HN 2000(05) Trilucent™ breast implants: recommendation to remove

Please note that contact names and/or numbers may have changed since this notice was published. If you need to contact us about a particular notice, email dts@mhra.gsi.gov.uk quoting the reference number and title of the notice.
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June 2000

MANUFACTURER/SUPPLIER
Lipomatrix Inc/AEI Inc (formerly Collagen Aesthetics International Inc)

PROBLEM
Production of potentially genotoxic components from the breakdown of soya bean oil filler.

For immediate attention by:
Health Authorities (England) - Chief Executives
NHS Trusts (England) - Chief Executives
Primary Care Trusts (England) - Chief Executives

IMMEDIATE ACTION
1. Identify all women who have been implanted with Trilucent™ breast implants and arrange for them to have a consultation (see Annex 2) with a plastic surgeon to discuss the attached recommendations from an Independent Advisory Group (see Annex 1) and the options for clinical management.

2. Advise women to consider having their Trilucent™ breast implants removed. Priority should be given to those women who have already shown a reaction to the implants (such as local swelling) and those considering pregnancy.

3. Prior to removal of the implants, give advice regarding contraception, breast-feeding and replacement with other implants (see Annex 1).

4. During consultation, stress that all the above advice is precautionary. Although there have been reports of breast swelling and discomfort in some women with these implants, there has been no clinical evidence of any serious health problems so far.

5. As part of her consultation, ensure the woman is given a copy of Annex 3 'Information for women with Trilucent™ breast implants'

DISTRIBUTION REQUIRED
Please bring this notice to the attention of all who need to know or be aware of it. This will include distribution by:

TRUSTS to:

•  Liaison officers (for onward distribution)
•  Medical directors
•  Plastic surgeons and all surgeons involved in breast reconstruction
•  Directors of surgical units involved in breast reconstruction
•  Nurse executive directors
•  Directors of midwifery
•  Specialist nurses involved in breast cancer care

HEALTH AUTHORITIES to:

•  Liaison officers (for onward distribution)
•  Chief executives of primary care groups
•  Registration inspection units
•  General medical practitioners
•  Practice nurses
•  Health visitors
•  Private hospitals and clinics involved in cosmetic surgery

PRIMARY CARE TRUSTS to:

•  Chief executives (for onward distribution)

BACKGROUND
Trilucent™ (soya bean oil filled) breast implants obtained CE marking in 1995. Over 9,000 implants have been implanted into almost 5,000 women in the UK.

In 1999 the Medical Devices Agency (MDA) raised concerns relating to the long term safety of Trilucent™ breast implants particularly in relation to the breakdown of the filler. As a result of MDA's concerns the company voluntarily withdrew the product from the marked in March 1999 as a precautionary measure. At this time MDA issued advice to the Health Service­­¹. The Advice Notice stated that there were no data to suggest that removal of Trilucent™ breast implants was indicated. However, women were advised to seek an immediate consultation if they noticed unusual breast swelling or inflammation associated with their Trilucent™ breast implants.

The company agreed to MDA's request to carry out further toxicological testing. The results of these preliminary tests suggest that genotoxic products may be created when the soya bean oil breaks down.

Further investigation
MDA is working with AEI Inc in the continuing investigation of the nature and amount of breakdown products arising from the filler. In addition, further clinical monitoring is proposed. MDA will provide further advice as necessary.

Reference
1. AN1999(01) Trilucent™ breast implants: voluntary withdrawal. Medical Devices Agency Advice Notice, March 1999. Copies can be obtained from
MDA DTS Business Services,
Hannibal House,
Elephant and Castle,
London
SE1 6TQ,

Tel 020 7972 8250
Fax 020 7972 8124

REIMBURSEMENT AND CLINICAL MANAGEMENT
Arrangements for reimbursement have been made with AEI Inc, under which the company has undertaken to pay certain agreed expenses for consultation, implant removal, replacement with other implants (where indicated), and follow-up care.

AEI Inc has established the Trilucent Care Centre to manage the programme of activities arising from this Notice. Women with Trilucent implants, plastic surgeons, GPs and all other interested parties are encouraged to contact the centre at the address/telephone number given below. The centre will be open 24 hours a day, seven days a week.

ENQUIRIES
Trilucent™ breast implants were manufactured by Lipomatrix Inc. Product liability now rests with AEI Inc which has confirmed its willingness to act in the best interests of affected women and has taken on responsibility for the current healthcare management and explantation programme.

Enquiries to the manufacturer should be addressed to:

Ann Richardson
AEI Inc
37 St Peters Avenue
Caversham
Berkshire
RG4 7DH

Tel: 0118 9469 100
Fax: 0118 9461 010

Mrs Sue Warburton
Trilucent Care Centre
Freepost
Anchorage 3
Anchorage Quay
Salford Quays
M5 2XL

Tel for clinicians: 0845 608 0808
Tel for women: 0800 028 6622

Enquiries to the MHRA should quote reference number 20000211.011-31.

