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According to allegations raised in a recently filed product liability lawsuit, Allergan’s McGhan breast implants caused a Louisiana woman to develop breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
The complaint (PDF) was filed by Christine Downey and her husband, Drake, in the U.S. District Court for the Western District of Louisiana on August 3, indicating that the cancer was caused by the company’s Biocell textured surface process used for the recalled breast implants.
According to the lawsuit, Downey received McGhan breast implants after being diagnosed with bilateral breast cancer in 2000. However, years later she developed a separate type of lymphoma that formed in the tissue surrounding the McGhan breast implant, indicating that the manufacturer knew about the risk, yet withheld information from consumers and the medical community.
“At the time the McGhan Breast Implants were placed into Christine Downey’s body, she was not advised, nor did she have any independent knowledge, that the McGhan Breast Implants were anything other than safe, life-long products,” the lawsuit notes. “Nor was she advised that the product was associated and/or known to cause BIA-ALCL.”
In December 2011, Downey began suffering pain and swelling in her left breast. An examination, including ultrasound and mammogram, revealed a build-up of fluid around that implant. Following a number of attempts to identify the problem, she had the left saline breast implant removed in February 2012. Later that year, in April 2012, she was diagnosed with anaplastic large cell lymphoma of the left breast.
However, her problems were not done.
In October 2019, after noticing an enlargement in one of her breast implants, she was diagnosed with BIA-ALCL.
Allergan was forced to issue a worldwide breast implant recall last year for products featuring its macrotextured Biocell design, which some say was a successor to the McGhan design. The action was taken after the FDA determined last year that the products were linked to nearly all reported cases of BIA-ALCL, which is a form of non-Hodgkins lymphoma.
Although Allergan allegedly knew about the breast implant lymphoma risk for years, the lawsuit notes that the only reason the implants are off the market is because the FDA forced the issue.
The FDA indicates there are at least 573 known cases of BIA-ALCL diagnosed worldwide, including 33 deaths. 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.
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.
The case joins dozens of similar class action lawsuits filed in recent months, as well as individual product liability complaints brought by women diagnosed with the breast implant lymphoma, which have been centralized as part of a multidistrict litigation (MDL) in the federal court system.