Breast implants get 'high-risk' status to improve safety

Breast implants have been reclassified as "high-risk" medical devices in an attempt to tighten regulation of cosmetic surgery.

The safety measures introduced by the European Commission will see silicone implants treated in the same risk category as replacement heart valves and neurological implants.

It means that manufacturers must employ an independent assessment body to examine all aspects of the design and production process.

A recent study in America found that 69 per cent of silicone implants ruptured within 10 years. Under the measures, stringent safety checks will be imposed on all implants used throughout Europe.

Lord Warner, a Health minister, said the new rules would boost public confidence in breast implants after a series of health scares.

Dr David Jeffreys, head of the devices sector of the Medicines and Healthcare Regulatory Agency, said: "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."

Implants filled with soya bean oil and hydrogel were banned in the UK after hundreds of women suffered serious damage from leaking and other problems.

More than 7,500 women undergo breast enhancement surgery every year, and many thousands more travel to countries such as Poland for cut-price operations.

But the growth in popularity has been matched by rising rates of problems, including botched surgery and serious complications.

The Medical Defence Union has paid £7m in compensation over the past 10 years to victims of cosmetic surgery mistakes. The majority of the money went to to women who had breast operations.

Patients groups welcomed the new laws, but warned that they were still not rigorous enough.