Certain breast implants have been linked to a rare form of cancer called anaplastic large cell lymphoma (ALCL). According to the U.S. Food & Drug Administration (FDA), breast implant cancer has claimed the lives of at least 33 women, 12 of whom are known to have received Allergan’s Biocell textured breast implants.
Allergan agreed to recall Biocell breast implants July 2019, after the FDA concluded that those specific devices “appeared to be directly linked to significant patient harm.”
The nationwide law firm of Bernstein Liebhard LLP is investigating breast implant lawsuits on behalf of patients who were diagnosed with anaplastic large cell lymphoma (ALCL) in the wake of breast augmentation or reconstruction surgery. If you or someone you love received breast implants, especially Allergan’s textured Biocell breast implants, and were later diagnosed with this rare cancer, please call (888) 994-5118 to discuss your potential case with one of our attorneys today.
The FDA first warned of a possible link between breast implants and ALCL in 2011. At the time, the agency asked all breast implant manufacturers to update their product labeling to include this possible risk. Doctors were also asked to pay particular attention to patients who presented with fluid around their implant. However, the FDA was unable to determine what factors increased risk for the disease due to the limited number of cases reported up until that point.
By March 2017, the FDA had received 359 reports of ALCL in breast implant patients, including nine deaths.
“All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants,” the FDA reported in an updated alert.
Most cases of breast implant cancer occurred in women who had textured, rather than smooth devices. Of the 231 reports to the FDA that contained information about the implant, 203 had textured surfaces. 312 of the 359 reports included information on implant fill types. Of these, 186 reported implants filled with silicone gel and 126 reported implants filled with saline. Read More
By July 2019, more than two dozen countries, including Canada, France, and Australia, had ordered breast implant recalls for Allergan’s Biocell textured devices due to their association with ALCL. Allergan announced a worldwide Biocell breast implant recall that month, following a request from the FDA.
By that time, the agency had identified 573 cases of breast implant-associated ALCL, including 116 that had been reported since February 2019. According to the FDA, 481 cases were known to have involved Allergan Biocell textured breast implants.
At least 33 deaths were attributed to breast implant cancer. Of the 13 deaths in which the FDA identified a manufacturer, 12 involved Allergan breast implants.
The agency’s analysis indicated the risk for breast implant-associated ALCL with Allergan BIOCELL textured implants is about six times greater than the risk with textured implants from other manufacturers marketing their products in the United States.
It is important to note that ALCL is NOT breast cancer. It is a rare form of non-Hodgkins lymphoma that affects the cells of the immune system. In patients with implants, the cancer occurs in the breast, usually in scar tissue around the implant. However, ALCL can also occur in the skin or lymph nodes.
Symptoms of ALCL breast implant cancer may include:
ALCL can occur years after breast implant surgery. The cancer is generally slow growing, and is treatable if detected early. Patients with confirmed breast implant-associated ALCL should undergo implant removal and removal of the surrounding scar capsule, which is a more extensive operation than implant removal alone
At this time, the FDA is not recommending that women have Biocell breast implant removed if they’re not experiencing symptoms. However, they should continue monitoring the area around their breast implants and report any changes to their doctor.
Bernstein Liebhard LLP is now offering free, no-obligation legal reviews to alleged victims of breast implant cancer. If you or a loved one were diagnosed with ALCL following breast implant surgery, please call (888) 994-5118 to ensure that your legal rights are protected.
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