As of the May 2019 the FDA has decided not to ban textured implants in the U.S. due to the lack of a strong causal relationship between this particular type of implant and Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).
In contrast, Canada has the sales of textured implants are being put to a halt.
In late May 2019 this article, “Health Canada suspends Allergan’s licences for its Biocell breast implants after safety review concludes an increased risk of cancer”, informed that Health Canada has determined that 85% of the 26 confirmed BIA-ALCL cases in Canadain involved macro-textured implants. As a result, they have suspended the sale and import of Allergan’s Biocell breast implants and Allergan is voluntarily recalling such unused implants.
An article from Reuters published on the same day, “Allergan to recall textured breast implants in Canada” delivers this quote:
Health Canada’s decision is in contrast to public rulings and positions by other regulatory bodies around the world, including the U.S. Food and Drug Administration’s (FDA) recent position, Allergan said.
With such a strong conclusion from Health Canada regarding the risk of BIA-ALCL from textured implants and the hundreds of women who have been diagnosed, even some deaths occurring, we should wonder… is the FDA going to change its mind and ban textured implants in the US?[Read article in full at original source]
Written by: Laura Beasley, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Strictly Confidential, No Obligation.