Advisers to the U.S. government said they needed more data on the long-term effects of silicone-gel breast implants before deciding on whether to allow wider sales.

The FDA held public hearings on an application from Inamed Corp., a company that wants to restart sales of the implants.

The FDA heard sometimes emotional testimony from women lining up to give their views, some saying that women should have a right to choose silicone, and others describing the health problems they blame on their implants.




The U.S. Food and Drug Administration is expected to make a decision on the breast implants Wednesday night.

Many Canadian plastic surgeons say the FDA's decision could influence the regulation on the implants in Canada. Both the U.S. and Canada banned the silicone-gel breast implants 10 years ago.

Thousands of women said their implants leaked and caused health problems, everything from chronic fatigue and depression, to cancer and lupus.

Dr. Walter Peters
Dr. Walter Peters

Most breast implants since then have been filled with a saline solution.

But silicone-gel implants never went away entirely. In Canada last year, 14 per cent of breast implants were silicone, three times as many as the year before.

Health Canada allows the use of silicone-gel implants if the surgeon performing the operation fills out a form saying they would be better for the patient than saline.

Dr. Sydney Wolfe
Dr. Sydney Wolfe

Dr. Walter Peters, a plastic surgeon, says saline breast implants can form unattractive ripples and folds on the breast surface, which is why more women are choosing silicone.

Peters says newer silicone-gel implants are less likely to break and if they do, the gel inside doesn't move through the body.

Manufacturers of silicone breast implants say the FDA should lift all restrictions because studies have failed to show a link between the implants and long-term health problems, even if they do rupture.

Public Citizen, a U.S. consumer group, is fighting the manufacturers' petition to the FDA, not because the group believes the implants cause health problems, but because the companies don't have long-term data on their safety.

"The idea of surgically implanting something in a woman who's already had surgery for breast cancer, and finding that after 10 years, half of them have to be removed, is an appalling idea," said Dr. Sydney Wolfe of Public Citizen.