Allergan™ Breast Implant Recall 2019: Patient Information
Posted October 11, 2022 in Breast Implant Recall
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On July 24, 2019 Allergan™ announced a voluntary recall of all BIOCELL® textured breast implants.
The Food and Drug Administration (FDA) has long been studying the correlation between textured breast implants and the development of breast-implant associated anaplastic large-cell lymphoma (BIA-ALCL), a rare cancer dealing with the lymphatic system.
Textured surface implants are the only relevant products (smooth-surface implants are not affected).
The Allergan™ implant recall comes after a new study that states “… of the 573 unique cases of BIA-ALCL, 481 are attributed to (textured) Allergan implants.”
The report also states, “Of the 33 patient deaths the FDA is reporting today, 12 of the 13 patients for which the manufacturer of the implant is known, are confirmed to have an Allergan™ breast implant at the time of their BIA-ALCL diagnosis.”
The release of this statement has stimulated concern among women with these implants (the full list of recalled implants can be found here).
While worrying about your implants is a valid concern, it is important to understand the facts and know your options before you choose to remove your implants.
What Is BIA-ALCL?
BIA-ALCL is a cancer that develops in the scar tissue that forms after the implant or expander has been implanted in the chest; it is not breast cancer.
BIA-ALCL is often identified by an excessive amount of fluid buildup around the implant. This fluid causes swelling, lumps, and pain in the breast.
Fortunately, when discovered early enough, BIA-ALCL is treatable and often curable, by removing the breast implant and the surrounding capsule. You should be vigilant about your self-checkups and address any unexplainable changes in your breasts.
It is also important to remember that while the recent study does provide a link to BIA-ALCL and textured implants, there is no evidence linking smooth implants to this condition.
What Are Your Options?
As previously mentioned, this is a voluntary recall. The FDA is recommending that women only address their implants if they are experiencing any of the related symptoms.
You do have the option of keeping and closely monitoring your implants, removing and swapping the implants for a smooth set, or removing them permanently.
Breast Implant Removal Comes With Risks
Even with the new statistics, BIA-ALCL is extremely rare. Millions of women around the world have textured Allergan™ implants, and the vast majority of them never experience any complications.
If you are concerned and wish to have your implants removed, call Dr. Grazer to discuss you options.
Breast revision can remove the implant and the surrounding scar tissue capsule (where the cancer is known to develop).
While this surgery can often be performed using your initial breast augmentation incision, it is still surgery and requires anesthesia. Breast revision has the same risk as your initial surgery.
Have More Questions?
If you are concerned, contact Dr. Grazer today for a consultation to discuss your options. Call us at (949) 644-1240 or fill out our online contact form.