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An Illinois woman has filed a product liability lawsuit over Natrelle silicone implants, alleging that Allergan and its Inamed subsidiary should have warned about the risk that women may develop a rare form of cancer in the tissue surrounding the implant, which is now known as breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL).
The complaint (PDF) was filed by Kimberly Commisso in the Superior Court of New Jersey on May 23, indicating that the manufacturers knew or should have known about the risk, yet withheld information from consumers and the medical community.
Commisso underwent reconstructive surgery in July 2015 after being diagnosed with breast cancer and undergoing a bilateral mastectomy. She was implanted with Allergan Natrelle 410 Highly Cohesive Silicone-Filled breast implants. However, just two years later, in May 2017, she noticed breast swelling, and a biopsy revealed that she had developed BIA-ALCL. In June 2017, the breast implant was removed, and it appears that resolved the illness.
According to the lawsuit, if Allergan had properly tested its products and provided warnings about the risk of breast implant lymphoma, Commisso and hundreds, or even thousands of women nationwide would not have contracted cancer.
“At the time the Allergan Breast Implants were placed into Kimberly Commisso’s body, she was not advised, nor did she have any independent knowledge, that the Allergan Breast Implants were anything other than safe, life-long products,” the lawsuit notes. “Nor was she advised that the product was associated and/or known to cause BIA-ALCL.”
Breast Implant Lymphoma Warnings
The FDA first released a report about case studies and epidemiological research that suggested there was a link between breast implants and anaplastic large-cell lymphoma (ALCL) in January 2011.
In 2017, the agency issued an updated statement about emerging information on the breast implant lymphoma problems, and a number of subsequent studies have confirmed that the breast implant ALCL cancer risk is real.
In June 2017, a month after Commisso was diagnosed with BIA-ALCL, 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 March 2018, 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 breast implant cancer lawsuits against Allergan and other manufacturers, for women diagnosed with the ALCL in recent years.