Press Notice

The Independent Review Group on Silicone Gel Breast Implants

The Independent Review Group (IRG) on Silicone Gel Breast Implants is pleased to present its final report to Sir Kenneth Calman, the Chief Medical Officer.

Because of continuing concerns expressed by some implanted women, the IRG was set up by the Chief Medical Officer, at the request of the Minister of Health, Baroness Jay, to review the possible health issues associated with silicone gel breast implants and examine the issues relating to pre-operative patient information.

The members of the IRG were selected for their independent views, their knowledge and understanding of the issues and lack of any vested interest in the conclusions reached.

Although the IRG recognised the physical and psychological benefits of breast implantation, they were also aware of the health concerns of implanted women and those contemplating implant surgery. The IRG therefore felt that in order to fulfil its remit and help address these concerns, it was very important to obtain both written and oral information from a wide range of relevant sources, in addition to reviewing the existing and emerging scientific evidence. These sources included implanted women, representatives of women's support groups, physicians, lawyers, industry and plaintiff and defence submissions to the scientific panel appointed to review the scientific merits of the evidence presented in litigation in the USA.

On the basis of the information available the IRG concluded that:

i. silicone gel breast implants are not associated with any greater health risk than other surgical implants

ii. whilst it is recognised that there are a number of local complications such as capsular contracture and gel bleed, the incidence of ill- health in women implanted with silicone gel breast implants is no greater than in the general population. In particular, there is no evidence of an association with an abnormal immune response or typical or atypical connective tissue diseases or syndromes

iii. children of implanted women are not at increased risk of connective tissue disease

iv. the information provided to women undergoing breast implantation is often inadequate.

In the light of the conclusions drawn and at the same time bearing the mind the concerns raised by some implanted women, the IRG has made a number of recommendations covering:

i. the adequate provision of information prior to breast implantation, in order to assist women in making informed decisions about whether to proceed to implant surgery

ii. the need for extending principles of good clinical practice and clinical audit across some areas of the private sector

iii. areas that require future research, including the incidence of rupture and the investigation of conditions such as low grade infection which may account for some of the non-specific illnesses noted in some implanted women
It is the intention that the IRG continue to meet to consider any new evidence on issues relating to breast implants or associated health concerns, setting out additional recommendations as necessary.

Copies of the report are available from:

Department of Health
PO Box 410
Wetherby
Yorkshire LS23 7LN

Tel: 01937 840 250