France’s National Agency for the Safety of Medicines and Health Products said that it hasn’t “identified any immediate risk for the health of women carrying the implants,” and that it plans to convene an expert committee to discuss the matter in February next year.
The New York Times reported this week that the implants were linked to an uncommon form of lymphoma that can arise years after the implant is placed.
Allergan’s CE Mark in the E.U. for the implants expired on Sunday and French regulators asked for more data about the devices before it would consider renewing the clearance.
Allergan plans to appeal the agency’s decision, it said in a statement, and that it will continue to push for the renewal of its CE Mark for the textured implants.
The company noted that its smooth breast implants are still on the market.
“Patient safety and product quality are Allergan’s highest priorities. Allergan takes this situation very seriously and is committed to engaging with all stakeholders to ensure they have the most up to date information,” CMO Charles Hugh-Jones said in prepared remarks. “We are committed to strict adherence to all regulatory requirements, to the most rigorous scientific evidence and to the highest industry standards for our products.”
In the U.S. (where the textured implants are still available), the FDA detailed 414 reports in 2018 of the breast implant-associated anaplastic large-cell lymphoma. Of the 414 cases, just 272 specified the implant’s texture and 242 of those featured a textured device. Nine of the 414 cases were fatal, according to the report from the New York Times.
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