DA 2000(07) - Breast Implants: PIP Hydrogel®

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, please call on 020 7084 3272 or e-mail dts@mhra.gsi.gov.uk quoting the reference number and title of the notice.
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December 2000

MANUFACTURER/SUPPLIER
Poly Implant Prosthesis (PIP)/Clover Leaf Products Ltd

PROBLEM
Voluntary recall of PIP Hydrogel® breast implants

For immediate attention by:

Health Authorities (England) - Chief Executives
NHS Trusts (England) - Chief Executives
Primary Care Trusts (England ) - Chief Executives

IMMEDIATE ACTION

1. Do not implant PIP Hydrogel® breast implants.

2. Identify and isolate all stocks of PIP Hydrogel® breast implants and return them to the supplier.

3. Report any adverse incidents concerning implanted devices to MDA.

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
• Specialist Nurses involved in breast cancer care

HEALTH AUTHORITIES to:

• Liaison Officers (for onward distribution)
• Registration Inspection Units
• Chairs of Primary Care Groups
• General Medical Practitioners - for Information in case women contact you
• Practice Nurses - for Information in case women contact you
• Private hospitals and clinics involved in plastic, cosmetic and breast reconstructive surgery

PRIMARY CARE TRUSTS to:

• Chief Executives (for onward distribution)

BACKGROUND
PIP Hydrogel® breast implants are made in France and are supplied by Clover Leaf Products Ltd in the UK. Approximately 4000 women in the UK have been implanted with these products since they were first introduced in 1994.

PIP Hydrogel® breast implants have a silicone elastomer shell and are filled with a hydroxypropyl cellulose hydrogel (polysaccharide) gel.

Hydrogels are polymeric materials that have the ability to swell in water without dissolving and to retain water within their structures. There are many different types of hydrogels which are used in a wide variety of products including, pharmaceuticals, foods and medical devices such as contact lenses and surgical dressings. The information given in this Device Alert applies only to PIP Hydrogel® breast implants and not to other uses of hydrogel.

Each PIP Hydrogel® breast implant is marked with the manufacturer's name, the lot number, the serial number and the model size.

CONCERNS

Because of concerns raise in relation to breast implants, MDA has been undertaking a series of planned investigations into the safety of breast implant fill materials. Only one adverse incident (a report of a filler leak, which is still at an early stage in MDA's investigation) has been reported involving PIP Hydrogel® breast implants. However, MDA's review has identified that the manufacturer's biological safety assessment of this product in inadequate, due to the lack of long-term toxicity data or clinical follow-up, together with methodological flaws in some of the pre-clinical tests. The particular concerns are:

• uncertainty over the metabolic fate of the filling material;
• pathological changes suggesting a systemic effect in rats following implantation of the filling material. No long-term toxicity data are available to allow an assessment of the significance or reversibility of these effects. The Department of Health's Committee on Toxicity considered that there were serious deficiencies in these data and that some of the changes seen were of concern.

The manufacturer has, as a precautionary measure, voluntarily withdrawn PIP Hydrogel® breast implants from the UK market until sufficient information to address MDA's concerns is available.

ADVICE FOR IMPLANTED WOMEN
Women who are worried should be offered a consultation. It should be emphasised that a definite risk has not been identified. The concern lies only with the adequacy of the safety assessment for PIP Hydrogel® breast implants. There is no evidence at present to recommend explantation of PIP Hydrogel® breast implants. Any decision to explant PIP Hydrogel® breast implants should be taken jointly be the woman and her clinician/surgeon, based upon the individual clinical circumstances, balancing the potential risk arising from the lack of safety data against the known risks associated with any surgical procedure.

At present, there is no information to indicate that there are any specific risks to women or any effects on children, either prior to or during pregnancy or from breast feeding.

There is no indication from the scientific studies currently available to suggest that pregnancy should be postponed. Women who are concerned about the inadequacy of the safety assessment may wish to consider waiting until further safety tests have been performed and evaluated, before planning a pregnancy.

Annex 1 has been written to provide information to women. In addition they can ring the Health Information Service on 0800 665544 or, where it is available NHS Direct on 0845 46 47. (In Scotland, the Scottish NHS Helpline on 0800 224488).

PAYMENT FOR CONSULTATION
The Department of Health is currently discussing reimbursement for clinical consultations with the manufacturer.

FUTURE INVESTIGATION/ADVICE
The manufacturer has agreed to carry out further testing and to provide the results to MDA for review. MDA's analysis of the test results will be made available along with clear recommendations.

ENQUIRIES
Enquiries to the company should be addressed to:

Mr Andrew Hay
Clover Leaf Products Ltd
6-10 Church Farm Courtyard
High Street
Chalfont St Giles
Buckinghamshire
HP8 4QH

Tel: 01494 876990
Fax: 01494 876991

Enquiries to the MHRA should quote reference number 20001109.015-2.

© Crown Copyright 2000

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ANNEX 1

INFORMATION FOR WOMEN ABOUT PIP Hydrogel® 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 PIP Hydrogel® breast implants.

Background
PIP Hydrogel® breast implants are filled with a hydrogel. Hydrogels consist mainly of water with a substance to give them a 'jelly-like' consistency.

There are many different types of hydrogels used in a wide range of products including foods, medicines and contact lenses. MDA's advice relates only to the hydrogels used in the PIP Hydrogel® breast implants on sale in the UK, and not to hydrogels used in other products.

Reason for removing PIP Hydrogel® breast implants from the UK market

It should be emphasised that a definite risk has not been identified. There are no known cases of harm caused by PIP Hydrogel® breast implants. The concern is only with the way the safety of the hydrogel filler has been assessed.

MDA has looked at the breast implants filled with hydrogel on the UK market. The information provided by the makers of PIP Hydrogel® breast implants was looked at and MDA found that there is not enough information to fully assess the filler material.

MDA is not recommending the removal of PIP Hydrogel® breast implants.

The makers of PIP Hydrogel® have agreed to carry out further tests and provide additional information to MDA. In the meantime they have agreed to stop selling these breast implants in the UK.

If new information comes to light which changes MDA's advice they will immediately inform doctors and women about this.

General Advice
If you think you have PIP Hydrogel® breast implants and you are worried you may wish to:

•  contact your surgeon or your doctor,
• get advice from the Health Information Service on tel. 0800 665544 or, where available, NHS Direct on tel. 0845 4647. (in Scotland, the Scottish NHS Helpline on 0800 224488)

Removal - At present there is no information to suggest that you should have your PIP Hydrogel® breast implants removed. If you have concerns discuss these with your surgeon or doctor.

Rupture - If your PIP Hydrogel® breast implants have ruptured, you should discuss this with your surgeon.

Having a baby or breast feeding - At present there is no information to indicate that there is any actual risk of effects on children, either prior to or during pregnancy or from breast feeding.