In July 2019, the FDA released a statement announcing evidence linking Allergan textured breast implants to a higher risk of BIA-ALCL than other manufacturers. The FDA requested Allergan to recall the defective devices from the US market. Allergan identified some Biocell textured breast implant brands from markets across the world, with some recalled products coming from Allergan’s subsidiaries, McGhan and Inamed.
The FDA recall led to numerous Allergan breast implant lawsuits, with women claiming Allergan’s defective implants caused them to develop Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). The lawsuits seek compensation to cover all medical expenses for issues related to their breast implants.
The lawsuits are still streaming in as part of various multi-district litigations (MDLs). Although compensation does not undo the painful symptoms or trauma, it will help to cover the costs of surgery, treatment, and follow-up medical tests.
It’s possible you could be owed compensation if you received a BIA-ALCL diagnosis after using the recalled Allergan breast implants. You can discuss your case with Join the Many to learn about your legal options and how to move forward with your case.
History of Allergan Breast Implants
Various breast implants include silicone, saline, shaped, round, textured, and smooth.
Textured breast implants differ from other types because they have a rough surface that helps them stick to the soft breast tissue.
According to the American Society of Plastic Surgeons, the textured surface prevents the implants from moving inside the breast after surgery. It aims to reduce the risk of forming a tight scar capsule that can cause hard breasts with an unnatural feel.
In July 2019, the FDA requested that Allergan withdraw its Biocell textured tissue expanders and breast implants from the US market. In their statement, the FDA highlighted a possible connection between textured mammary glands implants and BIA-ALCL. New data showed that Allergan BIOCELL textured implants carried a higher risk of BIA-ALCL than similar products by up to six times.
Out of 573 BIA-ALCL reports they reviewed, 481 involved Allergan’s Biocell textured breast implants. Distributing more Allergan textured breast implants could potentially cause severe health consequences and possible fatalities from BIA-ALCL.
The FDA’s statement encouraged thousands of affected women to pursue legal action against Allergan.
Other Names to Look For
Besides Allergan, other manufacturers also produce breast implants with finely textured surfaces. However, Allergan uses a unique Biocell process to texture the surfaces.
Biocell implants can cause irritation and friction inside the patient’s breast tissue. This increases the risk of BIA-ALCL more than other brands.
The recalled Allergan products include styles such as:
- Allergan Natrelle style 133 Plus Tissue Expanders
- Natrelle style 133 Tissue Expanders (with and without suture tabs)
- Natrelle Saline-Filled Textured Breast Implants
- Allergan Natrelle Inspira Silicone-Filled Textured Breast Implants
- Allergan Natrelle style 410 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants
- Natrelle Inspira Silicone-Filled Breast Implants
- Biospan Tissue Expander Style 133
- McGhan BioDimensional Silicone-Filled Biocell Textured Breast Implants
- McGhan style 134 Croissant-Shaped Tissue Expander
- McGhan Magna-Site Tissue Expander
After the recall, Allergan offered to replace the Biocell textured implants with smooth implants free of charge. However, they won’t cover the surgery costs for the removal and replacement procedures. They are also not responsible for diagnostic procedures and medical monitoring fees. The current lawsuits seek to have Allergan take responsibility for all these vital procedures to mitigate the risk of BIA-ALCL caused by their implants.
Join the Many works with experienced attorneys who don’t back down from such fights against established corporations.
Overview of Research Findings
Researchers first identified the connection between implants and Anaplastic Large Cell Lymphoma (ALCL) in 2011. That same year, the FDA released a preliminary report on ALCL and women with implants.
However, the report did not highlight the heightened risks associated with textured implants. It stated that the ALCL developed more or less frequently in people with textured breast implants than in those with smooth implants.
In 2017, the reports of women with textured implants developing ALCL increased significantly. Researchers discovered that one out of 30,000 women with textured implants in Europe and the US was likely to develop ALCL.
In 2018, Canada, Brazil, Israel, Australia, and 33 European countries banned Allergan implants. In the US, the FDA identified 414 cases of ALCL in women with implants.
In 272 cases, it was possible to identify the implant surface type, and 242 cases involved textured implants. Nine of the 414 cases were fatal.
