Allergan Breast Implants Lawsuit
Allergan Drug Recall Claims
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 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 have a 6 times higher rate of BIA-ALCL cancer development than other types of implants or tissue expanders. It may also account for about 80% of BIA-ALCL cases, including 15 of 16 associated deaths.
Allergan BIOCELL Natrelle textured implants were recalled in July 2019 but the U.S. Food and Drug Administration (FDA) 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, and who may not have been adequately tracked.
Some women, however, may have experienced difficulty getting treatment or medical services from the company. If you have been diagnosed with BIA-ALCL and have had an Allergan textured breast implant, you may be entitled to file an Allergan breast implant lawsuit to seek compensation for your 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. Contact the defective product attorneys at Jinks Crow today for a free consultation.
When was Breast Implant-Associated Cancer Discovered?
A link between breast implants and “anaplastic large cell lymphoma” or ALCL was first identified in 2011 by the FDA. In 2016, it was further classified as a type of T-cell Lymphoma known as “breast implant-associated anaplastic large cell lymphoma” or BIA-ALCL by the WHO. In 2017, the FDA announced that the connection between BIA-ALCL and textured implants was higher than smooth implants.
What is Breast Implant Cancer?
BIA-ALCL is not breast cancer that forms in breast tissue but is a non-Hodgkin’s lymphoma or type of T-cell lymphoma. BIA-ALCL 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 kinase (ALK1). ALK1 triggers an increase in the growth of cells in the lymph tissue that forms in the scar tissue surrounding a breast implant, or “capsule”.
It may be related to inflammation caused by the breast implant. It 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. This design may be good for implant placement and retention but results in medical harm for some patients.
How is BIA-ALCL Treated?
When detected early, BIA-ALCL may be treatable by the removal of the implant and the surrounding tissue. In other cases, cancer may spread or metastasize to other areas of the body which may require chemotherapy or radiation.
Reports show that the time from breast implant surgery to a cancer diagnosis is a median of about 8 years. Some women are choosing to have their implants removed but the recall does not currently cover the cost of medical treatments or surgery. Lack of coverage has prompted many women are choosing to file lawsuits to seek assistance.
Who is Affected by the Allergan BIOCELL Natrelle Textured Breast Implant Recall?
All textured breast implants may increase the risk for BIA-ALCL. Allergan implants, however, may cause even greater risk. Analysis of BIA-ALCL reports has shown that Allergan BIOCELL textured implants and tissue expanders may pose 6 times higher risk 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. immediately. In July 2019, the FDA asked that the company voluntarily recall all of its BIOCELL products after analysis showed the higher risk of Allergan implants. Allergan textured implants accounted for 620 cases or 85% of the 733 reports of BIA-ALCL studied.
Overall, textured implants were associated with 36 deaths due to BIA-ALCL. Fifteen out of 16 reports which included manufacturer information, were associated with Allergan breast implants.
What Allergan implants are recalled?
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 Silicone-Filled Textured Breast Implants
Allergan Natrelle 410 Highly Cohesive Anatomically Shaped Silicone
Filled Breast Implants
Allergan Natrelle 133 Tissue Expanders
Allergan Natrelle Inspira Silicone-Filled Breast Implants
McGhan BioDimensional Silicone-Filled Textured Breast Implants
McGhan Magna-Site Tissue Expander
McGhan 134 Croissant-Shaped Tissue Expander
FDA Addresses Concerns Over Allergan Device and Recall Tracking
In May 2020, shortly after Allergan was acquired by the pharmaceutical company, AbbVie, an FDA warning letter was issued. Though the implants had been recalled 10 months earlier, Allergan was accused of failing to complete post-market safety studies. The FDA warning letter 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 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.
Allergan apparently lacked inadequate device tracking systems for the implants. Consequently, patients with implants may not have received 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. Estimates also show that many more, possibly hundreds of thousands of women may have Allergan Biocell breast implants.
Allergan Textured Breast Implant Recall Coverage Inadequate
Allergan’s July 2019 recall offered financial coverage for the cost of implants or replacement implants. The company, however, did not include coverage for the cost of surgery to remove or replace the implants. Diagnostic or medical testing and future medical monitoring to ensure that cancer did not develop were not included. The recall also failed to address medical injury claims that may result from the textured implants.