In December 2018 France’s National Agency for the Safety of Medicines and Health Products (ANSM) announced that Allergan textured breast implants can no longer be marketed in France and elsewhere in Europe.
As regards what the FDA is doing on this developing medical device safety issue, we turn to this NBC News piece, “Allergan’s textured breast implants recalled by French authorities”:
On [December 19, 2018], the Food and Drug Administration responded that it has been tracking the relationship between textured breast implants and breast implant-associated ALCL (BIA-ALCL).
“The FDA is aware of the recent decision by the French Notified Body to not renew the CE mark for Allergan textured breast implants,” according to the FDA statement. “We have been in contact with French regulatory authorities discuss the issue.”
The FDA is meeting next year to review the safety of all breast implants.
“Breast implants, regardless of surface texture, are associated with a small risk of BIA-ALCL,” the FDA said in the statement. “There may be multiple factors involved in the development of BIA-ALCL such as patient characteristics, operative procedure history, breast implant characteristics — including surface characteristics, and duration the breast implant is in place.”
We have been reviewing breast implant lymphoma cases as possible lawsuits against Allergan and other manufacturers since March 2017, and will continue to do so.[View article at original source]
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