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By Jane Weaver
The Canadian health regulatory body announced Thursday that it was informing Allergan of its intention to suspend licenses for Biocell breast implants as a precautionary measure.
Health Canada has announced that this decision was made following the evaluation of textured breast implants as part of a more in-depth and continuous review of the safety of breast implants.
Textured breast implants are associated with a type of cancer called breast implant associated with anaplastic large cell lymphoma, BIA-ALCL, which develops in the scar tissue surrounding the breast implant. Lymphoma has been diagnosed in nearly 700 women worldwide and the FDA thinks it's caused by implants covered with a textured coating resembling sand paper. Removal of this scar tissue and implant usually heals cancer if it is detected early enough. But 17 women in the world have died as a result of the disease.
"Health Canada has initiated the review due to the increase in the number of BIA-ALCL cases in Canada and in other countries," said the government agency in a statement on Thursday. . According to Health Canada, 28 cases of BIA-ALCL in Canada were confirmed – 24 (or 86%) of the diseases were related to Allergan's Biocell Breast Implant.
The decision in Canada comes after the US Food and Drug Administration's meeting last month on breast implant safety. An advisory committee, following the two-day public hearing, expressed its support for a simpler and standardized consent form to explain to patients and physicians the main risks associated with devices before surgery.
A member of the FDA's expert group, Texan plastic surgeon Pierre Chevray, has called for the ban on textured implants related to cancer. The committee did not recommend that implants be removed from the market.
On Thursday, the Dutch authorities also temporarily suspended macro-texture and polyurethane implants, two categories of implants linked to higher risks of BIA-ALCL, according to a report published by the International Consortium of Investigative Journalists .
In February, French regulatory authorities sought to ban Allergan's textured breast implants, while cautioning doctors and patients against the use of other brands of textured implants.
Susan Wagner, Medical Producer Senior Coordinator, NBC News, contributed to this report
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