The American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS) together make efforts to update the public twice a year. These updates cover recent discoveries about diseases, notices from the government, and advice from groups of experts in the US and worldwide. This document is part of these efforts.

Q: What is BIA-ALCL?

A: BIA-ALCL stands for Breast Implant-Associated Anaplastic Large Cell Lymphoma. It is an uncommon cancer found only in patients with breast implants that have a rough surface. These implants are known as textured implants. When BIA-ALCL is caught early, it can be cured in most patients. BIA-ALCL is not a cancer of the breast tissue. Instead, it is located in the scar tissue that naturally forms around the implant. This tissue is called the capsule.

The disease is slow growing in most patients. BIA-ALCL may affect the lymph nodes, but it rarely spreads to tissues further away. Researchers are currently trying to understand BIA-ALCL better.

Q: What are the symptoms of BIA-ALCL?

A: The most common symptom of BIA-ALCL is a swelling of the breast. This swelling develops over several years after a patient receives breast implants. On average, this swelling develops eight years after receiving the implant, but the range is 2-28 years. A lump in the breast or armpit may also appear.

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

A: In March 2018, the Food and Drug Administration (FDA) received 414 reports of side effects related to BIA-ALCL. These included nine deaths. However, this number may include duplicate and unverified cases. The ASPS/FDA PROFILE Registry contains 230 unique cases in the US. Every year, doctors in the US perform around 300,000 surgeries to increase the size of breasts and 150,000 surgeries to rebuild breasts. Of these, around 12% of the patients receive textured implants.

The risk of BIA-ALCL over a lifetime is based on data from risk studies in the US, Canada, the Netherlands, and Australia. This risk ranges from 1:1000 to 1:30,000 in people with textured implants. Risk may change based on implant manufacturer. The risk is higher when the implants have rougher surface than when they have less rough surface. BIA-ALCL has been identified in patients with all types of textured implants though the risk may be different. BIA-ALCL has not been found in patients with only smooth implants.

Q: What did the latest FDA statement say in regards to BIA-ALCL?

A: In March 2018, the FDA stated that BIA-ALCL is uncommon and can be cured. It is most common in patients with textured implants. The FDA agrees with the World Health Organization (WHO) that BIA-ALCL is a lymphoma. It supports the National Comprehensive Cancer Network (NCCN) treatment guidelines.* Most patients have to have surgery. BIA-ALCL cases should be reported to the PROFILE registry for detailed tracking. If women with breast implants have no symptoms, they do not need to change their routine medical care and follow-up.

The ASPS and ASAPS are funding studies to find out the causes and cures for this cancer.

Q: Is BIA-ALCL a major concern?

A: All women planning to get breast implants should know that there is a risk of BIA-ALCL. The disease is uncommon, but any procedure with the risk of a patient’s death is a major concern. Patients should know about the risk before breast implant surgery. As of September 19, 2018, the PROFILE registry* has recorded 239 cases of BIA-ALCL in the US. Of these, 56% had received implants to make their breasts bigger or fuller, and 44% had their breasts rebuilt after they had been removed. Worldwide, 595 cases have been reported. Among these, 16 patients have died.

The ASPS and ASAPS offer free online tools to help patients to understand this disease. ALCL risk is low, but patient safety is the primary focus of the plastic surgery community. We try to educate and inform our members and the public about BIA-ALCL symptoms and risks.

Q: Can you explain the differences in implant texture and what role it plays in the research?

A: BIA-ALCL seems to occur in only women who have or have had textured implants. BIA-ALCL could be caused by textured implant particles, having allergies to the implants for a long time, or from reacting to bacteria on the implant surface. Scientists are studying these factors.

Worldwide, the risk of BIA-ACL does not seem to differ between patients with silicone- and saline-filled implants. The risk of BIA-ACL seems the same for patients who get implants to rebuild their breasts and those who get implants to make their breasts bigger or fuller.

Q: How does this impact women with breast implants?

A: ASPS, ASAPS, and the FDA encourage all women to follow their normal medical care and follow-up routines. This includes an x-ray of the breasts when appropriate. Women with breast implants should also follow these guidelines. Patients should contact their doctors at once if the breast looks abnormal or changes remarkably. Patients without symptoms do not need special tests for BIA-ALCL.

Fluid can collect around the implants and within the implant capsules. This is usually not cancerous. However, if fluid collects several years after implantation, it should be considered suspicious.

Q: What about patients considering breast implants?

A: Doctors should include BIA-ALCL in the materials given to patients who are thinking about getting breast implants. Patients should be told about BIA-ACL before they give their doctors permission to do any surgery. This allows patients to choose the right type of surgery for them. Many researchers have studied breast implant use. There is data on the safety of these implants in the long run.

