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Following a global breast implant recall issued for certain textured designs that may increase the risk of cancer, a product liability lawsuit filed by a Georgia woman alleges that Allergan’s Natrelle Biocell design caused her to develop breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
The complaint (PDF) was filed by Jennifer Ann Cook, and her husband David Christopher Cook, in California Superior Court for Los Angeles County on July 25, naming Allergan Inc., Nusil, LLC, and 100 unidentified parties as defendants.
The lawsuit came just one day after the FDA announced that Allergan had agreed to issue a worldwide breast implant recall for all of its Biocell microtextured products, which have been linked to the rare form of lymphoma that is known to develop in the tissue surrounding certain textured breast implants.
Cook indicates that she was only of the women who received an Allergan Natrelle Style 115 Biocell breast implant, which was used in August 2010. Seven years later, she was diagnosed with breast implant ALCL, and had the implants removed in September 2017.
“As a result of Plaintiff’s diagnosis of BIA-ALCL, Plaintiff Ms. Cook had seven rounds of brentuximab, a type of systemic immunotherapy, administered to her body to try to eliminate the disease,” the lawsuit states. “Prior to her development of ALCL, Ms. Cook enjoyed an active, full life. Subsequently, she endured pain, swelling, and other injuries from this terrible disease.”
The FDA indicates there are at least 573 known cases of breast implant ALCL diagnosed worldwide, including at least 33 deaths. Of those, 481 have been linked to Allergan breast implants, which have also been linked to at least 12 of the 13 deaths where the manufacturer of the breast implant was known.
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 that doctors and patients may not be aware of BIA-ALCL.
That following month is when Cook’s doctors removed her breast implants following repeated immunotherapy treatments.
For women who have the recalled Allergan breast implants, the FDA is not recommending removal of the device if they are not showing symptoms. Instead, the regulators recommend recipients of these implants become familiar with the symptoms of ALCL, including persistent swelling or pain near the implant, and talk to their health care provider for further information. Those diagnosed with ALCL should undergo breast implant removal and removal of the surrounding scar capsule, according to the latest recommendations from health regulators.
The FDA 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.
Those with questions regarding the safety communication can email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or by calling 800-638-2041 or 301-796-7100.
Cook’s complaint is one of a growing number of breast implant ALCL lawsuits filed against Allergan by women throughout the United States, including several class action lawsuits for medical monitoring.