September 9th, 2019
Here are some of the most frequently asked questions we hear from our patients regarding Breast Implant Associated Anaplastic Large Cell Lymphoma.
WHAT IS BIA-ALCL?
BIA-ALCL is a rare spectrum of disease that has been linked to textured breast implants. It can range from a painless fluid collection around the implant to a form of lymphoma when diagnosis is delayed. This disease is currently classified as a lymphoma, but is thought by many experts to be a spectrum of lymphoproliferative disease. The spectrum ranges from benign CD30+ seromas to malignant CD30+ seromas to invasive disease of the implant capsule. Very rare cases of metastasis have been reported with delays in diagnosis.
Current research is ongoing to further understand this disorder.
BIA-ALCL is highly treatable with high cure rates.
WHAT ARE THE SYMPTOMS OF BIA-ALCL?
Significant, rapid swelling of the breast (over a period of days or weeks) is usually the first symptom of BIA-ALCL. Typically, this occurs at an average of 8 years after implantation (range: 2-28 years). Other presenting symptoms include a lump in the breast or armpit, firmness of the breast, or pain.
BIA-ALCL is usually easily and completely treated if patients see their doctor when symptoms first arise.
IF A PATIENT BEGINS TO EXPERIENCE SYMPTOMS AND SEES HER PLASTIC SURGEON, WILL SHE BE CURED IF BIA-ALCL IS DISCOVERED:
This is an “it depends” type of answer. Most of the time, patients see their plastic surgeon immediately when they develop breast swelling with an implant in place. In these cases, the disease is nearly always caught early and cured with a straightforward procedure (removal of the implant and the implant capsule).
The disease advances in some cases in women who ignored earlier symptoms or saw a physician (or urgent care clinic, or “physician extender”) who did not properly diagnose them.
WHAT IS THE RISK OF DEVELOPING BIA-ALCL?
The FDA reports that the risk of developing BIA-ALCL is between 1:3,817 and 1:30,000; this is accurate as of this writing (July 2019).
As of July of 2019, there appears to be no risk of developing BIA-ALCL if the surface of the implant is smooth; only textured implants (both round and shaped) have been present in cases where BIA-ALCL has developed. All textured implant types and implant manufacturers have had cases reported to the FDA. As the implant texturing gets more aggressive (the surface of the implant is rougher), the incidence increases.
WHY DOES BIA-ALCL ONLY DEVELOP IN PATIENTS WITH TEXTURED IMPLANTS?
The exact answer is not known, but to date (as of July 2019), no cases of BIA-ALCL have been found in patients with smooth implants. It appears that the common final pathway in the development of BIA-ALCL is chronic inflammation, which leads to the proliferation of lymphocytes and ultimate mutation to disorganized cell lines (which is what cancer ultimately is). Genetic factors may play a role in the development of BIA-ALCL, and current research is looking into what role genetics play in the development of the disease.
There are several theories around the development of BIA-ALCL in patients with textured implants:
- Increased surface area around the implant allows for higher bacterial numbers around an implant (not necessarily leading to infection), which creates a biofilm and results in chronic inflammation.
- Microscopic “shedding” of silicone leads to chronic inflammation.
- Chronic mechanical irritation from the placement of a textured implant under the pectoral muscle (which is where most surgeons place these devices) leads to chronic inflammation. I personally feel that this is theory the most likely explanation for the development of BIA-ALCL.
There are 4 factors that seem to be required for the development of BIA-ALCL, given our current understanding of the disease:
- Textured implants
- Chronic inflammation
- Genetic predisposition
DOES IT MATTER IF THE IMPLANTS ARE SILICONE OR SALINE?
No. It seems that the only factor that is related to the development of BIA-ALCL is the suface of the implant, not what the implant is filled with. Both silicone and saline filled implants have been found in reported cases of BIA-ALCL.
I HAVE BREAST IMPLANTS AND AM WORRIED ABOUT DEVELOPING BIA-ALCL. WHAT DO I DO?
First, remember how rare BIA-ALCL is. Given the current statistics, for women with textured breast implants (the only women with implants who are at risk of developing this rare disease), you are 300 times more likely to develop breast cancer than you are to develop BIA-ALCL.
For this reason, both the ASAPS and the ASERF emphasize that the most important thing you can do is screen yourself for breast cancer with monthly self-exam, a regular physical examination by your physician, and screening mammograms/ultrasounds/MRI as recommended by your doctor.
Regardless of BIA-ALCL, all women with breast implants should see their plastic surgeon immediately if they notice a change in shape, size, or feel of their breasts.
HOW IS BIA-ALCL DIAGNOSED?
If a woman develops swelling in an augmented breast, she should undergo an ultrasound. If fluid is detected, it should be drained and sent for a) cytology and b) CD30. It is important to remember that the majority of fluid collections around a breast implant are benign and are not representative of BIA-ALCL.
CD30 is NOT diagnostic of BIA-ALCL, but is a marker for activated T-cells.
Positive CD30 and negative cytology should be treated with implant removal and capsulectomy, as it may represent “early” BIA-ALCL, or pre-BIA-ALCL.
Negative CD30 and negative cytology should be treated as a benign seroma and managed according to your surgeon’s individual protocol.
Management of all peri-implant fluid collections should be done by board-certified plastic surgeons.
HOW IS BIA-ALCL TREATED AND WHAT IS THE PROGNOSIS?
Current recommendations for treatment of BIA-ALCL are removal of bilateral breast implants with total capsulectomy, which is a very common procedure. It is identical to the procedure performed when a breast implant has ruptured or when a significant capsular contracture has developed.
The implants can then be replaced with a smooth implant, or the patient can choose not to have implants replaced at all – this is up to you as a patient after discussion with your plastic surgeon.
The majority of patients will be cured by implant removal and capsulectomy; advanced cases may require chemotherapy and radiation treatment, but this is uncommon for this disease.
I HAVE TEXTURED IMPLANTS! SHOULD I HAVE MY IMPLANTS REMOVED??
As of August 2019, neither the FDA nor any plastic surgery society recommends that patients with textured implants remove their implants as a “preventative” measure. However, some women are concerned about the remote possibility of developing BIA-ALCL and choose to have their implants removed.
Current recommendations by both the FDA and ASAPS indicate that women with textured implants who are not experiencing signs and symptoms of BIA-ALCL should not do anything different and that implant removal is not recommended.
SHOULD ALL WOMEN WITH BREAST IMPLANTS BE SCREENED FOR BIA-ALCL?
Currently, there is no screening test for BIA-ALCL. The current expert opinions are that women without symptoms do not require more than routine mammograms and breast exams.
If a patient experiences a change in their breasts, especially if there is a new mass or significant swelling, she should undergo an immediate examination by a plastic surgeon and appropriate imaging should be obtained. Any fluid around an implant should be evaluated.