Allergan Biocell Breast Implant Lawsuits

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What Is BIA-ALCL?

Breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL, is a rare cancer of the immune system. It is not breast cancer but is a form of T-cell lymphoma that may occur in people who have received breast implants.

BIA-ALCL primarily affects women who received textured breast implants. The lymphoma (cancer) occurs in the fibrous capsule—the scar tissue—that surrounds the implant. In advanced cases, the cancer may spread to the lymph nodes near the breast.

What Are Textured Breast Implants?

Textured breast implants, introduced in the 1980s, are implants with a rough surface, as opposed to smooth breast implants. Their textured surface makes them adhere to the surrounding tissue and be less likely to slip out of place or rotate than their smooth counterparts. Textured implants may be filled with saline or with silicone gel; they may be round or teardrop-shaped. However, all teardrop-shaped implants are textured, because if a teardrop-shaped implant were to rotate or flip, the shape of the breast would seem distorted.

In the United States, textured implants have been used more often for reconstructive breast surgery than for breast augmentation surgery. Even so, less than 10 percent of implants sold in in the U.S. in 2018 were textured, and macro-textured implants, which have a surface with bigger, deeper divots and include Allergan’s Biocell Implants, accounted for less than 5 percent of U.S. sales.

How Common Is Breast Implant-Associated Lymphoma?

BIA-ALCL is not common; it is very rare. Each year, fewer than 10 patients are diagnosed with breast implant-associated lymphoma.  According to the FDA, the vast majority of women diagnosed with BIA-ALCL received textured breast implants. The risk for people with textured breast implants developing BIA-ALCL is estimated to range from one in 1,000 to one in 30,000.

What Are the Symptoms of BIA-ALCL?

The most common symptoms of BIA-ALCL are swelling or pain in the area of the breast implant. Changes in the size or shape of the breast may be noticed; one breast may seem larger or different than the other. Sometimes there is a lump near the implant or a lump in the lymph node in the nearby armpit.

Symptoms of BIA-ALCL may include:

• Pain
• Swelling
• Redness
• Changes in the shape or size of the breast(s)
• Enlarged lymph nodes
• Lump or lumps near the breast(s)
• Fluid accumulation near the breast(s)
• Skin rash
• Fever
• Weight loss

The symptoms of BIA-ALCL usually take at least two years after surgery to develop, but the average time for symptoms to develop is even longer—at 8 years after surgery. The FDA recalled the Allergan Biocell Breast Implant in July 2019.

What Causes Breast Implant-Associated Lymphoma?

Researchers are not sure exactly what causes BIA-ALCL. Data does indicate that implants with textured surfaces increase the risk for BIA-ALCL. Research also indicates it does not matter if the implants are filled with saline or silicone. In addition, the risk is the same for women who received the implant for reconstructive surgery and those who received it for breast augmentation.

One theory as to why BIA-ALCL is associated with textured breast implants is that their rough surface may cause persistent inflammation that could lead to lymphoma. Another theory centers on the facts that not only is the surface of textured implants rough but also textured implants have a greater surface area than smooth implants, so more bacteria can get trapped in the area, creating a biofilm that causes inflammation and leads to lymphoma. A bacterial biofilm is a colony of microorganisms that can grow on different surfaces, including on the surface of the breast implant.

Allergan Biocell Breast Implants may be associated with more cases of BIA-ALCL than other types of implants because they are more deeply textured. In fact, Allergan’s Biocell implants are what are known as macro-textured implants, meaning, their surface has bigger, deeper divots.

Researchers also believe genetics may play a role in the development of BIA-ALCL. They have found that certain genetic mutations seem to increase a person’s risk of developing the disease. It is possible that in the future a combination of genetic testing and certain blood tests may be used to predict if a person is at increased risk for developing BIA-ALCL.

How Is BIA-ALCL Diagnosed?

National Comprehensive Cancer Network (NCCN) guidelines for diagnosing BIA-ALCL begin with ordering an ultrasound or MRI to see if there is increased fluid around the implant or a mass near it. If excess fluid is detected, then a sample of the fluid is taken using a very fine needle. Then tests performed on that fluid can further inform the appropriate course of action. If a mass is detected, a biopsy should be performed.

What Is the Treatment for BIA-ALCL?

Once breast-implant associated lymphoma is diagnosed, NCCN guidelines recommend the surgeon remove the implants and the entire surrounding scar tissue capsules in one piece, which is called an en bloc capsulotomy. Both implants should be removed even if only one is affected by BIA-ALCL. Furthermore, if there are any tumors found or if there are any suspicious lymph nodes, those, too, should be removed during the surgery.

Some patients also require chemotherapy, radiation therapy, or stem cell transplant therapy as part of their treatment for breast-implant associated lymphoma.

If it’s diagnosed early and treated appropriately, BIA-ALCL is curable in most patients. Research shows that 93 percent of patients are disease free three years after treatment. A very small number of people have died from breast-implant associated lymphoma.

FDA Recall of Allergan Biocell Breast Implants

Allergan manufactured Natrelle Biocell Textured Implants from July 25, 2014, to June 21, 2019, and the implants were distributed from September 14, 2014, to July 24, 2019. In July 2019, the FDA recalled Allergan Biocell Breast Implants. The FDA identified the recall of Allergan Biocell Breast Implants as a Class I recall, which is the FDA’s most serious type of recall. Class I recalls are issued when the FDA finds that use of the product may cause serious injuries or death.