A 2021 study by Rice University discovered that the textured surface on implants could cause a heightened response from the immune cells. These cells can mutate with time, causing BIA-ALCL.
What is BIA-ALCL?
BIA-ALCL is one example of cancer of the lymphatic (immune) system or non-Hodgkin’s lymphoma. It interferes with the immune system instead of forming on the breast tissue, skin, or internal organs.
BIA-ALCL develops in the fluid and fibrous scar tissue surrounding the breast tissue during the healing process. It causes gene mutations that trigger T-cells to produce excessive amounts of a protein known as ALK1 (anaplastic lymphoma kinase).
The protein encourages abnormal cell growth in the lymph tissue around the breast implant.
Common symptoms of BIA-ALCL include:
- Painless swelling(s) in lymph node areas like the neck, groin, and armpit
- Changes in breast appearance or asymmetry
- Enlarged breasts
- Breast hardening
- Skin rash
- Unexplained or sudden weight loss
- Night sweats
- Loss of appetite
If you notice such symptoms, it’s essential to seek medical attention immediately. BIA-ALCL is highly treatable when detected in the early stages. BIA-ALCL diagnosis often involves ultrasounds and MRIs to look for scar tissues and any fluid buildup. You may also need a biopsy for an accurate diagnosis.
Treatment involves removal surgery for the implants and any scar tissue around the area. You can opt for other implants or breast reconstruction using fat tissue, depending on your situation. You may also need radiation and chemotherapy for more advanced stages.
If you used the recalled implants for your surgery, you could still pursue compensation without a cancer diagnosis.
Allergan Breast Implants Recalls
Most people with Allergan’s textured breast implants are unaware of the particular product used in the surgery. The FDA recall did not include all styles of Allergan tissue expanders and breast implants. The specific products subject to FDA recalls include:
Allergan Natrelle Saline-Filled Textured Breast Implants
The recalled styles were:
- Textured Shaped Full Height Moderate Projection Saline Breast Implants Style 468
- Textured Shaped Full Height, Full Projection Saline Breast Implants Style 163
- Textured Shaped Moderate Height, Full Projection Saline Breast Implants Style 363
- Textured Round Moderate Profile Saline Breast Implants Style 168
Allergan Natrelle Silicone-Filled Textured Breast Implants
The recalled styles are:
- Natrelle Inspira Textured Cohesive Silicone-Filled Breast Implants Style TCL
- Natrelle Inspira Textured Silicone-Filled Breast Implants Style TCF
- Natrelle Inspira Textured Cohesive Silicone-Filled Implants Style TCM
- Natrelle Inspira Textured Silicone-Filled Implants Style TCLP
- Natrelle Inspira Textured Cohesive Silicone-Filled Implants Style TCX
- Natrelle Textured Soft Touch Silicone-Filled Implants Style TSF
- Natrelle Textured Silicone-Filled Breast Implants Style TSLP
- Natrelle Textured Soft Touch Silicone-Filled Implants Style TSL
- Natrelle Textured Silicone-Filled Breast Implants Style TSX
- Natrelle Textured Soft Touch Silicone-Filled Implants Style TSM
- Natrelle Inspira Textured Responsive Silicone-Filled Implants Style TRF
- Natrelle Inspira Textured Silicone-Filled Breast Implants Style TRX
- Natrelle Inspira Textured Silicone-Filled Implants Style TRLP
- Natrelle Inspira Textured Responsive Silicone-Filled Implants Style TRM
- Natrelle Inspira Textured Silicone-Filled Implants Style TRL
- Textured Round Midrange Projection Gel-Filled Implants Style 115
- Textured Round Moderate Projection Gel-Filled Implants Style 110
- Textured Round High Projection Gel-Filled Breast Implants Style 120
- Natrelle Ritz Princess Breast Implant styles RFL, RML, RMM and RFM
- Natrelle Komuro Breast Implants styles KLM, KML, KLL, and KMM
- Natrelle Full Height and Short Height double lumen implants style 150
Natrelle and McGhan 410 Soft Touch Highly Cohesive Silicone-Filled Implants
The recalled textured styles are:
- Style 410 FX
- Style 410 FL
- Style 410FF
- Style 410FM
- Style 410 LF
- Style 410 LL
- Style 410 LM
- Style 410 LX
- Style 410 MF
- Style 410 ML
- Style 410MM
- Style 410 MX
Allergan Textured Tissue Expanders
The recalled products are:
- Natrelle Tissue Expander with Suture Tabs Style 133
- Natrelle Plus Tissue Expander style 133
In most cases, BIA-ALCL occurs in the fluid and scar tissue surrounding the implant. However, it can spread to other body organs and become fatal.
