Agonising wait for 5,000 women told that their breast implants might leak and cause cancer

Outcry as health officials admit soya prosthetics did not undergo clinical trials before being launched in Britain five years ago

By Jeremy Laurance, Health Editor

7 June 2000

Women with breast implants filled with soya oil were left in an agonising quandary last night after the Government warned them to have the implants removed but offered no advice on whether they should be replaced with another type.

The warning was issued after the Medical Devices Agency, which tests medical equipment, found evidence that oil from the implants

leaking into the breast could cause cancer or harm fetuses.

The disclosure, affecting 5,000 women in Britain, triggered protests that the system for monitoring safety of breast implants was inadequate. At a tense press conference, health department officials admitted no clinical trials had been carried out before they were introduced. Pat Troop, the government's deputy chief medical officer, said allowing the implants on to the market was regrettable. "Certainly, in retrospect, it was obviously the wrong decision. But the regulation of medical devices is not in the same league as the regulation of pharmaceuticals."

The government is pressing its European partners to put implants in a higher risk category to ensure they are subject to tougher checks and clinical trials before they are marketed, she said.

The warning, contained in a "hazard" letter sent to all NHS trusts and health authorities, applies to Trilucent implants which were withdrawn from sale last year, after 74 cases in which women had suffered a toxic reaction after their implants ruptured. Some experienced swelling and in a few the leaking oil had emulsified and turned rancid.

At that stage women without symptoms were reassured there was no need for immediate action but further tests have revealed the potential risks.

The Department of Health said there was insufficient data to be clear whether there was an increased risk of cancer or damage to an unborn baby but the risks could not be excluded. Dr Troop 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. Therefore, I am advising today that women should have these Trilucent breast implants removed."

Until their implants have been removed, women should avoid becoming pregnant and should not breast feed their children, she said. Women are to be offered early surgery to remove the implants but it will be left to them to decide whether to replace them with a different type, such as one filled with silicone gel, or to do without and adjust to their new body shape.

Dr Suzanne Ludgate, the medical director of the Medical Devices Agency, said: "There is no evidence either way that to replace them is safe or unsafe. It is very important these women discuss this with their plastic surgeons."

Barry Jones, president of the British Association of Aesthetic [Cosmetic] Plastic Surgeons, said: "We can only act on the advice we are given. Clearly there is no long term information on replacing Trilucent implants. It is fair to say that if women want to take the safest possible route they should not replace them."

Trilucent implants filled with soya oil were launched in 1995 as a natural alternative to silicone, available since the 1960s, over which there were safety fears. Safety fears over silicone breast implants provoked multi-million pound law suits in the US and Britain. Silicone implants have since been cleared after two government inquiries and an independent review. Of an estimated 3 million women with implants worldwide, 9,000 have the soya oil type, more than half of them in the UK.

The implants were made by a Swiss company, Lipomatrix, formerly Collagen Aesthetics International, but responsibility for them has passed to AEI, which manufactures medical products. The company has set up a Trilucent Care Centre with a 24-hour help line and said it would pay all the costs of care, which are expected to run into tens of millions of pounds. The number of the patients helpline is 0800 028 6622.

Barry Hatt, the director of AEI's Trilucent programme, said compensation payments would be considered. "We deeply regret any distress suffered by patients and their families," he said. "As a responsible company, we have set up a programme which is designed to provide them with support and assistance at this time."

About 100 women given the implants between 1995 and 1999, when they were withdrawn, have had them removed. Studies showed that there was a constant seepage of oil, even from intact implants, and laboratory tests revealed that it was "genotoxic", meaning it could damage the DNA in cells in breast tissue.

Professor J Chipman, of the Committee on Toxicology, said: "If there is leakage from the implant the oil becomes oxidised and produces products called aldehydes which are potentially cancer causing chemicals. Once the implant has been removed, the potentially toxic aldehydes will be disposed of quickly by the body."

Health officials admitted that the potential risks of the implants rupturing and the oil breaking down into cancer causing aldehydes were known before they were introduced in 1995. The Trilucent implant was given marketing approval by a German agency, TUV Munich, which permitted its sale throughout the EU.

Dr Ludgate said the risk associated with implants had been designated as "medium grade," but as a result of the problems with the soya oil type the Medical Devices Agency was pressing for them to be upgraded, which would require them to undergo clinical trials, lasting an expected three to five years, before being approved for sale.

She denied anyone could be held responsible for the disaster. "I don't think there is. There were a number of things that were not recognised then [in 1995] and could not have been recognised."

Christine Williamson, the head of Silicone Support UK, a group for women suffering from implants, said: "It is appalling that they have left these women so long with this condition. These women have been left with implants in after the product was taken off the market and now we hear that they can cause cancer and should be removed."