Payout for women with leaky breast implants

Women with soya-oil breast implants are to receive compensation worth thousands of pounds each under a multimillion-pound deal agreed yesterday.

Women with soya-oil breast implants are to receive compensation worth thousands of pounds each under a multimillion-pound deal agreed yesterday.

A minimum of £5,250 will be paid to every woman who has the implants removed, with more offered to those who have suffered complications or loss of earnings. They will have the option of having the implants replaced free of charge with others of a different material.

The compensation, to be paid by the suppliers, has been agreed after the Government issued a safety warning in June advising women to have the implants removed. The Medical Devices Agency, which tests medical equipment, found evidence that oil from the implants leaking into the breast could cause cancer or harm foetuses.

So far, 1,400 women have had the operation to remove the implants and hundreds more are believed to be booked. Women who choose to keep their implants and ignore the safety fears will receive nothing.

About 5,000 women are known to have had Trilucent soya-oil implants, introduced in 1995. They were made by a Swiss firm, Lipomatrix, but responsibility has passed to AEI of the United States, which makes medical products.

AEI agreed in June to pay all the medical costs of having the implants removed and replaced, estimated at £3,000 per patient. If all affected women elect to have them removed, compensation plus medical and legal costs could reach £50m.

The deal also allows women to return for more compensation in future if they suffer from cancer or reproductive difficulties that were the subject of the government warning.

Paul Balen of freethcartwright solicitorsof Nottingham, which is representing 2,000 women, said: "I am very concerned that a product has been withdrawn after it was licensed. I think the licensing situation, which involves Europe, isn't working. More protection should be given to women who relied on the products being safe."

The first claims should be paid by the end of January, with other women receiving interim payments while claims are reviewed. Mr Balen said the scheme would "ensure that women receive fair compensation as quickly as possible without having to go to court, and in some cases without having to produce any evidence at all".

Trilucent soya-oil implants were launched in 1995 as a "natural" alternative to silicone. However, the new implants were found to harbour more dangers than the old and were withdrawn from sale last year after 74 cases in which women suffered a toxic reaction when the implants ruptured.

Safety fears over silicone breast implants had provoked multimillion-pound lawsuits in America and Britain and some women have received payouts, although many others failed to qualify or are still waiting for compensation.

Silicone implants have since been cleared as safe after two UK government inquiries and an independent review. Of an estimated three million women with implants worldwide, 9,000 have the soya-oil type, more than half of them in Britain.

Elaine Coomber, 53, of Hextable, Kent, had her silicone implants replaced with Trilucent soya implants four years ago, on the advice of her cosmetic surgeon. "I was told they were a safer alternative. I can't believe I had it done. But at the time I felt confident in the surgeon," she said.

She had problems with her silicone implants, which leaked and caused her pain, but the new Trilucent ones brought little improvement.

"They have been painful ever since. The question I would like to ask the Health Department is why they didn't do proper testing before they let them on to the market."

The Department of Health admitted in June, when it issued a "hazard" letter to NHS health authorities and trusts advising removal of the implants, that the regulation of medical devices was too lax.

Pat Troop, the deputy chief medical officer, said the Government was pressing European partner states to put implants in a higher risk category to ensure they were subject to tougher checks and clinical trials.