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256-340-5188
1206 Somerville Rd
Decatur, AL 35603

Breast Implant Associated Anaplastic Large Cell Lymphoma / BIA-ALCL

Overview
Breast Implant-Associated Anaplastic Large Cell Lymphoma or BIA-ALCL is a lymphoma cancer of the capsule, your body's biologic container around your implant. Therefore, it is not a cancer of the breast tissue itself.  It has become better understood over the past 5 years as more cases of the cancer have been identified and studied.  In the past 2 years, serious concerns about the causes and risks have become more clearly communicated.  But it is still a new disease and the entire plastic surgery surgical community and the implant manufacturers are trying to figure out the relationship to implants and formulate the best recommendations for patients with breast implants.

FDA
The recent analysis of information from known cases leads to textured surface implants being the main risk factor.  And in particular, the Allegan Biocell textured surface seems to have the most risk.  Therefore, as a precaution, and in agreement with the FDA, on July 24, 2019, Allergan asked all surgeons around the world to stop inserting implants with the Biocell surface and recalled all devices that were on the shelves in hospitals and doctors' offices.  This was done as a precaution.  The exact mechanism for textured surfaces causing the disease is NOT known at this time.  Implants with smooth outer surfaces do not seem to cause the risk of the disease.  

At the present time, the FDA is NOT recommending that it is necessary for women with Biocell implants to have them removed or exchanged.  For those women, the FDA is only recommending routine breast exams and mammograms and being aware of the possible presenting signs of BIA-ALCL.  The presenting signs of BIA-ALCL can be breast swelling or fluid collection causing breast asymmetry (70%), lumps in the breast (20%) or lymph node in the armpit (5%), pain, redness or rash (rare).  The most common presenting symptom is breast swelling due to fluid around the implant.

Present Data
With the women who have been diagnosed with BIA-ALCL the average time for the disease to occur is about 10 years from the time of implantation (range 1 to 27 years). I have been using Biocell textured implants in my practice for over 25 years and I have never had a patient, that I am aware of, develop the disease.  However, a year ago a stopped using textured implants because of the new information that was becoming available about the disease.

The overall lifetime predicted risk, with the data available now, is low but covers a wide range.  From 1:443 to 1:3,300 in women with Biocell implants, to 1:30,000 when all textures implants are lumped together in the data analysis.  Put this into perspective by considering the breast cancer risk in women is 1:7 to 1:8 women.

There have been just over 700 cases of BIA-ALCL reported worldwide.  There have been about 33 deaths due to the disease reported worldwide.

Early diagnosis by recognizing one of the presenting symptoms listed above is important.  To repeat, these are, breast swelling or fluid collection causing breast asymmetry (70%), lumps in the breast (20%) or lymph node in the arm pit (5%), pain, redness or rash (rare).  When found early the treatment is 100% capsule removal and implant removal and the disease can be cured. Missed disease or neglected disease can become more severe, spread through the body and at that point would be treated like a lymphoma requiring chemotherapy and possibly radiation therapy.  The procedures to confirm the diagnosis include a special test on the fluid around the implant to look for a marker called CD30 immunohistochemistry.  Other lumps, masses or swollen lymph nodes would be surgically biopsied.  There is not a simple blood test to screen for the disease.  If a positive diagnosis is obtained a referral to an oncologist would be made and a PET-CT scan would be obtained.

Current Status For Patients To Consider
All of my breast implant patients are encouraged to make an appointment to come to the office and discuss the issues regarding breast implants and allow me to questions about their care.

Other patients who have implants and would like to see me are encouraged to make an appointment to come to my office and discuss the issues. 256-340-5188

Previous breast cancer patientswho have had a reconstruction are obviously worried about any risk of having a second cancer and I am very sensitive to that.  I know that the local oncolgists have been suggesting that their breast cancer patients with textured implants have them exchanged to smooth walled implants. Obviously, the oncologists do not want to treat these patients for a lymphoma.  Exchanging implants is an easy thing for me to do, with low surgical risk, but the data we have right not does not stongly support this.  Also, in a routine implant exchange there is no evidence to support the added surgical risk of performing a total capsulectomy.  Furthermore, although it seems logical that changing to a smooth-walled implant decreases the risk, the risk reduction benefit is unknown and not something that can be calculated.  But it is clearly a patient's decision and I have already been doing exchanges for my breast recontruction patients.  So I will do the surgery if they decide they want to do it.  At this point, the insurance companies have been approving and paying for the exchange.

Previous cosmetic augmentation patients have all of the same considerations; they can do a simple exchange to smooth walled implants, there is no know benefit with doing a complete capsulectomy at the time of the exchange and although logic would say that changing to smooth-walled implants would decrease the risk, this potential decrease cannot be calculated at this time.  There will also be associated fees to redo the breast augmentation since this will not be an insurance covered case.  **However, through July 24, 2021, Allergan will give the patient a smooth walled set of implants at the same size at no charge.**

The American Society of Plastic Surgery has patient information available about this problem and that information can be found at this link. Tap Here

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