Six women from around the United States are suing Allergan, Inc. over textured breast implants allegedly linked to a rare form of cancer.
According to separate complaints filed in New Jersey Superior Court in Morristown, each of the women received Biocell textured breast implants. Their lawsuits claim Allergan obscured the frequency of breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) and other adverse events by submitting reports to a non-public U.S. Food & Drug Administration (FDA) database.
Some of these reports used manufacturer names like “Santa Barbara” and “Costa Rice” instead of Allergan and included incorrect medical information. In at least one case, Allergan determined there was “no apparent adverse event” associated with its textured breast implants. In another, the company characterized BIA-ALCL as a “cancer, non-breast.”
All of the plaintiffs claim their Biocell textured breast implants have placed them at an increased risk of cancer. Several have already had the devices removed, and the others are planning to do so.
BIA-ALCL is not breast cancer, but a rare, slow-growing form of lymphoma that develops in the scar capsule that forms around breast implants. Symptoms usually include:
When detected early, BIA-ALCL usually resolves once the breast implants and surrounding scar tissue are surgically removed. However, more advanced cases may require radiation, chemotherapy, and other interventions. BIA-ALCL can result in a patient’s death if diagnosis is delayed.
The FDA began investigating reports of BIA-ALCL in 2011, and was already aware that the majority of cases had occurred in women with textured breast implants. Last summer, however, the agency warned that Allergan Biocell textured breast implants had been implicated in 80% of BIA-ALCL reports, as well as 12 of the 13 fatalities in which a manufacturer was identified.
Allergan ultimately complied with an FDA request to recall Biocell textured breast implants and tissue expanders.
For now, however, the agency is not recommending removal of these devices for women who are not experiencing symptoms. Breast implant recipients should continue with regular follow-up and report any changes to their doctor, regardless of device type.