Allergan Biocell textured breast implants and tissue expanders have been linked to the development of a type of non-Hodgkin’s lymphoma called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). BIA-ALCL is not breast cancer. It is a rare form of T-cell lymphoma that develops after receiving breast implants, as classified by the World Health Organization in 2016. As of June 2020, there were 903 worldwide cases of BIA-ALCL and 33 known deaths. Of those patients diagnosed with BIA-ALCL, more than 84% of them were implanted with Allergan textured breast implants.
In July of 2019, in light of the rising number of cases of BIA-ALCL, the U.S. Food and Drug Administration (FDA) requested that Allergan recall its textured breast implants from the U.S. market. Despite this recall, as one of the largest manufacturers of breast implants in the world, hundreds of thousands of women received Allergan’s textured breast implants, which were sold under the brands McGhan, Inamed, and Natrelle® from 1998 to 2019. Sadly, those women are all now potentially at risk for developing BIA-ALCL. Women who received Allergan textured breast implants, and who have been diagnosed with BIA-ALCL, are now suing the manufacturer, and seeking compensation for the devastating harms they have suffered.
Lawsuits are moving forward, with the consolidation of more than 100 cases in a multicounty litigation (MCL) in state court in New Jersey, as well as in a multidistrict litigation (MDL No. 2921) in New Jersey federal court. Discovery efforts are underway in state and federal court, and the judges overseeing the cases are expected to focus on pretrial motions and preparation for the first “bellwether” trials.
After the implants were recalled in 2019, in May 2020, the FDA issued a warning letter to Allergan for its failure to complete post-market safety studies. Allergan did not adequately collect data from patients for a safety study, which was a condition of the FDA’s approval of the breast implants. Because many women were not informed about the recall, Allergan launched a social media and internet campaign in an attempt to identify and alert patients who may have received the Biocell textured implants and tissue expanders.
SYMPTOMS OF BIA-ALCL
Symptoms commonly associated with BIA-ALCL are breast pain and swelling, the accumulation of excess fluid near the implant site, skin rashes, and a lump or a mass surrounding the implant. In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it spreads throughout the body. Nevertheless, unless the patient has been diagnosed with BIA-ALCL, or is experiencing symptoms of BIA-ALCL, the FDA does not recommend that people have the implants removed. Instead, it is recommended that these women know the symptoms of BIA-ALCL and monitor their health accordingly. Most cases of BIA-ALCL occur, on average, 9 years after breast implant placement, so there are potentially hundreds of thousands of women who are estimated to be at risk of developing this cancer.
ALLERGAN’S FALSE CLAIMS REGARDING TEXTURED IMPLANTS
Allergan falsely claimed that textured implants are a better option than smooth implants because they reduce capsular contracture (condition where the scar tissue squeezes the implant) and provide better positioning and adherence to tissue. These claims are patently false. In fact, during a 2011 study, it was determined that Biocell texturing actually increased the capsular contracture rate. Then, in Allergan’s 2014 clinical trial, it was determined that there were no significant differences in capsular contracture rates between textured and smooth implants. However, in a 2018 long-term study, it was found that Biocell implants are more frequently associated with problems related to implant performance failure and, more specifically, pain.
ALLERGAN’S UNETHICAL ATTEMPT TO BRIBE PATIENTS
In an attempt to mitigate thousands of potential lawsuits, Allergan offered two “warranty programs” for patients who received its textured implants. The first option called “ConfidencePlus” applies to all Allergan products and pre-dates the product recall. This option offers to cover the cost of a patient’s late seroma diagnostic testing for up to $1,000 as well as $7,500 for BIA-ALCL treatment coverage, and free replacement implants. This option, however, requires patients to sign a general release which releases and forever discharges Allergan from any and all claims arising from the use of its Natralle implants.
Allergan’s second option called “BIOCELL Replacement” gives patients until July 24, 2021 to have their textured implants removed and replaced with smooth Allergan implants. However, even though the patient is not required to sign a release, they are requested to sign an informed consent and pay for their own surgery!
DO YOU HAVE A CASE?
The attorneys at The Yost Legal Group are currently investigating and pursuing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) lawsuits for women who have been diagnosed after receiving Allergan Biocell textured breast implants. If you or a loved one has been diagnosed with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) after breast implant surgery, please contact our experienced attorneys for a free case evaluation.
We can be reached by email or phone at email@example.com or 1-800-YOST-LAW, or you can fill out our web inquiry form and we will respond to you as soon as possible. We will investigate the circumstances of your individual case, answer any questions you have, and fight to get you the compensation you deserve.