establishes whether these are isolated events or if there is a wider problem. Where significant risks to public health are identified, either from the investigation of an individual incident or from periodic trend analyses, the MDA ensures that appropriate remedial action is taken to minimise those risks. This may include a product recall or the issue of an Advisory Notice to the Health Service.

  20.  The MDA has investigated a total of 265 reports involving breast implants (including breast implants filled with silicone gel, saline, soya bean oil and hydrogels). With respect to silicone gel, polyurethane-coated and hydrogel-filled breast implants, neither the assessment of individual reports nor trend analyses revealed any unexpected problems. However, reports of breast swelling led ultimately to the advice that soya bean oil-filled implants should be removed.

  21.  In response to the recommendation of the IRG that all clinicians should report breast implant adverse effects to the MDA,[53] specific guidance on the reporting of adverse incidents with breast implants was published in August 1999 and circulated to all plastic surgeons in the UK.[54]


  22.  With regard to dealing with professionals and offering guidance, the MDA's policy on matters relating to breast implantation has been two-fold, namely:

    —  to provide all relevant clinicians with full information about the MDA's investigations, the actions taken and the background to those actions, so that they can keep both themselves and their patients fully informed;

    —  to discuss emerging issues with representatives of all the relevant professional bodies and clinical specialists, prior to any information being sent out to the Health Service. This ensures that such information is in a format which is helpful in terms of setting out the proposed action points and the background to those action points. It also ensures that the documentation contains helpful, detailed information, so that patients' questions can be sensibly addressed.

  The overall aim is to ensure close liaison between the MDA and clinicians in terms of working towards the best interests of the public.

  23.  MDA maintains close contact with relevant professional bodies[55] to ensure that appropriate advice and information is communicated to clinicians.

  24.  Table 2 summarises the measures taken by MDA to inform healthcare professionals of issues relating to breast implants.

Table 2

DateInformation disseminated to the Health Service
Jan 1992CMO letter to all doctors in England/regional directors of public health/district directors of public health (similar letters sent out by the Chief Medical Officers of Scotland, Wales and Northern Ireland) on the possible health risks associated with silicone gel breast implants.

Copies of CMO letter circulated to individual members of relevant professional bodies: British Association of Plastic Surgeons (BAPS), British Association of Aesthetic Plastic Surgeons (BAAPS), British Association of Cosmetic Surgeons (BACS), following discussion with the Presidents of these bodies.
Mar 1993Second CMO letter to all doctors in England:

—laying out the conclusions from the Independent Expert Advisory Group;

—laying out advice from the Advisory Committee on Breast Cancer Screening (ACBCS) and the Royal College of Radiologists Breast Group (RCRBG);

—setting out details of the National Breast Implant Registry.

A copy of the letter and the report from the Expert Advisory Group individually circulated to all members of the professional bodies following discussion with the Presidents of those bodies.

Article in CMO Update circulated to all doctors, setting out information about the setting up of the National Breast Implant Registry and how to register.
May 1994US District Court in Birmingham, Alabama, announced the commencement of an international outreach programme to advise women and their family members of a proposed Class Settlement. The US Court employed the services of a London based PR agency to disseminate the information in the UK and this agency discharged its obligation by sending a letter to a number of Ministers, DoH officials, Health Service managers and professional bodies. Because of the increasing anxiety of implanted patients, resulting from ill-informed press coverage of the Court action, and because it was felt that the majority of patients might never hear about the Class Action, MDA proposed that the most appropriate course of action would be the issue of a suitably worded Press Notice. This was agreed by Ministers.

MDA held meetings with the professional bodies, requesting their help in promulgating the conditions of the settlement to all relevant patients.
June 1994Article in CMO Update circulated to all doctors setting out the results of the Expert Analysis requested by MDA in respect of a paper claiming oesophageal abnormalities in children of Breast implanted women.
Sept 1994Safety Action Bulletin issued by MDA in respect of further evidence from the Committee on Carcinogenicity on polyurethane coated breast implants with potential release of a possible carcinogenic degradation product following breakdown of polyurethane foam, to relevant health care professionals.

A copy of this Notice was circulated to all members of the relevant professional bodies following discussion with the Presidents of those bodies, with a covering letter.
Dec 1994The results of the MDA publication of updated analysis of all medical and scientific literature relating to silicone breast implants and connective tissue disease communicated with the professional bodies. Copies of the documents individually circulated to all members of these bodies.
Jan 1995Article in CMO Update circulated to all doctors providing results of updated analysis.

American courts announced registration for Class Action was extended until March 1995. Proposal for a further Press notice was agreed by Ministers.

