Allergan Breast Implant Lawsuits: Shedding Light on BIA-ALCL Risks

by | Feb 9, 2024 | Mass Tort | 0 comments

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In a society that celebrates individuality and self-expression, the journey to aesthetics takes many forms. One such road, taken by countless women seeking empowerment and confidence, is breast augmentation. This blog dives deep into the dark and flip side of breast augmentation- Allergan breast implant lawsuits.

Before answering the query ‘what is the lawsuit against Allergan?’ let’s understand about breast augmentation.

What is breast augmentation?

Breast augmentation or augmentation mammoplasty is a surgical procedure to increase breast size.  The procedure involves artificial devices or prostheses that are placed under the breast tissue, thereby enhancing breast size. Breast implants are silicone shells filled with either silicone gel or saline (sterile salt water).

Though the terms breast augmentation or breast reconstruction are used on a common ground, the circumstances under which each of them are used are different. Breast augmentation is done when the size of the breasts of an individual is increased for cosmetic purposes. On the other hand, breast reconstruction is the term used when breast implants are used to reconstruct the breast of an individual suffering from a medical condition like breast cancer.

The decision to undergo breast implant surgery is a personal one, driven by a myriad of motivations ranging from aesthetic aspirations to reclaiming one’s sense of femininity. Beyond the confines of beauty standards, breast implants have become a canvas for self-expression, allowing individuals to sculpt their bodies in alignment with their inner visions of confidence and attraction.

The glamor of breast augmentation is undeniable, but, as with any medical procedure, it’s crucial to understand the nuances and potential risks associated with breast implantation. In recent years, a growing concern has emerged surrounding the side effects of these enhancements, leading to a surge in litigations like Allergan breast implants lawsuit that echoes the voices of the victims affected by the unexpected challenges post breast augmentation.

From physical discomfort to more serious health issues, the side effects associated with breast implants have triggered the controversies and lawsuits in the U.S.

Allergan: The Birth of the Corporate Shark

Allergan Pharmaceuticals was founded by Gavin S. Herbert, a pharmacist in 1948. The company was originally founded as an American multinational pharmaceutical company, Allergan, Inc. concentrated on urologics, breast augmentation, medical aesthetics, neurosciences, medical dermatology, and eye care.

Through a series of acquisitions, Actavis acquired Allergan in March 2015 and Allergan plc was formed. In June 2019, AbbVie announced the agreement to acquire Allergan for $63 billion. The global headquarters of the company are located in Dublin, and Ireland.

Among the prominent names in the industry, Allergan has established itself as a key player, offering a range of breast implants designed to meet diverse aesthetic goals.

What are Allergan breast implants?

Allergan breast implants are made up of silicone elastomer, a type of silicone with elastic properties similar to rubber, for the outer shell of their breast implants. The shells can be stuffed with silicone gel, sterile saline, or a saltwater solution. From saline to silicone, Allergan’s product portfolio holds a variety of implants, each designed to provide a customizable and natural look. In the US market, Allergan breast implants are among the most prevalent choices.

What is the story of Allergan breast implant recall?

The journey of Allergan breast implants is not without its complexities, as the manufacturer has navigated both innovation and controversy in its pursuit of providing safe and effective breast augmentation options.

What are the risks of Allergan breast implants?

The Food and Drug Administration declared on July 24, 2019, that it had discovered evidence linking Allergan BIOCELL textured breast implants to a higher incidence of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) compared to other textured implants. As per the FDA, approximately 85% of BIA-ALCL cases have been in people who received BIOCELL® textured implants from Allergan.

BIA-ALCL is a rare type of non-Hodgkin’s lymphoma that is distinct from breast cancer. The condition was first identified in the early 1990s, and since then, there have been efforts to better understand its causes, symptoms, and effects.

Are all Allergan implants recalled?

No, the Allergan BIOCELL textured breast implant products covered in the recall are as follows.

  • Natrelle Saline-Filled breast implants
  • Natrelle Silicone-Filled breast implants
  • Natrelle Inspira Silicone-Filled breast implants
  • Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
  • Natrelle 133 Plus Tissue Expander
  • Natrelle 133 Tissue Expander with Suture Tabs

The intention of the recall ensured that unsold breast implants of Allergan in the recalled list were taken out of suppliers’ and physicians’ offices. A safety communication was also released by the agency for individuals who already had breast implants, those who were thinking about getting one, and their medical providers.

The safety communication outlines the known risks associated with the procedure as well as the precautions that should be taken when a patient notices symptoms of BIA-ALCL, such as breast pain and swelling. Information about every model and style number covered by the recall is also included in the safety communication.

This incident prompted a more thorough examination of the connection between breast implants and possible health risks as well as a reevaluation of implant safety regulations.

“Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” said the FDA.

These textured breast implants were sold from 1998 to 2019, and hundreds of thousands of women continued to receive them in spite of the recall, which put them at risk of developing BIA-ALCL.

The precise number of implants impacted was not disclosed by the FDA. There had been 573 documented cases of breast implant BIA-ALCL globally at the time of the recall in 2019. Out of those 573 cases, 481 were reported to have involved Allergan Textured Breast Implants, and 33 deaths were linked to BIA-ALCL.

