5 Things Dr. Brian Reedy Wants You to Know About the Allergan Recall of Textured Breast Implants
If you have breast implants or have been considering breast augmentation, you’ve likely come across some scary headlines about a textured breast implant recall last week. On July 24th, 2019, Allergan voluntarily recalled all of their BIOCELL textured breast implants in response to a request from the FDA. This move was prompted by growing evidence that the texturizing process used for some breast implants leads to an increased risk of developing BIA-ALCL.
The decision is big news for plastic surgeons and breast augmentation patients alike—though the quick announcement and confusing news reports resulted in many people wondering what it all means. While I have rarely used textured implants in my own practice (and never for cosmetic patients), as a service to the public I want to better explain Allergan’s decision, including what the implant recall means to patients.
1. 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 scar tissue that naturally forms around breast implants, not in the lymph nodes. BIA-ALCL is not breast cancer as it is not a cancer of the breast tissue.
When detected early, BIA-ALCL is curable through removal of the breast implant, surrounding scar tissue capsule, and the cells inside this capsule.
While any loss of life or cancer diagnosis is heartbreaking, your risk of developing BIA-ALCL is exceedingly low. To date, the FDA reports 573 confirmed cases of BIA-ALCL and 33 fatalities worldwide (among ~10 million women with breast implants). The current lifetime risk of developing BIA-ALCL is approximately 1 in 3,817 to 1 in 30,000 women with textured breast impalnts. Compare this with the lifetime risk of developing breast cancer, which is, unfortunately, 1 in 8.
2. The recall does not affect those who currently have Allergan’s textured breast implants
Before getting into the specifics of this decision from Allergan, I wanted to clear up something that is understandably leading to a lot of anxiety and confusion among patients. Typically, when we hear news of a “recall,” it prompts action on our part—we throw away the frozen spinach in the fridge, take our car in to get serviced, or return a hygiene product to the store. This mentality has many women asking themselves, “do I need to have my textured breast implants removed?”
Allergan’s recall does not require you to have your breast implants removed if you do not have any symptoms. Rather, they are recalling BIOCELL textured implants from physician practices, and surgeons will no longer use these breast implants for new patients.
If you have textured breast implants, are happy with your look, and haven’t noticed any strange symptoms, we—along with the FDA—do not recommend scheduling explantation surgery. Because the risk of developing BIA-ALCL is so very low, removing your breast implants if you have not been diagnosed with BIA-ALCL may cause unnecessary trauma to your body.
That being said, if you no longer wish to have your breast implants, I’m happy to discuss your breast implant removal options during a consultation.
3. What breast implants were recalled?
Allergan has recalled all of their BIOCELL textured breast implants and tissue expanders, including:
- Natrelle Saline-Filled Breast Implants (Styles 163, 168, 363, and 468)
- Natrelle Silicone-Filled Textured Breast Implants (Styles 110, 115, 120, TRL, TRLP, TRM, TRF, TRX, TCL, TCLP, TCM, TCF, TCX, TSL, TSLP, TSM, TSF, and TSX)
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
- Natrelle 133 Plus Tissue Expander
- Natrelle 133 Tissue Expander with Suture Tabs
Allergan’s line of smooth Natrelle and Microcell breast implants have not been recalled.
4. High surface area textured implants may increase your risk for BIA-ALCL
The decision to remove these breast implants from the market was prompted by in-depth review of medical device reports submitted to the FDA showing that most confirmed cases of BIA-ALCL occured in patients who have or have had textured breast implants at one point in their lives. Further research has indicated that high surface area textured implants specifically increase risk of BIA-ALCL.
While Allergan is front and center of this recent development, as more research emerges and we learn more about BIA-ALCL, it’s possible we will see other textured implants taken off of the market.
5. We only use smooth breast implants for cosmetic patients
For my cosmetic patients, I have always used and preferred smooth-walled breast implants. I believe smooth implants provide the most natural look, feel, and movement for patients, so I do not use or offer textured breast implants in my cosmetic practice.
That being said, I have used textured breast implants for certain breast reconstruction patients. For patients with little-to-no breast tissue after mastectomy, textured breast implants tend to provide a more optimal result in addition to preventing too much movement within the breast cavity. I will be directly reaching out to my breast reconstruction patients to discuss the recall but want to reiterate here that, per the FDA, if you do not have any symptoms, you do not need to have your textured breast implants removed.
If you have any questions or concerns, please do not hesitate to contact my office.