Two California women who received Allergan Inc.’s Biocell textured breast implants claim the company failed to warn of cancer risks.
Allergan issued a worldwide recall for Biocell breast implants earlier this summer, after the textured devices were linked to a rare cancer called breast implant associated anaplastic large cell lymphoma, or BIA-ALCL.
According to separate complaints filed in Los Angeles Superior Court on August 28th, Hilary Corts and Cari Dietzel are breast cancer survivors and received Allergan Biocell breast implants after bilateral mastectomies. While they were led to believe the devices were safe, both women claim that Allergan had known for years that Biocell textured implants were associated with an increased risk of ALCL.
But rather than issue any warnings, the company allegedly dismissed, diminished, or downplayed the issue to women around the world.
BIA-ALCL is not breast cancer. Rather, it is a rare form of non-Hodgkin’s lymphoma that develops in the scar capsule surrounding breast implants. Symptoms include:
Fortunately, BIA-ALCL is slow-growing and highly treatable when detected early. Treatment generally includes removal of the breast implants and surrounding tissue. However, if the cancer has spread beyond the scar capsule, chemo and radiation may also be necessary.
Roughly 93% of patients who undergo treatment for BIA-ALCL remain disease free three years later. When deaths have occurred, diagnosis and treatment were delayed an average of two years after symptoms first appeared.
In July, the U.S. Food & Drug Administration (FDA) confirmed 573 cases of BIA-ALCL, including 31 deaths. Allergan Biocell textured breast implants were implicated in 80% of the reports, as well as 12 of the 13 fatalities in which a manufacturer was identified.
Following a request from the FDA, Allergan agreed to recall Biocell breast implants and tissue expanders from the worldwide market.
Right now, the FDA is not advising women with recalled Allergan breast implants to have the devices removed if they are not experiencing symptoms. Instead, these patients should monitor their implants for any changes, especially persistent swelling or pain in the vicinity of the breast implant, and immediately report any concerns to their doctor.