Allergan, a global pharmaceutical company based in Dublin, has issued a voluntary recall for Biocell textured breast implants and tissue expanders after the action was requested by the FDA. The implants have been linked with several health problems and complications, including a rare form of cancer and death.
Specifically, the products have been linked to anaplastic large cell lymphoma (BIA-ALCL). Of 573 cases of the disease, 481 are attributed to Allergan implants, the FDA announced. In addition, 33 patient deaths have been linked to implants from the BIA-ALCL, 12 having Allergan implants at the time of diagnosis. Textured implants represent about 5% of all breast implants sold in the U.S.
The action follows that of France, Canada and Australia, which have initiated the recall or removal of certain textured breast implants from the market, including Allergan products.
“Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, said in a statement.
The association between breast implants and ALCL was first identified in 2011. According to the FDA, the possible association was communicated to patients and providers of the increased risk to women with breast implants.
“As this issue and the science have continued to develop, we have been monitoring the reports in databases, including external patient registries, and in scientific literature,” Abernethy said. “Based on new data, our team concluded that action is necessary at this time to protect the public health.”
In a statement, Allergan noted the Biocell saline- and silicone-filled textured breast implants and tissue expanders would no longer be distributed or sold. However, the FDA has not yet recommended the removal or replacement of the products, Allergan noted in its statement.
“The FDA does not recommend removal for patients without symptoms due to potential risks, but we provide helpful information for patients and providers to consider when discussing next steps,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in the statement.