FDA Won’t Ban Breast Implants Linked to Cancer

 

By Lynn Fugaro, Staff Writer

Recent news stories have revealed that certain breast implants placed during breast augmentation surgery have been linked a cancer of the immune system known as “breast implant-associated anaplastic large cell lymphoma” (BIA-ALCL). Anaplastic large cell lymphoma is a rare type of cancer that for many years has been estimated to affect only one in 500,000, but that statistic has changed. The number of cases of this type of cancer is on the rise, according to the Food and Drug Administration (FDA). ALCL usually develops in the lymph nodes, skin, lungs, or liver; however, ALCL sometimes develops in the breast area of women with breast implants, specifically, textured breast implants.

Trump’s FDA Says There’s No Justification to Banning the Implants

Textured implants have been banned in many other countries, but the FDA has decided to not ban the textured breast implants here in the U.S. According to an FDA spokesperson, even though the risk of cancer in textured implants has increased, it is still low and there “was not enough data to justify banning the implants.” The FDA reports that worldwide, there have been over 600 cases of the lymphoma and about 20 deaths attributed to BIA-ALCL. So, it’s not clear how many women have to die from BIA-ALCL before the Trump administration’s FDA will see these implants as a serious health risk.

There have been hundreds of cases of this deadly cancer reported thus far, and in 2019, it’s estimated that approximately 10 million women have implants worldwide, so the number of deaths could rise even higher. The textured implants in question are used for cosmetic breast enlargement or for reconstruction after a mastectomy for breast cancer. The statement by the FDA did acknowledge the fact that “in some women, implants may be associated with systemic problems called ‘breast implant illness,’ which includes a constellation of symptoms like chronic fatigue, pain, cognitive and immune problems.”

Timeline of ALCL and Breast Implants Link

The FDA first reported the link between ALCL and textured breast implants (mainly made by the company Allergen) in January of 2011. In 2013, researchers at the MD Anderson Cancer Center studied 60 women with breast implants who had been diagnosed with ALCL. Since ALCL was previously found in only one in 500,000 women, the new numbers are much higher than ever expected. In 2014, the National Comprehensive Cancer Network (NCCN), a nonprofit network of cancer experts, released an oncology standard for surgeons and oncologists worldwide to test for and diagnose BIA-ALCL.

It was not until March 2017 that the FDA finally updated its website to officially report that breast implants could cause ALCL. At the time of the FDA’s announcement in March 2017, it reported that it had received 359 reports of ALCL among women with breast implants.

No Longer “Safe”

For several decades, breast implant manufacturers, cosmetic surgeons, and the FDA assured women that breast implants were safe and would not cause cancer. Up until recently, a link to some types of cancer and autoimmune diseases, including provided by researchers at the National Cancer Institute, was completely dismissed.

If you have silicone or saline breast implants, please check with your surgeon to see if you’re at risk for BIA-ALCL. If you’re having any of the symptoms listed below, please contact your doctor immediately:

  • Lumps in the breast
  • Swelling or pain in the breast
  • Hardening of the area around the implants
  • Buildup of fluid around the implants

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