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In a recently filed product liability lawsuit over Allergan’s Natrelle Silicone breast implants, a Virgina woman indicates that the macrotextured implants caused her to develop a rare form of cancer, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
The complaint (PDF) was filed last week in New Jersey Superior Court, but Michele Rea and her husband, Carl, indicating that Allergan concealed the potential ALCL cancer risk with Natrelle breast implants.
Rea indicates that an Allergan Natrelle Style 410 macrotextured breast implant was used during breast reconstruction surgery in January 2011, after she had a partial mastectomy of her right breast the year before due to breast cancer. She received the implant as a participant in a study to evaluate it’s safety and effectiveness, before it was approved by the FDA.
The lawsuit notes that Rea was given an informed consent form that was supposed to warn her of all the dangers of participating in the study. However, the form included no information regarding the risk of ALCL associated with textured breast implants, according to the complaint.
The complaint indicates that “unknown risks” section of the informed consent form did indicate that there was “no scientific evidence that silicone-filled breast implants can increase the risk of cancer in women”, which Rea claims was a false statement.
As early as 1996, Rea indicates that the first case of ALCL associated with silicone breast implants was reported. In addition, a retroactive analysis published in the Journal of the American Medical Association (JAMA) in November 2008 highlighted 11 cases of ALCL between 1994 and 2006, concluding that the evidence indicated an association between the silicone breast implant and the ALCL cancer diagnoses.
On January 26, 2011, just five days after Rea underwent the procedure to receive the Natrelle breast implant, the FDA released a report warning that case studies and epidemiological research suggested there was a link between breast implants and ALCL. The lawsuit suggests that Allergan had to be aware of those case studies and research before Rea was given the informed consent form.
Even after the FDA warning, Rea indicates that Allergan failed to adequately warn patients or the medical community about the risks of its implants.
The FDA approved the Natrelle in 2013, and Rea was diagnosed with BIA-ALCL in May 2016.
“At the time the Allergan implants were placed into Mrs. Rea’s 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 lawsuit notes. “If Mrs. Rea had been advised that implantation was associated with even the slightest risk of developing ALCL and/or BIA-ALCL she would not have proceeded with implantation of the Products.”
Breast Implant ALCL Cancer Warnings
The FDA issued a statement about emerging information about the breast implant lymphoma problems last year, and a number of subsequent studies have confirmed that the ALCL cancer risk is real. The issue appears to be linked specifically to the use of certain textured breast implants with larger surface areas.
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.
In October 2017, a study published in the medical journal JAMA Surgery 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.
In March, the FDA indicated that it was aware of more than 400 cases of breast implant-related cancer. As more information becomes public about the breast implant cancer cases, experts have warned that the number of cases reported will likely increase significantly.
As regulators and researchers worldwide continue to evaluate the specific cause of the breast implant lymphoma problems, other women are also raising serious questions about why certain products appear to be more likely to be associated with the development of cancer, and how manufacturers failed to address potential design defects earlier.
Product liability lawyers in the U.S. are now reviewing other potential textured breast implant lawsuits for women diagnosed with anaplastic large cell lymphoma (ALCL), which develops in the tissue surrounding the breast.