April 12, 2005

By SHERYL UBELACKER

TORONTO (CP) - Thirteen years after silicone breast implants were pulled off the market over concerns they might be causing severe health problems for women, the controversial devices could be about to make a second debut.

Canada and the United States are reviewing whether silicone-gel implants should again be made widely available to women for cosmetic breast augmentation and reconstruction after cancer surgery.

Late last month, Health Canada convened a two-day, closed-door review by a panel of scientific experts to look at six licensing applications for the devices from two U.S. manufacturers, Inamed Corp. and Mentor Corp.

Health Minister Ujjal Dosanjh said Tuesday the nine-member panel is to make its report in about two weeks, after which interested Canadians will have their say on the issue to an advisory group from Health Canada's regulatory division, possibly through public hearings, written submissions or some other means.

"There is going to be public input," Dosanjh said from Ottawa. "I want to make sure that input is received in public and then, of course, the (regulatory) panel would return and make a decision and make the decision public."

The minister would give no deadline for the ruling on approval, but he predicted it could take six to eight weeks or even longer.

Toronto plastic surgeon Dr. Mitchell Brown, a member of the scientific panel, said the experts were asked to address a number of safety and efficacy questions Health Canada had about the implants. The panel is still in the process of writing its report. It will then be up to the federal agency to decide whether to approve the implants for general use.

That differs from the process in the United States, where the Food and Drug Administration is to end three days of public hearings Wednesday, when its panel of experts is to decide whether the devices should go back on the market. The FDA may or may not follow their recommendation.

While Brown would not discuss the Canadian panel's deliberations, he said his own experience performing breast augmentation and reconstruction with new-generation silicone implants has been positive for patients. (Under special access rules, doctors can seek permission from Health Canada to use the silicone inserts on a case-by-case basis.)

"The data that has come out of independent, scientific and epidemiological studies has shown that there's no identifiable increase in disease process in patients with silicone implants," said Brown of Sunnybrook and Women's Health Sciences Centre.

"A lot of the concern has been related to local issues of rupture and local complications within the breast tissue if an implant were to break. And most of the studies show very favourable rupture rates that are very low."

The new implants have a thicker shell and a barrier layer to stop the silicone filler from being secreted should it split, Brown said. As well, the filler is different - "much more the consistency of a gummy bear, as opposed to a liquid gel."

But Joyce Attis, president of the Toronto-based support group Breast Implant Line of Canada, worries women will again be made guinea pigs for products that she says have not been rigorously tested.

"It scares me very, very much to think that they may come back on the market, because they have not been studied long enough to know what kind of long-term implications and complications there may be," said Attis, who blames a ruptured silicone implant for a cascade of severe health problems, including rheumatoid arthritis, she's experienced since the mid-'70s. Her single implant was removed in 1992.

"And what I'd also like to know is where is the proof that they don't make us sick?"

Silicone and saline breast implants came on the Canadian market in 1962, but the manufacturers voluntarily withdrew those containing silicone in January 1992 after Health Canada raised concerns about their safety. They were also pulled from the U.S market.

Thousands of women joined class-action lawsuits over the implants, with many saying they had developed auto-immune diseases and vascular conditions after silicone leaked into their bodies from the implants.

Dow Corning Corp. was granted bankruptcy protection in 1995. The manufacturer agreed to pay up to $3.2 billion US to settle claims from more than 300,000 women - including Canadians - who said they had been harmed by the product.