HESA Committee Report

Government Response to the Third Report of the Standing Committee on Health

Silicone Gel-filled Implants: Areas of Concern

Mr. Rob Merrifield, M.P.
Chair, Standing Committee on Health

Room 304, Justice Building
House of Commons
Ottawa, ON  K1A 0A6

Dear Mr. Merrifield:

Attached you will find the Government’s response to the Third Report of the Standing Committee on Health (39th Parliament, 1st Session), on “Silicone Gel-Filled Implants: Areas of Concern”. I would like to thank the Committee for their work and their helpful advice on this important issue.

With respect to the Committee’s report, I would like to recognize the importance of each of the recommendations and the concerns underlying them. My Department has considered each recommendation carefully and prepared a response to the concerns and advice contained in the Committee’s report, which I respectfully submit to you. I am happy to report that for the most part, the Government’s response and actions are in line with the Committee’s recommendations.

Yours sincerely,

Tony Clement

DETAILED RESPONSES TO THE RECOMMENDATIONS

Recommendation 1 — Safety Assessment

The Committee therefore recommends that Health Canada immediately implements the Expert Advisory Panel on Breast Implants’ recommendations 1a and 2a.

Response

Health Canada has acted upon these Expert Advisory Panel recommendations. Recommendations 1a and 2a resulted in requests for additional information being made to each manufacturer in January 2006. The additional information was received and reviewed. Health Canada considered all the advice received from the Expert Advisory Panel (EAP) on Breast Implants in its review of the medical device licence applications. Recommendation 1a pertained to a concern of the possible effect of low molecular weight silicones. The EAP concerns were specific to possible health effects such as hypersensitivity and autoimmune reactions. Each company was asked to respond to this issue. Inamed Corporation and Mentor Medical Systems each submitted a literature review on hypersensitivity and autoimmune reactions. Several studies have reported evidence of delayed-type hypersensitivity in animal models, suggesting that silicone may induce cell-mediated immunity. However, based on the consistent lack of association between autoimmune diseases and breast implants in humans cited in a significant body of published literature and the absence of standardized animal models to conduct such testing, further animal testing is not justified at this time.

Each company has submitted to Health Canada a protocol for a large-scale, long term post-approval study that would further examine rare events for their potential link to hypersensitivity and autoimmune reactions in women with silicone gel-filled breast implants.

Health Canada has reviewed these study protocols which are designed to measure the rate of local complications (such as device rupture) as well as potential rare adverse events including: connective tissue disease (CTD), and rheumatological signs and symptoms, neurological disease, neurological signs and symptoms, offspring, reproductive events, effects on lactation, cancer, and suicide. The scale of these studies will be substantially large enough to track rare adverse events. Health Canada has included these studies as a condition of the licence.

In recommendation 2a, Health Canada’s EAP recommended that annual reports of the Core Clinical Studies be submitted to Health Canada through to 10 years and that a synthesis of this information be made publicly available. This recommendation has been implemented as a condition of licence in Health Canada’s decision to license silicone gel-filled implants. Further, Health Canada will provide annual updates to the publicly available Summary Basis of Decision documents, which would include a reporting and analysis of the information received. Patient and physician labelling will also be updated as new data is obtained from the Core Clinical Studies.

Recommendation 2 — Special Access Program for Medical Devices

The Committee therefore recommends that:

Health Canada redesign the application form for the Special Access Program for Medical Devices with respect to silicone gel-filled breast implants so that:

• more space is provided on the application for information on risk and benefit;
• on the English application, the term “medical conditions” is changed to “diagnosis, treatment or prevention”; and on the French application, the term “ou les mesures prophylactiques“ is added to the existing terms “le type de diagnostic ou le traitement“
• the declaration which accompanies the application form states that the physician has already discussed risks and benefits with the patient, as opposed to stating that the physician undertakes to discuss these risks and benefits with the patient.

Response

Since Health Canada issued market licences on October 20, 2006 to two manufacturers of silicone gel-filled breast implants, there will no longer be requests made through the Special Access Programme (SAP) for these products when they will be made available on the market.

However, Health Canada agrees to implement the changes recommended by the Committee to the Special Access Program application form, changes that will apply to all medical devices requested through this program.

The additional space requested in point one has been added. Substitutions to the wording as outlined in point two have also been incorporated and are in keeping with the wording in Part 2, Section 71.(1)(e) of the Medical Device Regulations (MDR).

