Getting the facts on BIA-ALCL, associated risk, and treatment
Breast implant safety has been discussed with a growing frequency in recent years, as we learn more information about a rare condition called Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). News about this form of non-Hodgkins lymphoma has understandably led many patients with implants to feel concern over their own health or question whether or not they should have their implants removed.
To help breast augmentation patients in Honolulu and beyond, Dr. Schlesinger has answered some of the most common questions he receives about BIA-ALCL.
- What is BIA-ALCL?
- What is the risk of developing BIA-ALCL?
- What causes BIA-ALCL?
- Why did Allergan recall BIOCELL textured breast implants?
- Will Allergan pay for BIOCELL textured implant removal?
- Should I have my textured breast implants removed?
- How do I know if I have BIA-ALCL?
- What do I do if I suspect I have BIA-ALCL?
What is BIA-ALCL?
BIA-ALCL is an extremely rare form of lymphoma that develops specifically in the tissue surrounding breast implants. It develops when there is a buildup of abnormal T-cells and impacts the immune system. Unlike other forms of ALCL, BIA-ALCL does not originate in the lymph nodes, though in rare cases, it can spread if left untreated.
BIA-ALCL is not a form of breast cancer and typically does not require the removal of natural breast tissues.
What is the risk of developing BIA-ALCL?
The risk of developing BIA-ALCL is incredibly low. According to the FDA medical device reports (MDRs), there is an estimated total of 573 unique cases of BIA-ALCL worldwide with approximately 33 global fatalities. These numbers were determined through a comprehensive analysis of submitted reports from physicians and patients to determine unique, confirmed cases. 457 of these cases are in the United States.
Currently, the estimated lifetime risk of developing BIA-ALCL is estimated to be between 1 in 30,000 across all textured implant manufacturers. This would put an individual’s lifetime risk at ~.003%. When you look at Allergan BIOCELL textured breast implants specifically, women with this particular style of breast implant or tissue expander has a lifetime risk of 1 in 2,207, or .045%.
Let’s put these numbers in perspective:
In 2018 alone, over 1.8 million patients had breast augmentation worldwide—and this number has remained consistently high for many years. Additionally, it is estimated that more than 35 million women have or have had textured breast implants.
What causes BIA-ALCL?
While there have been a few theories circulating, studies strongly indicate that certain types of textured implants increase the risk of developing BIA-ALCL. Of the analyzed MDRs, an overwhelming majority of confirmed cases occurred in patients who currently have or have had textured breast implants.
Further study suggests that the specific texturization process used can impact the risk, with high surface area textured implants posing the greatest risk. In fact, BIOCELL textured breast implants in particular are 14.11 times more likely to lead to BIA-ALCL.
This information prompted a recall of Allergan’s BIOCELL textured breast implants.
In July 2019, implant manufacturer Allergan voluntarily recalled their BIOCELL textured breast implants at the request of the FDA. This recall does not impact patients who have these implants but rather prevents future manufacturing and selling of the following styles:
- Natrelle saline breast implant styles 168, 363, 468
- Natrelle and McGhan 410 breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
- Natrelle and McGhan 410 Soft Touch breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
- Natrelle 510 Dual-Gel styles LX, MX, FX
- Natrelle Inspira breast implants, styles TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, TCX
- Natrelle and McGhan Round Gel Implants, styles 110, 110 Soft Touch, 120, 120 Soft Touch
- Natrelle Komuro breast implants styles KML, KMM, KLL, and KLM
- Natrelle Ritz Princess breast implant styles RML, RMM, RFL, RFM
- Natrelle 150 Full Height and Short Height double lumen implants
- Natrelle 133 tissue expanders with and without suture tabs: styles 133FV, 133MV, 133LV, 133MX, 133SX, 133SV, T-133FV, T-133MV, T-133LV, T-133MX, T-133SX, T-133SV, 133FV-T, 133MV-T, 133LV-T, 133MX-T, 133SX-T, 133SV-T
- Natrelle 133 Plus tissue expander styles 133P-FV, 133P-MV, 133P-LV, 133P-MX, 133P-SX, 133P-SV, T-133P-FV, T-133P-MV, T-133P-LV, T-133P-MX, T-133P-SX, T-133P-SV, 133P-FV-T, 133P-MV-T, 133P-LV-T, 133P-MX-T, 133P-SX-T, 133P-SV-T
The recall is in effect for only the above styles of BIOCELL textured implants and tissue expanders; smooth Natrelle and Microcell implants in the Allergan line were not recalled.
