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Following a diagnosis of anaplastic large cell lymphoma (ALCL), an Idaho woman has filed a lawsuit against Allergan, alleging that the rare cancer was caused by breast implants manufactured and sold by the company.
The complaint (PDF) was filed last week in the New Jersey Superior Court for Middlesex County by Kimra Rogers, and her husband, Robert, alleging that women and the medical community were not adequately warned about the risk of a ALCL cancer associated with the Inamed Silicone Breast Implants.
Rogers indicates that she underwent bilateral cosmetic breast implant surgery in 2000, but one of the implants ruptured and she was implanted with the Inamed implants manufactured by the Allegan subsidiary as replacements.
In April 2016, Rogers reports that she was diagnosed with a necrotic lymph node after experiencing swelling of the left breast. A month later, she underwent axillary lymphadenopathy, and an examination of the excised tissue led to a diagnosis of ALCL, which is a rare form of non-Hodgkins lymphoma that has been reported among many women who received breast implants.
Commonly referred to 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.
As a result of the breast implant ALCL cancer diagnosis, Rogers indicates that she has had to undergo six rounds of chemotherapy and 25 rounds of radiation treatment, resulting in her suffering fatigue, weight loss, oral sores, hospitalization, heartburn and loss of appetite.
According to allegations presented in the lawsuit, Allergan and its subsidiaries knew about the potential cancer risks years earlier, but failed to issue proper warnings.
“Allergan failed to report adverse events from the post market approval studies commissioned as part of the implant’s PMA approval, which would have led to reports suggesting the device’s contribution to serious injury, such as Plaintiff’s,” Rogers’ lawsuit states. “Had Defendants not intentionally failed to comply with their clearly-established post-market surveillance obligations, Mrs. Rogers would have decided against implantation and her injuries would not have occurred.”
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 lawsuits against Allergan and other manufacturers, for women diagnosed with anaplastic large cell lymphoma (ALCL) in recent years.