Two lawsuits were filed against Allergan Wednesday related to its line of Biocell textured breast implants, which are the subject of a worldwide recall, alleging a failure to warn of cancer risks.
The Los Angeles Superior Court complaints brought by Hilary Corts and Cari Dietzel allege that Allergan spent decades neglecting to properly advise consumers of the risks with the implants and concealed or misrepresented the dangers.
An Allergan representative did not immediately reply to a request for comment.
U.S. & World
The Allergan entities, including Allergan Inc. and Allergan USA Inc., have for decades made, promoted and offered for implantation the Biocell line of textured breast implants, according to the suits. Allergan has sold hundreds of thousands of the implants into the worldwide marketplace, with the product being implanted into women on both a reconstructive and cosmetic basis, the suits say.
The plaintiffs allege the implants carry a heightened and undisclosed risk of developing a type of cancer known as breast implant associated anaplastic large cell lymphoma or BIA-ALCL, a rare subtype of non-Hodgkin's lymphoma.
Despite knowing about the risk for years, Allergan has repeatedly dismissed, diminished, or downplayed the issue to women around the world, the suits allege.
On July 24, the U.S. Food and Drug Administration requested that Allergan recall its Biocell textured breast implants and tissue expanders marketed in the U.S., and the company subsequently notified the FDA earlier this month that it would be removing the products from the global market.
The FDA sought the recall based on analysis of 573 unique BIA-ALCL cases worldwide, including 33 patient deaths. Of the 573 cases, 481 were reported to have Allergan breast implants at the time of diagnosis. In addition, 12 of 13 deaths occurring in patients with BIA-ALCL where the manufacturer was known occurred in patients implanted with an Allergan breast implant at the time of their diagnosis, according to an FDA statement.
In 2014, Dietzel was diagnosed with breast cancer and underwent a bilateral mastectomy to remove the cancerous tissue from her breasts. She was implanted with Biocell implants, believing they were safe, her suit states. Corts, who had a history of breast cancer within her family, learned that she was also at a high risk of developing breast cancer, her suit states.
In 2016, she underwent a preventative bilateral mastectomy, but learned she had already developed breast cancer, according to her court papers.
After post-surgery issues with her Allergan tissue expanders, and recovering from an infection caused by the expanders, Corts in April 2017 received Biocell implants, but found they were not safe and effective in preventing her from developing further issues with cancer or infection, her suit alleges.