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Medical Devices / Submissions and Approvals

Allergan Pulls Textured Breast Implants, Tissue Expanders Over CE Marks

Dec. 27, 2018
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Allergan announced that it has halted sales of textured breast implants and tissue expanders in Europe due to expired CE Marks, and is initiating a withdrawal of all remaining supplies in those markets.

The company’s move to withdraw the products came after France’s regulatory authority, Agence Nationale de Sécurité du Médicament, requested a recall. The company said it disagreed with the need for a recall but agreed to comply.

Allergan said no immediate risk has been identified to women using the textured breast implants.

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