Further discussions held with Presidents of relevant professional bodies to ensure the promulgation of this information as widely as possible to all relevant patients.
Apr 1995Letter from CMO to opposite numbers in European Union sending out a copy of updated analysis for distribution to health care professionals
Sept 1996Following discussions with Presidents of relevant professional bodies, letter sent out to all members of professional bodies, drawing to their attention a press advertisement concerning bankruptcy of the breast implant manufacturer Dow Corning and preservation of the right to pursue existing or future claims undeer the US legal system.
1997Dr Ludgate (MDA's Medical Director) asked to sit on the Council of BAPS in order to regularly report any updates regarding silicone breast implants, so that this information could be promulgated to all members of the professional bodies via their newsletters. Dr Ludgate has attended these meetings regularly since this time.
July 1998Final report from the Independent Review Group. A copy of the final report with a covering letter sent to all members of the relevant professional bodies individually, including members of the British Association of Surgical Oncologists (BASO), following discussion and agreement with the Presidents.
Aug 1998Article in CMO Update circulated to all doctors setting out the outcomes and recommendations from the Independent Review Group Report.
Oct/Nov 1998Meeting with Presidents of relevant professional bodies to discuss the conclusions and recommendations from the Independent Review Group report and engage their help and explain their role in implementing the relevant recommendations.

With respect to IRG Recommendation 7 (that all clinicians should report breast implant related adverse incidents to the MDA Adverse Incidence Centre. The MDA should provide guidance to clinicians on which incidents should be reported), a specially prepared guidance document accompanied by a covering letter, sent individually to all members of relevant professional bodies.

At MDA's request, the Presidents of relevant professional bodies asked their members to report all adverse events encountered with Trilucent breast implants to MDA.
Mar 1999Medical Device Advice Notice issued re Trilucent Breast Implants. Contents agreed after prior discussion with the Presidents and office holders of relevant professional bodies. Individual copies of the Advice Notice sent to all members of the relevant professional bodies with a covering letter.
Nov 1999Meeting with Mr Michael Brough, Chairman of the Royal College of Surgeons Committee set up to produce Best Practice Guidelines on breast implantation to input to these Guidelines, particularly with regard to inputting information on which adverse incident to be reported and how to report adverse incidents.
June 2000Hazard Notice re Trilucent breast implants sent to all members of the relevant professional bodies, following a number of discussions with scientists and Presidents of relevant professional bodies and representatives of the independent and private sectors, as to the advice to be given and the strategy for implementation of this advice.
Oct 2000With respect to IRG Recommendation 1 (that all patients undergoing cosmetic breast augmentation surgery should be able to obtain information about the benefits and risks of such surgery), Department of Health booklet on Information for Women produced. Numbers of copies sent individually to all members of relevant professional bodies.
July 2000Letter sent to all members of relevant professional bodies providing further information on a number of issues in relation to Trilucent Breast Implants, in order to help in the future management of implanted women and in answering a number of queries raised both by implanting surgeons and their patients. This information also provided to the manufacturer for them to give out as appropriate, provided to NHS Direct, placed on the web site and promulgated by the National Breast Implant Registry to all implanting centres registered, including those in the independent and private health care sectors.
Nov 2000Invited lectures given by MDA to the Annual Meeting of the BAPS setting out the facts and updating information on Trilucent breast implants.
Nov/Dec 2000Discussions with the Presidents of all the relevant professional bodies and with representatives of private and independent health care sectors re hydrogel breast implants. Obtained their agreement to proposed strategy and wording of the Device Alert for handling withdrawal of these implants from the market. Individual copies of Notice sent to all members of professional bodies with attached information with respect to answering patients' questions. This information also on the Internet.
Dec 2000/Jan 2001Discussions held with Councils of all relevant professional bodies with regard to their agreement to a universal consent form, so as to facilitate future research projects into any associated short- and long-term health risks with breast implants. Agreement reached. Consent form to be circulated to all individual members of relevant professional bodies with an entry in the relevant Newsletters.


  25.  MDA interacts predominantly with the Health Service and manufacturers. However, in line with the general trend towards greater public access to Government departments, MDA has dealt increasingly with members of the public over the last six years. The provision of reliable information to the public, through the media and other relevant routes, now forms a key part of communications strategies developed by the Department of Health in response to identified risks. MDA's website contains information on breast implants and links to MDA's recent Advisory Notices and the IRG website.[56]

  26.  In 1996, the NHS Breast Screening Programme published a short leaflet for women who have breast implants.

  27.  The IRG report, published in 1998, is a source of information both for professionals and for women considering breast implantation or concerned about their breast implants. In this respect it differs from the previous expert reports published by the MDA, which were primarily intended to inform the medical and scientific community. Women can obtain a free copy of the IRG report.[57] 56

  28.  The IRG recommended that all patients undergoing cosmetic breast augmentation surgery should have access to information on the risks of surgery (see Appendix 1). In response to this, the Department of Health set up a drafting group, on which patient advocacy groups were represented. The resulting booklet, published in October 2000, is attached. 57[58]

  29.  The four MDA Advisory Notices issued in 1999-2000 relating to soyabean oil- and hydrogel-filled breast implants included annexes which provide information that is intended to be passed on, during a clinical consultation, to women who have these types of breast implants. This information is also available via the MDA's website.[59] 58

  30.  At the same time that these Notices were issued, the Department of Health arranged for appropriate information to be available to the press and through existing help lines (such as NHS Direct). Manufacturers also made arrangements for the same information to be available, for example, through help lines.

