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TORONTO -- Health Canada should set up and administer a registry of women with breast implants and seek more information about the long-term safety of the silicone-gel form of the devices, an expert scientific panel says in its long-awaited report.

The report, made public yesterday on Health Canada's website, will be used in part to decide if sales of the controversial devices should be resumed in Canada.

Silicone breast implants were taken off the Canadian market by manufacturers in 1992 -- 30 years after they were first approved -- when Health Canada raised concerns about their safety. The devices were also removed from the U.S. market.

"Now that we've received the report, it becomes an element of the body of evidence that needs to be reviewed in order to make a decision as to whether or not the gel-filled breast implants should be authorized for sale in Canada," Health Canada spokesperson Nathalie Lalonde said.

In its report, the 13-member expert panel said that while it had received sufficient data from manufacturers to show how the devices perform after being implanted, "they do not address all aspects of long-term safety."

"Annual reports must be submitted that update ongoing studies, particularly up to 10-year followup," said the report to Health Canada.

Thousands of women in Canada and the United States have joined class-action lawsuits, alleging that the implants caused auto-immune diseases and vascular conditions after silicone leaked into their bodies from ruptured implants.

At a public forum in Ottawa before the panel in late September, manufacturers Mentor Corp. and Inamed Corp. said their new silicone implants are safer than older versions.

However, the panel said in its report questions about the potential health effects of exposure to low molecular-weight silicones had not been sufficiently addressed, and it recommends that manufacturers be required to demonstrate that "migrated silicone provides acceptable risks of hypersensitivity and auto-immunity by a critical review of company and literature data and, if necessary, by undertaking studies in animal models."

http://lfpress.ca/newsstand/News/National/2006/01/13/1391696-sun.html