France’s National Agency for the Safety of Medicines and Health Products (ANSM) on Thursday announced that sales of macro-textured breast implants and polyurethane-coated breast implants will be suspended, while Health Canada, also on Thursday, announced that it intends to halt sales of Allergan’s Biocell breast implant.
Both decisions are related to the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
In Canada, the decision follows the regulator’s completion of a scientific assessment of macro-textured implants, which launched in November 2018. Health Canada initiated the review because of an increase in Canadian and international cases of BIA-ALCL. And as of Thursday, Health Canada said it has been notified of 28 confirmed Canadian cases of BIA-ALCL, of which 24 (86%) involve Allergan's Biocell breast implant, which is macro-textured.
Allergan has 15 days to respond with new evidence to Health Canada’s decision. “If a satisfactory response is not received by then, it is Health Canada's intention that the Biocell medical device licences will be suspended.
"This means that the product would no longer be permitted to be sold in Canada,” Health Canada said, explaining that its entire safety review on breast implants and BIA-ALCL will be released at the end of this month.
Similarly, in France, ANSM said that as a precautionary measure it will halt the marketing, distribution and use of targeted macro-textured breast implants and polyurethane-coated breast implants produced by six manufacturers (see more details on which manufacturers in link at bottom).
But ANSM said it does not recommend that these implants be taken out of women because of the rarity of the risk of BIA-ALCL. ANSM also said it will continue its surveillance of these implants and that a national register of breast implants has been approved and will be set up quickly.
Meanwhile, in the US, an advisory panel late last month called
for the US Food and Drug Administration (FDA) to consider additional postmarket data reporting requirements on breast implant manufacturers.
But on whether to remove textured breast implants from the US market, the panel argued that the data is lacking to support such a recommendation.
FDA spokeswoman Stephanie Caccomo told Focus
: “The FDA is aware that that the French National Agency for the Safety of Medicines and Health Products (ANSM) has taken action to ban a small subset of textured breast implants and that Health Canada has banned one textured breast implant.
“We intend to communicate to the public what actions we plan take in light of the panel meeting and current state of the evidence in the coming weeks. We are committed to continuing to strengthen our understanding and assessment of BIA-ALCL, as a necessary step, under the US regulations, in considering whether further regulatory action is appropriate and reflects the totality of scientific evidence,” she said.
ANSM (in French)