© Crown copyright 2000

Annex 1

CONCLUSIONS AND RECOMMENDATION FROM THE INDEPENDENT ADVISORY GROUP
In response to recent information, MDA set up an Independent Advisory Group to evaluate the evidence available on the toxicity of the breakdown products of the filler material used in Trilucent™ breast implants. The group assessed the resulting clinical risk and gave recommendations to MDA on appropriate action to protect public health.

In coming to these conclusions, the group recognise that metabolism of fats in the body produce low concentrations of breakdown products and that some of these are known to have a number of biological effects.

The Advisory Group concluded that:

• there was evidence to suggest that the concentration of breakdown products from Trilucent™ breast implants was much higher than the concentration normally found in the body;
• there was an explicit risk from the potential release of genotoxic products as a result of the on-going diffusion of filler through the implant shell and possible rupture of the shell;
• although there were insufficient data to establish an increased risk of cancer or reproductive toxicity, these possible risks could not be exclude;
• all women with these implants should be informed that removal of Trilucent™ breast implants is recommended because of these risks;
• there were no data on whether or not it is safe to implant other breast implants subsequent to the removal of Trilucent™ implants.

The Advisory Group were unable to exclude the risk of reproductive effects on the basis of the data available, although there was no direct evidence for such effects. Neither MDA nor the manufacturer has received any reports of problems or abnormalities in babies born to mothers with Trilucent™ breast implants. However the group provide the following advice, but stressed that it is precautionary:

• The Advisory Group agreed that it was prudent to advise that pregnancy should be avoided (by use of contraception) until the implants were removed, but that this precaution would not be necessary after explantation, as the breakdown products would be rapidly cleared by the body;
• In the Advisory Group's opinion, the possibility of genotoxic degradation products migrating from implants to breast tissue and milk could not be discounted. It is therefore prudent to recommend that breast-feeding should be avoided prior to explantation of Trilucent™ breast implants. The Advisory Group stressed that even if Trilucent™ breast implants were removed from women, additional studies would be needed to further characterise the risk and to form a basis for any further advice to affected women.

Annex 2

GUIDANCE ON CONSULTATION WITH WOMEN IMPLANTED WITH TRILUCENTTM BREAST IMPLANTS
The Department of Health has develop the following advice in consultation with relevant professional organisations.

General advice
A 24-hour helpline, the Trilucent Care Centre, has been set up on 0800 028 6622 for women with Trilucent™breast implants who are worried about the possible effects on their health. Women can also ring the Health Information Service on 0800 665544 or, where available, NHS Direct on 0845 4647.

Payment for consultation and removal of Trilucent™ breast implants
Arrangements for reimbursement have been made with AEI Inc, under which the company has undertaken to pay certain agreed expenses for consultation, implant removal, replacement with other implants (where indicated) and follow-up care. A 24-hour helpline for clinicians has been set up on 0845 608 0808.

Points to be discussed during consultation
The following points are listed as guidance to clinicians carrying out consultations with women implanted with Trilucent™ breast implants. Attached to this notice is an information sheet (see Annex 3) which can be photocopied and given to women with Trilucent™ breast implants.

• Women should be advised to have their Trilucent™ breast implants removed as a precautionary measure.
• Preliminary data suggest that the filler used in Trilucent™ breast implants may break down in the body to create products which may be harmful, including some which may be genotoxic. As more detailed results become available, MDA will issue advice as necessary.
• MDA set up an Independent Advisory Group which met to discuss the information available on the breakdown products. The group advised that although the data available were only preliminary, there were enough concerns to warrant advising the removal of Trilucent™ breast implants as a precautionary measure.
• Women should be advised that it would not be prudent to plan a pregnancy or to breast feed until after their Trilucent™ breast implants have been remove. They should be reassured that there have been no reports of reproductive or developmental problems in babies born to mothers with Trilucent™ breast implants and that this is just a precautionary measure. Where appropriate, women should be advised on the use of contraception.
• No information is available on whether or not it is safe to insert another breast implant at the time a Trilucent™ implant is removed. This is a matter for discussion between the surgeon and the woman.

Annex 3

INFORMATION FOR WOMEN ABOUT TRILUCENTTM BREAST IMPLANTS
The Medical Devices 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 will 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 advice 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 Trilucent™ breast implants you can phone:

• the Trilucent Care Centre on 0800 028 6622 (open 24-hours)
• the Health Information Service on 0800 665544
• where available, NHS Direct on 0845 4647

Points to discuss with your surgeon or GP
You may wish to talk to your surgeon or GP 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.