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Breast Implants Linked to Rare Cancer to Be Recalled By FDA
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Jul

26

The Food and Drug Administration is issuing a nationwide recall of textured breast implants manufactured by Allergan. The Allergan implants have been linked to an unusual form of cancer and will be facing a global recall at the wishes of the FDA.

Despite being banned in Europe as of late last year, the sale of Allergan devices continued across the United States. The sudden ban is based on the rapid increase in the number of cases and deaths associated with the rare form of cancer caused by Allergan devices.

According to the FDA, there have been 573 cases and 33 deaths worldwide. Out of those cases, 481 can be directly attributed to the Allergan Biocell implants. The data from the FDA’s study concludes that out of the 33 deaths, the specific type of implant was known across 13 of the cases, and out of those 13 implants, 12 were manufactured by Allergan.

The disease in question is called anaplastic large-cell lymphoma, which is a cancer of the immune system. The cancer itself, while not being breast cancer, forms around the site of the implant in the breast. Fortunately, if it is identified early enough, it can be removed surgically, curing most patients for life. However, if left untreated, it can quickly spread through a patient's immune system and kill them. The condition typically surfaces in implants used for reconstructive surgery following a mastectomy procedure. Despite the lymphoma being incredibly rare, there has been a steady rise in breast implant surgery in the United States. This increase has resulted in roughly 100,000 women receiving reconstructive surgery following mastectomy operations.

If you or a loved one have been affected by this recall, please do not hesitate to contact the team at Wallace and Graham and see how our expert litigation team can help you.

 

Sources: 

https://www.nytimes.com/2019/07/24/health/breast-implants-cancer-recall.html



https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma



https://www.allergan.com/news/news/thomson-reuters/allergan-voluntarily-recalls-biocell-textured-brea

 

https://www.plasticsurgery.org/news/blog/new-plastic-surgery-statistics-and-breast-reconstruction-trends

Drugs and Medical Devices, FDA Recall, medical Device Recall, US Food and Drug Administration (FDA)

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