On July 24, 2019, the FDA called on Allergan, the global pharmaceutical company, to recall textured breast implant products. The recall followed an increased number of breast implant cancer-related reports. Over the past several years, more cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) emerged. These cases linked the rare condition to Allergan’s Biocell textured implants.
This is a devastating development for thousands of women who received these implants in hopes of feeling more comfortable in their bodies, often after facing some sort of physical trauma or undergoing a mastectomy. If you or a loved one received a BIA-ALCL diagnosis due to Allergan’s breast implants, you might be eligible to receive compensation in an Allergan breast implant lawsuit.
A Brief History of Allergan Breast Implants
Breast expanders and implants are in the class of medical devices. They are helpful in reconstructive surgeries and breast augmentations after trauma or a mastectomy.
According to statistics, about 365,000 American women inserted breast implants in 2021.
About 10% of breast implants in the US are textured implants, with nearly 5% produced by Allergan. Textured or “gummy bear” implants present a textured exterior case and a teardrop shape. The outer shell’s texture and shape ensure the implants attach to soft tissue. The stability gives breasts a more natural appearance.
Allergan is an Irish pharmaceutical company recently purchased by AbbVie, the US pharma giant. Allergan was the first company to produce Biocell implant products in the US.
Biocell refers to Allergan’s process to texture tissue expanders and the implant surface. It gives the implants a rougher surface than other implants available in the market.
Smooth or finely-textured surfaces can cause the implants to move around inside the breast, causing discomfort and other issues. The textured surface on Allergan’s implants helps them stick to the breast tissues and remain in position.
Allergan Breast Implants and BIA-ALCL
The connection between Anaplastic Large Cell Lymphoma (ALCL) and breast implants first became evident in 2011 when the FDA published a preliminary report on ALCL and women with breast implants. In the report, the FDA acknowledged that ALCL is generally rare. However, they cautioned that there was a risk of the disease developing in the scar capsule near the implant.
The FDA did not provide sufficient warnings about the imminent danger. They assured consumers that approved breast implants were effective and safe when used as directed.
In January 2019, concerns about ALCL and breast cancer made headlines. Women who received lymphoma diagnoses due to implants shared their stories on social media. They requested the government ban the implants.
In February 2019, the FDA issued a warning that breast implants could cause the development of BIA-ALCL. The FDA declined to authorize a full ban despite a public advisory committee meeting held in March, during which numerous patients requested the ban due to concerns about the textured implants.
The FDA stated that they believed the product met the legal standards at that time. They based the decision on the available information and data. They claimed the risk of getting lymphoma was low, and the data was insufficient to justify recalling the products from the market.
The FDA issued another statement in July 2019, asking Allergan to voluntarily recall all Natrelle and BIOCELL textured breast implants after studies highlighted the high risk. By this time, there were 573 reported cases of BIA-ALCL cases across the world. The FDA reviewed about 481 BIA-ALCL cases before issuing the recall statement.
There were 13 fatal cases where the breast implant manufacturer was clear. Out of the thirteen cases, 12 involved breast implants produced by Allergan. In May 2020, the FDA sent warnings to Ideal Implant Incorporated in Texas and Allergan. The two companies failed to abide by regulatory requirements during studies on the textured breast implants recalled in 2019. The purpose of the studies was to evaluate the safety and potential risks associated with the implants.
The Food and Drug Administration explained that the move was to protect thousands of women from BIA-ALCL. Allergan failed to warn consumers of the risk of anaplastic large cell lymphoma progressing due to implants.
Although there are cases of BIA-ALCL in patients with smooth-surface implants, most cases involve textured implants. Textured breast implants attach better to the breast tissue and remain more stable than smooth implants. However, the surface causes more inflammation during the healing process, creating more scar tissue. It also triggers irritation and causes friction in the breast tissue.
Overview of Research Findings
Generally, textured breast implants have a higher risk of BIA-ALCL, according to the Food and Drug Administration. However, Allergan implants carry a greater risk by up to six times more than other brands.
Studies on BIA-ALCL reports indicated that 85% of the cases or 620 instances involved Allergan textured implants. Unfortunately, about 36 cases of BIA-ALCL related to textured breast implants were fatal. Of the 16 reports with manufacturer information, 15 involved Allergan breast implants.
The Biocell textured surface causes irritation and friction in the breast tissue, increasing the risk of BIA-ALCL.
Allergan discontinued the sale of textured implants in Israel, Australia, Brazil, and all countries of the European Union back in December 2018. HealthCanada canceled Allergan’s manufacturing license in May 2019, but they continued activities in the US. Unfortunately, most people, including those with textured implants, are unaware of the risk of BIA-ALCL.
What is BIA-ALCL?
BIA-ALCL is a type of non-Hodgkin’s lymphoma or T-cell cancer. It’s an immune cell cancer that develops in the lymph cells.
Unlike breast cancer, BIA-ALCL doesn’t form in the breast tissue. It develops in the scar capsule that forms around and under the breast implant due to the healing process.
BIA-ALCL triggers T-cells to generate excessive amounts of a protein called anaplastic lymphoma kinase (ALK1). The protein causes abnormal cell growth in the lymph tissue forming the scar tissue around the breast implant.
