Allergan, a global pharmaceutical company that develops and manufactures medical devices, faces a class action lawsuit filed by a group of women who claim that they were exposed to an increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) due to the company’s recalled Biocell breast implants and tissue expanders. Breast implant-associated anaplastic large cell lymphoma has been linked to both silicone and saline implants and has been diagnosed in both breast cancer reconstruction and cosmetic patients with Biocell implants and other textured breast implants. If you or someone you know has received a textured breast implant and you have been diagnosed with BIA-ALCL, do not hesitate to seek legal help. You may have grounds to file a product liability lawsuit against the manufacturer of the breast implant in order to seek compensation for your injuries and expenses.
Allergan’s recalled breast implants have linked to anaplastic large cell lymphoma, a rare cancer of the lymphatic system that develops when white blood cells called T-cells become abnormal. Known as breast implant-associated anaplastic large cell lymphoma, the cancer can develop around breast implants, particularly textured breast implants. These implants are made with a rough surface designed to adhere to the surrounding tissue to prevent the implants from moving around within the implant pocket. In a 2017 study published in the journal Plastic and Reconstructive Surgery, researchers found that certain textured breast implants may increase a recipient’s risk of developing anaplastic large cell lymphoma from 10 to 14 times, compared to smooth breast implants. In another study published that same year, researchers indicated that cancer from breast implants is underreported and estimated that the number of cases would increase as patients and doctors learned more about the potential risk of cancer from breast implants.
According to the FDA, there are now at least 573 known cases of BIA-ALCL that have been diagnosed in women worldwide and in 481 of those cases, the breast implants were Biocell implants. There have also been at least 33 deaths linked to defective breast implants and Allergan implants were implicated in 12 of the 13 cases where the device manufacturer was known. Despite the potential risk of cancer and death from recalled Biocell breast implants, the FDA is not recommending that women have the recalled implants removed if they are not experiencing symptoms, which may include persistent swelling or pain near the implant site. However, women diagnosed with BIA-ALCL are advised to undergo surgery to remove the breast implants and the scar capsule surrounding the implants.
It was back in 2011 that the FDA first identified a potential link between breast implants and ALCL. At that time, the agency issued a report indicating that “Overall, the types of adverse events submitted to the FDA are consistent with results from premarket and post-approval studies. No unexpected outcomes or complications were reported through December 2010, except for rare reports of possible Anaplastic Large Cell Lymphoma (ALCL) associated with breast implants.” Earlier this year, the U.S. Food and Drug Administration (FDA) determined that Biocell breast implants were associated with nearly all reported cases of breast-implant associated anaplastic large cell lymphoma. Still, it wasn’t until July 2019 that Allergan issued a worldwide recall for its Biocell textured breast implants and tissue expanders due to an “uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).”
This latest Allergan class action lawsuit was filed earlier this month in the U.S. District Court for the Central District of California, on behalf of 14 women who claim that Allergan knew about the risk of lymphoma from its breast implants for years, yet failed to disclose this risk to women who received Allergan breast implants. “Although it knew of the increased risks of BIA-ALCL as early as 2011, Allergan failed to warn women considering their implants,” the lawsuit states. “Although Allergan has now issued a recall pursuant to FDA’s directive, it refuses to take full responsibility and refuses to cover the significant costs associated with removal and replacement of the defective devices and medical monitoring, among other damages.” As a result, the plaintiffs in the lawsuit are seeking compensation from Allergan for the medical expenses associated with removing and replacing the recalled breast implants and have alleged that the company should provide medical monitoring for all women who received the defective implants.
The lawsuit joins dozens of similar class action lawsuits and individual product liability lawsuits filed in recent months on behalf of women with textured implants who were diagnosed with BIA-ALCL. The claims have been consolidated in the federal court system for coordinated pretrial proceedings as part of a multidistrict litigation (MDL).