SIRG(99)01

 Present:
Professor R Sturrock (Chairman)
Professor R Batchelor 
Mr T Milward 
Professor D London
Mrs V Harpwood
Professor A Silman 

Secretariat:
Dr S Ludgate
Dr D M Gott

 In attendance:
Dr V Chishty (DH _ HSD)
Ms S Bayes (DH _ HSD)

 Apologies:
Professor J Sloane

 1. Introduction

 The Chairman welcomed all members of the Group present. Apologies from Professor Sloane were noted. The Chairman welcomed Dr Chishty and Ms Bayes to the meeting and informed members that they represented the policy division responsible for taking forward several of the IRG's recommendations.

 2. Minutes of the last meeting

 The minutes of the previous meeting (5 June 1998) were agreed.

 3. Matters arising

 There were no matters arising that were not already on the agenda.

 4. Final report

 The general impression was that the report had been favourably received. IRG members had only received a few personal responses. The lack of criticism on the scientific analysis by professional groups was considered reassuring.

 The Chairman drew attention to the criticisms made by Professor Goldberg (circulated as SIRG(98)96). The criticisms were based largely on the lack of a materials scientist on the group, although Professor Goldberg had praised other aspects of the report. The IRG felt that appropriate sources of this expertise had been available as required.

 The Chairman outlined the correspondence he had received from patient groups. He suggested that comments from the Patients Association on openness should be borne in mind during the discussion on this subject later in the meeting.

 Implementation of the IRG's recommendations

 The Chairman introduced the tabled document outlining the progress made by DH on implementing the IRG's proposals. 

Dr Chishty outlined progress on establishing a group to develop the materials (patient information, consent form) to underpin recommendations 1,3 and 4. During the initial discussions on these aspects it had been recognized that surgeons needed to be prepared for informed patients asking questions. It was understood that the Council of the Royal College of Surgeons would be in discussion with the Presidents of BAPS and BAAPS about developing good practice guidelines. 

The Chairman informed the IRG of the letter he had received from Transform, who were concerned about the reference to surgical qualifications in the IRG checklist. It was noted that Transform's new documents on patient information and consent, which had been sent to the Chairman, incorporated all of the IRG suggestions. It was agreed that these documents should be circulated to IRG members and forwarded to the group working to implement recommendations 1,3 and 4.

 Dr Chishty outlined discussions with the Advertising Standards Authority (ASA) on recommendation 2. She indicated that there were a number of legal constraints on DH and that in some places the ASA "Help note" went beyond these. The ASA would encourage advertisers to include a symbol indicating availability of information. The ASA felt that some advertisers would embrace this readily and that others would subsequently follow. A number of concerns were expressed over the possibility that any such symbol might be misrepresented as a sign of quality. The need to control the use of the proposed symbol was recognized. This was a point that the Group implementing recommendations 1,3 and 4 would consider.

 The Chairman observed that the principles of clinical governance and quality were being taken on board by the private sector. It was recognized that further developments would come via the role of the General Medical Council, standards set by medical colleges and recognition of the inconsistency by major private sector providers. Professor London indicated that some major private sector providers were planning to introduce the principles of Commission for Health Improvement under their own auspices. By targeting these larger institutions voluntary controls on the majority of private sector surgeons could be introduced. A framework for controls was recognizable and would be enhanced by consumer pressure. Experience from kidney transplantation showed that once guidelines were in place, there was persuasive pressure to conform to them.

 Dr Ludgate described the strategy for implementing recommendation 6 by improving compliance and establishing a strategic management board for the National Breast Implant Registry. The key limitation was the potential increased cost; a strategy for obtaining further funding was currently being addressed. A number of suggestions were made regarding requirements for appropriate additional management skills.

 MDA had developed reporting guidelines to implement recommendation 7. These were based on other MDA implant vigilance guidelines. The secretariat indicated that MDA were about to consult industry and professional groups on the contents of the guidelines. It was agreed that the draft guidelines should be circulated to IRG members.

 IRG members were concerned that the proposed research steering group looking at implementing recommendation 8 appeared to be out of proportion to the task involved. The point of recommendation 8 was that the reproducibility of certain studies needed to be established before analysis of their significance could take place. The DH Research and Development Division had explained that this strategy was their normal practice where issues crossed boundaries. In practice this process was likely to be much simpler than it appeared on paper and it was envisaged that a single meeting would be sufficient. The IRG were content with the approach and Professor Batchelor agreed to represent the IRG at this meeting.

 The secretariat reported that the IRG website had attracted an average of seven to eight hundred "hits" per week. A document was tabled describing a review of the website. A number of minor errors had been identified and these would be corrected. It was suggested that the pages relating to implant rupture should be expanded. It was agreed that when resources were available a draft should be produced and circulated to the IRG for approval.

 5. Constitution of the IRG

 The Chairman suggested that, given its on-going role, the IRG needed to expand its membership to assuage some of the concerns expressed. The IRG proposed that a patient representative and a female surgeon be invited to join. The Secretariat was asked to verify that this was acceptable to Ministers.

 6. Recently published literature

 A number of scientific papers which had become available since the IRG report was finished had been circulated. Members agreed that these in the main supported the IRG's conclusions. Professor Silman informed the Group that a relevant paper on morbidity amongst implant recipients had been presented at a recent meeting of the American College of Rheumatology. The Chairman asked Professor Silman to provide the abstract so that it could be circulated.

 The summary of the U.S. National Science Panel report had been circulated. Members agreed that its conclusions concurred with their own.

 Representatives from Genesis Diagnostics had been unable to attend the meeting to provide details of their diagnostic test. It was agreed that waiting until the next IRG meeting to obtain details was impractical. MDA officials planned to visit the company to discuss a number of issues and it was agreed that Professor Batchelor should accompany them. It was understood that a paper on the test may have been presented at the recent BAPS meeting. The secretariat undertook to seek more information.

 7. Handling of mail and press enquiries

 IRG members were reminded of the agreed procedures for handling press enquiries. The Secretariat was happy to reply to correspondence on the IRG sent to members. The Secretariat responded to routine e-mail inquiries directly but consulted the Chairman on more complex replies.

 8. Openness

 It was agreed that the full minutes of future IRG meetings should be placed on the IRG website to increase stakeholder awareness of discussions. It was recognized that restrictions would apply to some material e.g. commercially sensitive information. Unless problems arose, the minutes would be agreed by correspondence to facilitate their timely publication.

 9. Date of next meeting

 It was noted that implementation of the recommendations would take some time and the IRG agreed it was desirable for this process to be well advanced before they next met. A meeting was therefore scheduled for 14 October 1999 at 10:30.