Health Canada announced 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.