As of June 2020, the number of BIA-ALCL reports worldwide became 903, with 84% of those cases linked to Allergan.

As of August 2022, 1,130 BIA-ALCL reports had been received, and 953 of those reports were connected with Allergan implants. Additional reports of cancers discovered in the scar tissue of smooth and textured implants in September 2022 that were unrelated to BIA-ALCL were also received by the FDA.

In response to the FDA report, Allergan issued a worldwide recall for several brands of its BIOCELL textured breast implants.

Breast Implant-Associated Anaplastic Large Cell Lymphoma

Causes

The exact cause of BIA-ALCL is not fully understood, but it is believed to be associated with certain types of breast implants, like that of textured implants. The conclusion is from the vast majority of reported cases of BIA-ALCL involving textured implants rather than smooth-surfaced ones. However, research is still underway to confirm that smooth surface implants doesn’t cause BIA-ALCL.

Allergan textured implants have a rough surface designed to reduce the risk of implant movement within the breast pocket and to minimize the formation of scar tissue around the implant. It is hypothesized that the texturing could foster an atmosphere favorable to BIA-ALCL development. Researchers speculate that this lymphoma develops as a result of immune response and chronic inflammation triggered by the textured surface of Allergan implants.

There are also study reports that textured implant surfaces promotes bacterial growth, leading to inflammation and the development of BIA-ALCL. Allergan implants also exhibit the highest level of surface shedding, according to studies on textured implants.

Symptoms 

Primarily associated with Allergan’s textured breast implants, BIA-ALCL typically manifests as late-onset symptoms, often several years after the implant surgery. The most common symptoms include the following.

  • Persistent swelling of the breast, usually occurring well after the initial surgical recovery period.
  • Pain in the breast, often associated with the swelling.
  • Changes in the shape or size of the breast.
  • Formation of lumps or masses in the breast or armpit.

Importantly, these symptoms are not unique to BIA-ALCL; they can also be associated with other illnesses, including more widespread problems like infection or fluid retention. On the other hand, a medical expert should assess any odd or enduring symptoms.

Diagnosis 

In a nutshell, a combination of imaging tests, seroma fluid analysis, and, if required, a biopsy of the affected tissue are used to diagnose BIA-ALCL. A crucial hurdle in the diagnosis is seroma fluid because BIA-ALCL frequently manifests as a seroma, or collection of fluid, around the implant. Let’s see the BIA-ALCL diagnosis step-by-step.

  • Physical examination and discussion about any pain, visible lumps or mass in the breast. A detailed discussion may reveal the history of procedures like breast augmentation or reconstruction.
  • Following physical exam, the physician may advise the patient to receive an ultrasound or a magnetic resonance imaging (MRI) of the breast. This would mirror any fluid accumulation or lumps around the implant and in the lymph nodes.
  • If needed, the patient might require a needle biopsy with drainage of the fluid. This fluid will be tested for CD30 immune staining (CD30IHC) for further assessment.

Treatment 

BIA-ALCL is generally considered a treatable form of cancer if detected early. The primary treatment is the removal of the affected implant and the surrounding capsule (capsulectomy). The implant, any masses, and the surrounding fibrous capsule can all be removed by your plastic surgeon.

If the capsule is not completely removed, there is a greater chance that the cancer will return. You might require alternative forms of treatment if this occurs or if the cancer has progressed.

In some cases, additional treatments such as chemotherapy or radiation therapy may be recommended, depending on the extent of the disease.

How should I proceed if I have recalled Allergan implants?

  • Identify the warning signs of BIA-ALCL and monitor any changes to your breasts
  • Consult your physician if you experience any BIA-ALCL symptoms
  • Keep a record of the Allergan implant you have, including the manufacturer, model name, and unique device number (e.g., lot or serial number)

Should I remove my Allergan implants?

If you do not exhibit BIA-ALCL symptoms, the FDA does not advise having your breast implants removed. This is because, BIA-ALCL is rare and if diagnosed early it is curable. However, for those who develop BIA-ALCL, the FDA recommends removal of the Allergan implant and surrounding scar tissue.

Will Allergan pay for my implant removal?

No, Allergan would not cover the cost of the breast implant removal process. Women who currently have recalled implants can receive a new set of implants at no cost; however, the manufacturer would not pay for the surgical expenses.

Allergan Breast Implant Lawsuits: Latest Updates

What is the Allergan breast implant lawsuit?

Federal lawsuits against the Natrelle BIOCELL Textured Breast Implants from Allergan surfaced several months after the company’s recall. All federal cases were combined by the U.S. Judicial Panel on Multidistrict Litigation into a New Jersey MDL class action in December 2019.

The multi-district litigation is called Allergan BIOCELL Textured Breast Implant Products Liability Litigation, No. 2:19-md-02921, MDL No. 2921 (D.N.J.). The MDL is pending in the United States District Court for the District of New Jersey and claims for personal injuries, economic harms, and medical monitoring, on behalf of women in the United States who have been victimized by Allergan’s Biocell® Textured Breast Implants.

