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According to allegations raised in a product liability lawsuit filed against Allergan, McGhan Style textured breast implants caused a woman’s breast to swell to three times its normal size, and resulted in the diagnosis of a rare cancer that is increasingly referred to as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
Maureen Byrnes filed the complaint (PDF) earlier this month in the U.S. District Court for the District of Columbia, pursuing damages from Allergan Inc., formerly known as Inamed Corporation and McGhan Medical Corporation.
According to the lawsuit, Byrnes was implanted with a Textured Saline 300 ml McGhan Style 468 breast implant in the left breast, and a 300 ml Allergan Style 468 breast implant on the right, after undergoing a double mastectomy in February 2009.
The implant was made using Biocell texturing technology, which has been linked to almost every reported case of anaplastic large cell lymphoma (ALCL) diagnosed among women who received breast implants in recent years. The rare cancer has been found to develop in the tissue surrounding implants that feature the textured surface, which research suggests may inflame surrounding tissue and lead to the development of ALCL.
In September 2017, Byrnes indicates in the complaint that her right breast swelled to three times its normal size. Upon examination, doctors found fluid buildup between the implant and the flesh surrounding it. As a result, she was diagnosed with BIA-ALCL and the implants were both removed later that same month.
“Ms. Byrnes suffered debilitating side effects from ALCL and/or BIA-ALCL including pain, swelling, and soreness in her right breast,” the lawsuit states. “At the time the implants were placed into Ms. Byrnes’ body, she was not advised, nor did she have any independent knowledge, that the Products were anything other than safe, life-long products. Nor was she advised that the product was associated and/or known to cause BIA-ALCL and that she would require future surgery and treatments.”
The complaint comes about three months after the FDA announced that the manufacturer had agreed to issue a worldwide breast implant recall for all of products featuring the microtextured design.
The manufacturer knew about the risk of BIA-ALCL from Allergan Biocell implants for years, according to allegations raised in the complaint, which indicates the manufacturer chose to ignore evidence linking to textured breast implants to cancer for years.
Biocell Textured Breast Implant Concerns
The FDA indicates there are at least 573 known cases of BIA-ALCL worldwide, including 33 deaths. Of those, 481 have been linked to Allergan breast implants. Allergan implants were also linked to 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.
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.
A number of women nationwide are now pursuing class action lawsuits to secure compensation for the defective and dangerous implants, and individual breast implant ALCL lawsuits are being filed against the manufacturer by women diagnosed with this rare cancer after receiving one of the recalled devices.