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A wrongful death lawsuit has been filed over Allergan Biocell breast implants, alleging that the textured design caused a Missouri woman to develop breast implant lymphoma, which was at least the 34th case of the rare cancer linked to the implants to turn fatal.
Calvin Parr filed the complaint (PDF) in the U.S. District Court for the Eastern District of Missouri on January 6, on behalf of himself and his late wife, Lizabeth Parr, who died in August 2019 following a battle with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which was allegedly caused by Allergan’s recalled Biocell textured design.
Allergan was forced to issue a worldwide breast implant recall last year for all products featuring its macrotextured Biocell design, which was a successor to the McGhan style design. The action was taken after federal regulators in the United States determined last year that the products were linked to nearly all reported cases of BIA-ALCL.
In most cases, BIA-ALCL can be successfully treated by removing the breast implants and surrounding tissue. However, in Lizabeth Parr’s case, the cancer metastasized and spread to other parts of her body, adding to the death total linked to the breast implants.
The lawsuit indicates she was implanted with McGhan Style 168 Biocell saline textured breast implants in 2002. She had them replaced with Allergan Natrelle 120 500 cc high profile silicone gel Biocell textured implants in 2010.
“Because Ms. Parr had two sets of Biocell implants – in 2002 and in 2010 – she was twice exposed to the dangerous and defective Biocell textured implant surface in the peri-implant capsule space and particles/toxins from the implants that directly caused her fatal case of BIA-ALCL,” the lawsuit states. “Notably, in the explantation surgery in 2010, no capsulectomy was performed. Capsulectomy is a procedure in which part or all of the ‘capsule’ of scar tissue surrounding a breast implant is removed. Thus, Ms. Parr’s tissue capsule was exposed to two Biocell implants. A dose-response relationship between exposure to foreign particulates from the implants may play a role in BIA-ALCL.”
The case joins dozens of similar breast implant lymphoma lawsuits and class action lawsuits filed in recent months, including a small number of wrongful death claims. Given similar allegations raised in complaints filed throughout the federal court system, the cases have been centralized as part of a multidistrict litigation (MDL) for coordinated discovery and pretrial proceedings.
Allergan Biocell Breast Implant Problems
The FDA previously indicated it knew of at least 573 known cases of BIA-ALCL diagnosed worldwide, including 33 deaths, before Parr’s death in August 2019. Of those, 481 have been linked to Biocell breast implant designs. Allergan implants were also linked to 12 of the 13 deaths where the manufacturer of the breast implant was known at the time.
In June 2017, a study published in the medical journal Plastic and Reconstructive Surgery suggested that certain textured breast implants may increase the risk of anaplastic large cell lymphoma anywhere from 10 to 14 times, when compared to smooth breast implants.
Another study, published in October 2017, warned that many breast implant cancer cases worldwide have likely not been reported, and noted doctors and patients may not be aware of BIA-ALCL.
The FDA is not recommending women have the breast implants removed if they are showing no symptoms. Instead, the regulators recommend recipients of these implants become familiar with the symptoms of BIA-ALCL, including persistent swelling or pain near the implant, and talk to their health care provider for further information. Those with BIA-ALCL should undergo breast implant removal and removal of the surrounding scar capsule.
The agency also recommends those who receive breast implants keep a record of the device manufacturer, unique device identifier and implant model name, which may have been provided on a patient device card from the surgeon.
As women diagnosed with the rare lymphoma continue to contact breast implant recall lawyers in the coming months and years, the size of the litigation is expected to continue to increase.