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INFORMATION FOR WOMEN ABOUT TRILUCENT™ BREAST IMPLANTS

The Medical Device Agency (MDA), which is part of the Department of Health, has provided this information sheet. It is designed to give you information about Trilucent™ breast implants.

Background

You may remember that in March 1999 Trilucent™ breast implants were withdrawn from sale. This was because the MDA was concerned about how safe these implants were.

There have been reports of breast swelling and discomfort in some women with these implants, but so far there have not been any serious health problems.

Trilucent breast implants are filled with soya bean oil. When you eat soya beans or soya bean oil it does not stay in your body very long. If you have Trilucent™ breast implants, the soya bean oil filling can very slowly leak out. The company did more tests to try to find out what happens to the soya bean oil inside the body.

The MDA asked a group of experts (the Independent Advisory Group) to look at the results of these tests. These experts think that Trilucent™ breast implants might cause serious health problems. Your doctor can explain these to you.

Proposed action

Although we don't know for sure yet if Trilucent™ breast implants cause serious health problems, the Independent Advisory Group recommended that, to be on the safe side:

• You should consider having your Trilucent™ breast implants removed. You should discuss with your surgeon whether to have another implant instead;

• It's best not to plan a pregnancy or breast feed until after the Trilucent™ breast implants have been removed and you should use contraception until they are removed;

Please remember that there are no known cases of harm caused by Trilucent™ breast implants to women or their babies and that this advise is given as a precaution.

What happens now?

If you think you may have Trilucent™ breast implants the first thing to do is to make an appointment with your doctor (GP) or with the surgeon who did the operation to put in the implant.

The company that is responsible for these implants, AEI Inc., has agreed to pay for treatment that is needed. If you do have Trilucent™ breast implants and decide to have them removed or replaced, you will not have to pay for this.

General advice

If you think you have a Trilucent™ breast implant you can phone:

• the Trilucent Care Centre on 0800 028 6622 (open 24 hours)
• the Health Information Service on 0800 665 544
• where available, NHS Direct on 0845 4647

Points to discuss with your surgeon or doctor

You may wish to talk to your surgeon or doctor about the following:

• the reasons behind the decision to recommend removal of the implant;

• why this advice is being given;

• what you should do if you are breast feeding or plan to have a baby;

• what you should do if you are pregnant or have had a baby;

• the need for contraception prior to removing the implants;

• the arrangements for future clinical follow-up.

Please remember that any decision to remove or replace the implants should be taken jointly by you and your doctor, after a full discussion.

Removal of Trilucent Breast Implants

If you are pregnant – Removal of your breast implants can wait until after you have had your baby and your breasts have returned to normal.

If you are breast-feeding – As a precaution you should stop breast-feeding.  The removal of your breast implants can wait until after your breasts have returned to normal.

If you are contemplating breast feeding – As a precaution do not do so until your implants have been removed.

Removal of the capsule – A capsule is formed by your body around your implants, as part of the normal response to your breast implants.  Your surgeon will discuss whether it is necessary to remove this capsule (it is not necessary to do so in all cases).

Need to take samples or keep removed implants – In most cases there is no need to take blood, urine or tissue samples for analysis or for the surgeon to keep your breast implants once they have been removed.  There are no tests available that can give any useful information about your own level of risk from Trilucent breast implants.  Samples are being taken from a small group of women for research purposes (see below) and if you are one of these you will be informed and asked for your consent.  Your breast implants should be disposed of by the hospital or clinic.

Future Research

Chemical studies – At present the company is carrying out further studies to look in more detail at the breakdown products of the soya bean oil filler.  It is hoped that this will give us a better understanding of the overall risks.  MDA will give more information on this when it is available.

Clinical studies – A long-term study to look at any health effects is being considered by the company.  They are discussing this with an expert in this type of research.  MDA will give more information on this when it is available.

Your Future Health

Health screening – You should continue with normal well women checkups, no special monitoring is available to detect any possible effects which may be associated with Trilucent breast implants.

Health problems – If you develop any health problems or symptoms in the future (whether or not you feel that they are associated with Trilucent breast implants) you should discuss them with your general practitioner, who can arrange referral to specialist services if necessary.

Routine Breast Implant Screening

If you have an appointment or are due to have routine breast screening (breast mammography), you should consider postponing this until your Trilucent breast implants have been removed. You may wish to discuss this with your general practitioner or breast care specialist.

MDA will issue further updates as more information becomes available.