cigarettes

Health Groups Ask Leadership Candidates To Support Measures To Reduce Tobacco Use

Today, the Campaign for a Smoke-Free Alberta launched a province-wide initiative to encourage the leadership candidates to support effective tobacco reduction measures.

The coalition is running compelling full page ads in major Alberta newspapers that convey the impact of tobacco use and list each candidate’s response to a survey of proposed tobacco control policies.

To date, five of the eight official candidates have responded to the coalition’s survey including Victor Doerksen, Dave Hancock, Mark Norris, Gary McPherson, and Lyle Oberg. Jim Dinning, Ted Morton and Ed Stelmach have not responded to the survey.

“Albertans want the next Premier to take strong action on the leading avoidable cause of premature death in our province,” said Lorie Boychuck of the Canadian Cancer Society, Alberta/NWT Division. “This campaign represents the wishes of the majority of Albertans who want to the government to take effective action on tobacco. If the leadership candidates are truly committed to improving the quality of life in Alberta, they cannot overlook the impact of tobacco use on individuals, families, communities and our healthcare system.”

In addition to the newspaper ads, the coalition is urging thousands of supporters to participate in all-candidates forums and events around the province and to pose questions to the candidates about their intentions on tobacco if they become Premier.

Specifically, the coalition is urging the candidates to support the following policy measures:

  • Legislation to make all indoor workplaces completely smoke-free, including liquor and gaming establishments
  • A tobacco tax increase of at least $1.00 per pack of cigarettes
  • A ban on all retail tobacco displays or powerwalls
  • A ban on tobacco sales in pharmacies and other healthcare settings
  • Legislation to enable healthcare cost-recovery suits against tobacco companies

“Now is the time for Albertans to speak up for the quality of life in our province,” said Dr. Roger Hodkinson of Action on Smoking & Health. “We are urging everyone who has been touched by the tobacco epidemic to attend the leadership forums and to ask the candidates where they stand on the issue. We cannot allow the next Premier to overlook this enormous public health problem.”

Over the next few weeks, coalition members will be meeting with various news media representatives around the province to discuss the relevance of tobacco reduction in the leadership debates. The coalition is committed to making tobacco reduction a significant leadership issue.

Alberta lags other provinces on effective tobacco control policies. Alberta’s tobacco taxes are presently the eighth lowest among all provinces it has the worst smoking control legislation of any province. In addition, Alberta is the only province without any legislation to control tobacco sales and marketing.

The coalition has posted all of the candidates’ survey responses on its website at www.smokefreealberta.com and it will be posting any new responses as they are received.

The Campaign for a Smoke-Free Alberta is a coalition of 15 prominent health organizations who are working to reduce tobacco use in Alberta.

Silicon breast implants available in Canada again

Silicone Gel-Filled Breast Implants Back On Canadian Market

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.

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.

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. 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:

  • 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.

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 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.)