Tough new rules on breast implants to be drawn up by EU

The European Commission has announced plans for tough new rules to protect women who have had breast implants, after a 10-year campaign in Britain for changes to the law.

Under pressure from MEPs, the European Commission said it wants legal changes to improve safety standards and to make research and advice to potential patients obligatory.

The European Commission insisted for years that it had little power to act, but health fears have grown in response to a spate of serious illnesses among women who had the implant surgery.

The EU's Enterprise Commissioner, Erkki Liikanen, told the European Parliament: "We should be aware that, like all implants and medical interventions, there may be inconveniences, and that patients may react in different ways. That is why patients should know the advantages and the disadvantages."

The Commission wants to amend an existing directive to include "essential safety requirements" for the surgery, including standards of design for medical equipment. Devices would have to be tested and EU and national authorities notified.

The proposal also calls for mandatory information kits to be distributed to patients who want to receive implants, including data on different types of silicone or saline implants, and their characteristics and differences. These would also spell out the risks of rupture or bleeding and the implants' expected life span.

Christine Williamson, the head of the campaign group Silicone Support UK, which has been arguing for a total ban on silicone implants, welcomed the commission's statement, calling it, "a step forward."

Ms Williamson, who had to have a mastectomy after an implant operation, said there was growing evidence of health risks associated with breast implants. Many women are unaware that their implants have ruptured, she added.

Bill Miller, the Scottish Labour MEP who has led the campaign in the European Parliament, said he hoped the amended legislation would be approved within a year.

"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," he said.

"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 proposals, set out in a formal communication for consideration by EU governments and MEPs, include guarantees that implant treatment would only be considered for those aged 18 and over. Women would have access to independent counselling before and after surgery and there would be compulsory national registers of every breast implant operation carried out in all 15 member states, with long-term studies to establish the risks.