Loophole allows banned silicone implants

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Just like in America..... http://www.canada.com/globaltv/national/story.html?id=f4ba541d-bd2e-4302-81dd-623b8cffb33f Loophole allows banned silicone implants Global National Thursday, February 16, 2006

TORONTO (Global National) -- An exclusive Global National investigation has uncovered a Health Canada loophole that allows women seeking cosmetic breast augmentation to exploit a Special Access Programme -- meant to allow patients with life-threatening conditions to access unapproved drugs -- to obtain silicone implants, which are banned in Canada. Global National's Health Specialist Tryon has determined that in the last five years, Health Canada has approved more than 21,000 special requests for silicone breast implants. In fact, 6,000 of the 9,000 requests (67 per cent) received annually through the Special Access Programme are applications for breast implant devices. Since January 1992, Health Canada

has stopped the sale of silicone implants after growing safety concerns that capsule ruptures and gel leakages may lead to various systemic illnesses -- although the degree of risk associated to the silicone gel-implants is still a matter of debate within the scientific and medical community. The U.S. Food and Drug Administration also made a similar decision restricting silicone implants. Health Canada is continuing to conduct further studies into the issue, but in the meantime, breast implants are limited to those that are saline-filled. But as Global National has uncovered, Canadian cosmetic surgeons have been stretching the conditions outlined by Health Canada's Special Access Programme to help patients obtain the banned device. "It's fairly routine," said Dr. Tim Sproule, an Ontario plastic surgeon. "You submit a form to Health and Welfare Canada." According to Health Canada's website: The Special Access Programme

(SAP) provides access to non-marketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The SAP authorizes a manufacturer to sell a drug that cannot otherwise be sold or distributed in Canada. And under these conditions, women are noting "small breasts" and "slight rippling of the skin through saline implants" as the medical conditions in which they obtain silicone implant devices. The programme works so well that one Toronto-area surgeon says 80 per cent of his clients get silicone. Dr. Andre Dupre says Health Canada has never denied his special requests, "providing you've got the right reasons for it." What is a legitimate reason to override a Health Canada safety ban? "A thin lady with very thin skin and not a lot of fat or breast tissue," said Dr. Dupre. Liz Contois, who is considering to switch from saline

to silicone, says told Global National's Tryon that she is aware that silicone gel-implants are no longer approved in Canada. "I know that. But from the literature I've read, I feel quite confident that they are safe." Meanwhile, Health Canada won't say either way on whether allowing Canadians to access silicone implants through SAP is a legitimate use of the system. "I can't comment on the overall safety and effectiveness," said Health Canada's Dr. Supra Sharma. "We're not approving them. We're actually authorizing their release under a special access programme. We can't say they've gone through the full Health Canada review process yet." A recent Health Canada advisory panel conducted a review of silicone implants to determine whether the latest versions of the gel capsule should be re-approved and allowed back on the market, but the panel wasn't convinced and ruled in a report that the government needs more long-term

studies to ensure long-term safety. In the meantime, while Health Canada investigates this apparent loophole, Canadian plastic surgeons are able to continue requesting silicone implants under the department's special request program. © Global National 2006__________________________________________________