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Health Canada to Review the Safety of Breast Implants

Posted in: Blog, Serious Personal Injury // Written on behalf of Cuming & Gillespie
March 14, 2019

Breast augmentation is the most popular cosmetic surgery worldwide with approximately 10 million women choosing breast implants in the last decade.

Health Canada recently announced that it is reviewing cancer risks associated with breast implants following an increase in reports in Canada.

Health Canada is expected to have completed its safety review in spring 2019 and has advised that it will take appropriate action and will provide information to healthcare providers and Canadians when the information is available.

WHAT HAPPENED?

Health Canada has confirmed that it has received 22 confirmed and 22 suspected cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by Canadians.

BIA-ALCL is a serious, but rare, type of non-Hodgkin lymphoma (a cancer that affects the immune system). This type of lymphoma is found to develop many months or years following a breast implant procedure. BIA-ALCL typically presents as an accumulation of fluid between the implant and the surrounding tissue and can occur in both saline-filled and silicone gel-filled breast implants. The cause of BIA-ALCL is unknown at this time.

The announcement by Health Canada came one week following a letter sent by the U.S. Food and Drug Administration to the medical community warning of the risks of BIA-ALCL. According to the U.S. FDA, it has found 660 medical device reports possibly linking breast implants and BIA-ALCL cases throughout the world in the past decade. This includes nine deaths.

Following public hearings that were held in France and attended by members of the FDA, Health Canada, and other European regulators regarding the use and safety of breast implants, France announced a ban on textured breast implants due to their link to higher risks of cancer.

JOINT NEWS INVESTIGATION

CBC News in collaboration with Radio-Canada, Toronto Star and International Consortium of Investigative Journalists (based in Washington) examined tens of thousands of medical devices. They specifically reviewed how the devices are made, approved and monitored by regulators throughout the globe.

This joint investigation revealed underreported numbers of deaths and serious injuries linked to breast implants and other medical devices in various countries, including Canada.

The investigation also revealed, through undercover visits to three Toronto plastic surgeons, that patients are not being warned about the possible link between BIA-ALCL and textured breast implants.

QUEBEC HEALTH DEPARTMENT WARNINGS

Last week, the Quebec Health Department provided a warning of a potential cancer risk to women in Quebec who received textured breast implants since 1995. It is estimated that 15,000 women in Quebec were implanted with textured implants.

According to Marie-Claude Lacasse, spokeswoman for the Quebec Health Department, the risk of women who received texted breast implants for developing cancer is very low (one in 30,000).

Quebec women with textured implants are being advised to visit their healthcare providers if they have any symptoms associated with lymphoma, including pain, swelling, or a mass.

MONTREAL LAW FIRMS COMMENCE CLASS ACTION AGAINST BREAST IMPLANT MANUFACTURERS

Two Montreal law firms have filed a petition for a class-action lawsuit against five breast implant manufacturers, Allergan, Mentor Worldwide, Johnson & Johnson Inc., Ideal Implant Inc. and Clarion Medical Technologies. It is alleged that textured breast implants are linked to BIA-ALCL.

The lawsuit will be seeking reimbursement of the initial operation costs and the costs for an additional operation to replace the implants. They are also seeking compensation for the inconvenience associated with surgery, moral damages, and punitive damages. According to the lawsuit, each plaintiff will be seeking $57,000.

A judge must give permission in order to commence a class action lawsuit. A judge must be satisfied that the following requirements are met:

  • Other people have a similar problem;
  • A class action is better for solving the problem than many separate court cases;
  • The representative (the person who starts a class action) is qualified to represent the members of the class; and
  • The class action has a chance of succeeding.

If the judge is satisfied that all the requirements are met, he/she will grant permission to start the class action lawsuit.

WHAT SHOULD YOU DO IF YOU HAVE BREAST IMPLANTS?

Health Canada recommends that individuals that have breast implants should conduct regular breast self-exams and visit with their healthcare providers for periodic follow-up appointments. These individuals should also consult their healthcare providers if they experience any unusual changes to their breasts, including breast pain, swelling, or a lump.

We will continue to follow any developments regarding the safety of breast implants and the potential class action lawsuit in Quebec and will report information of this nature in this blog.

In the meantime, if you or a loved one have suffered injuries as a result of a medical device, you may suffer from pain, disability, and expenses. At Cuming & Gillespie Lawyers, we will review your case and consult with medical experts to provide you with an honest evaluation of a potential claim. We provide free consultations for new clients to review your case and discuss potential options. Contact our office today online or call 403-571-0555 to make an appointment to speak with our experienced personal injury lawyers. We look forward to helping you obtain the compensation that you deserve.

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