The initial symptom of BIA-ALCL is a painless swelling in lymph node locations such as the neck, groin, and armpit. Some people also experience the following:
- General lack of energy
- Skin rash
- Loss of appetite
- Fluid accumulation around the implant
- Sudden or unexplained weight loss
- Changes in breast appearance
- Night sweats
- Swelling and hardening of the breasts
- Breast pain
However, accurate diagnosis requires a biopsy and other medical tests. If you experience such symptoms and you have breast implants, ensure you seek medical attention immediately.
Fortunately, BIA-ALCL is entirely treatable when detected in the early stages. In most cases, treatment involves surgery to eliminate the harmful implants and remove the affected tissues. More advanced stages may also require radiation and chemotherapy treatments.
If you have no symptoms, the chances of getting BIA-ALCL are low, so you may not need to remove the implants.
However, if you recently got a BIA-ALCL diagnosis after using textured implants, you may qualify to file a lawsuit against the company. Medical device companies are liable for failing to provide proper warnings about BIA-ALCL and producing unsafe products.
The FDA recall in 2019 sparked numerous lawsuits against Allergan and AbbVie, the parent company. Allergan is facing personal injury cases and class-action lawsuits filed by thousands of women who use their implants.
In August 2019, two women with Allergan implants from Arizona and Illinois submitted a class-action lawsuit in New Jersey’s federal district court. The lawsuit pursues compensation for cancer testing, medical expenses related to implant removal, and the initial cost of the implants.
After the FDA recall, Allergan released a statement regarding the affected women. They agreed to cover the costs of replacing Biocell implants with non-textured implants for anyone who wanted to switch. However, they were not responsible for the related surgical fees.
Allergan also offered up to $1,000 reimbursements to cover the costs of cancer testing for patients. They would also cover surgical fees of up to $7,500 for BIA-ALCL-related diagnosis and treatment.
In the class-action lawsuit, the two women claim these amounts are inadequate. They also accuse Allergan of failing to notify the FDA about the adverse results of the implant brands. This goes against the federal law that requires the same.
The lawsuit also states that Allergan knew of the possible link between ALCL and their implants since 2006. They failed to warn consumers and were negligent, violating the Illinois Consumer Fraud Act.
New Jersey District Court MDL
As more personal injury lawsuits followed, the court system merged the cases into multi-district litigations (MDLs).
Unlike a class-action lawsuit, cases in an MDL remain independent. Each person receives compensation based on their particular circumstances. MDLs save time and resources because only one judge handles the cases.
In December 2019, four cases merged to form multidistrict litigation in New Jersey’s federal district court. The cases were from:
- The Middle District of Tennessee
- The Southern District of New York
- The Central District of Illinois
- The Central District of California
The lawsuit seeks to recover financial damages for medical monitoring, diagnostic testing, and implant removal surgery. In April 2020, 66 more cases joined the New Jersey MDL (MDL 2921) before Judge Brian R. Martinotti.
Middle District of Florida Lawsuit
In October 2019, two women filed a lawsuit in the Middle District of Florida, seeking $5 million in damages. The two women aim to recover the costs of removing the breast implants, which Allergan is yet to offer.
Reports indicate Allergan applied conditions to cover the payments for patients who refused to insert new implants after removal.
They allegedly declined to cover the costs of medical monitoring and invasive diagnostic testing for these patients. The lawsuit also alleges Allergan has no plans for monitoring patients at risk of cancer, yet the basis of the FDA recall was this risk.
The lawsuit further claims that Allergan is misleading victims, requesting them to sign off their rights to the manufacturer. During the warranty claims process, Allergan requested their staff and doctors to present women with paperwork to sign. It seems like routine paperwork, but includes a clause in the fine print that is a release of claims.
Los Angeles Superior Court Lawsuits
Cari Dietzel and Hillary Corts presented individual lawsuits to Los Angeles’ Superior Court. The lawsuits claim Allergan failed to inform consumers properly of the risks associated with their implants. They buried and misrepresented the potential dangers for over a decade.
The two women don’t suffer from ALCL but seek financial damages for themselves and others with the implants.
They claim the implants exposed them to the risk of ALCL, so they will incur future costs such as:
- Medical monitoring
- Diagnostic and surgical fees
- Removal of the recalled implants
- Invasive diagnostic procedures
The mention of “other women” in this lawsuit may signify an impending class action.
Who Can File an Allergan Breast Implant lawsuit?
If you or a loved one received a BIA-ALCL diagnosis after inserting Allergan breast implants, you could qualify to receive compensation in a lawsuit. You can also file a claim if you currently have Allergan Biocell textured implants and have no cancer diagnosis or symptoms.
It’s Time for Allergan to Take Responsibility for Their Unsafe Products.
Most health insurance providers don’t cover breast implant removal surgery. Allergan refused to cover all cancer diagnosis and removal costs, leaving patients with expensive medical bills in addition to the trauma experienced by learning their implants were dangerous in the first place.
This lack of care is enough reason to hold them accountable for the potential harm their unsafe products could cause.
Don’t allow companies to get away with selling defective products, knowing they may harm you or your loved ones. We fight for hundreds of people like you to ensure you get fair compensation from a negligent manufacturer.