NATIONAL RESEARCH CENTER FOR WOMEN & FAMILIES
************************* Health Canada grants manufacturers Class IV licences with conditions to market silicone gel-filled breast implants
OTTAWA - 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:
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.
Note: Summary Basis of Decision documents regarding the Inamed and Mentor applications are available at the Health Canada Web site
************************* Statement of Dr. Diana Zuckerman, president, National Research Center for Women & Families
WASHINGTON, Oct. 20 - After more than a dozen years of limiting access to silicone gel breast implants, Health Canada today announced that it was granting licenses to two companies, Mentor and Inamed, to sell these products for breast augmentation or reconstruction.
The following is the statement of Dr. Diana Zuckerman of the National Research Center for Women & Families:
"This shocking and unfortunate decision will jeopardize women's health for many years to come. In addition to the impact on individual women, this ill-advised decision will create a financial strain on the Canadian health care system.
"A Canadian study by Aleina Tweed and her colleagues in British Columbia indicated that augmentation patients are hospitalized more often and for longer periods of time than other Canadian women of the same age.
"Will Health Canada pay for regular MRIs to determine if women's silicone gel breast implants are leaking? Will Health Canada pay for immediate removal of breast implants for women whose implants are leaking silicone into their bodies? If they don't, they are turning their backs on women whose health could be irreparably harmed by today's decision. If they do, it will cost Health Canada many millions of dollars that could otherwise be spent to fight deadly diseases. "Last week, very serious new allegations were made by a chemist who worked at one of the companies, Mentor Corporation. Health Canada appears to be indifferent to these and other allegations by Mentor scientists who have come forward to explain how the company provided inaccurate safety information about their breast implants.
"Although Dr. Sharma stated during today's press conference that Health Canada was aware of the allegations, it seems that she was referring to allegations made last year, not the ones made last week." Dr. Sharma stated during the press conference that Health Canada "can and will revoke the licenses if the required conditions are not met" or if other information comes to light about safety concerns.
Dr. Zuckerman has contacted Health Canada to urge them to immediately look into the allegations questioning the integrity of Mentor's safety data.
Meanwhile, the FDA is being urged by several organizations and individuals to investigate these allegations before making a decision in the U.S. The licenses are contingent on five conditions, most of which require additional research.
Since the companies have not conducted well-designed long-term studies in the more than 40 years that breast implants have been on the market, Zuckerman believes that "it is naive of Health Canada to think that this research will be appropriately conducted and completed after granting a green light to the companies." "It is especially shocking that Health Canada is granting licenses prior to meeting the conditions of approval regarding the use of focus groups to test labels that ensure informed consent for patients. Moreover, they do not even require a registry, as was recommended by their advisory committee. We would consider a registry a minimum safeguard."
The National Research Center for Women & Families is a nonprofit research and education organization that focuses on health and safety issues.
Dr. Zuckerman is an epidemiologist and former Congressional investigator, and can be reached at firstname.lastname@example.org