Here at The Parker Center, one of our primary goals is ensuring our patients are well-informed and up-to-date on medical news that is pertinent to their safety. Yesterday, July 24, 2019, the FDA and breast implant manufacturer Allergan announced a voluntary recall of all Allergan BIOCELL textured breast implants.
Understandably, this news has led to many of our patients reaching out to make sure they are safe and unaffected by this recall. Before we get into the specifics of BIA-ALCL, the Allergan recall, and what it means for you, we want to remind and reassure our patients that the Parker Center for Plastic Surgery does not use textured breast implants for breast augmentation. We only offer smooth, round breast implants from Mentor to our patients, based on their record of safety.
What is BIA-ALCL?
Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a very rare form of non-Hodgkin’s lymphoma that specifically develops in the capsule of breast tissue surrounding breast implants. It is not a form of breast cancer or cancer of the breast tissue itself.
To date, the FDA reports 573 unique cases of confirmed BIA-ALCL and 33 fatalities worldwide. When diagnosed early, BIA-ALCL is curable through the removal of the breast implant and implant capsule without recurrence of the disease.
Why were Allergan textured breast implants recalled?
The FDA, plastic surgery-related organizations, and individual researchers have been monitoring instances of BIA-ALCL since 2010. Over that course of time, the prevailing theory is that certain manufacturing processes used to texturize breast implants increase the risk of developing BIA-ALCL—an overwhelming majority of confirmed BIA-ALCL cases were found in patients who currently have textured breast implants or have had textured implants at one point in their lives.
Through further study and research, a trend emerged: in BIA-ALCL incident reports where the manufacturer of the implant was known, most cases involved patients who have or have had textured breast implants with a high surface area, such as Allergan BIOCELL textured breast implants.
After further monitoring, the FDA requested that Allergan voluntarily cease sales of BIOCELL textured implants and recommended that surgeons no longer implant these devices during breast augmentation.
Do I need to have my Allergan breast implants removed?
As of July 2019, the FDA does not recommend having Allergan textured breast implants removed if you are asymptomatic. This is because BIA-ALCL is a rare condition that has impacted only a very small percentage of women with breast implants, even among those with BIOCELL implants. Thus breast implant removal surgery is likely unnecessary if you are happy with your appearance and have no symptoms.
If you do notice any unexplained breast swelling or other symptoms, it’s important to inform your primary physician or board certified plastic surgeon. Properly diagnosing any breast augmentation complication is crucial to ensuring your health and happiness.
If you have any concerns or want to learn more about safe options for breast augmentation, or are considering implant removal, please contact my office.