Increased Cancer Risk Prompts Recall of Allergan BIOCELL Textured Products

by | Dec 10, 2019

Over the past several years, there has been an increase in concerns regarding the connection between breast implants and cancer. Recent studies have shown there is a possible connection between breast implants and a type of non-Hodgkin’s lymphoma – breast implant-associated anaplastic large cell lymphoma or BIA-ALCL. This rare type of non-Hodgkin’s lymphoma has been found in individuals with textured silicone breast implants and tissue expanders. While the cancer is commonly “found in the scar tissue and fluid near the implant”, delayed detection can allow for it to spread throughout the body.

In recent months, several lawsuits have been filed against Allergan Inc., the manufacturer of BIOCELL textured silicone breast implants and tissue expanders because of the products’ connection to BIA-ALCL. These lawsuits allege that Allergan had known about their products’ link to the cancer since at least 2006, and continued to produce the implants anyway. In July 2019, Allergan issued a voluntary recall after the FDA requested their textured silicone breast implants and tissue expanders be pulled from the global market.  For those patients who have the textured silicone implants, Allergan has offered to replace those implants with a safer implant, but has not offered to cover the surgery costs. As part of their lawsuits, the plaintiffs are urging the company to create and fund a medical monitoring program to detect diseases like BIA-ALCL.

On October 3, 2019, plaintiffs in several of the pending class action lawsuits made a motion to the Judicial Panel on Multidistrict Litigation to consolidate their cases in either the United States District Court for the Middle District of Tennessee or the United States District Court for the Central District of California, citing the large number of women potentially affected by Allergan’s products.

Recent data from the FDA1 reports over 500 cases of BIA-ALCL where over 400 of those patients had Allergan implants. Another study has shown that the risk of BIA-ALCL is six times greater with an Allergan textured implant than other implants.

Given Allergan’s global presence in the implant industry, we anticipate the number of lawsuits will continue to grow.

1 – The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication

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