14 October, 1999, Hannibal House, Elephant and Castle
 
 

Present: Professor R Sturrock (Chairman)

Professor R Batchelor 

Dr J Evans 

Professor D London 

Mr T Milward

Ms C Rayner 

Professor J Sloane

Secretariat: Dr A Austin 

Mr A Crosbie

Dr D M Gott

Dr S Ludgate

Mr J Tinkler

Apologies: Mrs V Harpwood 

Professor A Silman
 
 

1. Introduction

The Chairman welcomed all members of the Group present. Apologies from Mrs Harpwood and Professor Silman were noted. The Chairman welcomed the new members, Dr Evans and Ms Rayner, to the meeting.
 
 

2. Minutes of the last meeting

The minutes of the previous meeting held on the 11 December 1998 (SIRG(99)01) were confirmed. These had been agreed by IRG members by correspondence before their publication on the IRG Website.
 
 
 
 

3. Matters arising

3.1. New IRG members

The Chairman noted that Dr Evans and Ms Rayner had been asked to join the group in response to the IRG’s decision to expand.

3.2. Genesis Diagnostics assay

At the last meeting, it had been agreed that Professor Batchelor and MDA officials should visit Genesis Diagnostics to obtain details of their diagnostic test for silicone antibodies. This visit had not taken place because Genesis Diagnostics had subsequently written to MDA explaining that they had withdrawn the test after discovering that it produced inconsistent results with fresh and stored serum (SIRG(99)20). The company had indicated that they planned to publish their findings. The need for authors and journals to ensure that retractions or corrections of erroneous results or claims in publications was agreed by members. The IRG asked the Secretariat to approach Genesis Diagnostics to ensure that they had submitted their findings on the silicone test to the appropriate journal.

The IRG discussed the relationship between the Genesis Diagnostics assay and that described in the Lancet by Tennenbaum et al. and agreed that it was unclear. Members agreed that further information was needed from the company on this issue.

The IRG noted that RIVM, a Dutch Government laboratory, was undertaking a thorough assessment of the Tennenbaum assay. This was a phased assessment, commencing with validation of the assay method and then proceeding to assess its clinical usefulness. It was noted that RIVM had described their methods in English but that the full test protocol was only available in Dutch. RIVM had indicated that validation of the assay had been successfully completed. The IRG asked the Secretariat to ascertain whether RIVM had made further progress and to confirm that they were evaluating any effects of storage.

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

4. Implementation of the IRG's recommendations 

The IRG noted that the committee addressing Recommendations 1, 3 and 4 (in relation to patient information) had widely circulated a draft patient information leaflet for comment and were scheduled to meet to discuss comments received during October. An article from Health Which (SIRG(99)42) expressing concern about the contents of the patient information leaflet was tabled for the IRG’s information. 
 
 

The IRG noted that meeting of the group addressing compliance with the National Breast Implant Registry (Recommendation 6) was taking place on the following day. 
 
 

The IRG noted that MDA had published guidelines on reporting adverse incidents with breast implants in response to Recommendation 7. The IRG expressed their satisfaction these guidelines were being circulated to UK plastic surgeons.

Ms Rayner explained that she had joined the IRG in order to represent patients; some women still felt excluded. She indicated that patients felt that their distress was not sufficiently recognised. She indicated that what patients wanted was information, implementation of the principles of good clinical practice and the prevention of future problems. Ms Rayner recognised that the IRG’s recommendations had covered most of these aspects. In Ms Rayner’s view there remained sufficient reports of alleged problems to justify their anxiety. Ms Rayner suggested that it was difficult to explain the risk/benefit concept to these individuals when their distress appeared to be ignored. Ms Rayner believed that the failure to communicate to these individuals was a failure in informing patients. 

The Chairman emphasised that the IRG had recognised the distress arising from implanted women’s health problems and had striven to ensure that implanted women were heard. In answering their remit however the IRG had to rely on the scientific evidence for their conclusions on the risks of silicone gel breast implants. Mr Milward suggested that irrespective of the scientific debate these women needed someone to address their health concerns. The IRG suggested that the Department of Health should consider adopting such an approach. The IRG agreed that conclusions based on science could not be overturned just to appease critics. The Chairman noted that the IRG’s conclusions reassured those implanted women without health problems, who had been made anxious by the allegations of adverse health effects.

Professor Batchelor and Mr Tinkler were asked to provide feedback on the minutes of the Research Steering Group (SIRG(99)07) established by the DH Research and Development Division to address Recommendation 8. Professor Batchelor expressed his disatisfaction that there had been considerable delays in the DH Research Division arranging a meeting of this group and a further prolonged delay in producing the minutes of this meeting. The IRG agreed that the delays were unacceptable and agreed that the Chairman should write to the Minister on this matter.

The Chairman reported that the Secretariat had been contacted seeking part funding for a study on rupture of third generation breast implants. The IRG were of the opinion that this was a timely proposal but that it could only be considered on the basis of a detailed proposal submitted (in the usual way) for independent scrutiny and assessment. The Chairman indicated that the IRG would be interested in seeing a copy of this proposal. Dr Evans indicated that such a proposal was likely to be supported by the British Association of Plastic Surgeons (BAPS) and she would discuss this with the BAPS Council at their next meeting. The IRG agreed that a detailed proposal for the study should be sought and submitted to the DH Research Division for further consideration. 

5. Update on adverse incidents reported to MDA

The IRG noted the summary by Dr Austin of the information given in her written report to the IRG (SIRG(99)09) for the period to 31 July 1999. This was an update of information previously provided to the IRG in SIRG(98)50. The IRG observed that no significant trends had been observed for either device performance or self reported symptoms over the period. The IRG noted that there was increased reporting to MDA by surgeons and felt that this trend would continue following the publication of the MDA vigilance guidelines. The IRG agreed that it was useful for them to receive a regular update and analysis of breast implant adverse incident reports.

6. Recently published literature

Scientific papers on breast implants published since the last IRG meeting had been circulated. Members had been asked to pay particular attention to papers in their particular field of expertise. It was agreed that relevant members should provide a written summary of the key points in these papers. These summaries appear as an annex to these minutes.

The IRG agreed that these papers did not alter the IRG's conclusions, but one or two papers had identified areas that required continued monitoring. 

A review paper on the published literature on rupture had been prepared and circulated. This expanded on the short text currently available on the IRG website. It was agreed that this paper should replace the current rupture page on the IRG website after IRG members had submitted any written comments. 

7. Correspondence

7.1 TrilucentÒ breast implants

The Chairman observed that the withdrawal of lipid filled TrilucentÒ breast implants had resulted in considerable correspondence with women who were concerned at the apparent inconsistency between the actions taken on TrilucentÒ breast implants and those taken on silicone gel breast implants. The Secretariat informed members that the manufacturer’s decision to withdraw the product had been based on three technical issues: greater than expected degree of chemical breakdown of the oil; inadequate evaluation of the toxicology of some biologically active substances resulting from this breakdown and unexplained clinical observations (local swelling).

7.2.Remploy.

The Chairman reported that he had received correspondence alleging that the IRG’s conclusions had been influenced because Remploy, a former manufacturer of silicone gel breast implants, had received government funding. The Chairman stated that the IRG had been unaware of Remploy’s status and could not therefore have been influenced in the manner suggested.

8. Date of next meeting

A meeting was scheduled for 9 March 2000 at 10:30.