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33 Patient Deaths Linked To Breast Implant-Associated Lymphoma

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Allergan Plc's (AGN) BIOCELL textured breast implants and tissue expanders are withdrawn from the market worldwide as they have been linked to breast implant-associated anaplastic large cell lymphoma.

Recalled Implants:

The recalled BIOCELL textured breast implant products include Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants.

The tissue expanders used by patients prior to breast augmentation or reconstruction that have been recalled include Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.

What is Breast Implant-Associated Lymphoma (BIA-ALCL)?

Breast Implant-Associated Lymphoma is a type of non-Hodgkin's lymphoma (cancer of the immune system). It is not breast cancer. In most of the cases, BIA-ALCL occurs in the *scar tissue that surrounds the implant, but in some cases, it can spread throughout the body.

(*Once a breast implant is in place, fibrous scar tissue forms around it, creating a tissue capsule. Source: breastcancer.org)

Latest update on BIA-ALCL cases

As of July 6, 2019, a total of 573 cases of breast implant-associated anaplastic large cell lymphoma and 33 patient deaths due to that cancer have been reported worldwide. Of the 573 cases, 481 are attributed to Allergan implants, and of the 33 patient deaths, 12 are confirmed to have an Allergan breast implant at the time of their BIA-ALCL diagnosis, according to the FDA.

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