Allergan Halts Sales, Recalls Some Breast Implants in Europe
(Bloomberg) -- Allergan Plc will stop selling and recall remaining supplies of some of its breast implant products in Europe, after French regulators requested that they be pulled off the market after their clearance lapsed.
The company’s decision to pull its textured breast implants and tissue expanders, also follows a report by several media organizations that cited cases of a rare cancer in patients who got the implants. The products are used in breast augmentation and enhancement.
Allergan said in a statement that it disagreed with the recall request by France’s Agence Nationale de Securite du Medicament, or ANSM, but will cooperate. The agency isn’t calling for patients who have the implants to get them removed, and the company said there was no new scientific information pointing to problems with the products.
“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,” said Charles Hugh-Jones, Allergan’s chief medical officer.
Shares of Allergan fell 3.9 percent to $141.05 in trading in New York before the market opened.
The recall follows the expiration of a certification that allows the products to be sold in 31 European countries, which share some regulatory oversight of drugs and medical products. Allergan’s approval expired on Monday, and the company has been asked for more information on the products, said the ANSM.
There’s no demonstrated health risk with the products, the French agency said in a statement.
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