The FDA advises you to consult a medical professional and consider removal if you notice fluid buildup and swelling around the implant. If you experience no symptoms, you don’t have to remove the implants, as the chances of developing BIA-ALCL are low.
Still, receiving a cancer diagnosis is incredibly stressful and traumatic. Dr. Eric Swanson, a plastic surgeon at Swanson Center for Cosmetic Surgery, discusses some of the challenges of women with textured implants. He highlights that the financial and emotional effects of BIA-ALCL on women with implants take a toll even when the case is not fatal. These women have to cover expensive costs such as:
- Computed tomography
- Positron emission tomography
- Medications like Brentuximab
Dr. Eric Swanson and other plastic surgeons felt it was time to stop using textured implants, citing independent studies that show even more complications involved with Allergan’s implants.
History of BIA-ALCA Cancer Lawsuits
After the FDA recall in 2019, women who used the recalled products filed Allergan breast implant lawsuits. The first case, in August 2019, involved two women from Arizona and Illinois. They submitted a class-action lawsuit in New Jersey’s federal district court seeking compensation for:
- Cancer testing
- Medical expenses related to implant removal
- The initial cost of the implants
As more personal injury lawsuits streamed in, the US Judicial Panel on Multidistrict Litigation (JPML) merged the cases into multi-district litigations (MDLs).
The primary purpose of MDLs is to hasten the litigation process and streamline discovery. Unlike class action lawsuits, the cases in an MDL remain independent. The MDL judge will select several representative cases that will proceed to test trials. These test trials, known as bellwether trials, will provide settlement guidelines for the other cases.
New Jersey District Court MDL
There’s an active Allergan MDL (MDL 2921) in the federal district of New Jersey. The Allergan BIOCELL Textured Breast Implant Products Liability Litigation is under Honorable judges Joseph A. Dickson and Brian R. Martinotti.
Most claims in the Allergan breast implant lawsuits include:
- Failure to Warn (strict liability)
- Defective Design (strict liability)
- Punitive Damages
- Breach of Warranty
Middle District of Florida Lawsuit
In October 2019, two women filed a lawsuit in the Middle District of Florida, seeking a class action status and $5 million in damages.
The women are pursuing compensation for the costs of removing the implants that Allergan failed to offer. The lawsuit claims Allergan has no intentions of monitoring people at risk of cancer even though the basis of the FDA recall was this risk. The lawsuit also claims Allergan is misleading victims to sign their rights away.
Los Angeles Superior Court Lawsuits
Two women, Cari Dietzel and Hillary Corts, submitted individual lawsuits to the Los Angeles Superior Court. The lawsuits claim that Allergan failed to issue proper warnings about the risks of the implants. They also misrepresented the risks for years. The two women are cancer-free but are pursuing financial compensation for themselves and others in the future.
As of September 2022, there were 1,078 cases in the New Jersey MDL and before other state courts. If you wish to file a lawsuit, Join the Many can connect you with experienced attorneys to fight on your behalf at no upfront costs.
The Statute of Limitations for Bia-Alcl Cancer Lawsuits
Every state has different statutes of limitations for product liability lawsuits. Some states allow five years, others one or two years.
It’s best to consult legal experts to determine the time limits to file an Allergan Breast Implants Lawsuit. Join the Many gives you access to free legal advice and a legal team to fight your case in court.
Let Join the Many Help You with Your Breast Implant Lawsuit
Pursuing legal action against established corporations can feel like an uphill battle. The legal system is complex, and litigation sounds intimidating to most people. At Join the Many, we level the field for people like you, empowering you with the necessary resources to pursue the compensation you deserve.