Allergan, Inc. is facing mounting lawsuits in connection with the recently announced Biocell breast implant recall, including class actions for medical monitoring and personal injury claims that blame the textured devices for causing a rare cancer/
One of the latest individual breast implant cancer lawsuits was filed in Los Angeles Superior Court on July 25th. According to the complaint, Jennifer Ann Cook received Allergan Natrelle Style 115 Biocell breast implants in 2010. She was diagnosed with anaplastic large cell lymphoma (ALCL) just seven years later, resulting in their removal in September 2017.
“As a result of Plaintiff’s diagnosis of BIA-ALCL, Plaintiff Ms. Cook had seven rounds of brentuximab, a type of systemic immunotherapy, administered to her body to try to eliminate the disease,” the complaint states “Prior to her development of ALCL, Ms. Cook enjoyed an active, full life. Subsequently, she endured pain, swelling, and other injuries from this terrible disease.” (Case No. 19STCV25941)
ALCL is a rare type of non-Hodgkin’s lymphoma that sometimes develops in the tissue surrounding breast implants. The U.S. Food & Drug Administration (FDA) first began investigating breast implant cancer reports in 2011. Since then, multiple studies have suggested that recipients of textured breast implants face a higher risk of ALCL compared to those who receive smooth-surfaced devices.
In December 2018, Allergan recalled textured breast implants and tissue expanders in the European Union, following a compulsory request from French regulators. The devices were removed from the Canadian market the following May.
However, Biocell textured breast implants remained available in the United States until the FDA requested their recall in July 2019. By that time, 573 cases of breast implant cancer had been reported worldwide, including 33 deaths. The agency was able to confirm that 481 cases occurred in women who had received Biocell textured implants. Out of 13 fatalities in which the FDA was able to identify the type of implant, 12 involved Allergan’s devices.
In most cases, breast implant-associated ALCL is treatable if detected early. Treatment generally involves removal of the breast implants, as well as any cancerous masses. However, additional therapy will be necessary if the cancer spreads beyond the scar capsule.
Roughly 93% of patients who undergo treatment for breast implant cancer remain disease free three years later. In cases were ALCL proved fatal, diagnosis and treatment were delayed an average of two years after symptoms first appeared.
The FDA is not recommending removal of Biocell textured breast implants in women who are symptom free. However, the agency recommends that all implant recipients become familiar with the signs of ALCL, primarily persistent swelling or pain in the vicinity of the breast implant, and keep alert for any changes. Those who experience any breast implant cancer symptoms or other changes should talk to their healthcare provider regarding the need for further evaluation.