Dr. Zuckerman's comments on Canadian Decision

[Guest guest]

Excerpt: The U.S.-based National Research Center for Women and Families, which has lobbied against the implants in the United States, said Canada also was making an ill-advised decision.

" This shocking and unfortunate decision will jeopardize women's health for many years to come, " the group's president, Zuckerman, said from Washington.

She said possible silicone leaks could spread to other organs and could cost Canada's public health system millions of dollars.

~~~~~~~~~~~~~~`

http://ca.today.reuters.com/news/newsArticle.aspx?type=domesticNews & storyID=2006-10-20T191648Z_01_N20444142_RTRIDST_0_CANADA-CANADA-IMPLANTS-COL.XML & archived=False

Canada allows silicone breast implants againFri Oct 20, 2006 3:16 PM EDT

By Randall Palmer

OTTAWA (Reuters) - The Canadian government licensed the sale of silicone gel breast implants on Friday, reversing a partial ban that was in place for more than 13 years over health concerns.

Health Canada granted licenses to two U.S. companies, Mentor Corp. and Inamed Corp., a unit of Allergan Inc. to market their implants in Canada.

The two firms had already received conditional approval from the U.S. Food and Drug Administration, but are waiting for a final go-ahead to begin selling the devices in the United States.

Canada had brought in a voluntary moratorium on the implants in 1992 and turned it into an effective ban in 1993 by saying they would not be allowed on the market without new clinical studies.

The government did allow 24,000 silicone implants since then through a Special Access program, under which doctors had to certify that suitable alternative procedures were not available.

Saline-filled breast implants were the only kind that had been generally available in Canada in the meantime.

" Health Canada's licensing of a medical device does not mean the device is risk-free, " the Canadian agency said.

" Rather, it means the device has the potential to provide benefits, and the risks have been reduced as much as possible. "

The agency cited comprehensive reviews in Britain and the United States from 1995 to 2004 as concluding there was no evidence of silicone implants causing auto-immune diseases or other systemic illnesses.

Two further studies showed that women undergoing cosmetic breast augmentation did not appear to have an increased long-term risk of cancer and that breast implants did not appear to directly increase mortality.

The U.S.-based National Research Center for Women and Families, which has lobbied against the implants in the United States, said Canada also was making an ill-advised decision.

" This shocking and unfortunate decision will jeopardize women's health for many years to come, " the group's president, Zuckerman, said from Washington.

She said possible silicone leaks could spread to other organs and could cost Canada's public health system millions of dollars.