In July 2019, the US Food and Drug Administration requested Allergan, a pharmaceutical company, voluntarily recall BIOCELL textured breast implants. This request was issued after findings that link the implants to a rare cancer, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). If you’ve been diagnosed with this rare form of cancer and have breast implants, making the proactive decision to speak with a lawyer as soon as possible could lead to compensation to aid in your recovery.
Recalling BIOCELL Textured Breast Implants
According to CNN, Allergan has agreed to voluntarily recall their BIOCELL breast implants. The company has issued a notice stating they are taking the action as a precaution because of the new global safety information regarding the cancer connection. While the occurrence of BIA-ALCL is seemingly low, significant patient harm or death is possible.
As a result of the recall, the FDA plans to monitor cancer incidents. If needed, additional actions can be taken in the future to protect patients. The FDA Medical Devices Advisory Committee’s General and Plastic Surgery Devices Panel is planning on maintaining the surveillance of breast implant safety.
It’s estimated that hundreds of thousands of women have the implants. While removal is not recommended in women without symptoms of BIA-ALCL, it is recommended that women know the symptoms and monitor the area around the implants. If any changes occur, speaking with a doctor as soon as possible is crucial.
If a patient is considering breast augmentation or reconstruction, discussing the benefits and risks with a plastic surgeon is important. In conjunction with a physician’s advice, the FDA provides general information about breast implants that patients should consider before going under the knife.
Recalled Allergan Products
If you have Allergan BIOCELL breast implants, it’s important to review which device you have. If your device is listed below, discuss what your options are with your plastic surgeon and primary care physician. Currently, the recall list include the following products:
- Natrelle Saline breast implant styles 168, 363, 468
- Natrelle and McGhan 410 breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
- Natrelle and McGhan 410 Soft Touch breast implant style LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
- Natrelle 510 Dual-Gel styles LX, MX, FX
- Natrelle INSPIRA breast implants, styles TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, TCX
- Natrelle and McGhan Round Gel Implants, styles 110, 110 Soft Touch, 120, 120 Soft Touch
- Natrelle Komuro breast implants styles KML, KMM, KLL, and KLM
- Natrelle Ritz Princess breast implant styles RML, RMM, RFL, RFM
- Natrelle 150 Full Height and Short Height double lumen implants
- Natrelle 133 tissue expanders with and without suture tabs: styles 133FV, 133MV, 133LV, 133MX, 133SX, 133SV, T-133FV, T-133MV, T-133LV, T-133MX, T-133SX, T-133SV, 133FV-T, 133MV-T, 133LV-T, 133MX-T, 133SX-T, 133SV-T
- Natrelle 133 Plus tissue expander styles 133P-FV, 133P-MV, 133P-LV, 133P-MX, 133P-SX, 133P-SV, T-133P-FV, T-133P-MV, T-133P-LV, T-133P-MX, T-133P-SX, T-133P-SV, 133P-FV-T, 133P-MV-T, 133P-LV-T, 133P-MX-T, 133P-SX-T, 133P-SV-T
For updates, check out the FDA’s list here.
Information About Breast Implant-Associated Anaplastic Large Cell Lymphoma
According to the FDA, the first association between breast implants and the development of BIA-ALCL was in 2011. There were so few cases at the time, however, that the FDA was unable to determine what factors increased the risk of cancer. In 2016, the World Health Organization officially defined the cancer as a T-cell lymphoma that can develop following breast implants. It’s important to note that this type of cancer is rare and not every person with BIOCELL breast implants will develop the disease.
Even though BIA-ALCL is typically found in the fluid and scar tissue near breast implants, this type of cancer is not breast cancer because it is not in the breast tissue itself. BIA-ALCL is a type of non-Hodgkin’s lymphoma, which means it’s a cancer of the immune system. If left untreated, the cancer can spread to other parts of the body.
To effectively treat this type of cancer, it’s crucial for it to be identified as soon as possible. Surgery to remove the implant and the surrounding scar tissue is often done. Depending on how the cancer has spread, patients may need to undergo chemotherapy and radiation therapy.
Seek Legal Advice From Thomas Law Offices
If you’ve been diagnosed with BIA-ALCL, you may be eligible for compensation from the breast implant manufacturer. It’s important for victims to step forward and hold the negligent party accountable for their actions. Filing a breast implant lawsuit can help patients recovery physically, mentally, and financially. Additionally it will discourage companies from taking similar actions in the future that put patients at risk. If you’re ready to file a claim or want to know more about your legal rights and options, contact our office today.