Date: Mon, 11 Dec 2000 12:21:44 -0800

IMMEDIATE ACTION

Urgent notice to all who need to know of it!

Cosima Meyer

SSF Switzerland

MDA has issued TWO Device Alerts on 11December 2000, both relating to Hydrogel Breast Implants.

Home Page

------------------------------------------------------------------------

MDA DA2000(08)

December 2000

Breast Implants: NovaGoldTM

MANUFACTURER/SUPPLIER

Novamedical/Somatech Medical Ltd

PROBLEM

Recall of NovaGoldTM breast implants

For immediate attention by:

Health Authorities (England)

NHS Trusts (England)

Primary Care Trusts (England) - Chief Executives

Chief Executives

Chief Executives

IMMEDIATE ACTION

1. Do not implant NovaGoldTM breast implants.

2. Identify and isolate all stocks of NovaGoldTM 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

NovaGoldTM breast implants are made in Germany and are supplied by Somatech Medical Ltd in the UK. Approximately 250 women in the UK have been implanted with these products since they were first introduced in 1996. NovaGoldTM breast implants have a silicone elastomer shell and are filled with a polyvinylpyrrolidone (PVP) hydrogel and guar gum gel. PVP was previously used in the filler of another breast implant (MistiGold) manufactured by Bioplasty Inc which were supplied until the mid 90's. 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 NovaGoldTM breast implants and not to other uses of hydrogels.

CONCERNS

Because of concerns raised in relation to breast implants, MDA has been undertaking a series of planned investigations into the safety of breast implant filler materials. Only one adverse incident (an implant rupture) has been reported involving NovaGoldTM breast implants. However, MDA's investigation has identified that the manufacturer's biological safety assessment of this product is 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 rabbits following implantation of the filling material for 28 days. No long-term toxicity data are available to allow an assessment of the significance or reversibility of these effects.

* lack of data to assess risks arising from the implantation of guar gum.

In light of this, MDA has concluded that, as a precautionary measure, no more NovaGoldTM breast implants should be implanted until these concerns have been addressed.

ADVICE FOR IMPLANTED WOMEN

Women who are worried should be offered a consultation. It should be emphasised that a definite health risk has not been identified. The concern lies only with the adequacy of the safety assessment for NovaGoldTM breast implants. There is no evidence at present to recommend explantation of NovaGoldTM breast implants. Any decision to explant NovaGoldTM breast implants should be taken jointly by 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 4647. (In Scotland, the Scottish NHS Helpline on 0800 22 44 88)

Payment for Consultation

The Department of Health is currently pursuing reimbursement for clinical consultations with the manufacturer. Future Investigation/Advice The manufacturer has been asked 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 if appropriate.

ENQUIRIES

Enquiries to the company should be addressed to:

Dr Aydin Dogan

NOVAMEDICAL Products GmbH

Heinestr. 3

D-40789 Monheim

Germany

Tel: +49 21 73 95 38 0

Fax: +49 21 73 95 38 55

Enquiries to the MDA should quote reference number 20001109.015-1 and be addressed to:

MDA Adverse Incident Centre

Medical Devices Agency

Hannibal House

Elephant & Castle

London SE1 6TQ

Tel : 020 7972 8080

Fax : 020 7972 8109

© Crown Copyright 2000

------------------------------------------------------------------------

ANNEX 1

INFORMATION FOR WOMEN ABOUT NovaGoldTM 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 NovaGoldTM breast implants.

Background

NovaGoldTM 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 NovaGoldTM breast implants on sale in the UK, and not to hydrogels used in other products.

Reason for removing NovaGoldTMbreast 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 NovaGoldTM 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 NovaGoldTM breast implants was looked at and MDA found that there is not enough information to fully assess the filler material. Because of their concerns, MDA has decided that no more NovaGoldTM breast implants should be used until more information is available. MDA is not recommending the removal of NovaGoldTM breast implants. 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 NovaGoldTM 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 NovaGoldTM breast implants removed. If you have concerns discuss these with your surgeon or doctor. Rupture - If your NovaGoldTM 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.

------------------------------------------------------------------------

Last updated : 11 December 2000

Home Page

Breast Implants: PIP Hydrogel®

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)

NHS Trusts (England)

Primary Care Trusts (England) - Chief Executives

- Chief Executives

- 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 raised in relation to breast implants, MDA has been undertaking a series of planned investigations into the safety of breast implant filler 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 is 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:

Uuncertainty 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 health 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 by 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 4647. (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 our 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 MDA should quote reference number 20001109.015-2 and be addressed to:

MDA Adverse Incident Centre

Medical Devices Agency

Hannibal House

Elephant & Castle

London SE1 6TQ

Tel : 020 7972 8080

Fax : 020 7972 8109

E-mail : aic@medical-devices.gov.uk

© Crown Copyright 2000

------------------------------------------------------------------------

ANNEX 1

INFORMATION FOR WOMEN ABOUT PIP Hydrogel® 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.

------------------------------------------------------------------------

Last updated : 11 December 2000