China NMPA Product Recall - Mammary Implantable Paragel

EUROSILICONE S.A.S. has initiated a voluntary Class I recall of specific models and batches of its Mammary Implantable Paragel. This action, reported through Wuxi Like Trading Co., Ltd. and published by the National Medical Products Administration (NMPA) on June 22, 2021, addresses a significant safety concern. The primary issue is a potential association between these textured implants and an elevated risk of Anaplastic Large Cell Lymphoma (ALCL), a rare form of non-Hodgkin's lymphoma. The recall affects products with Registration Certificate No.: 20163462629. A Class I recall signifies a situation where there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. While specific inspection dates are not detailed in this announcement, the NMPA's involvement underscores the regulatory oversight for medical devices in China. EUROSILICONE S.A.S. is responsible for implementing this recall, with further details on affected models, specifications, and batches available in the "Medical Device Recall Event Report Form" attachment. This proactive measure aims to mitigate potential health risks for patients with these implants.