TORONTO, CANADA – As reported online by www.newkerala.com, Allergan, a well-known pharmaceutical and medical device manufacturer, has issued a voluntary recall of its textured breast implants in Canada.
Allergan Canada has issued a voluntary recall of its textured breast implants following a decision by Health Canada (similar to the United States Food and Drug Administration (FDA)) to suspend the BIOCELL textured breast implant license. Health Canada’s position on Allergan’s textured breast implants is that the product is not safe enough for use.
Specifically, some women with Allergan’s textured breast implants have developed Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Health Canada has not reported any known cause of BIA-ALCL but has taken the step to suspend the BIOCELL license because BIA-ALCL has been reported in women with textured breast implants including those manufactured by Allergan along with other textured breast implant manufacturers.
However, Health Canada’s decision to suspend the BIOCELL license is contrary to the position expressed by the FDA as well as numerous other regulatory agencies around the world. Allergan intends to appeal Health Canada’s decision, stating that the textured breast implants are not proven to be unsafe for women.
Allergan also asserts that women need the option of textured breast implants, especially women who have a medical need to have their breasts removed (such as in the case of breast cancer). Additionally, Allergan believes that doctors need a variety of options to offer women, as different types of breast implants may be better suited for some women than for others.
Allergan states that women should have an informed discussion with their doctors about the risks and benefits of textured breast implants so that women are aware that there may be a link between implantation of textured breast implants and the development of BIA-ALCL and other health consequences. But, despite a potential link between the textured breast implants and BIA-ALCL, Allergan still maintains the position that such a link has not been scientifically proven.
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