Top Class Actions  |  November 1, 2022

Category: Breast Implants

Natrelle & Allergan breast implant cancer lawsuit: Who’s affected?

textured breast implants may cause cancer

Were you implanted with Allergan BIOCELL or Natrelle textured breast implants?

On May 14, 2020, the U.S. Food and Drug Administration (FDA) issued a warning letter to two breast implant manufacturers, Allergan of California and Ideal Implant Incorporated of Texas, for failure to comply with regulatory requirements in studies they conducted to determine the potential risks and safety of two textured breast implants recalled in 2019.

The FDA first requested that Allergan issue a voluntary recall of several of its implants in July 2019. And in September 2019, the FDA requested a recall of all Allergan BIOCELL and Natrelle textured breast implants.

Those who have Allergan BIOCELL textured breast implants may be at an increased risk for developing a specific type of cancer known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), according to the FDA.

The FDA said it made the request “to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).”

Allergan likely did not warn those who developed anaplastic large cell lymphoma after breast augmentation surgery that they could get cancer from breast implants and may benefit from a consultation with a medical device attorney to see if they qualify to file a breast implant lawsuit.

Few people are aware of the risk of BIA-ALCL, and even among those with breast implants, there was limited knowledge of the potential for getting cancer, per a study published in the July 2020 issue of Plastic and Reconstructive Surgery. In general, people may be left quite unaware of the risk of BIA-ALCL before getting implants.

What can you do?

You may qualify for this Natrelle or Allergan breast implant cancer lawsuit investigation under these circumstances: 

  • You were implanted with textured breast implants
  • You were diagnosed with Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA ALCL) or another type of cancer
  • You had revision surgery or had the implants removed (explanted)

Please fill out the form on this page to see if you qualify for a free case evaluation.

Watch Scott Hardy from Top Class Actions discuss how textured breast implants have been linked to cancer.

What are textured breast implants?

During breast augmentation surgery, breast implants are placed into the body, either behind the breast tissue or underneath the chest muscle. There are many types of implants available for use during this cosmetic surgery, including smooth, textured, round, shaped, saline, and silicone.

Textured breast implants differ from other implants because they encourage scar tissue to stick to the textured surface. This is supposed to keep implants from shifting and diminishes the risk of a tight scar capsule — something that can lead to hard, unnatural-feeling breasts, according to the American Society of Plastic Surgeons.

In June 2021, a study at Rice University found that the textured surface of these implants can trigger an increased response from immune cells. Over time, this could cause cell mutations and even cancer.

Read more: What Are Textured Breast Implants?

Can breast implants cause lymphoma?

In February 2019, the FDA warned that breast implants may cause BIA-ALCL, a type of lymphoma.

Unlike traditional breast cancer, which affects the breast tissue itself, this cancer develops within the scar capsule that forms around the breast implant during the healing process.

The link between breast implants and cancer was first identified in 2011, but a review of reports prompted the FDA to send out a larger safety announcement as well as contact doctors about the issue.

What are the FDA statistics on cancer from breast implants?

The FDA reported it had tallied 1,130 global BIA-ALCL cases as of April 1, 2022, with 505 of those coming from the United States. The FDA stated 59 people died from the cancer, including 14 from the U.S.

The FDA is still working with the American Society of Plastic Surgeons to understand the exact risk for cancer from breast implants. Some estimate that 1 in 3,817 patients will develop BIA-ALCL, while others estimate only 1 in 30,000 patients will develop breast implant cancer.

But the contributing factors are still not understood with perfect clarity.

Despite the general lack of information, the FDA released its safety announcement to help Americans stay informed on the issue.

“Though the number of identified cases of BIA-ALCL is small compared to the estimated 1.5 million patients who receive breast implants worldwide every year, confirmed data and published information reviewed to date suggests that patients with breast implants have an increased risk of BIA-ALCL,” the FDA stated.

Although the FDA issued its warning for all breast implants, the agency recognized most of the reported cases have been in individuals with textured implants.

Read More: FDA Warns Breast Implants May Be Linked to Cancer

Why was an Allergan Biocell recall on breast implants requested?

