PIP breast implants: summary of the interim report

An expert group, led by Sir Bruce Keogh, NHS Medical Director, met to review the policy relating to breast implants from the French company Poly Implant Prostheses (PIP) who have been found to be using industrial grade silicone in place of medical grade silicone. The issues considered by the group were categorised under two headings; safety issues and practical clinical issues.

Safety issues

The cancer risk: Based on the currently available data, the expert group considers that there is no evidence that the PIP implants are associated with a higher risk of cancer. The advice from the French National Institute for Cancer (INCA) is: ‘the number of breast cancers seen in women with PIP implants is less than the levels for the general population’.

Risk of rupture: Based on the currently available data, the expert group considers that there is no evidence of a higher rate of rupture for PIP implants compared with other implants. However, the group has recognised that there are limitations with the currently available data and to be able to validly compare different breast implants, additional information is required. The time elapsed since the original implant was put in is needed to accurately estimate a rate of rupture. This limitation in the data is not limited to PIP but also applies to other types of implants. Therefore, this will be reviewed further when better data becomes available.

Health consequences of a rupture: When breast implants rupture, leakage of silicone into surrounding tissues can result in an inflammatory response that can cause lumpiness, swelling and discomfort. Data from the AFSSAPS (Agence française de sécurité sanitaire des produits de santé) – a French agency that monitors the safety of health products – have shown that 495 women with PIP implants have suffered an inflammatory reaction (approximately 1.7 percent of 30,000 women in France). The expert group are not aware of any available data to compare other implants against these figures.

Risks associated with the removal of PIP implants: The risks of leaving the implants in place were reviewed compared to the risks of removing them. Guidance from the Royal College of Anaesthetists was sought to advise on the risk of undergoing a further operation and the anaesthetic involved. Assuming the women who received the implants were healthy, there is still a one in 100,000 to one in 250,000 chance of dying from the complications of surgery to remove the implants. The expert group states that based on the currently available data, removing the PIP implants would be a precautionary measure rather than a definite risk to women’s health.

Practical clinical issues

Now that it has become clear that a proportion of PIP implants have used industrial grade silicone, guidance from the expert group is that there ‘is a duty of care on the part of the providers of surgery to offer these women whatever is reasonably needed to reassure them that they will not suffer long-term health problems as a result of the deception’.

For individuals who received the PIP implants in the NHS as a result of reconstructive surgery, Ministers have already outlined their advice as follows.

• All women who have received a PIP implant from the NHS will be contacted to inform them that they have a PIP implant and to provide relevant information and advice. If, in the meantime, NHS patients seek information about the make of their implant, then this will be provided free of charge.
• Women who wish to, will able to seek a consultation with their GP, or with the surgical team who carried out the original implant, to seek clinical advice on the best way forward.
• If the woman chooses, this could include a non-urgent examination by imaging to see if there is any evidence that the implant has ruptured.
• The NHS will support removal of PIP implants if, informed by an assessment of clinical need, risk and the impact of unresolved concerns, a woman with her doctor decides that it is right to do so. The NHS will replace the implants if the original operation was done by the NHS.

The policy above is endorsed by the expert group and who expect the private sector to take similar action.

Next steps by the group are:

• to gather further information about the risks associated with the rupture of PIP implants and the potential resulting inflammatory reaction.
• for the expert group to meet again in two to four weeks with additional other healthcare bodies, such as the Care Quality Commission (CQC) and the National Patient Safety Agency (NPSA).

Conclusion

Based on the currently available data it would seem to suggest that the risk of cancer is not higher with PIP implants and additional information is still required to understand fully the associated rate of rupture and the effect a rupture may have on a woman’s health. We will provide an update as this becomes available.