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According to allegations raised in a product liability lawsuit filed against Allergan, the manufacturer has known that side effects of its breast implants could cause cancer since at least the 1990s, yet continued to sell textured designs that have been associated with the development of anaplastic large cell lymphoma (ALCL) .
The complaint (PDF) was filed by Carol Burnside in the U.S. District Court for the District of Colorado on April 10, naming Allergan and Inamed Corporation as defendants.
Burnside indicates that she underwent a double mastectomy in 2004, after being diagnosed with precancerous lesions. A year later she underwent breast reconstructive surgery with breast implants. However, one of those appeared to have ruptured, and she was implanted with Allergan’s McGhan style 410 implants.
For several years after, she experienced swelling and pain in her left breast, which lead to explant surgery in April 2017. That time it was discovered that cancer had developed in the tissue surrounding the implant and she was diagnosed with a rare form of cancer now commonly referred to as breast implant-associated lymphoma (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 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 the risks.
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.
However, the lawsuit indicates that the first cases of BIA-ALCL were reported as far back as 1994. The lawsuit claims Allergan knew this information and withheld it from consumers and the medical community to protect its profits.
“Despite Defendants’ knowledge of an association between breast implants and ALCL dating back to the 1990’s, Defendants purposefully failed to comply with their clearly-established post-market surveillance obligations and in doing so have exposed many hundreds of thousands of women to life-altering and avoidable cancer,” Burnside’s lawsuit states. “At the time the McGhan Breast Implants were placed into Carol Burnside’s body, she was not advised, nor did she have any independent knowledge, that the McGhan Breast Implants were anything other than safe, life-long products. Nor was she advised that the product was associated and/or known to cause BIA-ALCL.”
Last month, the FDA held a two-day hearing on breast implant safety and benefits, revealing that it has received tens of thousands of reports of breast implant complications.
Despite growing concerns, the panel of FDA advisers decided against recommending any breast implant recalls, indicating that it was too early to determine whether the risks were limited to specific breast implant designs.
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.