In July 2019, the FDA requested that Allergan issue a voluntary recall of Natrelle BIOCELL breast implants and tissue expanders. The FDA said it was requesting the recall “to protect individuals from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).”

The federal agency said its decision was based on new worldwide Medical Device Reports (MDRs) of BIA-ALCL diagnoses and related deaths linked to the Allergan breast implants. There were 573 cases of BIA-ALCL reported, and 481 of them were by people who had Allegan breast implants, the FDA said.

In September 2019, the FDA said it was identifying the recall of Allergan Natrelle BIOCELL textured breast implants and expanders as a Class I recall — the agency’s most serious — because the product has been linked to serious injury and death.

How are other countries responding to the link between breast implants and cancer?

Many textured implants have been banned around the world.

In early April 2018, France became the first country to ban certain textured breast implants due to their association with the breast-implant-linked lymphoma, ABC News reported.

Canada followed in France’s footsteps, according to the Toronto Star.

Australian regulators suspended eight breast implant models in September 2019, after there were 100 reported cases — and four deaths — of cancer from breast implants, The Guardian reported.

What is BIA-ALCL?

The disease that has come to be known as breast implant associated anaplastic large cell lymphoma (BIA-ALCL) is not breast cancer.

Rather, it is a variant of the same lymphoma that has been linked to the use of the herbicide glyphosate, a malignancy that attacks the immune system, specifically targeting the white blood cells, or T-cells. ALCL is the result of a genetic mutation, which causes the T-cells to produce excess quantities of a specific protein known as anaplastic lymphoma kinase, or ALK-1, according to the American Cancer Society.

BIA-LCL is a unique form of cancer because it affects cells within the scar capsule around an implant. This differs from traditional breast cancer in which the disease affects the tissue of the breast. The scar capsule, which forms during the healing process, can contain BIA-ALCL cancerous cells and often times prevents the spread of cancer to other parts of the body

What are the symptoms of BIA-ALCL?

The first symptoms are usually a painless swelling in the armpit, groin, neck, or other lymph node location.

The victim may then experience appetite loss or unexplained weight loss, fever, night sweats, and overall lack of energy.

A biopsy is necessary for an accurate diagnosis.

Fortunately, if this particular cancer from breast implants is diagnosed early, it can be treated successfully.

In most cases, surgery is performed to remove the implant and the affected tissues. However, more advanced cases may require chemotherapy and radiation treatments.

Those who are suffering from BIA-ALCL may experience these symptoms, according to the Cleveland Clinic:

  • Breast pain
  • Lumps in the breast or armpit
  • Swelling
  • Changes in breast appearance
  • Fluid buildup
  • Skin rash
  • Hardening of the breast

The FDA released new recommendations to health care providers to consider the possibility of BIA-ALCL when treating patients with these symptoms. Although this cancer from breast implants is rare, the agency wants doctors to keep the condition in mind rather than dismissing it based on probability.

“We want all healthcare providers to be aware of BIA-ALCL, particularly in patients with new swelling, lumps, or pain around breast implants, to expedite diagnosis of this malignancy,” the federal agency wrote in its safety announcement.

How does someone know if they have BIA-ALCL?

If a person has developed symptoms of BIA-ALCL, they should schedule a follow-up appointment with their doctor to be tested for the condition, according to PlasticSurgery.org.

During an appointment, a doctor may check for BIA-ALCL through various imaging tests, including an ultrasound or an MRI. This will give the doctor a clear idea of any fluids or lumps surrounding the implant.

If the imaging shows excess fluid or lumps around the implant or in the lymph nodes, the doctor will likely take a biopsy and drain the fluid to test for cancer. These samples will be tested for CD30 immune staining (CD30IHC) to confirm or rule out an BIA-ALCL diagnosis.

Is there a blood test for BIA-ALCL?

There is no blood test to confirm whether someone has BIA-ALCL.

A doctor must confirm BIA-ALCL through a biopsy and testing. The FDA recommends doctors test for BIA-ALCL by running pathology tests on freshly collected fluid and biopsies. This includes testing for CD30IHC and anaplastic lymphoma kinase (ALK) markers.

