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According to allegations raised in a product liability lawsuit filed by a Tennessee woman, Mentor saline implants caused her to develop breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare type of cancer that may develop in the tissue surrounding the implant.
The complaint (PDF) was filed by Kristen Watson in the Superior Court for New Jersey on October 8, indicating that Johnson & Johnson and it’s Mentor Worldwide and Ethicon subsidiaries failed to warn women, doctors and regulators about the cancer risk with textured breast implants.
ALCL is a form of non-Hodgkins lymphoma that has been reported among many women after receiving breast implants, leading many experts to refer to the condition as breast implant-associated ALCL, or BIA-ALCL. The cancer develops in the breast tissue surrounding the implant, and a growing body of research suggests that certain large surface area, textured implants may increase the risk.
Watson indicates that she received Mentor Saline Breast Implants during surgery in June 2005. About two years later, she noticed a lump under her left armpit and underwent an ultrasound in September 2017, which found that she had enlarged axillary lymph nodes. A later tissue biopsy suggested a malignant neoplasm.
In October 2017, Watson was diagnosed with anaplastic large-cell lymphoma and the left axillary lymph node was removed. It was not until several weeks later that she learned that the lymphoma may actually linked to her Mentor breast implant.
Following aggressive chemotherapy, which lasted for six months, Watson required additional surgery in June 2018, at which time the breast implants were removed along with scar tissue capsules surrounding them.
“Prior to her development, diagnosis and treatment of ALCL, Mrs. Watson enjoyed an active, full life, and did not experience the symptoms which arose after the Mentor Saline Breast Implants were placed in her body,” the lawsuit states. “Subsequently, she endured pain, swelling, and embarrassment of her deformed chest.”
Breast Implant Cancer Warnings
On January 26, 2011 the FDA first released a report about case studies and epidemiological research that suggested there was a link between breast implants and ALCL.
The agency then issued a statement about emerging information on the breast implant lymphoma problems last year, and a number of subsequent studies have confirmed that the breast implant ALCL cancer risk is real.
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 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 ALCL lawsuits against Allergan and other manufacturers, for women diagnosed with the cancer in recent years.