Breast Implants and BIA-ALCL: What You Need to Know
In recent years a type of blood cancer called Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) has been found to affect a very small number of patients with textured breast implants. Plastic Surgeons from around the world have been working together to learn more about this condition. One thing that we now know is that it is very rare compared to other types of serious illnesses that men and women frequently develop. When detected early BIA-ALCL is a very treatable disease. We have recently learned that the condition only occurs in patients who have textured surface implants.
Health Canada has been following this condition and has recently stopped the sale and use of Allergan textured Biocell implants in Canada. Health Canada is not recommending that women with these implants have them removed. There have only been two types of textured implant used in Canada, one made by Allergan and the other by Mentor. Allergan is the maker of the implant which is no longer available for use in Canada because it has a higher risk of BIA -ALCL.
The primary purpose of this message is to notify you of the existence of ALCL, and to inform you of the early warning signs of this problem which, if present, must not be ignored.
Things to Look for: Symptoms of BIA-ALCL
Symptoms of BIA-ALCL almost always include a new and distinct swelling of your breast.
Less common findings in this condition include:
- Redness
- Changes in the firmness of the breast
- Lumps around one or both implants.
Usually, the swelling comes on fairly rapidly, over several days or weeks, not over months or years. Typically, this occurs on one side only, but in exceptional cases, it can occur in both breasts.
If you are experiencing any of these symptoms, please contact us. It is important that you know that the vast majority of patients who have symptoms like this do not have BIA-ALCL and do not require any treatment. However, for safety reasons you should contact our office if you develop any of these symptoms.
Generally, it is also a good idea to follow up with your plastic surgeon periodically (every 2-3 years) to ensure that your implants are still intact and not producing any unwanted side effects.
Please call my office if you have any questions or concerns. My staff is very knowledgeable about this condition.
Additionally, I want to remind you of the importance of ongoing breast health surveillance including self-breast exams and mammograms scheduled by your family physician as we know that breast cancer is a condition that affects one in 10 women but is unrelated to BIA ALCL which has a risk that is thousands of times less frequent than breast cancer.
You may also be interested to read the FAQ at https://www.plasticsurgery.org/patient-safety/bia-alcl-summary/frequently-asked-questions
Please feel free to call 905 451 5855, email [email protected] or submit any questions you may have.
Frequently Asked Questions
BIA-ALCL is Breast Implant-Associated Anaplastic Large Cell Lymphoma, a T-cell lymphoma that can arise around breast implants placed for either reconstructive or cosmetic indications. Currently, the cause of BIA-ALCL is not clearly understood.
It is estimated that there are 35 million women worldwide who have breast implants. The trueincidence of BIA-ALCL is hard to estimate. To date,the estimated incidence rates in scientific literature range from 0.03% to 0.003%, or 1 in 3,817 to 1 in 30,000.
International health regulatory agencies are proactively working with implant manufacturers to study BIA-ALCL. To date, no specific risk factors have been identified, however implant texture,
genetics, and bacteria have been implicated and are undergoing further study.
BIA-ALCL is most commonly reported at an average of 8–10 years following implant placement. The first symptoms are usually a swelling of the breast—often caused by fluid building up around the implant. Other symptoms can include pain, lumps, and unevenness between breasts.
Yes. When diagnosed early by a surgical specialist, BIA-ALCL can be treated, often successfully. In most cases, BIA-ALCL can be treated by removing the breast implant and surrounding scar capsule, however, additional treatment may be necessary depending on the individual. In cases where the disease has spread throughout the body, rare cases of death have been reported.
Yes. When diagnosed early by a surgical specialist, BIA-ALCL can be treated, often successfully. In most cases, BIA-ALCL can be treated by removing the breast implant and surrounding scar capsule, however, additional treatment may be necessary depending on the individual. In cases where the disease has spread throughout the body, rare cases of death have been reported.
Breast implants have different surface textures, including smooth or textured. For cases reported to date, BIA-ALCL has been seen most often in patients with textured implants, however the risk of developing BIA-ALCL with textured implants is low. Although it is difficult to quantify the true incidence and prevalence of BIA-ALCL, to date the estimated incidence rates range from 0.03% to 0.003%, or 1 in 3,817 to 1 in 30,000.
For patients who currently have implants and are not experiencing any problems, international health regulatory agencies (i.e., United States Food and Drug Administration [FDA], Health Canada, United Kingdom Medicines and Healthcare Products Regulatory Agency [MHRA], France’s Agence Nationale de Sécurité du Médicament [ANSM], Australia’s Therapeutic Goods Administration [TGA]) do not recommend removal of the implants or any changes to their routine medical care.
If you are considering getting implants, ask your surgeon about the risks of BIA-ALCL, and what it means.
Patient safety is Allergan’s first priority. They are working closely with leading surgeons worldwide to increase awareness of the disease and the importance of early diagnosis. Allergan will continue to work with the medical community to further the understanding of this disease. Allergan also provides rare-events coverage, up to $5,000 USD, for its products in cases of BIA-ALCL.
Patients with Allergan implants are eligible for assistance with out-of-pocket surgical costs, not covered by insurance, including removal of the breast implant(s) and associated tissue.
