Health Canada

Health Canada

November 12, 2010 12:24 ET

Breastlight is Not Authorized for Use as a Screening Device for the Detection of Breast Cancer

OTTAWA, ONTARIO--(Marketwire - Nov. 12, 2010) - Health Canada is informing Canadians that PWB Health Ltd. (the "Company") is recalling its Breastlight product which is currently available on the Canadian market. PWB Health Ltd. is requesting that pharmacies and other distributors immediately stop sale of this product.

This recall comes as a result of Health Canada's evaluation of the safety and effectiveness information regarding this new technology.

Breastlight is marketed as a new health and well-being product for women, to aid in noticing changes in their breasts over time and as a component of a woman's "breast awareness", according to the Company. It is important to note that there is no clinical evidence that the Breastlight can be used effectively as a screening device for the early detection of breast cancer. As such, it may present a potential risk to women relying on it for early detection of breast cancer.

Health Canada will monitor the company's recall and will inform Canadians and take appropriate action if new safety information arises. Health Canada is also working with the Canada Border Services Agency to stop the importation of any shipments of Breastlight from entering Canada.

Health Canada is reminding consumers that Breastlight is not a replacement for routine monitoring and screening for breast cancer. Patients who have relied on this product for breast cancer screening should contact their physician for appropriate follow-up and testing.

For more information on breast cancer and related information, see Health Canada's It's Your Health ( http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/diseases-maladies/breast-sein-eng.php ) article on these topics. To confirm whether a device is licensed in Canada, please refer to the Medical Devices Active Licence Listing at www.mdall.ca.

Complaints involving Breastlight can be reported to the Health Products and Food Branch Inspectorate by calling the toll-free hotline at 1-800-267-9675, or by writing to:

Health Products and Food Branch Inspectorate
Health Canada
Address Locator: 2003D
Ottawa, Ontario K1A 0K9

Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

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Contact Information

  • Media Inquiries:
    Health Canada
    613-957-2983
    or
    Public Inquiries:
    613-957-2991
    1-866-225-0709