History of BIA-ALCL
In 2011, the Food and Drug Administration (FDA) reported 34 cases worldwide of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), bringing this unique disease into the public eye for the first time. Since then, BIA-ALCL has been recognized internationally as a distinct type of cancer, and prompted the 2019 US FDA Class 1 device recall as well as a worldwide voluntary recall of the Biocell textured breast implants by its manufacturer, Allergan. Many patient advocates and medical professionals have called for a more comprehensive warning of the BIA-ALCL risks associated with textured breast implants. Further, they advise patients to have a discussion with their healthcare professional before making a decision on undergoing a breast implant surgery.
This January 2021 article, “Advising patients about breast implant associated anaplastic large cell lymphoma” addresses the symptoms associated with BIA-ALCL:
Patients usually experience rapid onset and spontaneous unilateral breast enlargement, found to be a fluid collection or infiltrating mass at an average of 8 to 10 years after implant placement, with the shortest interval to date being 2.2 years from initial implantation. Other reported symptoms may include a change in breast shape, breast firmness, pain, pruritic skin rashes or lesions, fever, night sweats, fatigue, capsular contracture, or lymphadenopathy. [footnotes omitted]
Currently, according the the FDA, there are only 26 cases of BIA-ALCL associated with patients who received smooth breast implants. Of those 26 cases, 7 individuals previously had a textured breast implant, while the remaining 19 individuals had an unknown previous breast implant history.
Diagnosis and Treatment of BIA-ALCL
According to the same article, “Advising patients about breast implant associated anaplastic large cell lymphoma“, patients experiencing symptoms of BIA-ALCL may warrant careful further evaluation:
For community-based practices, pathology reports that are unclear or inconclusive may be referred to a tertiary cancer center for further evaluation. As a cautionary note, diagnosed patients have been misdiagnosed with a ruptured implant, yet upon explanation the implant is found intact but with a large surrounding malignant effusion.
The management of all confirmed BIA-ALCL patients initially involves imaging for metastasis with a PET-CT scan and oncology consultation, followed by surgical excision. This involves an oncologic en bloc resection, with implant removal, total capsulectomy, and tumor excision with negative margins. If there is residual disease or there is evidence of invasion beyond the capsule, adjuvant therapies may be required such as systemic chemotherapy, targeted immune therapy, chest wall radiation, and/or stem cell transplant.
Patients similarly should know that with early detection and adequate treatment, outcomes are encouraging. Multiple studies indicate overall survival rates greater than 90% if detected in early stages. [footnotes omitted]
In summary, treatment of BIA-ALCL is easier to manage and typically has better chances of survival if caught in the early stages.
Biocell Recall and Current FDA Position
In July 2019, Allergan complied with the FDA’s request to remove its Biocell breast implant products from the US market due to high risk of BIA-ALCL with a voluntary worldwide recall of the Biocell textured breast implants. In addition, Allergan sent a letter to any US patients with Biocell textured implants for whom they had active contact information, explaining the recall and warranty program. Since then, several ongoing lawsuits have been filed against Allergan citing “negligence” and “failure to warn” as the legal basis for their compensation claims.
According to the same January 2021 article, “Advising patients about breast implant associated anaplastic large cell lymphoma“, the FDA is in the process of drafting new guidance recommendations for breast implant package labeling:
In addition to epidemiological data, patients also need to be aware of the FDA’s stance on breast implant safety. The FDA is currently in the drafting stages of new guidance recommendations for breast implants package labeling and the informed consent process. These recommendations are designed to improve patient communication so that patients are better informed about the inherent risks implicit with implants. The pending recommendations act as a supplement to the FDA’s “Saline, Silicone Gel, and Alternative Breast Implants” guidance, issued in November of 2006. The new draft specifically provides recommendations for a boxed warning, a standardized patient decision checklist, and information on BIA-ALCL, which they now list as a risk of implant-based breast surgery. Currently, the FDA does not recommend prophylactic removal of textured devices for asymptomatic patients based on the relatively low risk of developing BIA-ALCL. For patients who are having high risk textured implants explanted, their exposure to BIA-ALCL risk is not completely eradicated and this should be clearly explained to the patient as part of the informed consent if contemplating explanation surgery. The FDA has restricted any further placement of Biocell textured and unused inventory should be returned to the manufacturer. They confirm that other breast implants currently approved within the US market remain acceptably safe and efficacious. [footnotes omitted]
As always, we will continue to monitor the worldwide issues surrounding Biocell textured breast implants as well as other breast implants and BIA-ALCL. We will provide you with any new or relevant information.
We encourage you to visit our Breast Implants Lymphoma Cancer page on our website for more information. Please submit a free case evaluation if you or someone you know has been diagnosed with BIA-ALCL.
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.