Allergan Breast Implant Lawsuit

Women who experienced harms from Biocell® textured breast implants and tissue expanders are suing Allergan. One of the key harms linked to the textured Biocell implants is breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.

BIA-ALCL is a type of cancer that affects the immune system. According to the U.S. Food and Drug Administration (FDA), approximately 85% of people diagnosed with BIA-ALCL cases had Biocell textured implants.

Plaintiffs allege that Allergan’s actions to address the defective implants and associated costs weren’t adequate.

Products involved in Allergan breast implant lawsuits and recalls

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.

In July 2019, the FDA requested a recall of Biocell® textured breast implants and tissue expanders after evidence linked them to BIA-ALCL. The recall notice explained that 481 of 573 BIA-ALCL cases had occurred in women with Allergan’s textured implants. The FDA considered this a significant number and issued the recall notice to Allergan. The company then made a voluntary recall notice the same day.

The recall 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 the only currently known complication associated with Allergan textured breast implants. But all types of breast implants have side effects. These include:

• Asymmetry
• Breast pain
• Breast tissue atrophy
• Calcification
• Capsular contracture
• Chest wall deformation
• Deflation
• Delayed wound healing
• Extrusion
• Hematoma
• Iatrogenic injury
• Infection
• Inflammation
• Lymphedema
• Malposition
• Necrosis
• Ptosis
• Redness
• Rupture
• Seroma
• Skin rash
• Wrinkling

Allergan’s worldwide recall for the Biocell implants 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

Removing textured implants costs more than buying new implants. Allergan has not offered to compensate affected women for the related costs of diagnosis, surgery, monitoring and potential cancer treatments.

Importantly, BIA-ALCL may develop many years after an implant. Removing the implant is no guarantee that cancer won’t re-occur.

BIA-ALCL is a type of non-Hodgkin lymphoma — a blood cancer 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.

Lymphatic cancers can spread through the lymphatic system or bloodstream and into other parts of the body. Symptoms can appear anywhere from six months to 26 years after implantation, making regular testing and monitoring essential.

The prescribing information and package insert included with the breast implants did not mention BIA-ALCL as a possible side effect. This information was left out despite available evidence that linked the implants with a risk of developing BIA-ALCL.

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

BIA-ALCL is NOT breast cancer or breast implant illness (BII).

Other BIA-ALCL risk factors

Genetics may be a factor in Biocell implant recipients developing BIA-ALCL. People with mutations in the JAK1 or STAT3 genes and those with BRCA1, BRCA2 and TP53 mutations may have higher risks.

BIA-ALCL symptoms

Several symptoms are often associated with BIA-ALCL. If you’ve had Biocell breast implants, consult your physician if you exhibit one or more symptoms and suspect the implants may be related.

• Enlarged lymph nodes
• Fever
• Hardening of the breast
• Lumps near armpit or breast
• Pain near breast or armpit
• Skin rash or redness near breast
• Swelling near the implant
• Weight loss

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

• 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

An attorney who has experience in medical device litigation can help determine whether you’re eligible 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. They include:

• McGhan Medical Corporation initially developed the breast implant technique that Allergan used. In 2006, Allergan acquired Inamed and all assets and liabilities of Inamed and McGhan and the company became part of Inamed Corporation.
• Allergan PLC (public limited company), which 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.
• AbbVie, Inc., which acquired Allergan PLC in May 2020. 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 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 MDL is a mass legal action in the U.S. District Court of New Jersey. MDL stands for multidistrict litigation. It refers to a court procedure that can streamline multiple individual cases that share common facts. This allows faster pretrial processes and helps avoid duplicate cases and conflicting rulings.

An MDL is similar to a class action lawsuit because they both consolidate similar cases. However, lawsuits in MDLs are handled and tried individually based on the facts of the plaintiffs’ own claims.

The mass legal action for Allergan breast implants is In Re: Allergan Biocell Textured Breast Implant Products Liability Litigation, MDL No. 2921. Judge Brian Martinotti is the presiding judge.

Is there an Allergan class action lawsuit?

No, there isn’t an Allergan breast implant class action lawsuit. MDLs are often mistaken for class action lawsuits, but they handle some aspects of litigation and awards differently. For example, class action lawsuits often pay plaintiffs the same amount. MDLs typically award different amounts depending on the factors of the individual case.

• 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

Plaintiffs may also receive compensatory damages for:

• Emotional distress
• Lost wages
• Pain and suffering

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. Each case in an MDL docket is different and may not have the same result.

Motley Rice attorneys have represented thousands of people harmed by defective medical devices and products. Our law firm has represented women with defective breast implants that caused serious complications for decades. Motley Rice lawyers have 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
• Talcum powder lawsuits

Learn more about our experience handling women's health cases.