Banned silicone breast implants safe, manufacturers tell expert panel

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Banned silicone breast implants safe, manufacturers

tell expert panel SHERYL UBELACKER

Thu Sep 29, 2:05 PM ET

http://news./news?tmpl=story & u=/cpress/20050929/ca_pr_on_he/health_brea\

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OTTAWA (CP) - New-generation silicone-gel breast

implants are safe and should be approved for

widespread use in Canada, two manufacturers of the

banned devices told an expert scientific panel during

a Health Canada public forum Thursday.

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In lengthy presentations to the 13-member panel,

representatives from both Mentor Corp. and Inamed

Corp. said their new silicone implants are not only

safer (less likely to rupture or leak) than older

versions removed from the market in the early 1990s,

but they offer superior breast augmentation and

reconstruction options for women compared to approved

saline implants.

Citing in-house and independent international studies,

Mentor's chief scientist Wixstrom said the

amount of small silicone molecules that would seep

into a woman's body should an implant break is

negligible and far less than that absorbed daily

through common consumer products like lipstick and

antiperspirant.

Today's silicone implants also allow plastic surgeons

to provide patients - both for cosmetic and

reconstructive purposes - soft, natural-looking

breasts that improve women's self-esteem and body

image.

Dr. Khanna, a plastic surgeon from Oakville,

Ont., told the panel that Inamed's 12 silicone implant

products allow her to tailor breasts for the needs of

individual patients, while saline versions " are barely

acceptable. "

" If Health Canada were going to ban any implant

product, it should be the saline ones, " said Khanna,

who appeared at the public forum as a volunteer

consultant for Inamed.

Silicone breast implants were pulled off the Canadian

market by manufacturers in 1992 - 30 years after they

were first approved - after Health Canada raised

concerns about their safety. The devices were also

removed from the U.S. market.

Thousands of women joined class-action lawsuits in

both countries, alleging that the implants had caused

auto-immune diseases and vascular conditions after

silicone leaked into their bodies from ruptured

implants.

Breast implant manufacturer Dow Corning Corp. was

granted bankruptcy protection in 1995. The company

agreed to pay up to $2.35 billion US to settle claims

from more than 300,000 women - including Canadians -

who said their health had been harmed by the product.

Mentor and Inamed have asked both Health Canada and

the U.S. Federal Drug Administration to approve their

products for widespread use.

Earlier this year, a U.S. scientific advisory panel

recommended that the FDA allow Mentor's silicone-gel

breast implants back on the market, but voted 5-4

against letting Inamed market its brand, citing safety

concerns. Last week, the FDA announced that Inamed's

product could be approved under certain strict

conditions; Mentor was given that green light in July

after clearing similar regulatory hurdles.

In March, Health Canada convened a two-day,

closed-door review by the scientific panel to look at

licensing applications from Mentor and Inamed.

Wednesday's forum was to hear submissions from the

public, among them breast implant patients and women's

health advocates.

Despite the ban, many Canadian women have had

breast-implant surgery under a special release

program, which is intended to give patients access to

non-approved products in cases of serious or

life-threatening illness.

Under that program, 10,000 breast implants have been

approved in the last two years, Health Canada says.