New lawsuit says Allergen hid BIA-ALCL cancer link from doctors, FDA
New Orleans, LAA breast implant side effects lawsuit filed in the Eastern District of Louisiana may soon join the growing list of cases to be considered as part of the federal multidistrict litigation forming in New Jersey. Seuzeneau v. Allergan USA, Inc. charges that Allergan, which marketed, advertised and sold Biocell textured breast implants, failed to disclose the connection between the implants and BIA-ALCL, a rare form of cancer.
This concealment deprived patients of the chance to make informed medical decisions. To make matters worse, Allergan has refused to provide any surgical fee assistance or reimbursement for the surgery to remove the textured implants and replace them with implants that have not been linked to BIA-ALCL. Women like Lori Seuzeneau have been forced to leave dangerous implants in place because they cannot afford to have them removed. The case will likely be consolidated in the multidistrict litigation (MDL) now pending in the District of New Jersey.
A dangerous product
In 2006, Ms. Seuzeneau had surgery to implant two Natrelle Biocell rough textured silicone breast implants into her body. She now suffers pain and leakage in the area of both implants. Pain is a known symptom of BIA-ALCL (breast implant associated anaplastic large cell lymphoma), a form of non-Hodgkin’s lymphoma.
The main symptoms of BIA-ALCL are:
persistent swelling or enlargement of a patient’s breast or surrounding tissue that develops a year or more after implant surgery;
lumps in the breast or armpit;
pain, rash, redness;
hardening of the breast; or
changes in the shape or size of the breast.
The symptoms of BIA-ALCL may occur years after the implant placement. Furthermore, the disease may be fatal, especially if not diagnosed early or promptly treated. Treatment involves surgically removing the implant and surrounding scar tissue. Some patients may also require chemotherapy and radiation treatments.
As of 2019, nearly 84 percent of the diagnosed BIA-ALCL cases involved individuals with Allergan’s Biocell implants. Of the 33 deaths caused by BIA-ALCL, 12 of the 13 patients where the implant manufacturer was known had Allergan’s Biocell textured implants.
Rising alarm
In January 2011, the FDA first identified a link between breast implants and BIA- ALCL. In March 2015, the French National Cancer Institute claimed “[t]here is a clearly established link between the occurrence of this disease [BIA-ALCL] and the presence of a breast implant.” On March 21, 2017, the FDA updated its 2011 warning and stated “[t]he risk of BIA-ALCL is higher for textured surface implants versus smooth surface implants.”
In December 2018, Allergan’s Biocell textured implants lost their European certification and were suspended from the European and Brazilian markets. Allergan textured implants were banned in France in April 2019 and in Canada one month later. On July 24, 2019, the FDA issued a worldwide recall the implants because of the link to the large majority of cases of BIA-ALCL.
Thereafter, Allergan began to offer a replacement warranty for customers who have the implants. The warranty provides that Allergan will provide Allergan smooth implants to replace the textured ones. However, the company will not provide any financial assistance for removal and replacement surgery. If a customer with a Biocell textured implant is diagnosed with BIA-ALCL, she will be reimbursed for diagnostic fees up to $1,000 and up to $7,500 in surgical fees related to diagnosis and treatment, a fraction of the likely cost.
Deadly Silence
As a condition of the initial FDA approval of Allergan’s line of breast implants, Allergan had an ongoing obligation to update the agency concerning adverse events and studies. The lawsuit claims that Allergan did not disclose the connection between the Biocell textured implants and BIA-ALCL to the FDA or the public. Nor did the company report adverse events each time an injury or malfunction occurred concerning the implants.
Until 2017, Allergan allegedly “buried evidence of ruptures and other injuries” involving its implants by reporting these as routine events that did not require any public disclosure through the Manufacturer and User Facility Device Experience (“MAUDE”) database. The general public, doctors and researchers rely on MAUDE to monitor the safety of medical devices. Allergen’s reporting failures arguably prevented Ms. Seuzeneau and her surgeon from making an informed decision whether to use the Biocell implants or select another product. In fact, Lori Seuzeneau first learned of the Allergen recall, not through medical channels but from a phone call from her sister-in-law.
Allergan MDL
The US Judicial Panel on Multidistrict Litigation has consolidated approximately 30 lawsuits that allege patients were not warned about a potential link between Allergan breast implants and cancer in the District of New Jersey. Still in its very early stages, the litigation is ultimately expected to include one hundred or more lawsuits.
Once the lawsuits are consolidated, they move to the discovery phase. In this phase, witnesses can be deposed and Allergan may be required to provide the plaintiffs with documents concerning its breast implants. Following this phase, bellwether trials may get underway. To date, none of those bellwether cases have been selected or scheduled for trial.
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