U.S. – August 25, 2020 – According to an online news report published on Fortune.com, the U.S. Food and Drug Administration (FDA) announced that three more women have passed away due to a rare, deadly type of cancer that has been linked to Allergan’s recalled breast implants. The tragic deaths all happened within just six months prior to the Allergan breast implant recall request, which the FDA executed on July 24, 2020.
The recalled implants associated with the rare form of cancer and subject to the recall are the “Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants” and the Allegan Tissue Expanders (Please refer to the affected, recalled products below or visit the FDA notice here.)
Allergan Tissue Expanders for use in breast augmentation and contain the BIOCELL texturing that was initially cleared, but are also part of the recall include:
- Natrelle 133 Plus Tissue Expander (K143354)
- Natrelle 133 Tissue Expander with Suture Tabs (K102806)
What is Breast Implant–Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)?
According to the FDA, at minimum, 36 women developed and passed away from “breast implant–associated anaplastic large cell lymphoma (BIA-ALCL).” BIA-ALCL is not a form of breast cancer. BIA-ALCL is a form of cancer that has only been linked with certain “textured” types of breast implants. Several companies manufacture “textured” implants, but the “textured” implants manufactured by Allergan has significantly harmed patients.
In July 2019, at least 33 women had passed away from BIA-ALCL. The FDA asked Allergan to voluntarily recall the company’s textured breast implants. However, women continue to be harmed by Allergan’s textured implants and tissue expanders announced in the July 2019 recall.
The news report claims that the current number of fatalities caused by BIA-ALCL is likely much more than 36. The news article suggests that the latest FDA data was made public in January, and the FDA received that information in the second half of 2019. The FDA did not explain the delay in publishing the data. The FDA did not publish the names of the three most recent victims in the agency’s fatal BIA-ALCL statistics.
Numerous wrongful death lawsuits have been filed against Allergan. Allergan recently filed a motion requesting that the court dismiss all BIOCELL breast implant and tissue expander BIA-ALCL cancer lawsuits on the grounds of federal preemption. The legal argument asserts that individual breast implant lawsuits may not be filed over a medical device that was already FDA approved.
The FDA has registered 160 new BIA-ALCL cases since August 2019. Of those, 139 BIA-ALCL cases were linked to the recalled Allergan implants. According to the FDA’s most recent information, over 733 women worldwide have developed the BIA-ALCL. The American Society of Plastic Surgeons, which recognizes 953 global cases of BIA-ALCL.
Textured breast implants manufactured by Johnson & Johnson, and Sientra, and other manufacturers were linked to some of the 953 BIA-ALCL cases. However, a majority of BIA-ALCL cases were linked to Allergan’s textured breast implants. The company made announcements to shareholders and investors regarding the potential for the BIA-ALCL disease to impact its business in 2011.
Allergan, Johnson & Johnson, and Sientra received FDA warning letters concerning their breast-implant business operations. The FDA stated that Allergan’s failure to investigate their textured implants’ long-term health impact was “unacceptable.” The FDA alleged that Allergan had not made an acceptable effort to find and warn thousands of women who have the recalled implants.
The FDA recently recognized about 2,500 new cases of “breast implant illness” or BII. BII is a disorder that includes numerous, severe symptoms but doesn’t have a clear diagnosis. Some of the symptoms include chronic fatigue, memory loss, and joint pain. Celebrity Ashley Tisdale indicated that she has been suffering many of these symptoms and has publicly discussed her decision to have her breast implants surgically removed.
Women who have textured breast implants have universally lamented over these severe symptoms for many years. Regulators and medical professionals are now taking these complaints more seriously. The FDA stated that the agency does not have conclusive evidence that demonstrates how breast implants cause these symptoms, but some patients experience relief from these systemic symptoms once their textured breast implants were removed.
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