HYDROGEL BREAST IMPLANTS WITHDRAWN FROM THE UK MARKET

11 Dec 2000 12:00 AM

Medical Devices Agency Issues advice over Hydrogel Breast Implants

The Government today issued advice concerning the withdrawal of hydrogel-filled breast implants from the UK market as a precautionary measure.

At the request of Health Minister Lord Philip Hunt, the Medical Devices Agency (MDA) has been carrying out a series of planned investigations into the safety of breast implant filler materials following concerns over breast implants containing soya oil last year. This latest review looked at two breast implants filled with hydrogels - the only breast implants remaining on the UK market filled with materials other than silicone gel or saline.

The MDA''s review revealed inadequacies in the manufacturers'' biological safety assessments and concluded that there was not enough information to fully assess either of the filler materials.

No definite risk has been identified. There are no known cases of harm caused by these breast implants and there is no evidence to suggest that they should be removed from women who currently have them. The concern is only with the way the safety of the hydrogel fillers has been assessed.

There are two models of hydrogel filled breast implants on the UK market. PIP Hydrogel breast implants are made in France and supplied in the UK by Clover Leaf Products Ltd. Approximately 4000 women in the UK have received these implants since they were first introduced in 1994. NovaGoldTM breast implants are made in Germany and are supplied in the UK by Somatech Medical Ltd. Approximately 250 women in the UK have received these implants since they were first introduced in 1996.

When they were made aware of the results of MDA''s reviews, both manufacturers decided to withdraw their hydrogel filled breast implants from the market as a precautionary measure, while further studies are conducted to establish the safety of the filler material.

Deputy Chief Medical Officer Dr Pat Troop said:

''It must be stressed that no definite health risk has been identified. At present there is no information to indicate that there is any risk to women with these implants or their children. The recall is purely a precautionary measure, until the manufacturers have addressed MDA''s concerns regarding their biological safety assessments.

''We have already taken action to ensure women considering breast implants have appropriate advice. In October we published a booklet summarising the key issues and suggesting questions women could ask to help them make an informed choice about surgery.

Dr David Jefferys, Chief Executive of the MDA, said

''MDA has been very active in seeking ways to tighten up the way European Medical Device Regulations are being implemented. As a result, the European Commission has agreed to a review of the operation of the European Directives for Medical Devices and the establishment of a European Notified Body Oversight Group. MDA is also pressing for reclassification of most medical implants, including breast implants, so that they will be subject to more vigorous controls.''

Women who think that they may have hydrogel breast implants and are concerned should contact the surgeon who carried out their operation, or their GP or get advice from NHS Direct on 0845 4647 or the Health Information Service on 0800 665 544 or in Scotland the Scottish NHS Helpline on 0800 224488.

As further information becomes available MDA will analyse the results and issue further public advice.

Notes to Editors:

1. The Medical Devices Agency (MDA) is an executive Agency of the Department of Health with responsibility for protecting public health where it relates to medical devices and equipment including breast implants.

2. Hydrogel breast implants consist of a silicone elastomer shell containing hydrogel filler. Hydrogels are polymeric materials that have the ability to swell in water without dissolving and 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 MDA''s Device Alerts applies only to hydrogels in breast implants and not to other uses of hydrogel.

3. It is estimated that around 80% of these implants were implanted by the private sector for cosmetic reasons.

4. The MDA had advised the European Commission and the Devolved Authorities of its actions.

5. Every medical intervention carries some risk but the risks normally associated with breast implants are no greater than for any other implant. It is because such risks exist that women need to have accurate and complete information prior to deciding to have surgery. In October this year the Department of Health has published a booklet giving advice to women who are considering breast implants. This can be obtained from the Health Information Service 0800 665 544 and from the web site www.doh.gov.uk/bimplants.

6. Both silicone and saline filled breast implants are available in the UK. The risks associated with silicone gel breast implants, have been investigated on three occasions by independent expert groups working on behalf of the Department of Health. The latest of these, the Independent Review Group, concluded that the risks were no greater than for other implants. MDA is not aware of any evidence suggesting that saline used to fill saline breast implants present any hazards.

7. In Europe, medical devices are not licensed by a Regulatory authority. Instead they carry CE marking to denote the manufacturer''s claim that the device is safe and fit for its intended purpose and meets all the requirements of the Medical Devices Regulations. Breast implants are in a medium risk category where that claim is assessed and endorsed by an independent certification organisation known as a Notifed Body. The CE marking means that the product can be freely marketed anywhere in the European Community without further control.

8. Working in conjunction with regulatory bodies throughout Europe, MDA has secured a review of the operation of the European Directive for Medical Devices. Measures under active discussion include the establishment of a European Notified Body Oversight Group and the reclassification of most medical implants, including breast implants, into the highest risk group. This would afford them the most vigorous controls allowed under the Regulations and, for example, require the Notified Bodies to assess the manufacturer''s design dossier for each device. In addition, at the request of the European Parliament, the European Commission is preparing a document that outlines specific measures to ensure the reliability of breast implants. These measures are expected to be in line with the recommendations made in June 1998 by the UK''s Independent Review Group, who looked into the safety of silicone gel breast implants. Most of these recommendations have already been implemented in the UK.