Actavis’ Breast Implants Snag FDA Approval
Actavis’ Naterelle Inspira round gel-filled textured breast implants for women undergoing reconstruction, augmentation, or revision have won FDA approval, the Parsippany, N.J., devicemaker announced Thursday.
The products are contraindicated for women with active infections, with existing cancer or pre-cancer of their breast who have not received adequate treatment and for those who are pregnant or nursing. The devicemaker also warns that complications may result from breast implant surgery and advises that women with certain conditions should take precautions.
The smooth version of the Naterelle Inspira implants was FDA-approved in February. — Jason Scott