WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has requested that pharmaceutical giant Allergan voluntarily recall some of their breast implants and tissue expanders from market.
In a web post today, the federal agency announced that they “took significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan, the manufacturer of a specific type of textured implant, recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL.”
FDA Principal Deputy Commissioner Amy Abernethy stated that the agency had evidence which indicated that “a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death,” and that the FDA has taken action “to alert the firm to new evidence indicating a recall is warranted to protect women’s health.”
Following the agency’s request, according to the FDA announcement, Allergan has notified the FDA that “it is moving forward with a worldwide recall of their BIOCELL textured breast implant products, including: 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.”
For more on this implant recall, which could affect the health of many adult performers, read the complete FDA announcement here.