Why Are People Filing Allergan Breast Implant Lawsuits?
Hundreds of lawsuits have been filed against Allergan due to the association of its breast implant product with anaplastic large cell lymphoma or ALCL. It categorized as a non-Hodgkin lymphoma and is a rare type of T-cell lymphoma. Breast Implant Associated ALCL (BIA-ALCL) develops in the tissue surrounding certain breast implants.
In July 2019, the U.S. Food and Drug Administration (FDA) requested that Allergan recall its textured breast implants due to their links to BIA-ALCL cancer which included several deaths. Some patients and doctors have also claimed that Allergan failed to give a warning on the risks that the product may pose. Allergan, now a part of AbbVie, has also been accused of failing to submit reports of the breast implant procedures as part of post-marketing studies required by the FDA.
Individuals who received the Biocell textured implants may be filing lawsuits to seek compensation for medical costs including:
- Cancer treatment
- Lost wages
- Pain and suffering
- Surgical removal
- Diagnostic testing
- Medical monitoring
What Is the Allergan Breast Implant Made from?
Allergan’s breast implants have shells of saline and silicone that are used in breast enlargement procedures. Allergan provides options like teardrop-shaped implants or round implants. Tear-drop implants are designed to imitate the shape of the breast while round implants are a fully circular look. The most recent and sophisticated implants, Natrelle Inspira breast implants, are made up of silicone elastomer. Its shell is wrapped with a delicate interrelated silicone gel.
What Is BIA-ALCL?
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is not considered breast cancer, but its effects are serious. It’s a type of non-Hodgkin lymphoma that targets the immune system, which may lead to death. It’s also called a T-cell lymphoma because it causes the T cells to produce an excess protein known as anaplastic lymphoma kinase (ALK1) which may increase the growth of certain cancer cells. Many patients can be treated effectively with chemotherapy and radiation, as well as the removal of the implant and nearby tissue.
BIA-ALCL is usually detected with the following symptoms:
- Swelling
- Pain around the implant
- Excess fluid or mass around the breast
- Lumps
- Redness
In some cases, rashes develop on the skin of the breasts.
If detected early enough, BIA-ALCL may be treatable by removal of the breast implant and the surrounding scar tissue but the disease may spread or metastasize to other areas of the body. The median time from breast implant placement to diagnosis with BIA-ALCL appears to be about 8 years and many people are having their implants removed preemptively.
How Are Allergan Breast Implants Linked to BIA-ALCL?
Textured breast implants may increase the risk for ALCL, possibly through inflammatory processes which occur in scar tissue formation to hold the implants in place. Experts also believe that bacterial contamination and family history may also increase the risk but the link to textured breast implants is so high, that it has been termed breast implant-associated ALCL, or BIA-ALCL.
Allergan implants have been linked to an increased risk of BIA-ALCL that is six times higher than textured implants manufactured by other companies. As of late 2022, at least 1,333 cases of BIA-ALCL had been reported, including 59 deaths. In 2019 at the time of recall, the majority of the reports (84%) received by the FDA, involved Allergan textured implants and 12 out of 13 deaths in which the implant manufacturer could be identified were linked to Allergan implants.
Has the FDA Issued Warnings About Allergan Breast Implants?
After studying growing evidence and examining the connection between Allergan breast implants and deaths due to BIA-ALCL, the FDA concluded that:
- Patients who have undergone or have plans to undergo breast augmentation surgery should be aware of the risks of BIA-ALCL
- Textured surface implants have a higher risk of BIA-ALCL than smooth implants
- Certain textured tissue expanders should not be used
Has the Allergan Breast Implant Been Recalled?
In 2018, two years after a non-Hodgkin’s lymphoma type, BIA-ALCL was identified by the World Health Organization, health authorities in Europe, Australia, Brazil, and Israel suspended sales of Allergan textured breast implants. The company continued to sell its implants in the U.S. until July 2019, when an analysis showed that the Allergan implant’s risk of BIA-ALCL was six times higher than other products. The FDA then requested that Allergan recall their BIOCELL textured breast implants.