With regards to the third point, the current wording of the physician’s undertaking in the “Declaration and Attestation” and “Déclaration et attestation” sections already reflects the wording as outlined in the MDR, Section 71.(1)(i). However, Health Canada will add a second statement, asking the physician to confirm that they have informed the patient of the fact that this is an unlicensed medical device and of the risks and benefits of the medical device.

In addition, as previously committed, the Department has undertaken an overall review of the SAP for both drugs and medical devices. The Committee will be kept informed of progress made.

Recommendation 3 — Informed Consent

The Committee recommends that:

The Minister of Health, or his/her delegate, not issue an authorization for a silicone gel-filled breast implant under the Special Access Program for Medical Devices unless there is a consent form signed by the patient and attached to the declaration and application form, indicating that the patient is aware that the device is unlicensed and the patient has discussed the risks and benefits with the physician; and

Health Canada develop a decision aid to help women make an informed decision.

Health Canada does not have the authority under the Medical Devices Regulations to require informed consent from individual patients. Informed Consent is a process that occurs between a doctor and his or her patient and is considered to be the practice of medicine. It is the provincial and territorial Governments who are responsible for the practice of medicine and regulation of health professionals. However, Health Canada has taken further steps within its jurisdiction to encourage informed consent by ensuring patients and physicians are provided with full, accessible information about the risks and benefits of silicone gel-filled breast implants.

In order to apply for Special Access to any medical device, Health Canada requires a health care professional to sign a written declaration stating that he or she will inform the patient of the risks and benefits associated with the use of the device. Currently, the application does not explicitly refer to the unlicensed nature of devices accessed through the SAP. Health Canada agrees to incorporate changes to the SAP declaration form that make explicit reference to the risks and benefits associated with the use of an unlicensed product.

The second recommendation provided by the Committee includes the suggestion to create a decision making aid. In reviewing the labelling information during its regulatory evaluation of the pre-market device applications for these implants, Health Canada has already requested that, manufacturers provide as part of their submission for licensing, patient brochures in the equivalent form of a decision aid. A “decision aid” is essentially information provided to the patient that will help prepare the patient to discuss options with his or her doctor. These brochures contain information on the alternatives to silicone gel-filled breast implants and provide accessible, patient-targeted information about the risks and benefits associated with the use of silicone gel-filled breast implants.

Health Canada’s licensing decision on these products ensures that the approved patient brochures will be available to patients prior to surgery. The documents include a form designed to facilitate and acknowledge an informed consent process. The patient and physician signature blocks are prefaced with important questions designed for the doctor to ask the patient before both the physician and patient sign the form to confirm that the patient has read and understand the risks and benefits related to this particular device. These questions are related to the risks and benefits associated with the use of the device (for example that they are not lifetime devices, that the devices may interfere with mammography, etc.) which are covered within the brochure.

Recommendation 4 — Post-Approval Conditions

The Committee recommends that:

If Health Canada grants a licence for any silicone gel-filled breast implant, the licence specify post-approval conditions including but not necessarily limited to:

1. long-term follow-up of each recipient;
2. public reporting of adverse events and public accessibility to this information.

Response

On October 20, 2006, Health Canada granted licences with conditions to the above-mentioned manufacturers of silicone gel-filled breast implants. This approval is conditional on the manufacturers meeting several requirements to ensure their products continue to meet the safety and effectiveness requirements of the Medical Devices Regulations.

The conditions imposed under the licence authorizing the sale of silicone gel-filled breast implants include:

• 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 (including Canadian 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 do 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.) Health Canada is working towards a regulatory amendment that would make registration cards for all breast implants a requirement.

It should be noted that the long-term follow-up of each individual recipient of any medical device is the role of a physician.

Under the law, manufacturers must report problems with licensed products that are related to failure of the device or deterioration in its effectiveness, inadequacy in its labelling, or that have led to the death or serious deterioration in the state of health of a patient. Additionally, health professionals and patients can voluntarily report adverse events regarding medical devices to Health Canada by phone, fax or through its online MedEffect reporting system.

Summaries of Adverse Event reports are currently made publicly available under the Access to Information Act. However, Health Canada agrees to consider including this summary information as part of the annual, publicly accessible updates to the Summary Basis of Decision documents proposed in Health Canada’s response to Recommendation 1.