Questions and Answers about Breast Implant | 合法醫療器材資訊網

2019年10月23日—Inmostcases,BIA-ALCLisfoundinthescartissueandfluidneartheimplant,butinsomecases,itcanspreadthroughoutthebody.An ...

Q1. What does the FDA know about Breast Implant Associated Lymphoma? A1. The FDA first identified a possible association between breast implants and the development of ALCL in 2011. At that time, the FDA knew of so few cases of this disease that it was not possible to determine what factors increased the risk. In a report[1] summarizing the Agencys findings, we emphasized the need to gather additional information to better characterize ALCL in individuals with breast implants. In 2016, the World Health Organization[2] designated breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a T-cell lymphoma that can develop following breast implants and noted that the exact number of cases remained difficult to determine due to significant limitations in world-wide reporting and lack of global breast implant sales data[3].

Since that time, the FDA has undertaken several steps to better ...