Will Allergan pay for textured breast implant removal?
In conjunction with the recall of BIOCELL textured breast implants, Allergan announced the BIOCELL Replacement Warranty for patients who currently have BIOCELL textured implants. Because the FDA does not recommend removal of implants outside of a BIA-ALCL diagnosis, the Allergan BIOCELL warranty does not cover surgical fees.
Here is what the warranty states: “For patients in the U.S. who, as a result of the recall announcement on July 24, 2019, choose to replace their BIOCELL® textured devices with smooth devices in consultation with their plastic surgeon, Allergan will provide Allergan smooth device replacements for free. The program will run for 24 months, until July 24, 2021, and will apply to revision surgeries on or after the date of the recall announcement, July 24, 2019.”
For those who have been diagnosed with BIA-ALCL, your insurance company will likely provide some level of coverage for the removal of your implants, oncological care, and any additional medical expenses. In addition to this, Allergan will provide reimbursement of up to $1,000 in diagnostic fees and up to $7,500 in surgical fees related to the diagnosis and treatment of BIA-ALCL.
Should I have my textured breast implants removed?
News of this Allergan recall understandably left patients with BIOCELL textured implants concerned. However, the FDA does not currently recommend prophylactic removal of textured breast implants if you have not been diagnosed with BIA-ALCL or exhibit symptoms of the condition because the risk of developing BIA-ALCL is so low.
While Dr. Schlesinger agrees that an unnecessary procedure can be potentially traumatic to your body, he also understands how scary this news can be and encourages patients with concerns to reach out to him directly. Ultimately, it is your body, and if you are no longer happy with your breast implants, Dr. Schlesinger can safely remove them.
How do I know if I have BIA-ALCL?
While there are specific symptoms that present with BIA-ALCL, Dr. Schlesinger encourages patients to schedule an appointment with their physician if anything feels off or wrong with your breast implants. Early detection is important for many complications and conditions—and ruling out potential problems can help keep you healthy and put your mind at ease.
The most common symptoms reported by patients with BIA-ALCL include:
- Breast pain
- Swelling or excess fluid accumulation around the implant
- Rash on the skin of the breast
- Lump around the implant
A number of these symptoms may also indicate issues other than BIA-ALCL, including capsular contracture or even a low-grade infection. That why we recommend patients avoid jumping to conclusions and contact their primary care doctor or a board certified plastic surgeon for a check-up. They can identify any underlying issues, completed necessary diagnostic testing, and determine the best treatment plan.
What do I do if I suspect I have BIA-ALCL?
If you have noticed any of the above symptoms, your first step is to contact your doctor. They will perform a physical examination and may recommend imaging with ultrasound or MRI to see if there is any fluid buildup around the breast implant. If fluid or a mass has been discovered, your doctor will order a needle biopsy to test for CD30 immune staining to determine if BIA-ALCL is present.
If tests come back positive, you will be scheduled for a full excision of your breast implant and the surrounding capsule of scar tissue. Your surgical team will include your plastic surgeon, oncologists, and pathologists per the National Comprehensive Cancer Network’s BIA-ALCL treatment recommendations.
If you have any questions about BIA-ALCL, suspect a problem with your breast implants, or want to discuss implant removal, please contact us to schedule a consultation with Dr. Schlesinger.
Federal Drug Administration Medical Device Reports & documentation related to BIA-ALCL; https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma , https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl
American Society of Plastic Surgeons BIA-ALCL Resources; https://www.plasticsurgery.org/for-medical-professionals/health-policy/bia-alcl-physician-resources/by-the-numbers , https://www.plasticsurgery.org/patient-safety/breast-implant-safety/bia-alcl-summary
International Society of Aesthetic Plastic Surgery cosmetic surgery statistics, 2018; https://www.isaps.org/wp-content/uploads/2019/12/ISAPS-Global-Survey-Results-2018-new.pdf
Plastic and Reconstructive Surgery Journal, “Breast Implant-Associated Anaplastic Large Cell Lymphoma in Australia and New Zealand: High-Surface-Area Textured Implants Associated with Increased Risk”; https://journals.lww.com/plasreconsurg/Abstract/2017/10000/Breast_Implant_Associated_Anaplastic_Large_Cell.1.aspx
Aesthetic Surgery Journal, “2019 NCCN Consensus Guidelines on the Diagnosis and Treatment of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL); https://academic.oup.com/asj/article/39/Supplement_1/S3/5304919