July 25, 2019
In February, health officials began notifying and warning the public that a rare cancer, anaplastic large cell lymphoma or BIA-ALCL, was linked to a certain type of textured breast implant. Now, those potentially harmful implants have finally been recalled.
Allergan, which manufactures Biocell textured breast implants and tissue expanders, announced a voluntary recall Wednesday of all Biocell products worldwide. The U.S. Food and Drug Administration had requested the recall earlier in the day.
An FDA analysis of the implants and expanders found that 573 BIA-ALCL global cases have been reported, and 481, or 84 percent of those were linked to Allergan implants. Further, of the 33 deaths from the rare cancer, 12 of the 13 deaths in which the breast implant manufacturer was known, were patients with implants made by Allergan.
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If you have the recalled implants or expanders in your body, you may be wondering what to do. According to Allergan's recall notice, the “FDA and other health authorities have not recommended removal or replacement of textured breast implants or tissue expanders in asymptomatic patients.”
“We understand that today’s news may be alarming to some patients with breast implants. In the safety communication issued today, we’re providing actionable information for individuals with specific breast implants and their health care professionals," said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. The FDA does not recommend removal for patients without symptoms due to potential risks, but we provide helpful information for patients and providers to consider when discussing next steps."
Textured breast implants are not as common in the United States as they are in other countries, the FDA noted.
The safety communication outlines the exact products affected by the recall, information about the cancer, recommendations for those who currently have Biocell breast implants and recommendations for health care providers.
BIA-ALCL is not a form of breast cancer, the FDA notes. Rather, it is form of non-Hodgkin’s lymphoma — a cancer of the immune system — and is found in the scar tissue and fluid surrounding the implant. The diagnosis of this rare cancer is serious and can lead to death, but is generally treated successfully with surgery.
The recall covers the following products: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. It also includes tissue expanders used by patients prior to breast augmentation or reconstruction, including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.