Allergan faces a class action from an Illinois resident who claims she is at a higher risk of developing BIA-ALCL, a cancer of the immune system, from the company's now-recalled textured breast implants.
An Illinois woman alleges in a proposed class action lawsuit that Allergan’s now-recalled Biocell textured silicone- and saline-filled breast implants and tissue expanders have increased her risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare cancer of the immune system.
The 24-page complaint states that the FDA in 2011 identified a link between breast implants and BIA-ALCL, a type of non-Hodgkin’s lymphoma. Breast implant-associated anaplastic large cell lymphoma is not breast cancer, the lawsuit clarifies, and is found in the scar tissue and fluid near a breast implant. In some instances, the case says, the cancer can spread throughout the body and become fatal if not diagnosed and treated early.
Symptoms of BIA-ALCL include persistent swelling or enlargement of the breast or surrounding tissue a year or more after breast implant surgery, the lawsuit continues. Patients can experience “lumps in the breast or armpit, pain, rash, redness, hardening of the breast, or changes in the shape or size of the breast,” according to the complaint.
In July 2019, the FDA issued a worldwide Class I recall—the most serious type of recall—of Allergan’s Biocell textured breast implants due to the product’s link to a “large majority” of cases of BIA-ALCL, the lawsuit continues, noting that a patient’s risk of developing the condition is “greatly increased” if the individual has textured implants. According to the case, the FDA determined that the risk of developing BIA-ALCL was “six times higher” with Allergan’s Biocell textured implants when compared to those from other manufacturers.
Cited in the lawsuit is data included in the FDA’s recall statement on BIA-ALCL cases and their apparent link to the defendant. From the complaint:
“On July 24, 2019, in its recall statement, the FDA stated there are 573 cases of BIA-ALCL worldwide. Of those 573 cases, 33 people have died as a result of BIA-ALCL. This is a ‘significant increase’ since the FDA’s last update earlier in 2019 which found there were 116 new cases of BIA-ALCL and 24 deaths. Of the 573 individuals with BIA-ALCL, 481, or 83.9%, had 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.”
Six days after the FDA recalled Allergan’s Biocell textured breast implants, the company announced the creation of a replacement warranty for all patients who currently had the product. The lawsuit says the warranty, which is to run until July 24, 2021 and apply only to revision surgeries done on or after July 24, 2019, provides that Allergan will replace patients’ Biocell textured implants with smooth implants. What the warranty does not provide, according to the lawsuit, is any surgical fee assistance or reimbursement for the surgery necessary to remove Allergan’s Biocell textured implants. As the plaintiff tells it, Allergan’s warranty fails on numerous levels, with particular regard to patients who are diagnosed with BIA-ALCL.
“The Warranty is insufficient because it does not provide for surgical fee assistance for breast implant revision and instead only provides free smooth Allergan implant replacement.
If a customer with a BIOCELL textured implant is diagnosed with BIA-ALCL, under the NATRELLE Confidence Plus Warranty, the customer will be reimbursed for diagnostic fees up to $1,000 and up to $7,500 in surgical fees related to diagnosing and treating BIA-ALCL.
The Confidence Plus Warranty is wholly insufficient as it applies to customers who are diagnosed with BIA-ALCL. The Warranty’s reimbursement of $1,000 for diagnostic fees and $7,500 for surgical removal and cancer treatment is entirely too low concerning the expensive and invasive nature of surgery and cancer treatment.”
From there, the case goes on to allege Allergan failed to timely and accurately file with the FDA adverse events reports after its Biocell textured implants received premarket approval in November 2006. According to the suit, Allergan was required to submit reports to the FDA concerning the safety and effectiveness of the medical device, as well as monitor all reasonably available information and clinical studies concerning the product.
The lawsuit alleges, however, that Allergan has known of the connection between its textured implants and the increased risk of developing BIA-ALCL “since at least 2011.” Despite Allergan’s purchase of a company that the complaint says began a 10-year study to determine the safety and performance of the products, notwithstanding its own long-term studies to assess the breast implants, the defendant “did not disclose the connection between the Biocell textured implants and BIA-ALCL to the FDA or the public,” the case claims, alleging Allergan “buried evidence of ruptures and other injuries.”
“Allergan did not accurately report adverse events each time an injury or malfunction occurred concerning the BIOCELL textured implants,” the complaint reads.
The plaintiff claims that she received two sets of Allergan breast implants. According to the case, the implants the plaintiff received in November 2016 were removed the following July due to “significant problems with pain and swelling.” The second set of implants the plaintiff received, in July 2017, were recalled by the FDA two years later, the suit says. The plaintiff asserts that she would not have had the procedure for her second set of implants had she known that the product would increase her risk of BIA-ALCL. The woman seeks through the lawsuit the removal of her Biocell textured implants at Allergan’s expense.
A complete list of the Allergan products recalled by the FDA can be found here. The lawsuit looks to certify a class of individuals who have been implanted with Biocell saline-filled or silicone-filled breast implants or tissue expanders that have since been recalled by the FDA while in Illinois.