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A Texas woman has filed a product liability lawsuit against Allergan, alleging that one of the company’s breast implants caused her to develop a form of cancer that went metastatic, and spread to other parts of her body.
The complaint (PDF) was filed last month in New Jersey state court by Sandra Rush, who was diagnosed with breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL).
According to the lawsuit, Rush received a McGhan textured saline breast implant in June 1995. However, in 2017, she noticed that her left breast had become swollen and sore, and underwent a mammogram and ultrasound in May of that year. The tests revealed that Rush had a rare type of lymphoma that has been known to develop in the tissue surrounding the implant.
As a result of the diagnosis, Rush had the breast implant removed and underwent additional surgery for reconstruction. However, she was later diagnosed with stage 4 BIA-ALCL, after it was discovered that the cancer had already spread.
“In September 2017, Plaintiff developed bone pain and a hard ‘knot’ at the base of her skull and another in her mid-back,” the lawsuit states. “PET scan and brain MRI on September 29, 2017, showed widespread skeletal metastasis including the cervical, thoracic and lumbar spine, pelvis, jaw and hypermetabolic subcutaneous nodules.”
Rush’s diagnosis was the first known case of BIA-ALCL spreading to bone marrow. She underwent numerous treatments and bone marrow transplant in 2018, has had to leave her job and continues to have pain in her bones and continues to develop skin lesions, as well as suffering depression, insomnia and nausea.
The lawsuit indicates Rush was never warned of these potential risks.
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 Rush 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.