China NMPA Product Recall - BIOCELL textured breast implants and tissue expanders

Allergan Information Consulting (Shanghai) Co., Ltd. initiated a voluntary global recall of its BIOCELL textured breast implants and tissue expanders, effective July 24, 2019, with the NMPA publishing the notification on August 1, 2019. This action was prompted by updated global safety information from the U.S. Food and Drug Administration (FDA) concerning a rare but serious health risk: breast implant-related anaplastic large cell lymphoma (BIA-ALCL). BIA-ALCL is a type of non-Hodgkin's lymphoma, not breast cancer, and has a very low incidence, with no reported cases in China and few across Asia. The recall, classified as Level II, specifically targets unused products, meaning implants already in patients are not affected. Allergan, acting as the registration agent in China, is executing this recall simultaneously with its global operations to ensure patient safety and compliance with international regulatory standards. The detailed models, specifications, and batch numbers of the affected devices are available in a supplementary "Medical Device Recall Event Report Form." This proactive measure underscores the company's commitment to patient well-being in response to evolving medical insights.