The litigation analyses if

  • Allergan knew or should have known of the risk of BIA-ALCL associated with their products
  • The manufacturer provided adequate warnings to the users
  • The product testing, manufacturing, and development standards were adequate

As per Berger Montague, the Co-Lead Counsel, in Allergan breast implant MDL, “Our clients have alleged that Allergan’s textured breast implants suffered from manufacturing defects, and that there were also serious deficiencies in Allergan’s reporting process concerning its textured breast implants and the link to BIA-ALCL. Allergan should be covering not just the costs of replacement breast implants, but all expenses that women incurred that were associated with the implantation and removal of the defective breast implants, the removal of the textured breast implants, surgical and diagnostic fees, and medical monitoring and diagnostic procedures required as a result of patients’ exposure to the increased risk of contracting BIA-ALCL. We look forward to litigating this case on behalf of our clients and women around the country, and their families.”

Following the 2019 implant recall, the FDA warned the manufacturer in May 2020 for neglecting to finish post-market safety studies.  The manufacturer initiated a social media and online campaign to try and identify and notify patients who might have received the specific textured implants and tissue expanders. The manufacturer also provided two “warranty programs” for patients who received its textured implants in an effort to reduce the possibility of lawsuits.

The False Claims of Allergan

One of the important allegations against the manufacturer in Allergan breast implant MDL is the false claims put forward by the manufacturer. They claimed that their textured implants were safer than smooth implants with a reduced capsular contracture. The company also claimed that the textured breast implants provide better positioning and adherence. According to a 2011 study and a clinical trial in 2014, both the claims were found to be untrue.

Am I qualified to join Allergan breast implant class action lawsuit?

To qualify for Allergan breast implant lawsuits, any of the below-mentioned prerequisites should be fulfilled.

  • You should have an Allergen breast implant that is covered in the lawsuit
  • You should have developed BIA-ALCL
  • You should be at the proven risk of developing BIA-ALCL
  • You should exhibit the symptoms of BIA-ALCL
  • You wish to remove the implant
  • You should have undergone the Allergan breast implant removal surgery with out of pocket expenses
  • You sustain scarring or disfigurement due stemming from the removal surgery or any surgery to address an implant-related complication

To proceed with a valid lawsuit, you should have the details about your implant surgery, including model number of your implants, documented in the medical records. The evidence to strengthen lawsuits should include medical bills and operative reports, medication bills, pathology reports etc.

What can I claim in Allergan breast implant lawsuit?

If you have a valid Allergan breast implant recall lawsuit, you can be entitled to receive compensation for the following damages.

  • Emotional Distress
  • Pain and Suffering
  • Hospital Expenses
  • Loss of Income
  • Rehabilitation Costs
  • Loss of Life Enjoyment

Allergan Breast Implant Lawsuits Update 2023

As of May 15, 2023, there were 1,129 pending cases in the Allergan breast implant class action lawsuit in federal court in New Jersey. In August 2023 it was increased to 1,157 pending cases

The most recent plaintiff in Allergan breast implants class action lawsuit was a woman from Pennsylvania, just outside Philadelphia, became one of the most recent plaintiffs to file a case in the Allergan breast implants class action lawsuit. As per the lawsuit, the plaintiff got Allergan silicone-filled breast implants in 2015, which had to be removed in 2019.

Although the plaintiff has not yet received a cancer diagnosis, her lawsuit claims that having breast implants greatly raised her chance of getting the disease in the future and caused her emotional distress.

Fatality Case in Allergan Breast Implant Lawsuit

The plaintiff is a Florida widower whose wife passed away from BIA-ALCL. As per the lawsuit, she was diagnosed with BIA-ALCL after Allergan breast implantation.  The plaintiff underwent a surgery to remove the capsules and implants.

The surgery was a failure as her nerves were damaged during the cancer treatment. The physicians removed a massive growth on the woman’s breast. A CT scan two months later showed several tumors in her breast. The victim passed away in between the treatment and hospital care.

What is the status of the Allergan lawsuit?

As of December 2023, there are no bellwether trials or any sorts of global settlement in the Allergan breast implant MDL. The lawsuit is active and Allergan breast implant lawyers around the country are accepting cases for the injured.

To sum up, the textured breast implant controversy involving Allergan emphasizes how crucial it is for patients to have complete knowledge about the advantages and disadvantages of medical devices. The crucial association between textured implants and BIA-ALCL should trigger prompt in-depth investigation, heightened consciousness, and modifications in medical advice concerning breast implant alternatives.

As a precaution, individuals with any sort of breast implants should undergo regular self-check and medical follow-ups to promptly identify and diagnose any unusual symptoms in their breast. Let’s hope that the ongoing lawsuits and expected settlements would provide hope for those who have suffered harm due to the negligence of manufacturers and medical providers.

Stay tuned with us for Allergan breast implant lawsuits update 2024.

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MedLegal360 is a specialized author in medical-legal matters, providing clear, authoritative insights on healthcare legislation and personal injury litigation for professionals and the curious.

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