Date: Fri, 16 Jun 2000 14:06:10 +1200

-----Original Message-----

From: USSW

Date: Friday, 24 July 1998 08:02

Subject: U.S. Advisory Panel Reviews Safety of Silicone Breast Implants

U.S. Advisory Panel Reviews Safety of Silicone Breast Implants

Washington, July 22 - A U.S. scientific panel reviewed conflicting studies on silicone gel breast implants as it met to consider a report to the government on whether the implants cause disease.

The Institute of Medicine, part of the National Academy of Sciences, convened the advisory panel to address the issue, which has divided scientists and cost implant makers billions of dollars to settle lawsuits filed by women claiming injuries. The group, which held its first meeting today, is expected to issue its report sometime next year.

The advisory panel's meeting comes after a U.K. government health panel last week concluded that the implants do not cause disease, contradicting claims by thousands of women.

Today, researchers on both sides of the issue presented their findings, including studies that found direct links between the implants and disease, and research that's found the implants rupture at rates ranging from 5 percent to 50 percent.

Researchers from Dow Corning Corp. and Mentor Corp., however, said Infections are minimal, and there's no evidence to suggest that implants can lead to any illnesses.

Furthermore, silicone oil or gel doesn't stimulate antibodies in the body, even in laboratory animals that are prone to infections, said Noel Rose of John Hopkins University, who's conducted research on immune system disorders for 25 years. That's important because experts previously had suggested silicone could stimulate antibodies, which then could cause problems in the system, he said.

Still, other researchers said the companies' studies have been too small to find all the problems encountered by women. Before the U.S. Food and Drug Administration put a moratorium on the use of silicone breast implants in the early 1990s, they were sold by companies including Dow Corning Corp., Bristol-Myers Squibb Co., Minnesota Mining and Manufacturing Co. and Baxter International Inc.

The U.K. Independent Review Panel on Silicone Gel Breast Implants spent a year investigating the connection between the implants and disease. After considering immense amounts of complex evidence, the panel said it found no link between breast implants and connective-tissue disease or abnormal immune- system reactions, as some women have claimed.

Connective-tissue disease causes breasts and surrounding tissue to become inflexible. Other women claimed their immune- system diseases came from silicone implants that leaked.

The findings came too late for Dow Corning, previously among the world's largest breast-implant makers. Two weeks ago, the Midland, Michigan company agreed to pay $3.2 billion to settle a class-action lawsuit by some 170,000 women claiming silicone implants made them sick. Dow Corning, a joint venture of Dow Chemical Co. and Corning Inc., filed for bankruptcy protection in 1995 after it was hit by a wave of lawsuits from women claiming that their rheumatoid arthritis, lupus and other diseases were caused by breast implants. The company denied any connection, although it continues to be in Chapter 11 while plaintiffs consider the company's offer.

Other former makers of the implants had already agreed to settle lawsuits pending against them.

Use of the silicone implants has fallen dramatically in recent years because of concerns about their safety. Currently most breast implants are filled with saline solution or soy oil.

Mentor said today that in its five-year, 21,000-patient study, the rate of infections was 4.3 percent for reconstructive surgery users and 1.3 percent for women who used implants for breast enlargement. The rupture rate was about 1 percent in both groups.

Meanwhile, in a three-year study of saline implants, which are generally considered safer, infections were noted in 1.3 percent of the 1,600-member study group, though no ruptures occurred, Mentor said. Dow researchers said they reached similar conclusions.