ALLERGAN BIOCELL TEXTURED BREAST IMPLANTS AND TISSUE EXPANDERS

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 can develop after receiving Allergan 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 harm 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.

FDA RECALL OF ALLERGAN BREAST IMPLANTS

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 to identify and alert patients who may have received the Biocell textured implants and tissue expanders.  

WHAT ARE 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 (a 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, a 2018 long-term study 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

Allergan offered two “warranty programs” for patients who received its textured implants to mitigate thousands of potential lawsuits.  The first option, “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 and $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 claims arising from using its Natralle implants.

Allergan’s second option, “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!

ALLERGAN BREAST IMPLANT LITIGATION UPDATES

 October 31, 2024

• Federal courts have many tools to help resolve mass tort litigations, like the Allergan MDL. One of these tools is known as a ‘bellwether trial.’
• When a judge elects to use bellwether trials, the judge and the parties generally select a small sample of representative cases that will be fully prepared and tried by a jury. These selected cases, known as ‘bellwether cases, ’ typically represent issues that will arise in every injured person’s case.
• The bellwether process aims to give all interested parties a good indication of what is likely to happen in future trials and advance the overall litigation toward resolution.
• The first few jury verdicts during the bellwether process provide the judge and parties with enough information to determine whether cases should be settled and, if so, what a reasonable dollar range for such settlements might be.
• While plaintiffs not chosen as bellwether cases are not necessarily involved in the day-to-day aspects of the bellwether process, the work of the attorneys and judge applies to all cases in the litigation, not just those selected as bellwether cases.
• Judge Martinotti also employed a bellwether process in the Allergan MDL. As such, the parties will select 32 cases (16 to be picked by Plaintiffs and 16 to be picked by Allergan) on or before August 28 as the initial Allergan bellwether cases.
• Once selected, the 32 bellwether cases will begin the discovery phase (an exchange of information and documents via written requests and depositions). The deadline to complete discovery in the bellwether cases is January 31, 2025.
• Once discovery has been completed, the Court will randomly select a case from the pool of 32 to proceed to trial, which is tentatively scheduled to begin in mid-late 2025.
• The work, rulings and orders provided and obtained in the initial bellwether case(s), will also apply to the rest of the cases filed in the Allergan MDL.
• In the meantime, Judge Martinotti has ordered a stay for all the remaining (non-bellwether) cases. Accordingly, all cases not part of the bellwether process are temporarily paused (no work can be done in those cases), until Judge Martinotti lifts the stay.

September 3, 2024

• Over 2,000 Allergan cases are pending in a Multidistrict Litigation (MDL) in the United States District Court, District of New Jersey.
• The Allergan MDL is a consolidation of all federally filed Allergan cases involving those who have either been diagnosed with Breast-Implant Associated Anaplastic Large Cell Lymphoma (“BIA-ALCL”) and/or had their Allergan implants removed out of fear of developing BIA-ALCL.
• The MDL is located in New Jersey and is being overseen by Judge Brian Martinotti.
• The Allergan MDL should not be confused with a class action lawsuit. The MDL cases are NOT part of a class action but are separate individual claims for personal injuries.
• Unlike a class action where the settlement or verdict is split among the class members, a settlement or verdict in the Allergan MDL cases will be individual based on the facts and circumstances of each plaintiff’s case.
• Despite being formed in 2019, the Allergan MDL is still only in the early stages of litigation. Consequently, none of the Allergan cases have gone to trial, no trial dates have been scheduled, and, to our knowledge, no settlements have been reached.

DO YOU HAVE AN ALLERGAN DEFECTIVE BREAST IMPLANT 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 info@yostlaw.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.

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