SHAMIS & GENTILE, P.A., MASS TORTS LAW FIRMAllergan Breast Implant Lawsuits

Recall of the Allergan Biocell Breast Implants

In previous posts, we have commented on the July 2019 recall of Allergan Biocell breast implants. The Food and Drug Administration (FDA) issued a recall of the products due to their connection with breast implant illness and a rare form of cancer.

The link between certain types of breast implants and the risk of contracting anaplastic large cell lymphoma (ALCL) has been widely recognized by medical experts for quite some time. Recently there has been a marked increase in the number of cases of breast implant- associated (BIA) ALCL, specifically linked to Allergan products, leading ultimately to the FDA recall.

What does this mean to you? We hope to answer that question as thoroughly as possible. In addition, we want to inform you how Shamis & Gentile can help you if you have been affected by BIA-ALCL as a result of an Allergan breast implant.

Brest Implant Allergan Recall

Breast Implant Cancer Risk

BIA-ALCL is a type of lymphoma that develops as a result of specific types of breast implants. It is important to note that it is not a type of breast cancer. The risk of the disease has been associated with a number of Allergan’s silicone implant products, although it is not entirely certain how high the risk is of developing ALCL after receiving Allergan implants. While the condition remains rare, the FDA identified 573 cases of it worldwide – 33 of them fatal. Of these, 481 have been linked to Allergan products. This is a rate six times higher than products manufactured by any of Allergan’s competitors.

If you have Allergan breast implants, this does not automatically mean you are at risk of developing ALCL. The overall occurrence of the disease is still quite low; although the risk is higher than that of implants of a different brand. If, however, you or someone close to you has already developed ALCL and have one of these implants, then the chances of the condition having been caused by the Allergan products are significantly high, based on the FDA’s findings.

Lymphoma Cancer - Allergan Breast implants

What Is Lymphoma?

Lymphoma can develop anywhere in the body. It is a cancer that affects the lymphocytes, the infection-fighting cells of the immune system. They are found in the lymph nodes, spleen, thymus, bone marrow, and the tissue around the mammary glands. There are two types: Hodgkin’s and non-Hodgkin’s lymphoma. The difference between the two is a question of which types of lymphocytes are affected. Non-Hodgkin’s cases are more difficult to treat than Hodgkin’s ones, and also tend to be diagnosed only when they have reached a relatively late stage. ALCL is a form of non-Hodgkin’s lymphoma. However, BIA-ALCL is highly treatable once it has been identified.

What Are the Symptoms of BIA-ALCL

The main symptoms that act as obvious signposts of BIA-ALCL are pain, swelling, and lumps in the breast, neck or armpit, which are all caused by excessive fluid build-up around the implant. They usually occur anywhere between 2 and 14 years after the implant is placed. It should be noted that fluid build-up around the implant is fairly common, can occur for a number of reasons, and need not necessarily be regarded as a sign of ALCL

How Do You Test for BIA-ALCL

When a patient visits a doctor complaining of any of the symptoms of BIA-ALCL, a sample is taken of the fluid surrounding the implant. This is then analyzed for the presence of cancer cells. Labs test for the presence of CD30, which is a clear indicator of  BIA-ALCL.

Breast Cancer - Test for BIA-ALCL
Breast Cancer Diagnosis

How Is BIA-ALCL Diagnosed?

When lab results indicate the presence of CD30, a positive diagnosis of BIA-ALCL is made.

Can You Die from BIA-ALCL?

On the whole, sufferers of BIA-ALCL have an excellent prognosis: 93% of patients are disease-free within three years. Treatment consists of the removal of the implant. If the disease is caught early, this is often all that is needed. Sometimes the cancer may have spread beyond the lymph nodes and this may lead to the doctor prescribing chemotherapy, which is usually remarkably effective in fighting the disease. There have been rare cases (33 out of 573, as mentioned above) of people dying as a result of BIA-ALCL. This is usually only due to the diagnosis occurring at a very late stage and the cancer having spread far beyond the lymph nodes in the breasts to affect other tissues that are far riskier and more difficult to treat.