The Allergan textured breast implant recall requested by the FDA included:
- McGhan BioDimensional Silicone-Filled Biocell Textured Breast Implants
- McGhan Magna-Site Tissue Expander
- McGhan Style 134 Croissant Shaped Tissue Expander
- Natrelle 133 Plus Issue Expanders
- Natrelle 133 Tissue Expanders with and without suture tabs
- Natrelle 140 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
- Natrelle Inspira Silicone-Filled Breast Implants
- Natrelle Saline Breast Implants
- Natrelle Silicone-Filled Breast Implants
- Style 133 Biospan Tissue ExpanderAge-related macular degeneration
As part of the recall, the company agreed to pay for a portion of the implant cost but did not agree to surgical costs or medical costs associated with cancer concerns. This has prompted some recipients to file lawsuits, even if they have not been diagnosed with cancer. Allergan is also facing lawsuits filed by those who have been diagnosed with BIA-ALCL and are seeking compensation for injuries.
What Allergan Breast Implant Lawsuits Are There?
In 2019, two women filed a lawsuit against Allergan, claiming that they developed BIA-ALCL from the company’s breast implants. The women, who are from California and Michigan, developed symptoms of BIA-ALCL, one of them as quickly as 14 months after the breast augmentation surgery. They say that Allergan refused to pay for the removal of the breast implants, which is an essential part of the treatment for BIA-ALCL. As of 2020, an additional 64 women had joined the suit. I
It’s expected that even more women may join the lawsuit or sue independently of the class-action lawsuit. It may take some time for more women to sue Allergan because it can take some time for BIA-ALCL symptoms to develop.
Have There Been Any Allergan Lawsuit Settlements?
As of 2022, the lawsuits against Allergan had not yet been settled. The cases may have been delayed due to the COVID-19 pandemic, which caused many lawsuits to be pushed back until it was safe to resume in-court proceedings. In the case of the Allergan lawsuits, others still may join the class-action lawsuit.
Should You Consider an Allergan Breast Implant Lawsuit?
People who have been diagnosed or loved ones of those who died due to a BIA-ALCL diagnosis after breast augmentation surgery may be eligible for compensation through a medical injury or wrongful death lawsuit.
Patients who received an Allergan Biocell textured breast implant or tissue expander may be eligible for participation in a class-action lawsuit that is seeking compensation for costs associated with the July 2019 recall.
The lawsuits are seeking compensation for:
- Costs associated with surgical removal of the implant
- Medical and diagnostic testing and monitoring
- Lost wages
- Pin and suffering
- And more
How Do I Find an Allergan Breast Implant Attorney?
Law offices are still taking on new Allergan Breast Implant Lawsuit cases. If you or a loved one developed BIA-ALCL as a result of breast augmentation surgery that implanted Allergan breast implants, then you may have a case against Allergan. Contact Seeger Weiss to schedule a free consultation to discuss your case.
Each case is unique and must be evaluated separately but anyone who has been affected by the Allergan BIOCELL textured breast implant recall or cancer link may be eligible for compensation.
Sources
- Center for Devices and Radiological Health. (2019, October 23). Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). U.S. Food and Drug Administration. Retrieved June 30, 2022, from https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl
- Crotti, N. (2019a, October 11). Allergan sued over textured breast implants. MassDevice. Retrieved June 30, 2022, from https://www.massdevice.com/allergan-sued-over-textured-breast-implants/
- Crotti, N. (2019b, October 11). Number of cancer cases linked to breast implants soars. MassDevice. Retrieved June 30, 2022, from https://www.massdevice.com/number-of-cancer-cases-linked-to-breast-implants-soars/
- Steinberg, J. (2019, December 18). Allergan Breast Implant Cancer Suits Head for New Jersey. Bloomberg. Retrieved June 30, 2022, from https://news.bloomberglaw.com/product-liability-and-toxics-law/allergan-breast-implant-cancer-suits-head-for-new-jersey