APPENDIX 1: IRG CONCLUSIONS AND RECOMMENDATIONS
There is no histopathological or conclusive
immunological evidence for an abnormal immune response to silicone
from breast implants in tissue.
There is no epidemiological evidence for any
link between silicone gel breast implants and any established
connective tissue disease. If there is a risk of connective tissue
disease, it is too small to be quantified. The IRG cannot justify
recommending further epidemiological studies to investigate this
Good evidence for the existence of a typical
connective tissue disease or undefined conditions such as "silicone
poisoning" is lacking. It is possible that other conditions
such as low grade chronic infection may account for some of the
non-specific illnesses noted in some women with silicone gel breast
The overall biological response to silicone
is consistent with conventional forms of response to foreign materials,
rather than an unusual toxic reaction.
There is no evidence that children of women
with breast implants are at increased risk of connective tissue
The IRG recognised that there were issues such
as the precise incidence of rupture, where the scientific data
were incomplete so that rigorous conclusions could not be drawn.
Overall, the IRG recognised that there was some
risk to patients associated with the use of any implant, but concluded
that the risks associated with the use of silicone gel breast
implants were no greater than for other implants. The IRG also
recognised the physical and psychological benefits of breast implantation
but at the same time was aware that many women were concerned
about the effects of the procedure. The IRG therefore felt that
it was important to ensure that women are able to make informed
decisions by providing them with clear and comprehensive information
about the potential advantages and disadvantages of particular
products and treatments.
Two major areas of concern were brought to the
attention of the IRG by women giving oral and written evidence.
poor quality of information available
to assist women in making informed decisions about breast implant
inadequate follow-up which makes
it impossible to establish the true incidence of any short and
The IRG made nine recommendations to address
these areas of concern.
||Action taken||Advice given
|1. All women undergoing breast augmentation surgery should be able to obtain information about the benefits and risks of surgery
||Advisory Group formed to prepare information booklet. DH Health Services Division act as secretariat.
||Department of Health booklet on Information for Women considering breast implant surgery published (October 2000). Numbers of copies sent individually to all members of relevant professional bodies. Circulated widely to private clinics, GP surgeries, NHS Direct, etc. and available from the internet
|2. Advertisements promoting breast implant surgery should indicate where information about the operation can be found
||The Department of Health has discussed measures to control advertising with the Advertising Standards Agency.
|3. Appropriate advice on the benefits and risks of surgery should be provided on consultation with a surgeon
||The professional bodies ie 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
||The Royal College of Surgeons agreed to prepare Best Practice Guidelines on breast implantation. MDA met with the Chairman of the RCS Committee and reached Agreement with Councils of all relevant professional bodies regarding development of a universal consent form.
||Clinical Guidelines have been developed for breast implant surgery and patient consent.|
Consent form to be circulated to all individual members of relevant professional bodies with an entry in the relevant Newsletters.
|5. Measures shuld be introduced to ensure proper standards of care are followed in private clinics
||The Care Standards Act has been introduced to regulate private healthcare. Measures to implement this legislation are under development.
|6. Prospective registration of details of each breast implant operation with the National Breast Implant Registry should be compulsory
||Compulsory registration is not possible. However a Steering Group was set up to investigate ways of increasing participation in the NBIR. New Explanatory consent forms are being developed.
|7. All clinicians should report breast implant adverse effects to MDA
||MDA met with Presidents of relevant professional bodies to discuss the IRG conclusions and recommendations, engage their help and explain their role in implementing relevant recommendations. Particular attention was paid to information on which adverse incidents should be reported and how to report adverse incidents.
||In August 1999, MDA published a guidance document for manufacturers and clinicians on the reporting of breast implant-related adverse incidents. This was sent individually to all members of relevant Professional Bodies, accompanied by a covering letter.
|8. Further research is required into the evidence of implant rupture and the aetiology of symptoms
||Funding has been approved for a pilot study using NBIR data to investigate the evaluation of outcome measures. Work will begin in 2001.|
The development of a universal consent form will facilitate future research projects into any associated short- and long-term health risks with breast implants.
|9. The need for regular breast screening to detect rupture should be reviewed in the light of advances in imaging techniques
||The IRG continues to meet twice a year to review new evidence related to its remit.
Medical Devices Agency; Guidance on the medical devices vigilance
system for CE marked breast implants; MDA, August 1999. Back