The Food and Drug Administration requested that Allergan, a company that manufactures textured breast implants, voluntarily recall the devices on Wednesday, based on their link to an unusual form of cancer.
Why it matters: 573 cases and 33 deaths from anaplastic large cell lymphoma have been reported around the world, according to FDA data. Of the 573 cases, 481 have been attributed to the Allergan product.
Anaplastic large cell lymphoma is a cancer that affects the immune system. It is not breast cancer, but forms around the tissue of the implant.
- Of note: Women who have these implants, but go undiagnosed, should not have them removed. The recall is to only stop doctors from further using the implants.
- Symptoms include swelling and pain around the breasts. Fluid accumulation around the implant can also occur and should be drained and tested for cancer if symptoms persist, per the FDA.
- Taking out the implant and scar tissue can cure the cancer. The disease can be fatal if not detected early enough.
The big picture: Textured implants account for only about 5% of the implants used in the U.S. The product is more common in Europe, where it has already been recalled in many countries, the New York Times reports.
Allergan told the FDA it will remove BioCell textured breast implants and tissue expanders from the markets in which they're sold.
- A list of those models can be found here.