Allergan breast implant lawsuits are being filed on behalf of women who received Allergan Natrelle Biocell Textured Breast Implants and developed a cancer called BIA-ALCL—breast implant-associated anaplastic large cell lymphoma.
If you or a loved one received Allergan Biocell Breast Implants and have been diagnosed with BIA-ALCL cancer, you may be entitled to compensation. Trustwell Law is now pursuing lawsuits for people who received Allergan breast implants and qualify.
Our experienced attorneys take a personalized, compassionate approach. We cut through the legalese and partner with our clients. We also have access to the expertise, resources, and manpower to fully investigate each case and fight for and with our clients to get the justice they deserve.
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.
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.
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.
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.
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.
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.
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.
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.
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.
American Society of Plastic Surgeons. (2019, October). BIA-ALCL Physician Resources. Retrieved from https://www.plasticsurgery.org/for-medical-professionals/health-policy/bia-alcl-physician-resources
Breastcancer.org. (2020, February 25). What is BIA-ALCL? Retrieved from https://www.breastcancer.org/treatment/surgery/reconstruction/types/implants/special-report/anaplastic-large-cell-lymphoma
Clemens M. (2019, August). BIA-ALCL Resources. American Society of Plastic Surgeons. Retrieved from https://www.plasticsurgery.org/for-medical-professionals/health-policy/bia-alcl-physician-resources/by-the-numbers
Clemens, M. W., E. D. Jacobsen, and S. M. Horwitz. (2019, January 31). 2019 NCCN Consensus Guidelines on the Diagnosis and Treatment of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Retrieved from https://academic.oup.com/asj/article/39/Supplement_1/S3/5304919
Cleveland Clinic. (2019, February 21). Breast Implant-Associated Anaplastic Large Cell Lymphoma. Retrieved from https://my.clevelandclinic.org/health/diseases/21078-breast-implant-associated-anaplastic-large-cell-lymphoma
U.S. Food and Drug Administration. (2019, September 12). Allergan Recalls Natrelle Biocell Textured Breast Implants Due to Risk of BIA-ALCL Cancer. Retrieved from https://www.fda.gov/medical-devices/medical-device-recalls/allergan-recalls-natrelle-biocell-textured-breast-implants-due-risk-bia-alcl-cancer#:~:text=Allergan%20Recalls%20Natrelle%20Biocell%20Textured%20Breast%20Implants,Risk%20of%20BIA%2DALCL%20Cancer&text=The%20FDA%20has%20identified%20this,cause%20serious%20injuries%20or%20death
U.S. Food and Drug Administration. (2019, July 24). FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market. July 2019. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan
U.S. Food and Drug Administration. (2019, October 23). Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Retrieved from https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl
U.S. Food and Drug Administration. (2019, May 2). Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on FDA’s new efforts to protect women’s health and help to ensure the safety of breast implants. Retrieved from https://www.fda.gov/news-events/press-announcements/statement-fda-principal-deputy-commissioner-amy-abernethy-md-phd-and-jeff-shuren-md-jd-director-fdas