Breast implants recalled

by JENNY HOPE, Daily Mail

Breast implants used by thousands of women have been withdrawn on the orders of government safety officials.

The 'precautionary' move has been prompted by safety concerns but women are not being advised to have them removed.

It is claimed no definite health risk has been linked to the hydrogel-filled implants but an investigation by the Medical Devices Agency (MDA) revealed 'inadequacies' in the makers' safety assessments.

The latest health scare comes after 5,000 women who had breast implants filled with soya bean oil were told in June to get them removed amid fears that the Trilu-cent implants could trigger cancer.

More than 4,000 women are believed to have hydrogel implants - four out of five for cosmetic purposes - which have been available for at least six years.

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

Two types of implant are affected. About 4,000 women have a type made in France by PIP Hydrogel implants and supplied by Clover Leaf Products Ltd since 1994.

A further 250 have NovaGold, made in Germany and supplied in the UK by Somatech Medical Ltd since 1996.

Both manufacturers have decided to withdraw their breast implants from the market as a precautionary measure while further studies are carried out to establish the safety of the filler materials.

There have been no known cases of harm caused by the implants and there is no evidence to suggest they should be removed from women who currently have them, said the Department of Health.

The withdrawal leaves on the UK market only implants filled with silicone or saline which have a long history of use.

Women with hydrogel implants have been advised to contact their GP or surgeon or call the 24-hour helpline NHS Direct on 0845 4647.

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