Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

A rare and potentially deadly type of lymphoma has been linked to certain textured breast implants that could put recipients of these implants at risk for serious complications possibly requiring removal of the implants, chemotherapy and radiation, or even causing death in some cases. Known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), the cancer is believed to occur in individuals who receive silicone or saline breast implants for either breast augmentation or breast cancer reconstruction. When diagnosed early, BIA-ALCL is highly treatable and is curable in most patients. However, there are already hundreds of known cases of the lymphoma reported in breast implant recipients in the United States and around the world and at least nine women have died from the disease. If you or someone you know has been diagnosed with BIA-ALCL after receiving breast implants, contact a knowledgeable product liability lawyer to discuss the possibility of filing a BIA-ALCL cancer lawsuit against the breast implant manufacturer.

Textured Breast Implant Lawsuits

Current data on the risk of BIA-ALCL indicates that patients with textured breast implants have a small but increased risk of developing the disease in the tissue capsule surrounding the implants, or in the lymph nodes or skin. According to estimates, only about one in 3,817 to one in 30,000 patients who received textured breast implants are at risk for developing BIA-ALCL. While the overall risk of BIA-ALCL from textured breast implants may be low, the risk is there, and with a growing number of patients being diagnosed with BIA-ALCL caused by their breast implants, product liability lawsuits are expected to be filed by affected individuals seeking compensation for medical expenses, lost wages and pain and suffering, or wrongful death. In January 2019, investors filed a class action lawsuit against breast implant manufacturer Allergan, alleging that the company deliberately withheld information about the link between textured breast implants and BIA-ALCL, and what this cancer risk would mean for Allergan’s regulatory approvals.

Manufacturers of Breast Implants

  • Mentor Worldwide (Johnson & Johnson)
  • Allergan (Actavis)
  • Sientra
  • Arion Laboratories
  • Sebbin
  • Cereplas
  • Establishment Labs
  • GC Aesthetics
  • Silimed
  • Wanhe Plastic Materials
  • Hans Biomed
  • Ideal Implant
  • Nagor
  • Eurosilicone
  • Polytech

“Individuals implanted with certain textured breast implants may face an increased risk of breast implant-associated anaplastic large cell lymphoma. Even though BIA-ALCL is found in the breasts of some patients, it is not a type of breast cancer. Rather, it is a type of non-Hodgkin’s lymphoma, which is a cancer affecting the cells of the immune system. “

What is BIA-ALCL?

Individuals implanted with certain textured breast implants may face an increased risk of breast implant-associated anaplastic large cell lymphoma. Even though BIA-ALCL is found in the breasts of some patients, it is not a type of breast cancer. Rather, it is a type of non-Hodgkin’s lymphoma, which is a cancer affecting the cells of the immune system. In most cases of BIA-ALCL, the cancer is found in the fluid and scar tissue near the breast implant, but in some patients, it may spread throughout the body, affecting the lymph nodes and skin. The exact cause of BIA-ALCL is unknown at this time, but experts believe that textured implants may irritate the tissue and cause a reaction that could lead to malignancy. Known symptoms of BIA-ALCL include pain, swelling, lumps or asymmetry in the area of the breast implant, which may persist for years after implantation, long after the surgical incision has fully healed. Most of the available information regarding BIA-ALCL treatment involves removing the implant and the fibrous scar capsule surrounding the implant, and some patients with the disease may require additional treatment with radiation and chemotherapy. Although the risk of cancer from breast implants appears to be low, researchers believe that cases of BIA-ALCL are underreported and suggest that the diagnosis of the disease in breast implant recipients may be on the rise.

Reasons to Bring About Litigation

  • Breast implant manufacturers designed, sold and marketed defective and potentially dangerous products.
  • The manufacturing companies knew or should have known about the potential for their breast implants to cause cancer.
  • The breast implants lacked appropriate warnings about the risk of developing BIA-ALCL.
  • The manufacturing companies failed to report the results of breast implant post-marketing studies in a timely manner.
  • The manufacturing companies failed to provide adequate warnings to patients and healthcare providers about the risk of BIA-ALCL from breast implants.

BIA-ALCL FDA Information

The FDA first discovered a potential link between breast implants and the development of anaplastic large cell lymphoma (ALCL) in 2011, but there were so few cases of the disease at that time, it was difficult for regulators to determine what factors increased a patient’s risk of developing BIA-ALCL. In 2016, the World Health Organization categorized BIA-ALCL as a T-cell lymphoma potentially occurring after the implantation of artificial breast implants, and as more information came to light about the risk of BIA-ALCL, the FDA found that most data linked the cancer to breast implants with textured surfaces, rather than those with smooth surfaces. In November 2018, the International Consortium of Investigative Journalists released a global report highlighting the ongoing health problems affecting patients with breast implants, including the risk of BIA-ALCL, and the following month, regulatory officials in France ordered Allergan to remove its popular Microcell and Biocell breast implants from the market.

Following the regulatory action against Allergan, in February 2019, the FDA issued an update on the number of cases of BIA-ALCL, indicating that, as of September 2018, the agency was aware of 660 reports of the lymphoma diagnosed since 2010, including reports of nine patient deaths linked to the cancer. At that time, the FDA issued a statement to healthcare providers in order to “increase awareness about an association between all breast implants, regardless of filling or texture, and Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).” Additional significant regulatory actions have been taken against other brands of textured breast implants recently, due to the potential risk of BIA-ALCL. For instance, in April 2019, French authorities issued a historic ban on two categories of textured breast implants – macro-textured and polyurethane implants – due to the potential for the implants to cause lymphoma in patients.

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