Ottawa knew implants harmful, case alleges Health Canada wanted to ban silicone

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Ottawa knew implants harmful, case alleges Health Canada wanted to ban

silicone gel devices in 1978, but they stayed in use until 1992

_http://healthzone.ca/health/ article/432074_ (http://healthzone.ca/health/

article/432074)

 

May 28, 2008

 

Tracey Tyler

LEGAL AFFAIRS REPORTER

 

The federal government knew as early as 1962 that silicone gel breast

implants posed serious health hazards but did nothing for 30 years while

Canadian

women were fitted with them, the Ontario Court of Appeal heard yesterday.

 

Health Canada's own scientists examined Dow Corning implants and recommended

they be pulled from the market in 1978, but they remained in use until 1992

- despite studies showing they ruptured between 5 and 32 per cent of the

time, a three-judge panel was told.

 

" At the very least, they (federal officials) could have issued a warning, "

said Kirk Baert, a lawyer representing women who say they became severely

disabled after being fitted with implants.

 

Among them was Joyce Attis, who was in the province's highest court

yesterday while Baert and other lawyers tried to resurrect a proposed class

action

lawsuit against the federal government for failing to regulate the implants.

 

The case is one of a series of lawsuits launched around the world over

alleged breast implant failures. Ten years ago, a civil suit against Dow

Corning

settled in Ontario.

 

Attis, who suffers from a medical condition that prevented her right breast

from developing, received a silicone gel implant in 1972.

 

Her breast later hardened and became deformed. The North York woman

developed a long list of physical ailments, including connective tissue disease,

rheumatoid arthritis and chest pain, according to allegations in an affidavit

filed with the court.

 

" Health Canada owes it to its constituents to protect us and it's up to them

to ensure what it puts on the market is safe, " said Attis, who now walks

with a cane.

 

Her implant was leaking when she had it surgically removed in 1992, she

alleged in court documents.

 

Baert argued the health department's failure to ban Dow Corning implants or

warn of their dangers amounts to negligence.

 

But last year, a lower court disagreed and threw out the case. Justice

Warren Winkler of the Superior Court of Justice said allowing breast implants

to

remain on the market was a government policy decision and immune from lawsuit.

 

That's now the case's key issue.

 

In essence, the proposed class action lawsuit accuses Ottawa of " failing to

govern " by failing to pass regulations to prevent implants from being used,

Winkler said in his May 2007 ruling.

 

Since then, he's been elevated to Ontario chief justice. So it fell to Baert

and co-counsel John Legge yesterday to persuade the panel that Winkler got

it wrong.

 

The panel pressed him to point to a single federal regulation or statute

that required Health Canada to issue a public warning about unsafe products or

remove them from the market, as opposed to having that duty fall to the

manufacturer.

 

The Food and Drugs Act stipulates that nobody can sell a device that causes

health injuries through normal use, Baert said.

 

But that clearly puts the onus on manufacturers, such as Dow Corning, not

the government, argued federal justice department lawyer Paul Evraire.

 

" Regulation by Health Canada is at a sky-high level, " Evraire told the panel.

 

Some estimates say up to 200,000 Canadian women received breast implants

between 1969 and 1992, from various manufacturers, although the proposed class

action is against Dow Corning.

 

Only saline gel implants were authorized for use in Canada after silicone

gel implants were pulled from the market in 1992.

 

The Appeal Court panel reserved its decision.

 

Toronto Star

 

 

 

 

 

 

 

[Guest guest]

>

> Saline gel implants are really a double whammy,the envelope is

enclosed with a silicone strip. woops more silicone and inside the

saline bags dangereous bacteria grows and bleeds through the bag and

enters youy bloodstream.

>

>