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

Monday, July 26 2010

OTTAWA, Oct. 20 /CNW Telbec/ - 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:

In addition, the manufacturers have committed to the following:

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 (http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/sci-consult/implant-breast-mammaire/index_e.html).

Health Canada's Decision to Grant Licences with Conditions for Silicone Gel-Filled Breast Implants

Health Canada has made a decision to grant licences with conditions to Inamed Corporation and Mentor Medical Systems to allow them to market their silicone gel-filled breast implants. The licences come with several conditions to ensure that the devices continue to meet safety and effectiveness requirements.

The decision will allow women who are seeking breast reconstruction following a mastectomy and those seeking breast augmentation open access to silicone gel-filled breast implants.

This decision was reached only after Health Canada sought considerable external advice and public input and was based on a full review of the evidence-based scientific literature. Most importantly, the decision was made in accordance with Health Canada's number one priority: to protect and promote the health and safety of Canadians.

No medical device or drug is 100-per-cent safe, effective and without risks.

Health Canada's licensing of a medical device does not mean the device is risk-free. Rather, it means the device has the potential to provide benefits, and the risks have been reduced as much as possible. The risks that remain are always explained in the labelling. Women considering breast implant surgery should consult their doctors.

The current situation

Until now, only saline-filled breast implants have had the required licence for general sale in Canada. Silicone gel-filled implants have been available only through the Department's Special Access Programme for Medical Devices.

Between 1995 and 2004, several large-scale reviews - including comprehensive reviews of published scientific literature by the Independent Review Committee in the United Kingdom and the Institute of Medicine in the United States - concluded there was no evidence of a causal relationship between silicone gel-filled implants and a number of auto-immune diseases or other systemic illnesses.

Health Canada established a Scientific Advisory Panel which met in March of

2005 to study evidence regarding the safety and effectiveness of the silicone gel-filled breast implants then under review. Subsequently, an Expert Advisory Panel was established and held meetings in September of 2005, including a public forum at which groups and individuals could make submissions in person, as well as by fax, mail and online. The panel's report, in the form of advice to Health Canada, was posted on the Health Canada website in January 2006.

Subsequently, results of a study undertaken by the Public Health Agency of Canada in collaboration with the cancer agencies of Ontario and Quebec were published in the International Journal of Cancer in the spring of 2006. This study showed that women undergoing cosmetic breast augmentation do not appear to be at an increased long-term risk of developing cancer. A second publication in the American Journal of Epidemiology concluded that breast implants do not appear to directly increase mortality in women.

How the decision was made

The applications for licensing from Inamed and Mentor were carefully evaluated by Health Canada's scientific and medical staff to determine if the devices met safety and effectiveness requirements.

Health Canada decided to grant licences with conditions to market these silicone gel-filled breast implants following a complete review of the manufacturers' evidence, the panels' advice, the public's submissions and evidence-based scientific studies from the literature.

The Medical Devices Regulations set out a system for classifying medical devices into four groups, with Class IV being the highest risk. Health Canada requires the submission of more safety and effectiveness information for a Class IV medical device than any other category. Silicone gel-filled breast implants are Class IV medical devices.

Under the Regulations, manufacturers must take reasonable measures to identify the risks associated with the device and eliminate them or reduce them as much as possible. Manufacturers must also provide appropriate protection against the risks, provide information on the risks that remain and minimize the risks associated with potential failures during the lifetime of the device.

During the review process, a detailed risk analysis is made from the information provided and all of the above factors are considered. Also, manufacturers must ensure that adequate information is available to both the health care professional and the patient about all the known risks. This allows both parties to weigh the benefits of a device against the potential risks.

For these applications, the scientific and regulatory basis for the decisions included assessment of such criteria as:

Summary Basis of Decision documents, describing the type of information provided and what was considered during the licence applications review process, are available at the Health Canada website.

A summary of the conditions of approval

In granting the licences to Inamed and Mentor to market silicone gel-filled breast implants, Health Canada has required that the manufacturers:

In addition, the manufacturers have committed to the following:

 

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