US set to lift breast implant ban

Implants have been linked to health damage

The US is set to lift an 11-year ban on silicone breast implants imposed following concerns they may damage health.

Thousands of women claimed ill effects - including cancer - after their implants leaked.

But experts advising the Food And Drug Administration (FDA) have recommended that the implants again be made available - under strict conditions.

It said all women who have implants fitted should be checked annually for 10 years.

The risks should be made clear to women considering implants, and cosmetic surgeons should receive special training in how to fit them.

It's a black day for the women of this country when our government doesn't protect us from such dangerous products Lynda Roth

Since the ban was introduced in 1992, most US implants contain a saline solution - but these too have been known to leak.

Silicone implant manufacturers argued their products were no more dangerous than alternatives which were more freely available.

Hundreds of women staged a demonstration against the reintroduction of the implants last week ahead of two days of hearings by an expert advisory panel.

The panel heard from patients who described the side effects they had experienced.

But they also heard from women who said they had benefited greatly from the implants, including some who had suffered from breast cancer.

Disorders

Silicone gel is thought to be a "neutral" substance that does not react with the body - even if the implant ruptures.

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

Research suggested that 60% of silicone implants would rupture in the decade after they were fitted.

Lynda Roth, head of the Coalition of Silicone Survivors, said: "It's a black day for the women of this country when our government doesn't protect us from such dangerous products."

But Dr James Wells, president of the American Society of Plastic Surgeons, said: "It's not a perfect device, but the procedures significantly improve the quality of life for many patients."

Nick Teti, chairman of leading silicone implant manufacturer Inamed, welcomed the FDA decision.

He said: "It is an important decision for the many women who seek more options when considering reconstruction, augmentation or revision surgery."

He said the implants had continued to be available to women in 60 countries around the world during the time of the US ban.

Tough new safety rules on breast implants were introduced in the European Union this year.

Christine Williamson, organiser of Silicone Support UK, disputed the idea that silicone implants were as safe as those filled with a salt solution.

She said a leak in a saline implant would be instantly recognisable, as the breast would deflate, but a leak in a silicone implant was much less obvious, because it was filled with a gel which gradually seeped out and was carried about the body.

"This is just such a shame. It will mean more sick women in the US," she said.