Health Canada reviewing silicone breast implants

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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. 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.