Health Canada grants manufacturers Class IV licences with conditions to market silicone gel-filled breast implants

News Release

October 20, 2006
For immediate release

OTTAWA -Health Canada announced today that it will grant licences with conditions
to Inamed Corporation and Mentor Medical Systems to market their silicone gel-filled breast implants
in Canada. These Class IV licences are conditional on the manufacturers meeting several requirements
to ensure their devices continue to meet the safety and effectiveness requirements of the Medical
Devices Regulations.
Health Canada's number one priority is to protect and promote the health and safety of Canadians.
Decisions to grant licences for medical devices are strictly objective and based on evidence. Applications
from Inamed and Mentor were evaluated by Health Canada's scientific and medical staff to determine
if the devices met safety and effectiveness requirements.
Health Canada's decision followed a complete review of the manufacturers' evidence, independent
evidence-based studies, public submissions and an Expert Advisory Panel's advice. The Expert Advisory
Panel reviewed submissions from concerned Canadians and heard directly from the public at an open
meeting before it provided its advice to Health Canada.
In granting these licences, Health Canada has attached several conditions. The manufacturers are
required to:

Provide ongoing updates regarding long-term clinical trial results through to ten years.
Conduct
and report on at least two patient focus groups in Canada to determine the effectiveness of product
labelling.
Conduct a large, long term study involving tens of thousands of women. Manufacturers
are required to start the study within one year.
Survey Canadian plastic surgeons on the effectiveness
of the labelling and decision aids (brochures) provided with the implants.
Continue implant retrieval
and analysis studies - from all available sources - for further characterization of potential modes
and causes of implant failure.

In addition, the manufacturers have committed to the following:

Provide updated sales and marketing histories - including a summary of any reported problems
or recalls - in Canada and internationally.
Provide implant registration cards with the device.
(Patients receiving these cards from their surgeons can send them voluntarily to the manufacturer.
This will allow the manufacturer, in addition to using general methods of dissemination, to distribute
any new information directly to the persons affected.)

Until now, only saline-filled breast implants have been licensed for sale in Canada. Silicone gel-filled
implants have been available through the Department's Special Access Programme for Medical Devices.
In announcing this decision, Health Canada reminds Canadians that no medical device or drug is 100-per-cent
safe, effective and without risks. Silicone gel-filled implants are considered a Class IV medical
device, representing the highest degree of potential risk. A woman's decision to undergo breast reconstruction
after a mastectomy or for breast augmentation should be made only after consultation with a health
care provider and full consideration of the benefits versus any potential risks.
Note: Summary Basis of Decision documents regarding the Inamed and Mentor applications
are available at the Health
Canada Web site
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Media Inquiries:
Carole Saindon
Health Canada
(613) 957-1588
Erik Waddell
Office of the Honourable Tony Clement
Federal Minister of Health
(613) 957-0200
Public Enquiries:
(613) 957-2991
1-866 225-0709

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Date modified:: 2016-12-15

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Health Canada grants manufacturers Class IV licences with conditions to market silicone gel-filled breast implants

News Release

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