In other cancers, blood is tested because of the specific markers associated with that variety of tumor. But in BIA-ALCL the blood cannot be tested effectively for tumor markers. Fluid or tissue must be tested instead.

Is breast implant associated anaplastic large cell lymphoma curable?

If caught early, BIA-ALCL can be easily treated. Patients with early cases of BIA-ALCL usually see the cancer confined to the scar tissue capsule.

Because the cancer from breast implants has not spread to other parts of the body in these cases, treatment is as simple as removing the breast implant and scar tissue capsule.

What is involved with the BIA-ALCL treatment?

After a diagnosis of cancer from breast implants, a doctor may order a PET/CT scan to make sure that the cancer has not spread from the breast to other parts of the body, according to PlasticSurgery.org. The cancer’s spread, or lack thereof, drives the treatment and prognosis of the disease.

BIA-ALCL patients will be referred to an oncologist, a doctor who specializes in the treatment of cancer. The cancer doctor will be able to evaluate the disease and develop a personalized treatment plan.

If the cancer is only around the implant, treatment may be relatively simple.

The breast implant and scar capsule in which the cancer formed will be removed from the body. In these cases, more treatment may not be necessary.

In some cases, there may be lumps in the lymph nodes in the armpit. Although this could point to the spread of cancer, this could also reflect enlarged lymph nodes in response to sickness, according to PlasticSurgery.org.

If a person has enlarged lymph nodes, samples will likely be taken through a needle or surgical biopsy so that the doctor can test for the presence of cancer.

Radiation and chemotherapy are usually unnecessary for the treatment of BIA-ALCL, but in more advanced cases in which the cancer has spread throughout the body, radiation and/or chemotherapy may need to eliminate all remnants of the disease.

After BIA-ALCL is confirmed to be eradicated from the body, the patient will likely have to regularly follow up with imaging scans in intervals for two years.

If surgical removal was a part of the treatment for early stages of the disease, the risk of recurrence is low.

What is breast implant illness?

In 2018, more than 50,000 people across two Facebook groups reported experiencing a variety of symptoms that they said were from “breast implant illness.” The symptoms they reported have been classified as autoimmune or connective tissue disorder (CTD) symptoms, though they have not been connected with a specific autoimmune disease or CTD.

Plastic surgeons and manufacturers of implants say these autoimmune and connective tissue problems are unrelated to the breast implants, according to the National Center for Health Research (NCHR), but the organization says the research disagrees with that conclusion.

Breast implant studies have shown a connection in these illnesses after people received implants:

  • Sjögren’s Syndrome
  • Multiple sclerosis (MS)
  • Sarcoidosis
  • Scleroderma
  • Arthritis
  • Fibromyalgia
  • Hashimoto’s thyroiditis
  • Other autoimmune disorders
  • Other cancers

Should textured breast implants be removed?

Unless someone has developed cancer from breast implants, the FDA does not recommend that implants be removed. It does recommend that those who have the Allergan BIOCELL product undergo regular medical monitoring.

What is Allergan doing about it?

When Allergan issued its recall, the company announced it would pay the costs of new implants for those who have Biocell implants and want them replaced through July 24, 2021.

However, the company has refused to cover the costs of the surgery itself.

Despite recalling its implants, Allergan faces legal action from numerous consumers who allege that their cancers were a direct result of breast implants. In June 2021, a New Jersey state court ruled that Allergan must face these claims in a consolidated class action lawsuit.

Should you file an Allergan breast implants cancer lawsuit?

Treating breast implant lymphoma can be costly and difficult for both patients and their families. There are medical expenses, transportation costs, and even lodging expenses if families need to be closer to a specialist for treatment.

People who develop BIA-ALCL after being implanted with textured breast implants may be eligible to recover compensation for these expenses.

Medical device companies may be held liable through a breast implant lymphoma lawsuit for BIA-ALCL injuries if they failed to develop a safe product or failed to warn consumers of the breast implants lymphoma risk.

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