The lawsuit was filed soon after Allergan recalled all BIOCELL® textured breast implants due to the risk of cancer.
Neither woman has developed Anaplastic Large Cell Lymphoma (ALCL), a rare type of cancer that is linked to textured breast implants.
However, one woman paid to have her implants surgically removed due to her fears of developing ALCL. The other woman said she never would have gotten the implants if she had known of the risk.
Allergan’s recalled implants are specifically linked to 481 cases of ALCL, as well as a 6-fold increased risk of causing ALCL compared to other textured breast implants on the market in the U.S., the FDA warned.
The women are seeking financial compensation for themselves and other women with the recalled implants
They say they will be forced to spend “substantial sums for the removal of the recalled implants, surgical and diagnostic fees, and/or medical monitoring and invasive diagnostic procedures,” the lawsuit states.
On July 30, Allergan announced that the company would pay for new breast implants for women with the recalled Biocell implants — but Allergan will not pay for surgery costs. The program will run until July 24, 2021.
In July, the FDA reported a total of 573 known cases of breast implant-associated ALCL, as well as 33 deaths worldwide, from all types of breast implants.
The FDA is not recommending routine removal of Allergan’s recalled implants for women without symptoms. Instead, they say women with the implants should know the symptoms of ALCL, such as persistent breast pain and swelling, and tell their healthcare professional right away.