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, says an expert scientific panel.

Their 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.

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.

Health Canada spokeswoman Nathalie Lalonde said: "The report ... 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 ..."

A final decision will likely take "months, not weeks," she said.

The 13-member expert panel said it had received sufficient data from manufacturers to show how the devices perform after being implanted in a woman's body but added: "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.

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 not only safer (less likely to rupture or leak) than older versions, but they offer superior breast augmentation and reconstruction options for women compared to approved saline implants.

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

While the report said that potential means of rupture had been adequately studied, it is uncertain how long the implants will last.

"Labelling should acknowledge that the implant is not a lifetime device and that most likely the implant will need to be replaced with subsequent surgery," the report said.

A national breast implant registry should be established by Health Canada, as well as a program to help women make an informed decision about having silicone breast implant surgery, the panel said.

The experts also had concerns about information provided to patients considering surgery, saying information should accompany the product and also be available in printed material and via the Internet.

In addition, "patients presenting with depression and/or an eating disorder, if untreated, should be referred for treatment before considering breast augmentation surgery.

"If they are in treatment, communication between the plastic surgeon and the treating mental health professional is strongly recommended.

"Although no causal link was established between breast augmentation surgery and suicide, patients with psychiatric disorders such as depression and eating disorders should postpone the decision for breast augmentation until the complete resolution of the depression and/or the eating disorder." The panel also "strongly" advised that only Royal College-certified plastic surgeons, specifically trained, be allowed to implbe allowed to implant the devices.