Fw: GAZETTE: Breast implant ban 'a farce'

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----- Original Message ----- From: ilena rose

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Sent: Thursday, October 30, 2003 2:34 PM

Subject: GAZETTE: Breast implant ban 'a farce'

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Breast implant ban 'a farce'Thousands of women still get devices. Quebec groups say program that allows use is being abused; plastic surgeon defends it MIKE KING The Gazette

http://www.canada.com/montreal/story.asp?id=8832B876-7F98-4B4E-B8E6-81D0B46BF375

Thursday, October 30, 2003

Canadian plastic surgeons are using a loophole that allows them to provide women with banned silicone-gel breast implants, two Quebec groups charge.

"It's a farce," Bonnie O'Hearn, founder of the Access Information Silicone support group for fellow implant recipients, said of the special Health Canada program concerning banned medical devices. "The program is being abused and misused."

"It's a way around the moratorium," according to Harvey of the Montreal consumer-advocacy group Option Consommateurs.

Claudio De Lorenzi, a Canadian Society of Aesthetic Plastic Surgery board member and past president of the national organization, defended use of the program.

"It's not abuse, because the purpose of it is to control the devices," De Lorenzi said in a phone interview from his Kitchener, Ont., office.

"I work for the patient, not the government, and this is completely patient-driven," he stressed.

Health Canada initiated the moratorium on silicone-filled implants in January 1992 because of concerns about their safety.

The manufacturers then pulled their products off the market.

Harvey wrote an article for the group's member magazine last year revealing that 1,350 women across the country had received the prostheses during a two-year period.

Health Canada spokesperson Saunders acknowledged yesterday that 6,135 requests were approved for the silicone implants between April 2000 and August of this year under the program.

It stipulates the devices are allowed only "for emergency use or if conventional therapies have failed, are unavailable or are unsuitable to treat a patient."

The program requires health-care professionals to inform the intended patient of the associated risks and benefits.

Of the estimated 200,000 Canadian women who have had implants, O'Hearn said as many as 150,000 live in Quebec.

De Lorenzi does agree with O'Hearn and Harvey on one thing, however - the need for a national registry of patients who undergo breast-implant surgery.

De Lorenzi is also calling for a central depot - preferably run by a third party and funded by the devices' manufacturers - where all breast implants that are removed could be studied.

But while he supports lifting the moratorium, "as long as patients are followed through a central registry," both O'Hearn and Harvey insist it should remain in effect.

"They shouldn't lift the moratorium until they have the results of their study," O'Hearn said of the ambitious Breast Implant Cohort Study.

The country's largest epidemiology study, announced seven years ago, was designed to determine the risk of cancer among women with silicone implants.

It involves about 40,000 Quebec and Ontario women who received that type of prostheses between 1974 and 1999, compared with a control group of about 20,000 others who underwent elective cosmetic surgery that didn't involve implants.

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The Raw Numbers

Between April 1, 2000, and Aug. 13, 2003, the Medical

Devices Bureau of Health Canada approved 6,135 requests for silicone gel-filled breast implants.

Types of requests: Number %

Primary augmentation 3,204 52%

Reconstruction following mastectomy or to correcta defect 1,268 21%

Replacement of failed implants 1,689 28%

Source: Health Canada

CHERYL CORNACCHIA of The Gazette contributed to this story.

mking@...

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