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Last Updated: Monday, 1 September, 2003, 11:38 GMT 12:38 UK
Breast implant safety crackdown
Breast implant
There are concerns over implant safety
Tough safety standards for breast implants, created in response to fears over safety, come into force this week.

The rules were drawn up by the European Commission in 2001 in response to a campaign by British women.

Many women have been forced to undergo surgery to have implants removed after they say silicone leakage from the implants ruined their health.

The regulations will mean that new types of implant should be more thoroughly tested before going on sale.

Safety checks on implants have already been stepped up in the UK, but the new rules mean should improve standards across Europe.

The majority of implants used to contain silicone gel - but studies suggested that as many as 69% of the implants would rupture within a decade.

Many modern implants use saline - salt water - as an alternative to silicone.

This would leave patients facing more painful surgery to have them removed.

Health worries

While silicone gel is thought to be a "neutral" substance that does not react with the body, even if the implant ruptures, there are widespread fears that it can cause ill health.

Many women have reported "connective tissue disorders" causing painful, swollen joints, and even chronic fatigue syndrome, blaming the illnesses on their leaky implants.

Studies looking into this have not so far found a link.

Although no firm evidence of health risks to humans has yet emerged, the UK authorities set up a registry of breast implants in 1993 so that further long-term studies could be carried out - and women recalled for medical help more easily should a problem be found.

Dr David Jeffreys, Head of the Devices Sector of the Medicines and Healthcare products Regulatory Agency said: " I welcome the move to tighten safety checks on breast implants.

"We have pushed strongly for these changes. It will ensure that all breast implants sold throughout Europe meet the same high standards of quality and safety."

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