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Breast Implant Associated ALCL

Women considering breast augmentation, or those who already have breast implants, may have read or heard about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). BIA-ALCL is an uncommon illness linked to certain implants, which has been the subject of many news stories and discussions on social media. The information about this condition is constantly being updated and research is ongoing. Dr. Mosher wants to ensure our patients who have implants or those that are considering breast augmentation remain fully informed about this disease.

Based on clinical information provided by the American and Canadian Societies for Aesthetic Plastic Surgery, we’ve created this page and one about BII to help answer your questions.

Frequently Asked Questions

Q: What is BIA-ALCL?

A: BIA-ALCL (Breast Implant Associated-Anaplastic Large Cell Lymphoma) is an uncommon disease that can occur in association with textured surface breast implants.  BIA-ALCL is not a cancer of the breast tissue itself. When identified and treated early, it is readily curable with surgery. If the disease is advanced, in addition to surgery, adjunctive therapies may be needed such as chemotherapy or radiation. Worldwide there have been several hundred cases reported and some deaths attributed to this disease.

Q: What are the symptoms of BIA-ALCL?

A: The most common feature or  symptom of BIA-ALCL is significant swelling of the breast between 2 to 28 years after the insertion of breast implants, with an average onset of about 8 years after implantation. The swelling is due to a collection of fluid surrounding the implant. This fluid can cause the breast to enlarge significantly over a period of days or weeks. BIA-ALCL can also present as a lump in the breast or armpit, a change in the firmness of the breast, or pain. When these occur, patient should be reassured that these symptoms more commonly occur with benign disease in patients with breast implants. Seeking the advice of your doctor whenever there are changes noted is an important step in making the correct diagnosis and then successfully treating this disease.

Q: What is the risk of developing BIA-ALCL?

A: Worldwide, all cases of BIA-ALCL have involved the use of textured surface implants made by a variety of companies. In Canada, two implant manufacturers were approved to sell textured breast implants. Both have have been associated with documented cases of  BIA-ALCL. Based on current data, the lifetime risk can be stratified by the texture grade of the implants as follows:

• Grade 1 (Smooth only) – The current lifetime risk is considered to be zero.
• Grade 2 (e.g. Microtexture, Siltex and similar) – 1:82,000
• Grade 3 (e.g. Macrotexture, Biocell and similar) – 1:3,200
• Grade 4 (e.g. Polyurethane) – 1:2,800*

Q. Have there been any deaths due to BIA-ALCL?

A. There have been a few confirmed deaths attributed to BIA-ALCL since the disease was first reported nearly 20 years ago. This includes one patient in Canada. Current protocols for treatment of BIA-ALCL have resulted in a high degree of success and possible long-term cure. If diagnosis is delayed, then BIA-ALCL can spread outside of the breast and the prognosis becomes more guarded.

Q: Does BIA-ALCL occur with saline or silicone implants?

A: Of the 400-plus reported cases of BIA-ALCL, approximately three-quarters included information on the specific types of implants used. Of those, two-thirds of the implants were silicone gel filled and one-third of those reported were implants filled with saline. It currently appears that the risk is purely related to the surface of the implant and not to what the implant is filled with.

Q: How does this disease impact those with breast implants?

A: Patients should know what type, and specifically what texture is present on their implants. BIA-ALCL remains uncommon and therefore the Plastic Surgery National Societies and country specific health regulators emphasize that the most important issue for women with breast implants is to screen for breast cancer. This can be done with regular self-exam, an annual physician exam, and mammography/ultrasound/MRI as recommended by their physician. All women with implants should see their physician, their primary care or their plastic surgeon,  promptly when they note a significant change to the size, feel, or shape of their breasts.

Q: Why would my surgeon have recommended textured implants for me?

A: Worldwide, textured surface breast implants have been the most commonly recommended by Plastic Surgeons. Some studies indicate that texturing on the implant surface reduced some implant related complications compared to smooth surfaced implants. This benefit was thought to be more helpful for some patient situations than others. Textured and smooth implants have been approved for use in Canada for more than 30 years. Furthermore, anatomically shaped or “tear drop” shaped devices are only manufactured with a textured surface. For many years and prior to our current understanding about BIA-ALCL, textured implants were recommended for about 40% of our cosmetic breast enhancement patients. Although some textured implants remain available in Canada, we no longer recommend these devices because of the uncommon but serious nature of BIA-ALCL.

Q. How is BIA-ALCL treated and what is the prognosis?

A: Similar to the management of other malignancies, treatment protocols have been established for this disease. Prior to treatment, all patients with BIA-ALCL undergo a thorough assessment to help establish the “stage” of their disease. When confined to the space around the breast implants or the adjacent breast implant capsule – removal of the implant and capsule on both sides is recommended. For these patients diagnosed early, all but a few have been fully resolved by this surgery. However for those with a higher stage of disease, the lymphoma affects tissues at a distance from the breast and chemotherapy or radiation therapy may be recommended. Approximately 15% of patients have this more advanced disease at the time of their initial diagnosis.

Q. Should patients have their implants removed because of a risk of BIA-ALCL?

A: Since BIA-ALCL has only been associated with textured breast implants, patients with smooth implants do not need to be concerned. According to current FDA and Health Canada recommendations, patients with textured implants do not need to have their implants preventatively removed. Women who have concerns about BIA-ALCL should meet with their Plastic Surgeon to discuss whether it makes sense to leave their textured implants in place, replace their implants with smooth-surfaced devices, or remove their implants completely. At YES, we have extensive experience counselling, assessing, and when necessary, performing expert revisional breast implant surgery.

Q: Should women with breast implants be screened for BIA-ALCL?

A: There is no blood test to specifically screen for BIA-ALCL. The expert opinion is that asymptomatic women without breast changes do not require more than routine mammograms and breast exams. But if a patient experiences a change in her breasts – especially if there is swelling or a lump – she should undergo immediate examination, imaging, and subsequent consultation with a plastic surgeon. If there is fluid around the implant the fluid should be aspirated under ultrasound guidance and sent for analysis. This is most commonly performed by an interventional Radiologist.

Q: What causes BIA-ALCL?

A: Many different medical organizations and implant manufacturers are intensely studying BIA-ALCL. To date, no specific causal factors have been identified. Implant texturing, bacteriologic contamination and genetic factors have been implicated and are undergoing further study. The best available information is that a combination of four factors is required for the development of BIA-ALCL

1. Texturing of the implant

2. Chronic bacterial inflammation around the implant – the source is unknown

3. Genetic pre-disposition (specifics are not yet determined)

4. Time (2 or more years are required)

These factors seem to have a common role in many forms of non-Hodgkin’s lymphoma. Data collection and research are ongoing.

Q: Does Dr. Mosher recommend against the use of textured implants?

A: Although Health Canada and other regulatory agencies around the world continue to approve the use of some textured breast implants until we know more, Dr. Mosher does not recommend textured breast implants for cosmetic breast surgery.  Using smooth breast implants still allows for a high degree of patient satisfaction as well as a customized approach.

Q: Is the removal of textured implants covered by insurance?

A: At the present time, Provincial medical coverage does not cover the costs associated with the removal of textured breast implants unless the implant is ruptured or unless there is a diagnosis of BIA-ALCL. As the scientific information evolves, Provincial policy may change. For patients with Allergan (Biocell) textured breast implants, replacement smooth Allergan implants of a similar size may be provided by the manufacturer at no charge to the patient.

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