JUL 25, 2019 2:56 PM PDT

Textured Breast Implants Linked to Rare Cancer Recalled

WRITTEN BY: Tiffany Dazet

Yesterday, the U.S. Food and Drug Administration announced the recall of textured breast implants linked to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). According to the New York Times, BIA-ALCL is a rare cancer of the immune system. It impacts the tissue surrounding the implant but is not considered breast cancer. The manufacturer, Allergan, voluntarily recalled textured BIOCELL breast implants and tissue expanders worldwide. 

According to the press release from the FDA, a new global analysis reported 573 cases of BIA-ALCL with 33 patient deaths. Of these cases, 481 have Allergan breast implants. Thirty-six percent of the patient deaths occurred in those known to have Allergan breast implants. The FDA reports that textured breast implants are less common in the U.S. than other countries, representing less than 5% of all breast implants sold in the United States. For comparison, textured implants have made up as much as 80% of the implant market share in France, Canada, and Australia.

FDA Principal Deputy Commissioner Amy Abernathy stated, “Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health.” The FDA has been monitoring breast implant safety and associations with BIA-ALCL since the issue first came to light in 2011.

The FDA also released recommendations for those with Allergan BIOCELL breast implants. Because the risk of developing BIA-ALCL is considered low, they do not recommend removal if a patient is not showing symptoms. The FDA recommends monitoring the implant area for pain, swelling, and any other changes. Health care providers are to immediately halt the use of Allergan BIOCELL products and inform their patients about the risks of BIA-ALCL.

The video below is from earlier this month and is a summary of an advisory panel meeting on breast implant safety. The panel discussed BIA-ALCL as well as Breast Implant Illness (BII). Although currently there is no definitive evidence of BII, the FDA is working to gather information from patients and health care providers to monitor patient symptoms. 
 

Sources: FDA, New York Times, Header Image via FDA

About the Author
  • Tiffany grew up in Southern California, where she attended San Diego State University. She graduated with a degree in Biology with a marine emphasis, thanks to her love of the ocean and wildlife. With 13 years of science writing under her belt, she now works as a freelance writer in the Pacific Northwest.
You May Also Like
DEC 21, 2020
Cell & Molecular Biology
Mutagens May Be Having a Bigger Effect Than We Knew
DEC 21, 2020
Mutagens May Be Having a Bigger Effect Than We Knew
New research has suggested that our DNA is more susceptible to mutagenic influences than we've appreciated. While organi ...
DEC 24, 2020
Microbiology
A New, Infectious Strain of SARS-CoV-2 Emerges
DEC 24, 2020
A New, Infectious Strain of SARS-CoV-2 Emerges
The UK recently reported that it had detected a new variant of the SARS-CoV-2 pandemic virus, which causes COVID-19. Thi ...
JAN 10, 2021
Cell & Molecular Biology
A New Way to Defend Against Mosquito-Borne Viruses
JAN 10, 2021
A New Way to Defend Against Mosquito-Borne Viruses
Mosquitoes are killers; they are thought to be responsible for the deaths of millions of people every year because of th ...
JAN 12, 2021
Microbiology
Connecting Gut Microbes, Diet, and Health
JAN 12, 2021
Connecting Gut Microbes, Diet, and Health
Advances in genetic technologies have revolutionized biomedical research in recent years. One example is the discovery t ...
JAN 19, 2021
Immunology
How Breastfeeding improves Infants Immunity?
JAN 19, 2021
How Breastfeeding improves Infants Immunity?
Breastfeeding benefits are well known for ages, and it has many positive impacts on infant's lives that continue wit ...
JAN 18, 2021
Microbiology
Bacteria in Sediment is Likely Accelerating Greenland's Meltdown
JAN 18, 2021
Bacteria in Sediment is Likely Accelerating Greenland's Meltdown
For decades, scientists have been sounding the alarm about rising carbon dioxide levels in our planet's atmosphere, and ...
Loading Comments...