  31.  In November 2000, the IRG held an Open Day to allow interested parties to present new evidence and put questions to members of the Group.[60] 58


  32.  In around 1995, the MDA started to receive correspondence from members of the public regarding breast implants. Since then, theMDA has dealt with hundreds of letters and telephone calls from members of the public concerned about breast implants, with over 350 items of correspondence with one individual alone. The majority of concerns raised related to the biological safety of silicone gel breast implants.

  33.  Some of the women who contacted the MDA in the mid 1990's expressed concern that their silicone implants might be the cause of their ill health. The MDA's technical and clinical staff offered them reassurance that, in spite of considerable research, no causative link between implantation and disease could be established.

  34.  Several women disputed the consensus that there was no scientific evidence supporting a link between silicone gel breast implants and connective tissue disease and called for a ban. They felt that their belief that their disease was the result exposure to silicone implants was not taken seriously by MDA or the medical profession and that, as a result, they were denied proper treatment by the Health Service.

  35.  In around 1996, a few women organised various advocacy groups to campaign for the banning of silicone gel breast implants and/or the provision of better information to patients.

Parliamentary Ombudsman's investigations

  36.  The way MDA dealt with some of the letters received in around 1996 was the subject of a series of six investigations by the Parliamentary Ombudsman in 1998-99. The complainants asserted that, in addition to noting the information provided and responding to the concerns expressed, MDA should have logged their letters as adverse incident reports. In response to the wishes of these correspondents, from 1997, MDA logged all such letters as adverse incident reports, irrespective of whether a device performance problem was indicated.

  37.  The Ombudsman found that, in two cases, MDA had failed to respond effectively to the letters and, in five cases, MDA had been remiss in failing to keep some letters on file. However, in no case did he find sufficient grounds to criticise MDA for not taking the letters as a basis for action through the adverse incident procedure. 60[61] A further complaint to the Parliamentary Ombudsman, relating to the failure of MDA to disclose the identity of experts who had provided them with informal advice, was upheld. [62]


  38.  Breast implants are classed as medical devices and regulated by the European Medical Devices Directive (MDD). [63] This is a "new approach directive" which imposes a light touch to regulation and harmonises safety and performance requirements for medical devices throughout the EEA, thus ensuring a single market.

Operation of the Medical Devices Directive

  39.  The United Kingdom currently has some concerns over the operation of the MDD and, in July 2000, called for and secured a review of its operation by the European Commission. One of the main changes MDA is pursuing is the re-classification of all implants from an intermediate to the highest risk category. This will tighten the regulatory controls and the pre-market requirements for such products across Europe. The European Commission has already accepted that breast implants should be reclassified as high-risk devices and is currently preparing measures to achieve this.

  40.  MDA has also been concerned about the uneven performance of Notified Bodies across Europe. Notified Bodies are independent certification organisations, responsible for ensuring that a manufacturer's processes or products meet the requirements of the MDD. To improve the overall level of performance of Notified Bodies, MDA strongly promoted the establishment of The Notified Body Oversight Group (NBOG), whose first meeting took place in November 2000.

  41.  The two key issues being tackled by NBOG are transparency in the way each Member State carries out the designation and monitoring activities for Notified Bodies and the competence of both Member State and Notified Body assessors.

Petitions to the European Parliament

  42.  In March 1999, two petitions to the European Parliament, calling for an immediate ban on silicone gel breast implants, were tabled by MEPs on behalf of women who believe that breast implants have caused adverse effects. The Petitions Committee of the European Parliament commissioned a Scientific Technological Options Assessment to enable more informed legislative and policy decisions to be made.

  43.  The European Parliament assessment recommended that "critical specific measures be adopted and implemented to improve information for patients, tracking and surveillance, quality control and assurance and key research". The findings of this assessment were similar to those of the IRG and most of its recommendations have already been implemented in the UK (See Appendix 1).

  44.  The European Parliament Petitions Committee asked the European Commission to develop proposals along the recommended lines and the Commission adapted an existing draft document, that specified regulatory expectations for breast implants. MDA has assisted the European Commission in the development and adaptation of this document since 1995.

  45.  The Petitions Committee is due to meet on 21 March 2001, to consider a final response to the petitions laid before them and the Commission document.

March 2001

50   The Committees on Toxicity (COT) and Carcinogenicity (COC) of Chemicals in Food, Consumer Products and the Environment. Back

51   h Back

52 Back

53   See Appendix 1, Recommendation 7. Back

54   Medical Devices Agency; Guidance on the medical devices vigilance system for CE-marked breast implants; MDA, August 1999. ( Back

55   The most relevant bodies are The British Association of Plastic Surgeons (BAPS), The British Association of Aesthetic Plastic Surgeons (BAAPs) and The British Association of Cosmetic Surgeons. Back

56 Back

57   The IRG report can be ordered on 020 7972 8077 or downloaded: Back

58   Department of Health; Breast Implants: Information for women considering breast implants; October 2000. Available from the Health Information Service, NHS Direct and the Internet: Back

59 Back

60 Back

61 255/99, 338/99, 366/99, 391/99, 410/99 and 1100/99). Back

62 Back

63   Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Official Journal of the European Communities; L 169; 1-43 (12 July, 1993). Back

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