Meetings took place just two weeks after minister vowed more openness

Sharon Kirkey

The Ottawa Citizen

Monday, April 11, 2005

Health Canada has held private meetings with plastic surgeons and other experts to discuss ending a 13-year-old voluntary ban on controversial silicone gel-filled breast implants, CanWest News Services has learned.

The meetings were held in secret for two weeks after federal Health Minister Ujjal Dosanjh promised "more openness, more transparency, more accountability" in Health Canada's regulatory oversight systems.

The private meetings are also in sharp contrast to how U.S. regulators are dealing with a possible return to the market of silicone gel-filled breast implants. The U.S. Food and Drug Administration today begins three days of public hearings on the matter.

Members of the public have been invited to speak and the regulator has posted on its website hundreds of pages of background material, including independent and company-funded studies, some marked "Trade Secret -- Confidential," on the chemistry, toxicology, rupture rates and shelf life of breast implants, as well as the health consequences of silicone seepage. The agency has posted reports from reviewers, as well as e-mail correspondence between the regulator and company officials.

In the U.S., the public can listen as the 13-member panel discusses and votes on two licensing applications from silicone breast implant makers Inamed Corp. and Mentor Corp.

By contrast, Heath Canada is keeping even the names of the members of its scientific advisory panel private.

"Anything that was discussed in this meeting, where it's at, at this point, all that is confidential and private information," said Health Canada spokeswoman Nathalie Lalonde. "The privacy is necessary to protect proprietary information and confidential information that is submitted to Health Canada by the two manufacturers," Ms. Lalonde said. "It's a review process."

The nine-member panel met in-camera at a hotel in Ottawa on March 22 and 23 to discuss six licensing applications for silicone gel-filled breast implants from Inamed and Mentor and to make recommendations to the government.

Ms. Lalonde said it's not uncommon for Health Canada to turn to outside experts when dealing with complex regulatory issues. As well, she said the department plans to ask Canadians about their views on the safety of silicone breast implants.

But the membership of the advisory panel is private, she said. "Furthermore, the advice proffered by members of the panel will not be made public" for privacy reasons, she wrote in a follow-up e-mail.

"I want to know, why is it private? If there is nothing to hide, then why did Health Canada keep those meetings hidden?" asks Joyce Attis, president of Breast Implant Line of Canada, a support group for women who have had breast implants.

"For many decades, we were told there is no proof that these implants make people ill. I want the proof showing silicone gel implants do not make us ill," said Ms. Attis, of North York, Ont.

"My reaction is one of sadness. They (Health Canada) should know better," added Madeline Boscoe, executive director of the Canadian Women's Health Network in Winnipeg.

"I have lots of questions about this meeting: Who was there? What kinds of questions did they ask? Did they look at this in the context of healthy women (getting implants), and a standard that addresses their health, and not interfering with it?" Ms. Boscoe asked.

Silicone gel-filled implants were voluntarily pulled from the market in 1992 following reports that linked them to arthritis, vascular disease and a range of autoimmune disorders.

Currently, the implants are available only through the government's special access program, meaning doctors must apply to Health Canada for permission to use them on a case-by-case basis.

About 5,000 Inamed implants were sold under the special access program last year, said Dan Cohen, Inamed's vice-president of global corporate and government affairs.

At last month's in-camera meetings with Health Canada's scientific advisory panel, Inamed presented more than 100 peer-reviewed, published epidemiological studies "that looked at every issue that has been raised, from the serious to the superfluous, as far as adverse health outcomes from silicone," Mr. Cohen said. The studies were "unanimous" in concluding that there is no relationship between silicone and adverse health outcomes, he said.

In 1996, Health Canada announced it was funding a study to look at cancer and death rates in women with breast implants, compared with women without implants. Data have been collected on about 30,000 Ontario and Quebec breast implant patients, and the results were expected by the year 2000. But the study still hasn't been released.

Inamed says 2.5 per cent of its older implants will rupture within three years. The company estimates the 10-year rupture rate is 13.9 per cent.

However, reviewers with the U.S. Food and Drug Administration estimated the likelihood of silicone breast implants rupturing over 10 years ranges from 21 to 74 per cent, and up to 93 per cent for women who have the implants for breast reconstruction surgery.

An estimated 100,000 to 200,000 women in Canada have breast implants, about 80 per cent for cosmetic reasons.