ALCL Cancer Facts

Here is a breakdown of the essential facts you need to know about ALCL:

  • It’s a rare type of non-Hodgkin’s lymphoma.
  • It is actually more common in children than in adults. The risk is slightly higher in women with breast implants than in other adults.
  • It develops when T-cells, special types of lymphocytes, become abnormal and grow out of control.
  • Symptoms include swelling in the breast, armpit or neck, as well as a loss of appetite, tiredness, night sweats, fevers, and weight loss.
  • Generally speaking, as with all non-Hodgkin’s lymphomas, it is more difficult to treat than Hodgkin’s Although, in the case of BIA-ALCL, it is highly treatable, provided it has not spread to other tissues.
  • It is usually treated with chemotherapy.
chemotherapy treatment for breast cancer
allergan recall

Allergan Implants Recalled

The products that the FDA ordered to be recalled were closely associated with the incidence of BIA-ALCL in women around the world. Allergan makes a variety of different types of implant and only some of them – those in their Natrelle range – were affected by the recall. They are as follows:

  • Natrelle saline-filled implants,
  • Natrelle silicone-filled implants,
  • Natrelle Inspira silicone-filled implants, and
  • Natrelle 410 highly cohesive anatomically shaped silicone-filled breast implants.

The common factor in all these variants is Allergan’s Biocell textured shell. The safety risks of these were actually identified as long ago as 2017! However, Allergan refused a voluntary recall. This meant that they remained on the market in the U.S. until the FDA forced a recall. They were recalled in Europe at the end of 2018, while Canadian authorities imposed a recall in May 2019, but Allergan still continued to sell the product in the U.S. until they were legally required to desist.

Textured Breast Implants

The implants most often connected with cases of BIA-ALCL are of the textured variety. These are designed with a rough surface to prevent them from moving around too much inside the breast. This innovation was introduced as a result of implants sometimes shifting position and causing patients’ chests to appear misshapen. Surgeons have tended to favor textured implants as a result. However, they are not necessarily dangerous per se. It’s only the particular types listed above that have been found to be risky by the FDA.

It should also be remembered that textured implants, although increasingly popular, actually represent only 5-10% breast implant sales in the United States.

Allergan Breast Implant Lawsuit

What Does the Recall of
Allergan Breast Implants Mean to You?

What this means for women who suffer from the disease as a result of the Allergan breast implants, is that they may be eligible for settlement benefits. Shamis & Gentile are currently reviewing cases of Allergan-linked ALCL around the country to assess the strength of individual claims to compensation.

Although the condition is now commonly described as BIA-ALCL, it has, in fact, been described by a variety of names. If you have ever been diagnosed with any of the following, linked to an Allergan implant, then you may have a case for financial compensation:

  • ALCL,
  • Breast Implant Lymphoma or Cancer,
  • Non-Hodgkin’s Lymphoma following breast implant,
  • Late peri-implant Seroma,
  • Peripheral T-cell lymphoma,
  • CD-30 Expressing T-Cell Lymphoma, and
  • Breast Implant.

If you have any of the recalled implant types but have not developed any symptoms, you should not worry, rush to have them removed or consider a suit against the manufacturer. Despite the connection that has been established between the four Allergan products and  BIA-ALCL, your risk of developing the disease is actually still low. It is best to consult your medical practitioner if you have any concerns.

However, if you do develop any symptoms, consult your doctor immediately. If it is found that your complaints are a result of your Allergan breast implants, the medical professionals will take the appropriate action, and you can then come and talk to us regarding any case you could possibly bring against Allergan.

Allergan Breast Implant Recall

How We Can Help

When you undergo a medical procedure, you put your trust not only in the medical practitioners themselves, but also in the manufacturers of the drugs and devices being used. If you are at risk any kind of side effect – especially a dreaded disease like cancer – you have a right to know. If manufacturers do not inform the public of the risks, it is either because they have concealed the truth or because they themselves were unaware of it. In the latter case, questions must be asked as to why they didn’t know. In either case, there is a need for accountability and you have the right to demand compensation.

If you have suffered from BIA-ALCL as a result of having received any of the recalled implants, you likely have a case to claim damages from Allergan. Shamis & Gentile is a class action law firm based in Miami, FL, that can help you get the damages that are due to you.

If you personally have suffered damages in connection with Allergan, you could claim back past and future medical expenses, lost wages, losses arising from changes in employability, as well as reasonable compensation for pain and suffering.

Family members of someone who has died due to BIA-ALCL could be awarded funeral expenses, medical expenses prior to death, loss of economic support, and loss of companionship.

Contact us today for a free consultation and we will assess your case, evaluate what you are entitled to, and help you in your fight.

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