Last month a judge in Birmingham, Alabama, approved a worldwide compensation deal of $4.25 billion for more than 90,500 women worldwide with silicone breast implants. The settlement, which is to cover claims arising over the next 30 years, represents

The most common reaction complained of was capsular contraction. This occurs when the breast tissue, in an effort to protect the body from the invasion of the foreign element, creates a tough fibrous capsule around the implant. This makes the breast unnaturally firm and oftenextremely sensitive and painful. Sometimes the implant then ruptures naturally, spreading silicone throughout the body.

Scientists also observed that silicone gel can leak through the envelope of the implant itself, even without the implant rupturing. The silicone travels to other parts of the body, particularly through the lymph system. This can lead to unsightly lumps in the neck and armpits; silicone has even been discovered in fallopian tubes. Removal of the implants in such circumstances does not always resolve the problem because it is next to impossible to remove all the silicone spread throughout the body.

In some women the body mounts an inflammatory reaction in an attempt to clear the silicone out of the way. This inflammation can lead to joint pains, skin lesions, fatigue, fever and weight loss. Often symptoms may surface years after the implantation.

It was only when complaints reached a crescendo in America in the late 1980s that the American Food and Drug Administration, which had not previously regulated breast implants, called for the manufacturers to supply information demonstrating their safety in humans. It became apparent that no such information was available and that no human testing had previously been carried out. In February 1992, the Food and Drug Administration recommended that silicone gel implants should only be used on a very limited basis in America. Most breast-implant manufacturers then withdrew from the market or sent their supplies abroad where no such ban applied.

Court proceedings against the breast-implant manufacturers began in America in the late 1980s. It was alleged that the manufacturers had known all along that the implants would rupture, leak silicone and caused auto-immune-system reactions.

One of the main manufacturers decided to launch an enquiry, headed by a former American attorney general. That enquiry produced damning evidence that the company’s own staff had falsified records of the manufacturing process.

Thousands of women worldwide joined the American cases. Real doubts surfaced as to whether the manufacturers and their insurers could meet all the claims that were being made.

As a result of detailed negotiations, an enormous worldwide settlement was last month approved by Birmingham’s Judge Sam Pointer. British and other foreign women who register with the court in America are able to take advantage of the settlement, provided that their implants were inserted before June 1993 and they register with the court before 1 December 1994.

The settlement provides funds to pay for private medical treatment, including the cost of removing the implants if the operation is not available on the NHS. One part of the settlement provides compensation for women who have a recognized breast implant related disease. It is not necessary for these women to demonstrate that the implant manufacturers were negligent, nor that the implant itself caused the relevant disease.

Many women have been highly pleased with their implants, but if they do not register their names by 1 December 1994, they will be outside the terms of settlement and should they wish to bring claims in the future they will have to pursue an independent course.

In the UK the Government continues to deny the existence of a link

between breast implants and auto-immune-type disorders. For the 100,000 or so British women who have had breast implants, the only step taken by the UK government has been an attempt to compile a register of women who have had breast implants.

In mid October, a press conference was called in London to accuse the American lawyers involved in breast-implant cases of scaremongering and to deny that implants caused women any injury. The press conference was sponsored by the breast-implant manufacturers.

While the implants continue to be used in Britain (and cautiously in

the States), the least that British women should expect is for the government to institute an independent review and to require the manufacturers to demonstrate the safety of their product. They should also require health authorities to identify women who have had implants and notify them that it may well be in their interests to register their names with the American settlement, even if they have no current health problems.

Paul Balen

Freeth Cartwright Hunt Dickins are operating a breast implant registration service (Willoughby House, 20 Low Pavement, Nottingham and can be contacted on (0602) 369369.

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