Open Day

IRG Open Day held on 5 October 2000 at Hannibal House London

Aims of the Open Day

• To give an update on the work of the IRG since the publication of their report in July 1998
• To receive any new submissions from women with silicone gel filled breast implants
• To address the concerns of the general public regarding silicone gel filled breast implants

Membership of IRG
Prof.R.D.Sturrock (Chairman)
Prof. J.R. Batchelor
Mrs V. Harpwood
Prof. D.R. London
Mr T. Milward
Mrs C. Rayner (not present at Open day)
Prof. A.J. Silman
Prof. R.A. Walker

Summary
An Open Day was held by the Independent Review Group (IRG) on silicone gel breast implantson 5th October 2000. The meeting was held at the Department of Health and it was chaired by Professor Sturrock. Around 50 people attended the meeting.

The aim of this forum was to provide members of the public, including implanted women, their relatives and members of the women's support groups, the opportunity to express their views and comments on the work of the Group, to share their concerns and to provide new evidence relating to breast implants and health issues.

The Open Day also provided the forum for the launch of a comprehensive information booklet for women considering breast implantation. The booklet outlines the risks, benefits and likely cost of surgery, with the aim of ensuring that women have the information they need to make an informed decision about breast implant surgery.

At the end of the Open day the IRG concluded that there were a number of important issues that had arisen from the excellent discussion and the evidence given. These included:

• the difficulty in communicating what is meant by "safety" and the fact that safety, as it applies to breast implants, needs to be interpreted within a risk/benefit analysis;
• the importance of keeping an open mind on the subject of breast implants and health issues and ensuring that any future conclusions and recommendations are determined on the basis of evidence;
• the importance of the IRG being approachable by any individual or Group who wish to express their views on the safety of silicone gel breast implants;
• the concern that attributing an illness to exposure to silicone may disadvantage some women in terms of their access to medical treatment or disability allowance;
• the importance of sharing information and of keeping open the lines of communication between the IRG and the women's support groups so that new issues and communication strategies for future advice could be discussed and planned together.

Progress on Recommendations
In 1998 the IRG made 9 recommendations relating to silicone gel filled breast implants as follows:

1. All women should be provided with information regarding the benefits and risks of surgery.
   Progress: An advisory group has produced an information booklet for women considering breast implant surgery.
2. Advertisements promoting breast implant surgery should indicate where information about the operation can be found.
   Progress: The Department of Health is discussing measures to control advertising with the Advertising Standards Agency.
3. A consultation with a surgeon should provide appropriate advice on the benefits and risks of surgery.
   Progress: The professional bodies i.e. British Association of Aesthetic Plastic Surgeons (BAAPS) and British Association of Plastic Surgeons (BAPS) have recommended new arrangements for patient consultations.
4. A specific consent form should be used prior to surgery.
   Progress: Clinical Guidelines have been developed for breast implant surgery and patient consent.
5. Measures should be introduced to ensure proper standards of care are followed in private clinics.
   Progress: The government has introduced the Care Standards Bill to regulate private healthcare.
6. Prospective registration of details of each breast implant operation with the National Breast Implant Registry should be compulsory.
   Progress: Compulsory registration is not possible. However a Steering Group has been set up to investigate ways of increasing participation in the National Breast Implant Registry. New Explanatory consent forms are also being developed.
7. All clinicians should report breast implant adverse effects to the Medical Devices Agency (MDA).
   Progress: The MDA has published guidance on the reporting of breast implant-related adverse incidents which has been circulated to all members of the relevant Professional Bodies.
8. Further research is required into the evidence of implant rupture and also the frequency of low grade infection.
   Progress: Funding for a pilot study has been approved. Work will begin in 2001.
9. The need for regular breast screening to detect rupture should be kept under review in the light of new advances in breast imaging techniques which may occur in the future.
10. The IRG continues to meet twice a year to review new evidence related to its remit.

Action taken regarding evidence presented at the IRG Open Day
Prior to the IRG's Open Day in October 2000, a dossier of criticism of the IRG report was submitted. This contained letters from several clinicians and scientists. In addition, at the meeting, several other clinicians/scientists were quoted as having information relating to the safety of silicone gel filled breast implants. Following the Open Day The IRG wrote to these clinicians/scientists to gather any new evidence in several areas relating to the safety of silicone gel breast implants.

Overall Review
The individuals replies were reviewed by the IRG. Any published scientific papers which had not already been reviewed were reviewed and the reports included in the scientif papers reviews attached to the minutes of the IRG meetings.

Platinum Toxicity
The subject of platinum toxicity was raised and the IRG is in the process of gathering and reviewing data on this subject. Further information will be available on the IRG website once this process is complete.

Disability Living Allowance
Difficulty in getting disability living allowance (DLA) as a result of the IRG's report was raised at the Open Day. Following the meeting, at the request of the IRG, the secretariat wrote to the Disability and Carer Benefits Directorate regarding this issue. They replied that "entitlement to DLA does not depend on the illness or disability a person has, but on the effects of the condition on their care and mobility needs". They also indicated that "decision makers make decisions fairly and impartially and are required to apply the law to the facts of the individual case". The IRG's conslusions should therefore have no bearing on entitlement to DLA.