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BMJ 2003;326:414 ( 22 February )
 

News roundup

 

EU parliament calls for tougher rules on breast implants

Rory Watson Brussels

 

 

The European parliament has given its backing to tougher health and safety rules across the European Union on breast implants. The move follows a 10 year campaign from women whose health has deteriorated after ruptured silicone gel implants.

While ruling out a complete ban, the members of the European parliament want to see an age limit introduced whereby breast implant surgery for women under 18 would be available only on medical grounds, not for purely cosmetic reasons.

They are also supporting an end to "before and after" pictures and the introduction of clear health warnings alongside any advertisements for cosmetic surgery. Patients would also have to read an information and advice sheet, drafted by the responsible health authority, warning of potential risks before any operation.

The parliament’s opinion is purely advisory. But given the public interest generated by the campaign the European Commission has already announced that it intends to implement some of the recommendations.

To establish a more effective surveillance system MEPs are also pressing for the introduction of a "passport" for implant recipients in which details of the operation and follow up care measures would be logged. This would need to be signed by the surgeon and the patient and to be produced for the annual check ups that MEPs want to see introduced.

The data would be collected and stored in national registers and be used in EU funded studies to establish the health risks of implants.

The parliament’s decision is a tribute to the tenacity of Scottish Labour MEP Bill Miller, who first brought to the attention of MEPs a decade ago the plight of women who had suffered from implants.

"When this campaign started 10 years ago, people used to laugh at these women and refuse to take them seriously. No one is laughing at silicone implants anymore," he said.

His Scottish Labour colleague Catherine Stihler, who steered the report through the parliament, said: "We have legal limits for alcohol to protect the young. An 18 year limit for implants will safeguard teenagers in school uniforms from an ill informed beauty choice."

In response to parliamentary pressure the EU’s public health commissioner, David Byrne, has announced that he intends to strengthen assessment procedures for breast implants and demand more stringent standards by reclassifying them under existing EU legislation on medical devices.

France is the only EU country so far to have imposed restrictions on the use of silicone gel breast implants, which it did in 1992. Three years later it banned all breast implants except saline filled ones.

In the United States silicone breast implants have been available since 1992 only for women with special medical needs who need breast reconstruction. In the same year restrictions were also introduced in Canada.
 


 

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