Allergan Recalls Textured Implants in the U.S.
The breast implant manufacturer Allergan has officially announced it will no longer sell its Biocell textured implants or tissue expanders in the US or anywhere across the globe. The company has also asked that physicians not use any previously purchased textured implant products and to return any unused implants.
This action comes after the US FDA announced that textured implants were associated with a rare cancer called Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). The company’s textured implants were first removed from the market in Europe at the end of 2018 and then Canada and Australia banned the products earlier this year.
“Based on the currently available information, including the newly submitted data, our analysis demonstrates that the risk of BIA-ALCL with Allergan Biocell textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the US,” the FDA said in their official announcement. The FDA has also updated the number of cases of BIA-ALCL to 573 total worldwide. Of those cases, 481 are attributed to Allergan implants with 33 associated deaths.
Currently, the FDA does not recommend the prophylactic removal or replacement of any textured implants, but patients should be aware of common BIA-ALCL symptoms and their options.
Author: Dr. Minas Chrysopoulo and Courtney Floyd
The breast implant manufacturer Allergan has officially announced it will no longer sell its Biocell textured implants or tissue expanders in the US or anywhere across the globe.