FDA requested recall to protect women from breast implant-associated anaplastic large cell lymphoma
WEDNESDAY, July 24, 2019 (HealthDay News) — Allergan’s textured breast implants will be recalled due to their link to a rare cancer, the U.S. Food and Drug Administration announced Wednesday.
Following a request from the FDA, the company will proceed with a worldwide recall of its Biocell textured breast implant products, the agency said. The recall stems from concerns about breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Though rare, cases of BIA-ALCL appear to be on the rise. The FDA noted that 573 cases of BIA-ALCL, including 33 related deaths, have been reported worldwide — that number is up from the 116 cases and 24 deaths reported earlier this year. Of the 573 cases, 481 are attributed to Allergan textured implants, the agency said. Of the 33 deaths, 12 of the 13 patients for whom the maker of the implant is known had an Allergan textured breast implant at the time of their cancer diagnosis.
The textured implants being recalled 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. Also included in the new recall are tissue expanders, used by patients before breast augmentation or reconstruction. Those products include the Natrelle 133 Plus Tissue Expander and the Natrelle 133 Tissue Expander with Suture Tabs.
In addition, the FDA issued a safety communication Wednesday for patients with breast implants, patients considering breast implants, and their health care providers. The communication outlines the known risks and what steps patients should consider when watching for the cancer, including swelling and pain in their breasts.
FDA Press Release
FDA Safety Communication
Allergan Press Release
Copyright © 2019 HealthDay. All rights reserved.
