Independent Review Group - silicone gel breast implants

The PDF version of the report of the Independent Review Group refers to supplementary information on a dedicated IRG website. The contents of the original IRG website have been transferred to this site and can be accessed from links on the left side of this webpage.

The Independent Review Group (IRG) was established in May 1997 in response to concerns expressed by women in relation to silicone gel breast implants.

The Chief Medical Officer, at the request of the Minister of Health, Baroness Jay, set up the IRG with the remit:

‘to review the evidence relating to the possible health risks associated with silicone gel breast implants, to examine the issues relating to pre-operative patient information, and to report to the Chief Medical Officer on its conclusions.’

In fulfilling the remit, the IRG took a fresh look at the existing and emerging scientific evidence for a link between silicone gel breast implants and effects on health. Additionally, the IRG gathered evidence on the quality and quantity of information routinely provided to women about to undergo breast implantation. The IRG:

  • reviewed the existing reports and evidence
  • identified and considered new evidence
  • considered the possible existence of a new, undefined syndrome
  • considered the range of risks associated with silicone gel breast implants
  • examined whether patient information is satisfactory
  • considered how good clinical practice can be assured.

The IRG's report was published in July 1998. The IRG considered evidence from a number of sources, including:

  • oral evidence from representatives/nominees of patient groups, lawyers, researchers, physicians, plastic surgeons, industry and the National Breast Implant Registry
  • written evidence from interested parties, including women with breast implants, replies to requests for information, and additional information from those who gave oral evidence
  • plaintiff and defence submissions to the scientific panel appointed to review the scientific merits of evidence presented in litigation in the United States
  • unpublished scientific information, legal submissions, letters from women with silicone gel breast implants, Internet and press articles
  • scientific publications
  • data provided by manufacturers.

The IRG considered immense amounts of complex evidence and reached a number of conclusions.

  1. There is no histopathological or conclusive immunological evidence for an abnormal immune response to silicone from breast implants in tissue.
  2. 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 hypothesis.
  3. Good evidence for the existence of atypical 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 implants.
  4. The overall biological response to silicone is consistent with conventional forms of response to foreign materials, rather than an unusual toxic reaction.
  5. There is no evidence that children of women with breast implants are at increased risk of connective tissue disease.
  6. 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.

The IRG recognised that:

  • there are physical and psychological benefits of breast implantation for many women
  • there are a number of complications such as capsular contracture and gel bleed associated with breast implantation
  • information provided to women to assist them in making informed decisions about whether to proceed with breast implant surgery is frequently inadequate, in terms of both quality and quantity
  • there is a need to extend the principles of good clinical practice and clinical audit across some areas of the private sector
  • there is a need to improve scientific quality in a number of areas of research relating to aspects of silicone gel breast implants.

To address these areas of concern, the IRG made a number of recommendations.

Recommendation 1
The IRG recommends that all patients undergoing cosmetic breast augmentation surgery should be able to obtain, free of charge, from a designated body, comprehensive information about the benefits and risks of such surgery. This should be accompanied by a checklist of topics (see Figure 2 in pdf of full report) which should be covered when the possibility of an operation is discussed.

Recommendation 2
The IRG recommends that advertisements in all media promoting breast implant surgery should include a statement indicating that anyone contemplating this type of surgery can obtain information about the operation and its risks from a designated body.

Recommendation 3
The IRG recommends that all women undergoing or proposing to undergo cosmetic breast augmentation surgery should be offered the following:

  1. an initial appointment with the surgeon carrying out the operation
  2. an opportunity to discuss the checklist of issues with that surgeon. Figure 2 (in pdf of full report) contains a list of issues that should be included in any checklist
  3. information on the likely financial implications of breast implant surgery including the fact that further treatment and expenditure may be necessary at some time in the future. These costs may include not only initial consultations and operation but also regular follow-up, screening for rupture if this is thought to have occurred, explantation and reimplantation
  4. a ‘cooling off’ period of several days between the initial consultation with the surgeon and the operation
  5. a guarantee that any deposit or payment for the operation will be fully refunded if for any reason the woman changes her mind, even at the very last moment, and cancels the operation
  6. an assurance that they will not come into direct contact with a representative of a particular manufacturer prior to agreeing to surgery.

Recommendation 4
The IRG recommends that a specific consent form be developed which incorporates, as an integral part, the checklist of issues (see Figure 2 in pdf of full report). The consent form should confirm that the different types of implant available have been discussed with the surgeon and the type agreed, and that all subjects on the checklist have been discussed to the woman’s satisfaction along with any other concerns that the woman wishes to address. This consent form should be signed by the surgeon and the woman. One copy should be kept by the surgeon in the notes, and one copy kept by the woman.

Recommendation 5
The IRG recommends that measures should be introduced to ensure that proper standards of care are implemented in clinics carrying out breast implantation within the private sector. In particular, a quality assurance system, including the sending of a routine letter to the woman’s GP, and clinical audit procedures should be standard practice within such clinics.

Recommendation 6
The IRG recommends that prospective registration of details of each breast implant and explant operation on the National Breast Implant Registry should be compulsory.

In addition all women should be given the opportunity to participate in long term follow-up projects with the full understanding that they may be contacted in the future to provide information to facilitate research.

It should be explained to the woman that the Registry will be used to gather accurate data on the outcomes associated with silicone gel breast implants, including the incidence of rupture.

Recommendation 7
The IRG recommends that all clinicians should report breast implant related adverse incidents to the Medicines and Healthcare products Agency Adverse Incident Centre. The MHRA should provide guidance to clinicians on which incidents should be reported.

Recommendation 8
The IRG recommends that a small steering group be set up to prioritise, plan and monitor the following programme of research. Priorities should include:

  • research into the true incidence of rupture
  • research into the aetiology of symptoms exhibited by a number of women who have had implants, in particular to elucidate the role, if any, of sub-clinical infection.

The IRG recommends that the steering group should also consider the need to validate the results of other studies, such as those by Ellis et al.

The IRG concluded that the publications of Tenenbaum et al., and Smalley et al., were not conclusive and are open to legitimate scientific criticisms. However, in view of concerns expressed by women’s groups, the IRG recommends that there would be scientific merit in determining whether the results of these studies can be reproduced by independent laboratories.

Recommendation 9
Although there is currently no justification for routine regular breast investigation to detect rupture, the IRG recommends that this subject should be kept under review and the decision revisited in the light of possible new information and technical advances relating to imaging techniques used in the detection of rupture.

Progress with these recommendations

Page last modified: 27 September 2007