Why a type of breast implant was pulled off the market, what worried patients need to know

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KNOXVILLE, Tenn. (WATE) – An estimated 10 million women in the United States have breast implants. A change recommended by the U.S. Food and Drug Administration aims to make the common procedure even safer for patients across the country.

In an announcement Wednesday, the agency said it asked Allergen to recall its biocell textured breast implants and tissue expanders. Allergen agreed. Now, surgeons are directed not to sue them and return any leftover inventory.


The type of implant
Before we dig into why they recommended the change, let’s start here:

There are two types of breast implants, smooth and textured. As we previously reported, textured implants are sometimes preferred because their shape and it reduces the risk of a capsular contracture, which can occure in smooth implants.

The textured implant is also the type the FDA has been looking at for a link to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). ALCL is a type of Non-Hodgkin’s Lymphoma, which is a cancer of the immune system.


The research
The FDA made the request after finding 116 new cases of ALCL since its last update in February.

The total number of ALCL cases, linked to breast implants, sits at 573. Four-hundred, eighty-one of those cases are reported in patients with the implants that have now been recalled.

The math, according to the FDA, means this specific Allergen implant carries six times the risk of other textured implants.

Textured implants, altogether, make up 10% of augmentations nationally. Allergan implants, and other Allergan-like implants, make up fewer than 5%. A source locally confirms just one surgeon in our area uses this specific brand of implant.

If you think you could have this type of textured implant, don’t panic.

In February, the FDA reported the ALCL risk in patients with textured breast implants to be 1 in 3,818 to 1 in 30,000. But, BIA-ALCL can be serious, even deadly, especially if it’s not diagnosed early or treated quickly.

Most ALCL cases occur many years after implants are placed.

What you need to know if you’re concerned with your odds:

  • Know who made your implant and the model
  • Because of the low ALCL risk, the FDA doesn’t recommend you remove your implants
  • If you have questions, talk to your doctor
  • Know your body, look for any swelling or pain near the implant and monitor any changes

Kamilia Kozlowskii, Medical Director with the Knoxville Comprehensive Breast Center, says because ALCL is detected by the fluid surrounding an implant, you should get an ultrasound with your mammogram each year, if you have implants.

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