There is nothing more important to the physicians and staff at Marietta Plastic Surgery than the safety of our patients. We want women to feel confident in FDA-approved breast implants and in their decision to have breast augmentation or reconstructive surgery. We understand recent media coverage may have created concern for our patients. We take these concerns very seriously, and would like to provide you with an update on BIA-ALCL.
*Actual Patient
Empowering Awareness
BIA-ALCL is a rare and highly treatable type of lymphoma that can develop around breast implants. BIA-ALCL occurs most frequently in patients who have breast implants with textured surfaces. This is a cancer of the immune system, not a type of breast cancer. The current lifetime risk of BIA-ALCL is estimated to be 1:3817 – 1:30,000 women with textured implants based upon current confirmed cases and textured implant sales data over the past two decades. When detected early, BIA-ALCL is usually curable.
Identifying Symptoms and Risks
Common symptoms include breast enlargement, pain, asymmetry, lump in the breast or armpit, overlying skin rash, hardening of the breast, or a large fluid collection typically developing at least more than one year after receiving an implant, and on average after 8 to 10 years. For any patient experiencing these or any symptoms, they should see their doctor for evaluation.
BIA-ALCL has been found with both silicone and saline implants and both breast cancer reconstruction and cosmetic patients. To date, there are not any confirmed BIA-ALCL cases that involve only a smooth implant. BIA-ALCL patients seem to have an allergic reaction to textured devices over many years. Currently, it is not possible to test for who is at risk of this disease.
Considering Reconstruction with Implants?
Breast cancer patients considering implant reconstruction should discuss the benefits and risks of different types of implants with their physician. There are many breast implant options such as smooth, textured, round, shaped, saline, and both liquid and solid silicone.
A physician may suggest a certain implant shape, surface and fill to achieve an optimal reconstruction while minimizing potential complications. BIA-ALCL is a rare risk associated with textured implants and patients should be aware when choosing the implant that is right for them.
Have you developed symptoms?
The most common symptoms are unexplained breast enlargement, asymmetry, fluid buildup or a lump in the breast or armpit. These symptoms are not specific for BIA-ALCL, therefore if you have any of these symptoms it does not mean you have BIA-ALCL. Women who develop these symptoms should see their physician to be evaluated with a physical exam and further testing.
- Schedule a follow-up appointment one of our board certified plastic surgeons to discuss and concerns you may have about your breast health.
- Following a physical examination, patients with BIA-ALCL symptoms may receive an ultrasound or a magnetic resonance imaging (MRI) of the symptomatic breast to evaluate for fluid or lumps around the implant and in the lymph nodes.
- If fluid or a mass is found, patients will require a needle biopsy with drainage of the fluid to test for BIA-ALCL. This fluid will be tested for CD30 immune staining (CD30IHC) performed by a pathologist. Testing for CD30IHC is required to confirm a diagnosis or rule out BIA-ALCL. Fluid collections ruled out by CD30IHC for BIA-ALCL will be treated as typical seromas by a physician. Specimens not testing for CD30 may miss the diagnosis of BIA-ALCL.
Have you been Diagnosed with BIA-ALCL?
Receiving the diagnosis of BIA-ALCL may cause anxiety and frustration but women should know that not all cancers are equal. When caught early, BIA-ALCL is curable in almost all patients.
Marietta Plastic Surgery endorses BIA-ALCL guidelines established by the National Comprehensive Center Networ (NCCN), which defines diagnosis and treatment based on proven methods to treat the disease.
Step by Step Treatment of BIA-ALCL
- When a woman is diagnosed with BIA-ALCL, her physician will refer her for a PET/CT scan to look for any disease that may have spread throughout the body. Any spread of the disease determines the stages, which is important for treatment.
- Newly diagnosed patients will be referred to an oncologist for evaluation of BIA-ALCL, staging of disease, and treatment planning.
- For patients with BIA-ALCL only around the implant, surgery is performed to remove the breast implant and the scar capsule around the implant.
- Lumps in the armpit may be disease that has spread to the lymph nodes or may still be a normal enlargement of the lymph nodes. Testing of the lymph nodes may be performed with a needle biopsy or with a surgery to remove a lymph node for testing. Additional tests may sometimes include blood tests and a bone marrow biopsy.
- Some patients with advanced cases may require further treatment with chemotherapy and in rare cases include radiation therapy and/or stem cell transplant therapy.
*Actual Patient
After Treatment
Following removal of the disease, patients are commonly followed for two years with imaging tests such as PET/CT scans in three- to six-month appointments. Disease re-occurrence is rare after surgical removal for early disease.
Reporting of Confirmed Cases
The U.S. Food and Drug Administration (FDA) specifically recommends that all confirmed cases be reported to the PROFILE registry. The PROFILE registry is a joint effort of the FDA and American Society of Plastic Surgeons/Plastic Surgery Foundation. If you have been diagnosed with BIA-ALCL, please ensure your physician has reported the case to the PROFILE registry for tracking of cases. Information reported to PROFILE is updated with the FDA on a monthly basis. While PROFILE is a physician reporting system, if you would like to report your case directly, you may contact PSF who can get you in contact with a physician willing and able to report your case.
BIA-ALCL Summary and Quick Facts
The following provides a summary of what is currently known about BIA-ALCL.
- Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare and treatable type of T-cell lymphoma that can develop around breast implants. BIA-ALCL is not a cancer of the breast tissue itself.
- The lag time between current implant insertion to diagnosis of BIA-ALCL has been from .08-27 years, with a mean of 9.2 years.
- No cases of BIA-ALCL have been reported with patients who have only had smooth implants in case series, case reports, or registries.
- The association of BIA‐ALCL and textured implants may be related to the increased surface area of the texturing; however, this has not yet been definitively proven. The variation in surface texturing among manufacturers may mean there are variable risks for the development of BIA-ALCL.
- The disease has been associated with both silicone and saline implants in aesthetic as well as reconstructive patients.
- The majority of patients present as a delayed seroma. Diagnosis is based on ultrasound‐guided fine needle aspiration of the peri-implant fluid, which is assessed with immunohistochemistry for CD 30-positive large anaplastic T-cell lymphocytes.
- The majority of patients can be cured of their disease by bilateral total capsulectomy and implant removal. Rare patients will present with a mass and have an increased risk of requiring radiotherapy and chemotherapy. Treatment approach should follow international guidelines established by the National Comprehensive Cancer Network (NCCN) for BIA-ALCL, available at nccn.org.
- Current treatment recommendation is for bilateral complete capsulectomy and implant removal, as a small number of women have had contralateral disease found incidentally.
