Date: Tue, 6 Jun 2000 13:28:47 -0700

To: Recipient List Suppressed:;

(posted on alt.support.breast-implant with no reference. Dr.Leroy Young sure had his 15 minutes of fame on Extra! Entertainment Tonite, and various magazines, promoting this horrible idea, dangerous money making idea.)

U.K. women told to have soya breast implants removed

LONDON, June 6 (Reuters) - Britain recommended on Tuesday that women with Trilucent breast implants, which have a soya bean oil filling, should have them removed because of health concerns.

The government stressed this was a precautionary measure and there was no evidence of any serious medical problems. But tests have shown that material produced if the oil breaks down in the body could potentially cause cancer or damage to a foetus.

The British health ministry said it had informed health authorities in Europe of its decision.

"The government is recommending that women with Trilucent breast implants should have them removed as a precautionary measure," the government's deputy chief medical officer, Dr Pat Troop, told a news conference.

The ministry also advised women not to breast feed or consider pregnancy until the implants had been removed.

An estimated 9,000 women worldwide have had Trilucent implants, including 5,000 in Britain -- most of them for cosmetic reasons.

The implants were manufactured by the Swiss company Lipomatrix Inc. which was bought by AEI Inc, whose parent company is U.S. breast implant maker Inamed Corp.

The implants were first licensed in Germany in 1995 and have since become available throughout Europe. They were withdrawn from sale in March last year amid fears that they could cause toxic reactions in the body if they leaked or ruptured.

AEI Inc, which is now responsible for the product, has set up a support programme to cover the medical and surgical costs of removing and replacing the Trilucent implants.

"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 during this time," AEI's Barry Hatt told a separate news conference.

He stressed that the removal recommendation applies only to soya bean oil-filled implants, not to silicone or saline implants.

The company said it could not speculate on the cost of the programme, which could reach tens of millions of pounds (dollars). AEI Inc. has also set up a help line (0800 028 6622) for women wanting information and assistance.

Medical experts first became aware of possible problems when women complained of breast swelling. Tests of the breakdown products of the filler material showed they could be toxic.

A government advisory committee recommended Tuesday's action after reviewing the latest medical evidence.

Professor JK Chipman, a biochemical toxicologist at the University of Birmingham, said degradation products called aldehydes, produced by the oil when it breaks down, can damage molecules in the body including DNA.

"They could potentially cause cancer," he told the news conference.

Chipman said the effects of aldehydes were known in 1995 when the Trilucent breast implants were originally approved in Europe. Troop said that when the implants became available it was not thought that they would break down as they have done.

"In retrospect it was a wrong decision," she said.

Medical devices are not tested as stringently as drugs, which must go through a lengthy safety process involving laboratory, animal and human trials.

Dr Susanne Ludgate, of the Medical Devices Agency, said it may recommend that breast implants be given a higher risk category and greater scrutiny including possible clinical trials before approval.

09:46 06-06-00