Canada Lifts Ban On Silicone Breast Implants

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  • user warning: Can't open file: 'cache.MYI' (errno: 144) query: UPDATE cache SET data = '<p>A 13-year moratorium on silicone implants was finally lifted when the Canadian government granted two American firms licenses to market such implants in Canada. <a href=\"http://www.news-medical.net/?id=20677\">News-Medical.net</a> has more:</p>\n<blockquote><p>Health Canada has granted licenses to two U.S. companies, Mentor Corp. and Inamed Corp., a unit of Allergan Inc. to market their implants in Canada, following conditional approval from the U.S. Food and Drug Administration (FDA).</p>\n<p>Under the conditions set by Health Canada the manufacturers must continue to provide data for at least 10 years from an ongoing clinical trial and must also agree to launch another large and long-term study, involving tens of thousands of women in Canada and elsewhere, to see if there are rare side-effects that would only become apparent once large numbers of women in /home/mybodypa/public_html/blog/includes/database.mysql.inc on line 120.
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  • user warning: Can't open file: 'cache.MYI' (errno: 144) query: UPDATE cache SET data = '<p>A 13-year moratorium on silicone implants was finally lifted when the Canadian government granted two American firms licenses to market such implants in Canada. <a href=\"http://www.news-medical.net/?id=20677\">News-Medical.net</a> has more:</p>\n<blockquote><p>Health Canada has granted licenses to two U.S. companies, Mentor Corp. and Inamed Corp., a unit of Allergan Inc. to market their implants in Canada, following conditional approval from the U.S. Food and Drug Administration (FDA).</p>\n<p>Under the conditions set by Health Canada the manufacturers must continue to provide data for at least 10 years from an ongoing clinical trial and must also agree to launch another large and long-term study, involving tens of thousands of women in Canada and elsewhere, to see if there are rare side-effects that would only become apparent once large numbers of women in /home/mybodypa/public_html/blog/includes/database.mysql.inc on line 120.
Posted on Oct. 27, 2006, 1:27am - by George Lindemann in Plastic Surgery News

A 13-year moratorium on silicone implants was finally lifted when the Canadian government granted two American firms licenses to market such implants in Canada. News-Medical.net has more:

Health Canada has granted licenses to two U.S. companies, Mentor Corp. and Inamed Corp., a unit of Allergan Inc. to market their implants in Canada, following conditional approval from the U.S. Food and Drug Administration (FDA).

Under the conditions set by Health Canada the manufacturers must continue to provide data for at least 10 years from an ongoing clinical trial and must also agree to launch another large and long-term study, involving tens of thousands of women in Canada and elsewhere, to see if there are rare side-effects that would only become apparent once large numbers of women have received the devices.

Health Canada also wants the companies to study the condition of "retrieved" implants when, at some point in the future, women have them extracted or replaced.

The manufacturers have had to agree with the conditions and develop new product labelling after holding focus group sessions with Canadian doctors and women who have the devices implanted.

The report also says that plastic surgeons applauded the decision, saying that silicone breast implants are far superior than the saline ones.

However, that remains to be seen. The silicone implants vs. saline implants issue has yet to be definitively resolved. Which makes the decision of the Canadian government to issue an accompanying warning that the licensing of a medical device does not mean the device is risk-free a wise one.

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