Allergan, Inc. is facing a growing number of lawsuits that allege the company’s recalled textured breast implants caused a rare form of lymphoma.
One of the most recent cases – a wrongful death lawsuit — was filed late last month in the U.S. District Court, District of New Jersey, on behalf of a man who tragically lost his wife to the disease. (Case No. 2:20-cv-03246)
According to the March 25th complaint, Rita Ann Creeden received Allergan’s Biocell textured breast implants in 1996. Ten years later, she developed a rash on her right breast and was subsequently diagnosed with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
Although her implants and the surrounding scar tissue were removed, the cancer was not cured, forcing Creeden to submit to additional treatment. However, that treatment ended prematurely due to resulting nerve damage.
By January 2019, Creeden had developed a large chest wall mass that eroded through her skin. Despite additional interventions including excision of the mass and 9 radiation treatments, a scan in March 2019 showed multiple tumors throughout her chest. Sadly, intense pain prevented Creeden from continuing radiation. She entered hospice care and died in August 2019.
Creeden’s husband alleges, among other things, that Allergen’s manufacturing process was defective and produced unwanted adulterated silicone particles that became embedded in breast tissue. He further asserts that the company was aware of this problem as early as the 1990s, but failed to issue required reports and warnings to the U.S. Food & Drug Administration (FDA).
“As a direct and proximate result of one or more of these wrongful acts or omissions of Defendants, or some or any one of them, Mrs. Creeden suffered a wrongful death and profound injuries that are permanent, required extensive medical treatment and hospitalization and resulted in medical and hospital expenses, lost future earning capacity, and other damages for which Plaintiff is entitled to compensatory and other damages in an amount to be proven at trial,” the complaint states.
BIA-ALCL is a type of non-Hodgkin’s lymphoma that occurs in the tissue surrounding breast implants. The FDA has been studying this rare cancer since 2011, when it noted that the vast majority of cases occurred in women with textured devices. Last summer, however, the agency warned that Allergan Biocell textured breast implants had been implicated in 80% of BIA-ALCL reports, as well as 12 of the 13 fatalities in which a manufacturer was identified.
The FDA ultimately asked Allergan to recall all Biocell textured breast implants and tissue expanders from the worldwide market. While Allergan complied, the company has not announced any plans to compensate recipients for medical monitoring and other costs related to the increased risk of BIA-ALCL or its treatment.
Symptoms of BIA-ALCL include:
While removal of the breast implants and surrounding scar tissue typically cures BIA-ALCL in the early stages, more advanced lymphomas may require radiation and other intervention. In most cases were BIA-ALCL has proven fatal, diagnosis and treatment were significantly delayed.