Healthy Skepticism Library item: 2612

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Health Canada reviewing silicone breast implants
CTV.ca 2005 Sep 30
http://www.ctv.ca/servlet/ArticleNews/story/CTVNews/20050929/silicone_implants_050929/20050929?hub=Health

Keywords:
silicone breast implants

Notes:

Ralph Faggotter’s Comments:
I can feel a case of deja vu coming on.
The re-introduction of silicone breast implants will be lucrative in 2 phases- initially for the surgeons and manufacturers, then a few years later for the lawyers and the plaintiffs!

Full text:

Health Canada reviewing silicone breast implants

CTV.ca News Staff

Silicone breast implants have been off the market in Canada for more than 10 years. But the manufacturers believe they are now safe and are asking Health Canada to license once again the implants.

Canada and the U.S. banned the silicone gel-filled implants in 1992, after thousands of women who had received the implants had them rupture and leak into their chest cavities. Many complained of years of pain and chronic illnesses that they blamed on the implants.

One of the implant manufacturers, Dow Corning Corp., later paid out $2.35 billion US to settle class-action claims brought against them by roughly 300,000 women, including Canadians.

Since then, only saline-filled implants have been licensed for use in Canada.

Saline implants are considered safer if they leak and have proved popular. Some estimates indicate that as many as 200,000 Canadian women have them implanted — most for cosmetic rather than reconstructive reasons.

But fans of silicone implants say silicone gel looks and feels more natural than salt water-filled implants and would like to see silicone implants return to the market.

The manufacturers say their silicone technology has improved.

Dr. Roger Wixtrom, a toxicologist who has reviewed the safety of silicone medical devices for over 16 years, primarily for Mentor Corp., tells CTV.ca that the new generation of silicone implants are much improved from the implants manufactured in the 1970s and ’80s.

He says the implant shell is thicker and the silicone gel is more cohesive and holds together better. What’s more, he believes the new implants would not only last longer than older generations of silicone implants, they would last significantly longer that the current saline gel implants on the market right now.

But Joyce Attis of the Breast Implant Line of Canada told CTV’s Canada AM she isn’t so sure.

“They say there’s less of a rupture than the ones from the 90’s. This is true because it’s a glue-like content. It’s not liquid. So when they say they don’t leak it’s true. But there’s semantics at play because glue won’t leak but the chemicals will still leech from the implants and go into people’s bodies.”

Attis said she’s still waiting to be convinced the new implants are safe.

“Women still want the implants and as far as I’m concerned I’d love to see implants on the market. I’m not against them. I want to make sure that they’re safe, that enough research has been done.”

Approval in the U.S.

Earlier this year, the U.S. Food and Drug Administration decided that Mentor Corp. could return their silicone product to the U.S. market as long as certain conditions were met. Those conditions have not yet been made public.

So far, Mentor’s implants have not received final approval for sale in the U.S., but that could come soon.

Last week, a second U.S. manufacturer, Inamed, cleared the same FDA regulatory hurdle — despite a recommendation by a government advisory panel that Inamed’s implants not be approved.

Now, Health Canada is assessing Canadian license applications from both Inamed and Mentor. A Scientific Advisory Panel was convened in March to consider Health Canada questions on the safety of silicone gel-filled implants.

This week, Health Canada is convening an expanded advisory panel that includes consumers and patient experts, to bring a broader perspective to the issues.

Health Canada says that while some studies have shown a link between silicone implants and autoimmune illnesses, “there is no definite answer to this issue.”

But many health groups, including one called Women and Health Protection, are worried about the safety of the implants and say there have not been enough long-term studies.

The experts hired by Health Canada will publish their opinion in a few weeks but a decision on silicone implants is still a way’s off. Health Minister Ujjal Dosanjh likely won’t make his decision until early next year.

The possibility of silicone’s return to the market has some health activists asking that Canada set up a national registry. Such a database would allow health officials to quickly contact women whose implants may pose a health risk, and would also allow the study the long-term health effects of the implants.

The federal New Democrats proposed legislation to create such a registry last year but the bill died when the election was called.