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At the request of the U.S. Food and Drug Administration (FDA), Allergan voluntarily recalled textured breast implants and expanders on July 26.
As a precaution, Allergan has recalled BIOCELL® textured breast implants and BIOCELL® textured tissue expanders after being notified about updated safety information concerning the uncommon incidence of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).
About the Recall
Breast augmentation continues to be the top cosmetic surgical procedure and has been since 2006, according to the American Society of Plastic Surgeons. However, the specific type of textured breast implants that the FDA suggested recalling represent less than 5% of the breast implants sold nationally.
This means about 95% of patients with implants in the U.S. do not have an implant that is included in the recall.
“Texturing refers to the outer shell of the implant and each manufacturer has a different texturing process,” said Dr. Richard Cashio, board certified plastic surgeon and chief of surgery at AdventHealth Palm Coast.
Currently, Allergan is the only the manufacturer the FDA asked to voluntarily recall implants, as the risk of developing BIA-ALCL with the Allergan BIOCELL textured implants is approximately six times the risk from other manufacturers in the U.S.
Mentor textured implants and expanders – another major manufacturer of breast implants in the U.S. – are currently not being recalled.
To see the full list of recalled products, see the FDA’s full announcement.
What is BIA-ALCL?
BIA-ALCL is not breast cancer, but rather, it is a type of rare cancer of the immune system.
At this time, the overall incidence of developing BIA-ALCL is considered to be low. Worldwide, less than 600 cases have been reported.
“Even though it isn’t common, a BIA-ALCL diagnosis is serious, especially if not diagnosed early or promptly treated,” Dr. Cashio said.
Across the globe, there have been 33 deaths, and 12 of those are confirmed to be related to these specific Allergan implants, he added.
In most cases, BIA-ALCL is found in the scar tissue and fluid surrounding the implant, but in some cases, it can spread throughout the body.
The main symptoms of BIA-ALCL are swelling or pain in the area of the implant, and on average, occurs about eight years after the implant was placed.
In most patients, BIA-ALCL is treated successfully with surgery to remove the implant and the scar tissue surrounding the implant. Some patients may also need chemotherapy and/or radiation therapy as additional treatment.
I Have Breast Implants. What Should I Do?
It is important to note that the FDA and other health authorities do not recommend removing or replacing textured breast implants or tissue expanders in patients who do not have any symptoms of BIA-ALCL. Currently, the recall only applies to implants and expanders that have not yet been implanted.
“If you have breast implants, it is important for you to review your implant card to learn your implant’s manufacturer and type,” Dr. Cashio said. “Patients should also be aware of the symptoms of BIA-ALCL and monitor the area around the breast implants, looking for any changes. If people experience any symptoms or changes, they should talk to their doctor right away.”