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Monday, 11 December, 2000, 11:26 GMT
Breast implants withdrawn
Implants
There are safety fears over breast implants
A type of breast implant has been withdrawn from the UK market amid fears that it could be unsafe.

The Department of Health acted after an investigation by the Medical Devices Agency found "inadequacies" in the safety assessments of the manufacturers of the hydrogel-filled implants.

However, experts have stressed that there is no definite health risk, and have not advised women who have already had the implant fitted to seek removal.


It must be stressed that no definite health risk has been identified

Dr Pat Troop, Deputy Chief Medical Officer
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 the MDA's concerns regarding their biological safety assessments."

Hydrogels

Hydrogels are polymeric materials that have the ability to swell in water without dissolving and retain water within their structures.

There are two types of the implant available in the UK.

Around 4,000 women have been fitted with PIP Hydrogel implants made in France and supplied by Clover Leaf Products Ltd.

A further 250 women have NovaGold, made in Germany and supplied in the UK by Somatech Medical Ltd.

There have been no reports of problems or complaints about the implants, which have been on the market since 1994.

Women who have the breast implants have been advised to contact their surgeon or GP.

An MDA statement says: "Any decision to explant 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."

The MDA concerns centre on uncertainties about how the material may react over time once it has been inserted into a patient.

The material was shown to damage the health of rabbits in laboratory experiments.

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