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Thursday, 15 November, 2001, 12:53 GMT
'Victory' for breast implant victims
Surgeons will need to give more advice before breast implant operations proceed if the EC proposals are adopted in the UK
Many women are concerned about breast implant risks
Plans to tighten up the safety procedures governing breast implants were adopted by the European Commission on Thursday.

It will mean women going for breast implant surgery will be better informed of the risks and side-effects of the operation.

This is a victory for the hundreds of women throughout the UK and Europe who have worked tirelessly to make sure other women do not repeat their painful experience of implant surgery

Bill Miller MEP

The proposals adopted by the EC include:

  • independent pre-surgery counselling with surgeons and patients reading through the long-term risks, replacement levels and side-effects of implants
  • national registers of every operation carried out in all of the 15 EU member states, with surveillance and monitoring of those undergoing surgery
  • raising the technical standards on silicone products, making them subject to the strictest assessment procedures
  • A recommendation that a minimum age is set for patients of cosmetic surgery

The European Commission communication invites member states, in the strongest terms, to adopt the measures.

A total ban on implants has been ruled out in the immediate future.

The EC move is a triumph for Margo Cameron, from Glasgow, who formed Silicone Support UK, after she became ill following silicone injections in her lips.

Scottish Euro-MP, Bill Miller who has championed the cause in the European Parliament for six years, said: "This is a victory for the hundreds of women throughout the UK and Europe who have worked tirelessly to make sure other women do not repeat their painful experience of implant surgery.

Mr Miller has waged a six year campaign for breast implant safety standards.
Bill Miller MEP

"This is a watershed in our campaign. Europe has recognised that there is a problem with silicone implants and is going to do something about it.

"The health of thousands of British women is put at risk by an implant industry which seems to have avoided basic standards of information and safety regulation."

The most crucial part of the communication is the pre-surgery counselling for women considering having implants. Many patients who have undergone the treatment claim they never would have considered it if they had known the likely side-effects.

If the EC proposals are adopted in the UK, it will mean women having to read material detailing the problems of ruptures, leakages, wrinkles and the possible need for the implants to be replaced, before they decide to go ahead with the surgery.

Cooling off period

They will be given a cooling off period so that they have time to contact patient support groups and then make a more informed decision about whether to proceed.

A spokeswoman for the Department of Health said the Medical Devices Agency had contributed to the development of the EC proposals.

"Most of the recommendations in the communication are similar to those made by the Independent Review Group on silicone gel filled breast implants in July 1998."

These were aimed at improving the availability of information to help women make informed choices about breast implantation, the spokeswoman said.

The Department of Health published a detailed patient information leaflet in October 2000 and a revision of it is now being considered.

Christine Williamson, head of Silicone Support UK, said the European Commission had "done its best".

"This is a step forward, but it is not enough," she told BBC News Online.


Mrs Williamson, who lost breast tissue, chest muscle and lymph nodes when her implant ruptured and had to be removed, said she was pleased the EC was recommending that women are told the truth about implants so they can make an informed consent.

It is not fair that women are lied to and get ill

Christine Williamson Silicone Support UK
"It is not fair that women are lied to and get ill. The side effects can hurt women so badly that they become suicidal," she said.

Silicone Support UK says surgeons are the wrong people to offer advice as they have a financial interest in the operation going ahead.

A National Breast Implant Registry has existed in the UK since mid 1993.

A recent US study found that 69% of silicone implants rupture within 10 years.

See also:

27 Apr 01 | Health
Breast implant cancer link
23 May 01 | Health
'Grow your own breasts'
11 Dec 00 | Health
Breast implants withdrawn
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