Allergan Breast Implant Lawsuit Overview
Allergan breast implants have been linked to a rare type of cancer called “breast implant-associated anaplastic large cell lymphoma” or BIA-ALCL. It has been identified by the World Health Association (WHO) as a type of T-cell cancer or non-Hodgkin’s lymphoma. BIA-ALCL is not a type of breast cancer but is an immune cell cancer that begins in lymph cells and forms in the scar capsule under and surrounding a breast implant.
Though BIA-ALCL has occurred in some patients with smooth implants, a recent analysis has shown that Allergan’s BIOCELL Natrelle textured implants has a 6 times higher rate of BIA-ALCL cancer development than other types of implants or tissue expanders and may account for about 80% of BIA-ALCL cases, including 12 of 13 associated deaths.
Though the implants were recalled in July 2019, the U.S. Food and Drug Administration has expressed concern that women may not know enough about the recall. Allergan and parent company AbbVie launched a digital and social media campaign to help identify patients who had received the implants, who may not have been adequately tracked, but some women may have experienced difficulty getting treatment or medical services from the company.
People who have been diagnosed with BIA-ALCL and who have had an Allergan textured breast implant are filing lawsuits to seek compensation for their medical costs, injuries, and damages. Others are considering lawsuits to seek compensation or assistance with surgical costs for removal or replacement and future medical monitoring of cancer risk.
Breast Implant-Associated Cancer
In 2016, a specific type of breast implant-related cancer was identified by the World Health Organization (WHO). It was termed “breast implant-associated anaplastic large cell lymphoma” or BIA-ALCL.
BIA-ALCL is not a breast cancer that forms in breast tissue but has been classified as a non-Hodgkin’s lymphoma or type of T-cell lymphoma which causes T-cells to produce an excess amount of a protein known as anaplastic lymphoma kinase (ALK1). ALK1 triggers an increase in the growth of cells in the lymph tissue that forms in the capsule or scar tissue surrounding a breast implant.
It may be related to inflammation caused by the breast implant and is more likely to occur in textured implants than smooth breast implants. Textured implants are thought to trigger a greater inflammatory process which contributes to scar tissue formation that holds the implants in place, a design that may be good for implant placement but results in medical harm for some patients.
When detected early, BIA-ALCL may be treatable by removal of the implant and the surrounding tissue but the cancer may spread or metastasize to other areas of the body and may require chemotherapy or radiation.
Reports show that the time from breast implant surgery to cancer diagnosis is a median of about 8 years and many women are choosing to have their implants removed. The recall does not currently cover the cost of medical treatments or surgery and many women are choosing to file lawsuits to seek assistance.
Allergan BIOCELL Natrelle Textured Breast Implant Recall
In addition to an already increased risk of BIA-ALCL that occurs with all textured implants, Allergan implants may cause an even greater risk. An analysis of BIA-ALCL reports has shown that Allergan BIOCELL textured implants such as the Natrelle implants and tissue expanders may pose a risk that is 6 times higher than other brands of textured implants.
Allergan suspended sales of its textured implants in all countries of the European Union, Brazil, Australia and Israel in December of 2018. In May 2019, HealthCanada withdrew Allergan’s manufacturing license but the company did not act in the U.S. until July 2019 when the FDA asked that the company voluntarily recall all of its BIOCELL product after analysis showed Allergan implants accounted for 84% (481) of the 573 reports of BIA-ALCL studied, including 12 out of 13 deaths where the implant manufacturer was known.
The July 2019 recall covers Allergan Biocell implants including:
- Allergan Natrelle Saline-Filled Textured Breast Implants
- Allergan Natrelle Silicone-Filled Textured Breast Implants
- Allergan Natrelle 140 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants.
FDA Addresses Concerns Over Allergan Device and RecallTracking
In May of 2020, shortly after Allergan was acquired by pharmaceutical company, AbbVie, the FDA issued a warning letter to Allergan for failure to complete post market safety studies. Though the implants had been recalled 10 months earlier, the FDA claimed that Allergan had failed to adequately recruit patients and collect data for a large safety study that had been required as part of the Natrelle implant approval.
In addition, the FDA appeared to have been concerned that public outreach methods were inadequate to inform women who may have received the implants about the recall. Allergan subsequently launched a dedicated social media and internet campaign to identify and contact patients who may have received the Biocell textured breast implants and tissue expanders.
Many of these patients may have previously been lost to follow up due to inadequate device tracking systems and did not receive direct communication from Allergan or the FDA. Allergan acknowledged that they did not have device-tracking information for an estimated 52,000 Biocell breast implants.
Allergan Textured Breast Implant Lawsuits
Allergan’s July 2019 recall also offered financial coverage for the cost of implants or replacement devices but did not include coverage for the cost of surgery to remove or replace the implants, for any diagnostic or medical testing, or medical monitoring to ensure that no cancer develops. It also did not address medical injury claims that may result from the textured implants.
People who have received Allergan Biocell Breast Implants and may be at risk to develop BIA-ALCL are filing Allergan breast implant lawsuits to seek compensation for costs associated with removal or replacement and with future cancer concerns.
More concerning, the company is also facing a growing number of Allergan breast implant lawsuits filed by implant recipients who have been diagnosed with BIA-ALCL, who are seeking compensation for their injuries and damages, some of whom have been unable to obtain assistance.
A number of women have asked courts to order Allergan to stop requesting that patients release the company from liability.
Allergan Breast Implant Lawsuit
People or loved ones of those who were diagnosed with non-Hodgkin’s lymphoma, specifically, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) after receiving an Allergan breast implant may be eligible for compensation through a medical injury lawsuit.
Those who have been implanted with Allergan BIOCELL textured implants but have not been diagnosed with cancer may also be eligible for compensation.
Each case is unique and must be evaluated separately.