Firm to fund breast implant removal

Warning over breast implants

The manufacturer of soya-filled breast implants, which women have been recommended to have removed, has said it will pay for the new operations.

Although this is a major step for us to take, it is a precautionary one

Dr Pat Troop, Deputy Chief Medical Officer

The Department of Health said on Tuesday the risk that the implants could cause cancer or harm an unborn baby could not be ruled out.

Women are also advised not to plan a pregnancy or breastfeed until after the Trilucent implants have been removed and to use contraception until then.

AEI Inc, which is responsible for the implants, will cover all medical and surgical expenses associated with their removal and replacement.

A spokesman said: "The scheme will be administered and managed through Bupa and treatment will be provided either by an NHS hospital or a private clinic."

Almost 5,000 women were given the Trilucent implants - 75% for cosmetic reasons - before they were withdrawn from sale in March 1999 amid fears they could cause harm if they leaked.

There have been reports of breast swelling and discomfort in a small number of women with these implants, the department said in a statement.

It added there had been no clinical evidence of any more serious health problems and there was not enough data to be clear whether there was an increased risk of cancer or damage to an unborn baby, but the risks remained.

New data on the long-term safety of the oil-based implants suggests some genotoxic products created when the soya bean oil deteriorates may be harmful to women.

The new advice from an independent advisory group set up by the Medical Devices Agency recommends that women consult their GP or plastic surgeon to discuss the removal of the implants, which were available between 1995 and March 1999.

Dr Pat Troop, Deputy Chief Medical Officer, said: "Although this is a major step for us to take, it is a precautionary one.

"The latest scientific data shows that this type of implant could be harmful, but, as yet, there is no evidence of actual harm to women."

'Distress'

Spokeswoman for the company Ann Richardson added: "We deeply regret any distress suffered by patients and their families.

"As a responsible company, we have set up a programme which is designed to provide them with support and assistance at this time."

The Department of Health has refused to advise women on whether they should opt for a different type of implant.

Barry Jones: 'No implant is 100% safe'

Dr Susanne Ludgate, medical director of the Medical Devices Agency, said: "It is very important that women talk these options through with their plastic surgeon."

The MDA has called for stricter licensing arrangements for breast implants. At the moment, implants are not subject to patient trials before being authorised.

Barry Jones, president of the British Association of Aesthetic Plastic Surgeons, said: "You can never say that any implant is going to be 100% safe over a lifetime. There is no evidence to say that having them replaced is safe or unsafe.

"We are giving women the information and it is their choice, but if you want to take the safest possible route, do not replace them."

Norman Waterhouse, a consultant plastic surgeon at the Chelsea and Westminster Hospital and Wellington Hospital, in London, said: "The adverts at the time said 'Made by women for women' and implied that these implants were natural and safe.

"But the time I thought they came onto the market with indecent haste.

"I had a sample of it from the manufacturers in my drawer and it went rotten and smelt like an old chip fryer.

"I thought if that happened in my drawer, what would happen in a woman's body."

Last month, the European Commission announced plans to launch an investigation into the safety of silicone implants after calls for them to be banned by a Scottish Member of the European Parliament, Bill Miller.