Deputy Fennell has given notice to the Chair of her intention to raise on the Adjournment the subject matter of breast implants and if the Minister for Health will indicate his Department's policy on breast implants in view of the US Food and Drugs Administration's findings. Deputy Fennell has five minutes to present her case.
Adjournment Debate. - Breast Implants.
Acting Chairmen
As this is my first time to meet the new Minister for Health I wish to congratulate him and wish him well in this very difficult time and in a very difficult Ministry. The question of breast implants has been ongoing for some months and originated with the decision of the US Food and Drugs Administration to suspend the use of silicone gel breast implants because of reported difficulties by some women and a number of court cases taken because of these difficulties. Many of the difficulties occurred many years after the operation. Silicone gel implants have been used for almost 30 years and are used for both cosmetic surgery, to enlarge the breast size, and for rebuilding breasts after mastectomy due to breast cancer. I have no statistics on the use of silicone gel in Ireland or the reasons for breast implant surgery.
In the US where one million women had implants, 80 per cent were for cosmetic reasons and 20 per cent resulted from breast cancer. Of the 6,000 British women who have had implants the majority were for reconstruction after necessary surgery. The use of silicone was suspended by the United States Food and Drugs Administration when it was feared that seepage of the gel into the breast could cause a range of auto immune diseases, including one which is fatal. Now the suspension has been lifted in the US, but not totally after a thorough investigation. Last month the use of silicone gel was approved in strictly limited and closely monitored cases. In the UK it appears there is a similar limited use. I would like to know how many Irish women have had breast implants over the years and for what reasons. Can the Minister ascertain if breast implants are safe? Should they be used for any purpose? Can women with implants which would have been inserted some years ago feel confident that there is no danger to them? I believe it is important to reassure women on this matter.
First, I would like to thank the Deputy for her kind words and let us hope they will be prophetic words. I am very glad the Deputy has afforded me an opportunity to clarify the position in relation to silicone gel breast implants. As the Deputy said, the United States Food and Drugs Administration in January of this year requested a panel of medical experts — the general and plastic surgery devices panel — to investigate the possible health risks associated with silicone gel in breast implant operations. Pending the outcome of this investigation the food and drugs administration recommended a suspension of silicone gel implants in breast implant operations. Plastic surgeons here in Ireland suspended the use of silicone gel breast implants until the United States review had been completed.
I understand that the general and plastic surgery devices panel unanimously recommended to the Food and drugs administration last week that silicone gel breast implants should be confined to women who require breast reconstruction and that limited trials should take place to study women who choose the implants for cosmetic purposes. In making their recommendations, the panel indicated that there was a special medical need for women with breast cancer, and certain other conditions to have access to breast implants under clinical protocols while expressing a concern about the risks represented by these implants. While the panel considered the possible link between certain immune-related or connected tissue disorders and the implants, the panel indicated that there was insufficient data to reach a conclusion on this matter.
The current position is that while the food and drugs administration are not bound to accept the panel's recommendations they will be carefully considered by the food and drugs administration in reaching a final decision which is expected to be announced by 20 April of this year. My Department are monitoring the situation and will study the final recommendations of the food and drugs administration when they become available. In the meantime, I understand plastic surgeons in Ireland are continuing to suspend the use of silicone gel in breast implant operations.
I wish to inform the Deputy that the use of implants in Ireland dates back over 20 years. The Eastern Health Board provided them free of charge to women with medical card entitlements under the provisions of the Health Act, for cosmetic purposes. I remember writing about them at the time and I must confess I did not agree with them. I should also inform the Deputy that for other EC countries the moratorium has been as follows: the United Kingdom has indicated there is no basis for advising a general change in practice in the UK pending consideration of the advice. The decision on whether the patient should have surgery should remain with the medical adviser; in Holland the approach has been similar to that of the United Kingdom; Belgium, Denmark, Germany and Greece have examined the matter and have decided to take no action in relation to it; in Spain a political decision was taken to prohibit the marketing and use of silicone gel implants; in France a working party was set up to examine the matter and they are expected to give their conclusions shortly; in Italy the use of silicone gel breast implants has been suspended for 90 days; Portugal are awaiting the results of the food and drugs administrations review and in the meantime surgeons will make their own decisions in regard to their patients. There has been a different response in each of the EFTA countries. In Austria a moratorium, similar to that recommended by the United States Food and Drugs Administration has been put in place. In Ireland, silicone gel breast implants have been voluntarily suspended pending the full review of the United States Food and Drugs Administration.
I am sorry I do not have information on the number of implants which have been carried out in Ireland since they were first introduced but I will ask my Department if we can get any information and, if so, I will be glad to give it to the Deputy.