Allergan Breast Implant Lawsuit

In July 2019, the FDA requested a recall of Biocell® textured breast implants and tissue expanders after evidence showed the products were linked to a type of cancer called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. 

Following the recall request, Allergan issued a worldwide recall for the Biocell implants. The Allergan recall letter offered patients a “warranty” if they had their textured Biocell implants removed. The company said it would replace the textured Allergan Biocell implants with smooth Allergan implants “free of charge.”

The warranty didn’t provide payment for any other costs or expenses associated with the textured Allergan implants, including:

• Surgery to remove the original implants if not being replaced
• Testing for BIA-ALCL
• Post-surgery recovery
• Post-surgery monitoring for BIA-ALCL

The costs of removing the textured implants exceed the costs of new implants. Allergan seemingly has no plans to compensate affected women for the related costs associated with diagnosis, surgical fees, monitoring, and potential treatment for cancer. BIA-ALCL may develop many years after an implant, and removal of an implant is no guarantee that cancer won’t reoccur.

These are the main reasons why women have filed and continue to file lawsuits against Allergan.

Products involved in Allergan breast implant lawsuits

The products involved in the Allergan implant lawsuits are all “textured” implants and tissue expanders. The textured implants feature a roughened surface originally thought to make them more comfortable than earlier, smooth breast implants. 

But these implants have significant risks. The FDA’s recall announcement came after doctors reported that 80% of known cases of BIA-ALCL had occurred in women with Allergan textured breast implants. The recall notice explained that 481 of 573 BIA-ALCL cases had occurred in women with Allergan’s textured implants. Analysis revealed this was a statistically significant amount, so the FDA issued the recall notice to Allergan. The company then made a voluntary recall notice the same day.

The recall notice affected all Allergan products made with a “salt-loss” process used to create the textured surface. These recalled products were:

• Natrelle 133 Plus tissue expander styles 133P-FV, 133P-MV, 133P-LV, 133P-MX, 133P-SX, 133P-SV, T-133P-FV, T-133P-MV, T-133P-LV, T-133P-MX, T-133P-SX, T-133P-SV, 133P-FV-T, 133P-MV-T, 133P-LV-T, 133P-MX-T, 133P-SX-T, 133P-SV-T
• Natrelle 133 tissue expanders with and without suture tabs: styles 133FV, 133MV, 133LV, 133MX, 133SX, 133SV, T-133FV, T-133MV, T-133LV, T-133MX, T-133SX, T-133SV, 133FV-T, 133MV-T, 133LV-T, 133MX-T, 133SX-T, 133SV-T
• Natrelle 150 Full Height and Short Height double lumen implants
• Natrelle 510 Dual-Gel styles LX, MX, FX
• Natrelle INSPIRA breast implants, styles TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, TCX
• Natrelle Komuro breast implants styles KML, KMM, KLL, and KLM
• Natrelle and McGhan 410 breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
• Natrelle and McGhan 410 Soft Touch breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
• Natrelle and McGhan Round Gel Implants, styles 110, 110 Soft Touch, 120, 120 Soft Touch
• Natrelle Ritz Princess breast implant styles RML, RMM, RFL, RFM
• Natrelle Saline breast implant styles 168, 363, 468

Allergan breast implant complications

BIA-ALCL is a type of non-Hodgkin’s lymphoma — a cancer of the blood cells in the immune system. These cancers cause lymphatic tissues, such as the lymph nodes and bone marrow, to grow and spread into other tissues. BIA-ALCL begins in the capsule or fluid that surrounds the breast implant. It is not a form of breast cancer. 

Lymphatic cancers can migrate through the lymphatic system or blood stream and into the rest of the body. Symptoms can appear anywhere from six months to 26 years post-implantation, making regular testing and monitoring essential.

The prescribing information and package insert included with the breast implants didn’t mention BIA-ALCL as a possible side effect of the implants, even after evidence emerged linking the implants with a risk of developing BIA-ALCL.

Without complete information in the prescribing information, doctors can’t provide their patients with accurate information and help patients make informed decisions about their health care.

