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Dozens of women are pursuing breast implant lawsuits after developing a rare type of cancer in the surrounding tissue. While most of the claims involve problems with Allergan’s recalled Biocell line of textured breast implants, a recent lawsuit suggests that silicone implants by Sientra may also result in a similar risk.
In a complaint (PDF) filed last week in the U.S. District Court for the Eastern District of Tennessee, Kelly Painter-Hart indicates that she was diagnosed with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) from Sientra silicone implants.
Painter-Hart underwent bilateral mastectomies in November 2013, as a preventative measure against breast cancer. At that time, she was implanted with Sientra textured oval-shaped silicone gel implants manufactured in Brazil.
By September 2019, she was suffering from acute swelling of her right breast, and was diagnosed with the breast lymphoma in October of that year. A month later, in November 2019, she had the implants surgically removed.
“Mrs. Hart chose to undergo double mastectomies in order to avoid the risk of developing cancer,” her lawsuit states. “Had she been informed of any increased risk of developing cancer associated with Sientra textured implants manufactured in Brazil, she would not have chosen to use that product and/or would have opted out of reconstruction.”
Concerns about the risk of BIA-ALCL emerged a few years ago, and researchers determined that the problems appeared to be linked to certain breast implant designs that featured large textured surfaces, which may result in persistent inflammation that produces lymphoma in the breast.
In July 2019, Allergan was forced to issue a worldwide breast implant recall for its entire line of “Biocell” textured breast implants, after the FDA determined the design was linked to more than 500 cases of BIA-ALCL diagnosed worldwide, including at least 33 deaths.
In a recent update, the FDA indicates it has identified an additional 160 new cases since July 7, 2019, as well as three new deaths. That brings the total cases to 733 BIA-ALCL diagnoses worldwide, and a total of 36 patient deaths globally.
At least 620 of those breast implant lymphoma cases were specifically linked to Allergan design, and in another 47 cases the manufacturer was unknown.
A recent study by Columbian researchers found only seven out of 18 cases of BIA-ALCL diagnosed in that country were linked to Allergan breast implants, with the rest caused by other designs.