BIA-ALCL FDA Information
The FDA first discovered a potential link between breast implants and the development of anaplastic large cell lymphoma (ALCL) in 2011, but there were so few cases of the disease at that time, it was difficult for regulators to determine what factors increased a patient’s risk of developing BIA-ALCL. In 2016, the World Health Organization categorized BIA-ALCL as a T-cell lymphoma potentially occurring after the implantation of artificial breast implants, and as more information came to light about the risk of BIA-ALCL, the FDA found that most data linked the cancer to breast implants with textured surfaces, rather than those with smooth surfaces. In November 2018, the International Consortium of Investigative Journalists released a global report highlighting the ongoing health problems affecting patients with breast implants, including the risk of BIA-ALCL, and the following month, regulatory officials in France ordered Allergan to remove its popular Microcell and Biocell breast implants from the market.
Following the regulatory action against Allergan, in February 2019, the FDA issued an update on the number of cases of BIA-ALCL, indicating that, as of September 2018, the agency was aware of 660 reports of the lymphoma diagnosed since 2010, including reports of nine patient deaths linked to the cancer. At that time, the FDA issued a statement to healthcare providers in order to “increase awareness about an association between all breast implants, regardless of filling or texture, and Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).” Additional significant regulatory actions have been taken against other brands of textured breast implants recently, due to the potential risk of BIA-ALCL. For instance, in April 2019, French authorities issued a historic ban on two categories of textured breast implants – macro-textured and polyurethane implants – due to the potential for the implants to cause lymphoma in patients.