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 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% were implanted with Allergan-textured breast implants.

BIA-ALCL and Allergan Implants: Multicounty and Multidistrict Litigations Underway

In July 2019, in light of the rising number of BIA-ALCL cases, 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 THE 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 surrounding the implant, but in some cases, it can spread 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 be aware of 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 covers the cost of a patient’s late seroma diagnostic testing up to $1,000 and provides $7,500 for BIA-ALCL treatment coverage, as well as free replacement implants. This option, however, requires patients to sign a general release, which releases and forever discharges Allergan from any claims arising from the use of 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

July 15, 2025 Update on Allergan Biocell Lawsuit

The first surgical explant trial is scheduled for June 15, 2026. It has not yet been decided if this will be a multi- or single-plaintiff trial. This issue should be decided by the Court following the November 11, 2025, Case Management Conference.
As of June 2025, initial core discovery is near complete for the sixteen explant/revision bellwether cases. By July 21, 2025, the parties will have selected the 12 surgical explant cases (8 selected by the Plaintiff and 4 selected by Allergan) to be prepared for trial.
Fact discovery for the 12 chosen cases will begin on July 21, 2025, and must be completed by November 7, 2025.
All fact discovery motions must be filed by no later than November 7, 2025.
Plaintiffs’ expert reports are due by November 12, 2025. Defendant expert reports are due by December 22, 2025. Plaintiffs’ rebuttal expert reports are due by January 27, 2026.
Expert depositions must be completed by February 27, 2026.
Dispositive motions and expert-related motions must be filed by March 3, 2026.
Motions in limine must be filed by April 10, 2026.
Pretrial disclosures, including deposition designations and trial exhibit lists, must be filed by April 22, 2026.
In the meantime, the parties have been directed to continue working in good faith with each other to attempt to resolve all claims in this litigation. Plaintiffs’ Settlement Committee and Allergan are directed to be fully prepared to participate in good faith, in-person mediation sessions scheduled before Judge Welsh on October 7 and October 10, 2025.

April 2025 Update on Allergan Biocell Lawsuit

1,261 lawsuits are pending in the Allergan breast implant multidistrict litigation (MDL) in federal court in New Jersey. While progress has been slow, the case is still moving forward, and patients with BIA-ALCL and their families still have time to file a lawsuit.

October 31, 2024 Update on Allergan Biocell Lawsuit

Federal courts have numerous tools at their disposal to help resolve mass tort litigations, such as 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 to a jury. These selected cases, known as ‘bellwether cases, ’ are typically representative of issues that will arise in every injured person’s case.
The goal of the bellwether process is to provide all interested parties with a clear indication of what is likely to happen in future trials and to advance the overall litigation toward resolution.
The first few jury verdicts during the bellwether process provide the judge and parties with sufficient information to determine whether cases should be settled, and if so, what a reasonable dollar range for such settlements might be.
Plaintiffs not chosen as bellwether cases, while 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.
A bellwether process was also employed by Judge Martinotti in the Allergan MDL. As such, a group of 32 cases (16 cases to be selected by Plaintiffs and 16 cases to be selected by Allergan) will be chosen by the parties on or before August 28 as the initial Allergan bellwether cases.
Once selected, the 32 bellwether cases will then begin what is called 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 then 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 bellwethercase(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 of 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 the stay is lifted by Judge Martinotti.

October 2024 Update on Allergan Biocell Lawsuit

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 Update on Allergan Biocell Lawsuit

There are now over 2,000 Allergan cases pending in a MultiDistrict Litigation or “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 Allergan implantees 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 members of the class, a settlement or verdict in the Allergan MDL cases will be individual, based on the facts and circumstances of each plaintiff’s case.
Despite having been 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 the best of our knowledge, no settlements have been reached.

September 2024 Update on Allergan Biocell Lawsuit

Over 1,200 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 at info@yostlaw.com or by phone at 1-800-YOST-LAW. You can also fill out our web inquiry form, and we will respond 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.

Allergan Biocell Lawsuit – Allergan Biocell Implant Lawsuit – Breast Implant Lawsuit

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