Allergan Issues Worldwide Recall of Biocell Textured Breast ... | 合法醫療器材資訊網

2019年7月24日—OnJuly24,2019,AllerganannouncedaglobalrecallofBiocelltexturedbreastimplantsandtissueexpandersaftertheU.S.FoodandDrug ...

On July 24, 2019, Allergan announced a global recall of Biocell textured breast implants and tissue expanders after the U.S. Food and Drug Administration (FDA) requested the recall.

The recall comes after a rare type of cancer called anaplastic large-cell lymphoma (ALCL) has been linked to textured breast implants. Lymphoma is cancer of the lymphatic system.

Currently, 38 other countries have recalled this implant because of its link to ALCL.

The FDA also updated the number of worldwide cases of ALCL associated with breast implants: 573 women have been diagnosed, and 33 women have died from the disease.

Of the 573 cases of ALCL, 481 are attributed to Allergan implants. Of the 33 deaths, the FDA reports that the implant maker was known for 13 women. Of these 13 women, 12 of them were confirmed to have an Allergan breast implant at the time of their ALCL diagnosis. ...