Microcell and Biocell textured breast implants of Allergan breast implant that has been linked to an emerging form of cancer has been recalled in Europe, French authorities announced on Tuesday.
Manufacturer Allergan was told to suspend sales and remove all stock of its Microcell and Biocell textured breast implants from health facilities in Europe after French regulator, the National Agency for the Safety of Medicines and Health Products (ANSM), refused to renew the implants’ expired CE marks. The CE mark is a certification required for all devices manufactured and sold in Europe.
Patients with textured implants already in place have been advised to continue regular monitoring of their implants with their doctor.
The U.S. regulator, the Food and Drug Administration, told ICIJ in November that it would hold a public meeting of a panel of medical advisers in 2019 to discuss breast implant safety.
Allergan Breast Implant Recall report - Safety of Medicines and Health Products - In French
Via ICIJ
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