You may qualify to file an Allergan breast implant lawsuit if you can show:

• You or your loved one had one of the recalled Allergan breast implants or tissue expanders
• A doctor properly placed the Allergan implant
• You suffered from BIA-ALCL as diagnosed by a physician

You should talk with an attorney who has experience in medical device litigation and can review your case to determine if you meet the requirements to join the multidistrict litigation. The attorney will examine the details of your medical history and help you decide the best course of action for your case.

The defendants in the Allergan breast implant lawsuits are the manufacturing companies, their predecessors and the current owners.

McGhan Medical Corporation, which later became part of Inamed Corporation, initially developed the breast implant technique that Allergan used. In 2006, Allergan acquired Inamed and all assets and liabilities of Inamed and McGhan.

Allergan PLC (public limited company) was headquartered in Dublin, Ireland, until 2015. It was purchased by Actavis, also headquartered in Dublin, with a principal place of business in New Jersey. Actavis bought Allergan, Inc. (a part of Allergan PLC), and took the Allergan PLC name.

In May 2020, U.S.-based AbbVie, Inc., acquired Allergan PLC. AbbVie also acquired Allergan, Inc., as a wholly owned subsidiary of Allergan PLC, along with acquiring all assets and liabilities of Allergan and all related holdings.

The defendants currently named in the multidistrict litigation (MDL) are listed in all legal paperwork as “Allergan plc n/k/a AbbVie, Inc.; Allergan, Inc.; and Allergan USA, Inc.”

What is the Allergan MDL?

The Allergan multidistrict litigation (MDL) is a legal action against the manufacturers of Allergan breast implants. The MDL has consolidated lawsuits filed by many plaintiffs who have alleged they suffered injuries and illnesses in connection with implants.

An MDL is a type of legal process designed to help federal courts consolidate many cases into a single court system for pretrial purposes. MDLs are often confused with class action lawsuits. In a class action lawsuit, many plaintiffs bring a single cause of action against the same defendant(s). In an MDL, many plaintiffs have individual cases against the defendants, or their cases arise in different jurisdictions with different laws. The federal court system allows MDLs under a specific statute — 28 U.S.C. § 1407— so the plaintiffs can get a fair hearing. MDLs are a tool to ensure legal consistency for all parties.

The Allergan MDL is being heard in the U.S. District Court, District of New Jersey. Judge Brian Martinotti is the presiding judge.

Recently, a case management conference took place to assess the status of discovery and venue waivers (a way of determining the location) for bellwether trials. These trials help determine how juries will respond to the information being presented in later litigation.

Is there a class action lawsuit against Allergan?

U.S. class actions have been filed against Allergan. All class action lawsuits against the company were consolidated into the MDL with other mass tort actions in 2018. 

Also in 2018, Allergan shareholders filed a class action lawsuit against the company. The suit accused the company of fraudulent activities for concealing the link between its implants and BIA-ALCL.

A class action lawsuit against Allergan is also pending in Canada. Health Canada canceled Allergan’s license and banned the sale of textured implants in 2019.

If a plaintiff wins an Allergan breast implant lawsuit, they may be awarded “damages” — the legal term for compensation received for the harm the defendant’s product caused them. In the Allergan case, the alleged losses suffered by the plaintiffs include:

• The costs of diagnosing, treating and recovering from BIA-ALCL
• The costs of removing (explanting) the recalled implants
• The costs of any reconstructive surgery needed after explantation
• The costs of medical monitoring for BIA-ALCL until it can be reasonably certain the patient is free of cancer
• Other damages, including lost wages, pain, suffering, and emotional distress

In a personal injury case, the damages are called “compensatory” damages. That means they compensate the victim for the money and emotional pain they’ve suffered because of the defendant’s actions. “Exemplary,” or “punitive,” damages punish the defendant for careless or negligent behavior.

If you join an MDL or a class action lawsuit, your attorney will review your case and discuss possible damages and the potential outcome of your case. Even in an MDL, each case is different and may not have the same result.

Motley Rice is on the front lines representing thousands of people harmed by defective medical devices and products. Our firm has represented women with defective breast implants involving serious complications since its beginnings. Motley Rice has extensive experience litigating breast implants, other implanted medical devices and medical drugs cases, including:

• Transvaginal mesh
• Toxic hair relaxer
• IUDs such as Paragard® birth control

Learn more about our experience handling defective medical device cases.