1206 Somerville Rd
Decatur, AL 35603
Breast Implant-Associated Anaplastic Large Cell Lymphoma or BIA-ALCL is a lymphoma cancer of the fluid around an implant and its 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.
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 doctor's offices. This was done as a precaution. The exact mechanism for textured surfaces causing the disease is NOT known at this time. The mechanism may be simple inflammation, due to a bacterial contamination or a genetic risk in the individual patient. 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 women with breast implants, 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 are most often breast swelling or fluid collection causing breast asymmetry (70%), lumps in the breast related to the capsule (20%) or lymph node in the armpit, distant lesion, pain, (10%) redness or rash (rare). But the most common presenting symptom is breast swelling due to fluid around the implant caused by the lymphoma.
With the women who have been diagnosed with BIA-ALCL the average time for the disease to occur is about 7 to 10 years from the time of implantation (range 1 to 27 years). Biocell textured implants were in use many years prior to the time I started my private practice over 25 years ago. My main implant of choice through time has been saline-filled implants with the BioCell textured surface. I used saline implants because they are safe and textured surface implants because they were shown to decrease the risk of capsular contracture. The relationship of textured surface implants to a new disease is surprising and troubling. Allergan, from a manufacturing perspective, had no reason to consider that texturing the surface of an implant could lead to pocket pathology. However, as the data accumulated I decided to stop using textured implants in the Fall of 2018.
Patients need to consider the risks as there are known at the present time. 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 textured implants are considered together in the data analysis. Put this into perspective by considering the breast cancer risk in women is 1:7 to 1:8 women.
At the time I am updating this website there have been just over 800 cases of BIA-ALCL reported worldwide. In the United States, there have been about 300 cases. There have been about 33 deaths due to the disease reported worldwide.
In my practice, I have had one of my patients get this lymphoma which I diagnosed in December of 2019.
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 armpit (10%), pain, redness or rash (rare). When found early as a fluid collection 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.
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 oncologists 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. Simply exchanging implants to smooth walled implants is an easy thing for me to do with low surgical risk. There is no data presently to support the absolute need to do a full capsule removal which increases the surgical time and the risk of complications. Also, in reconstructed breasts with thinner tissue due to mastectomy a full capsule removal can thin the tissues more. Furthermore, although it seems logical that changing to a smooth-walled implant would decrease 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 reconstruction patients. So I will do this procedure 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 with textured implants have all of the same considerations. They can do a simple exchange to smooth walled implants or an exchange including full capsulectomy. Augmentation patients have much thicker tissue over the implants so the capsule removal is less likely to affect the look of the breasts. However, at this time there is no way to calculate the risk reduction benefit for either of the procedures. Although logic would say that changing to smooth-walled implants with or without capsulectomy 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.
The American Society of Plastic Surgery has patient information available about this problem and that information can be found at this link. Tap Here