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 on breast implants

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 on silicone gel-filled breast implants 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:

• manufacturing and quality control;

• preclinical studies (including chemical, physical, biocompatability tests);

• clinical effectiveness and safety; and

• labelling of the devices (including the patient brochure).

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 of silicone gel-filled breast implants

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

• Produce annual reports through to 10 years for the core clinical studies underway outlining complications (such as reports of connective tissue disorders, diagnoses of cancer) and patient/physician satisfaction measures.

• Conduct at least two patient focus groups in Canada to determine the effectiveness of device labelling. A report on these sessions, along with analysis and recommendations for labelling challenges, will be submitted to Health Canada within a year of licensing.

• Conduct a large, long term appropriate post-approvals study, involving tens of thousands of women. The study will include Canadian women, and will be designed to measure any previously undiscovered connection between use of silicone gel-filled breast implants and potential rare events, such as: connective tissue diseases; rheumatological signs and symptoms; neurological disease; neurological signs and symptoms; effect on offspring; reproductive events; effects on lactation; cancer rates; and incidences of suicide. Manufacturers are required to start the study within one year.

• Survey Canadian plastic surgeons who use the implants to determine the effectiveness of the labelling and decision aids (brochures) provided with the implants. A report on the survey is to be submitted to Health Canada within one year.

• 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 Health Canada with updated marketing histories - including the number of units sold and a summary of any reported problems or recalls concerning the devices - in Canada and internationally.

• Provide breast implant registration cards with the devices. (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.)