HESA Committee Meeting

The Standing Committee on Health met in camera at 11:13 a.m. this day, in Room 253-D, Centre Block, the Chair, Rob Merrifield, presiding.

The Committee commenced consideration of a draft report.

The Committee commenced consideration of a document on silicone gel-filled breast implants.

At 12:35 p.m., the sitting was suspended.

At 12:36 p.m., the Committee proceeded to sit in public.

The Clerk of the Committee presided over the election of the First Vice-Chair.

On motion of Tina Keeper, it was agreed, — That Ruby Dhalla be elected First Vice-Chair of the Committee.

Nicole Demers moved, — Whereas:

• There have been no objective, long-term studies on silicone gel breast implants and their effect on women’s health.

• The document “Decisions in the Dark,” published by the National Research Center for Women and Families, informs us that the file that Inaed presented to the FDA contained little longitudinal data on breast cancer patients with breast implants.

• That same document informs us that Mentor, in its file to the FDA, had no long-term data on patients with breast cancer and very little data on implant ruptures.

• On January 27, we learned in FDA Week that the FDA’s Office of Criminal Investigations had interrogated a former employee of Mentor who stated that:
  • the company was hiding data on ruptures;
  • the textured silicone implants made by Mentor had a design flaw and thus a higher rupture rate than smooth implants;
  • the company was concealing leakages by claiming they are seal or component breakage;
  • the company had not revealed these details to the FDA.

• A study published in Analytical Chemistry by Ernest Lykissa and Susan Maharaj states that women with silicone breast implants have higher concentrations of platinum than the general population and that the metal’s oxidization indicate that the exposure could be toxic.

• The team of Doctor Robert Guidoin, a specialist in biomaterials at the Université Laval, demonstrated that the silicone gel prostheses implanted in 12,000 Canadian women can deteriorate, mix with tissue and release a potentially carcinogenic product into the human body.

• Aleina Tweed tells us that a study carried out by the Centre of Excellence for Women’s Health indicates that 51% of women who were given silicone implants had to undergo one or more other operations and that 70% of the implants removed after 11 to 15 years were perforated.

In light of all the information collected and heard to date, we are asking the Minister of Health to postpone his decision on silicone gel breast implants.

Debate arose thereon.

Dave Batters moved, — That the motion be amended by deleting all the words from “Whereas” to “perforated.” and by adding after the word “implants” in the final paragraph the following: “until he has received enough scientific information to make an informed decision on the safety of silicone gel breast implants .”.

After debate, the question was put on the amendment of Dave Batters and it was negatived, by a show of hands: YEAS: 4; NAYS: 7.

The question was put on the motion and it was agreed to, by a show of hands: YEAS: 7; NAYS: 4.

Nicole Demers moved, — Whereas:

• Silicone gel breast implants were withdrawn from the market in 1992 because they were causing health problems in women.

• Dow Corning faced a number of lawsuits following the withdrawal of the breast implants and was required to pay $2.35 billion to over 300,000 women.

• Aleina Tweed of the Canadian Women’s Health Network tells us that 80% of breast surgery is for breast augmentations and only 20% is for reconstructions.

• The Special Access Program for Medical Devices was meant to allow silicone gel breast implants only for breast reconstructions.

• Only 45 of the 24,045 requests to the Special Access Program, for silicone gel breast implants, since the program began have been refused.

• Of the 8,159 requests made this year, 80% were for breast augmentations.

We are asking the Minister of Health to tighten the conditions for the Special Access Program by allowing surgeons to obtain silicone gel implants only for purposes other than breast augmentations unless they are medically necessary.

Debate arose thereon.

The question was put on the motion and it was agreed to, by a show of hands: YEAS: 7; NAYS: 4.

At 1:07 p.m., the Committee adjourned to the call of the Chair.