Q. How is BIA-ALCL treated and what happens during the disease?

A. BIA-ALCL is diagnosed and treated based on the NCCN guidelines. (The algorithm is available on the ASPS and ASAPS websites.) The current treatment recommended for BIA-ALCL is removing the breast implant entirely and removing any related lumps or masses. For some patients, both breasts are affected. Surgeons may therefore remove implants and capsules from both breasts.

So far, researchers have found that BIA-ALCL affects only the scar tissue around the breast capsule. Removing this completely through surgery cured most patients. Most patients in the early stages of BIA-ACL did not need further treatment once the implant was entirely removed. Patients need cancer medications when surgery cannot completely remove the disease or if the disease spreads to the lymph nodes or other parts of the body.

Q: Should healthy patients have their implants removed just in case?

A: The FDA does not suggest the removal of implants for women without symptoms. These women also do not need extra testing.

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

A: The FDA advises that women without breast changes need only routine follow-up. If a patient experiences a change in her breasts, she should see her doctor. These changes could be swelling or a lump in the breast. In this case, the patient should receive an examination, imaging, and testing of any fluid present.

Q: How is BIA-ALCL currently being studied to find the cause?

A: Several groups are studying BIA-ALCL. These are ASPS, the Plastic Surgery Foundation (The PSF), ASAPS, the Aesthetic Surgery Education and Research Foundation (ASERF), and the FDA. Research is ongoing. Diagnosed cases are being monitored. Worldwide, the concentrations of reported cases vary. Some areas have reported few cases. Ongoing, worldwide data collection will help determine gene factors that may increase the risk for BIA-ALCL.

Q: Does the FDA say that textured implants should not be used?

A: The FDA says that all breast implants are safe when used properly. Plastic surgeons should inform their patients about any known risks and any complications that might occur. Patients and surgeons should openly discuss available treatment options and their risks. This discussion should include BIA-ALCL. They should talk openly about the benefits and risks of both smooth and textured implants. Then, the patient must make an informed decision. This decision should be based on her needs and the risks involved. If the surgeon examines the patient and finds that both smooth and textured implants are equally good for her, a smooth implant may be best.

Q. What should doctors do if their patients show symptoms that suggest they might have BIA-ALCL?

A. BIA-ALCL should be diagnosed using the NCCN international recommendations.* The NCCN guidelines include using breast imaging to detect fluid, a mass, or lymph node swelling.

The fluid should be removed using a needle. As much fluid as available (at least 50 mL) should be sent for:

1. CD30 immune staining
2. Cytology and flow cytometry

CD30 is a substance that indicates the presence of this kind of cancer. Immune staining is a way of checking for CD30. CD30 testing provides information critical for pathologists. Doctors should try to confirm a diagnosis before surgery.

*In July 2016, ASPS and ASAPS issued a joint “Tear Sheet.” This describes the recommended clinical treatment for patients with symptoms that suggest they might have BIA-ALCL. These recommendations were the framework for the NCCN guidelines. For a copy of the ASPS/ASAPS Tear Sheet, please go to: Joint ASPS-ASAPS Statement On Breast Implant-Associated ALCL. The document may also be accessed on the ASAPS website at: http://www.surgery.org/professionals.

Q. After Diagnosis, what tests are performed before surgery?

A. An x-ray of the breast is not useful for diagnosing BIA-ALCL. After it is diagnosed, positron emission tomography (PET) computer tomography (CT) scanning can help doctors know what stage the disease is. Doctors can use these scans to examine the spread of the cancer to lymph nodes or other organs. Patients with ALCL should consult a cancer specialist before any surgery.

Q: Should patients who already have textured implants be followed on a routine basis, i.e., annually?

A: Currently, there are no guidelines about testing for BIA-ALCL. The FDA recommends that after surgery, patients be tested using magnetic resonance imaging (MRI) after three years and then every two years. This helps detect implant ruptures. Implant patients should undergo regular check-ups. These may include tests for complications such as capsular contracture. Depending on their age, they should have breast x-rays for breast cancer. They should also examine their breasts every month.

Q: Where can I find more information on BIA-ALCL?

A: Further information, downloadable manuscripts and resources on BIA-ALCL are available online at www.thepsf.org/PROFILE and at www.plasticsurgery.org/ALCL. Further resources are found in the Medical Professionals section of www.surgery.org aand by searching “ALCL” on RADAR.

Reporters seeking information or plastic surgeons contacted by a member of the media are encouraged to forward inquiries to:

• Adam Ross, ASPS integrated communications manager, at aross@plasticsurgery.org or 847-228-3361.
• Leigh Hope Fountain at leigh@surgery.org or Sarah Lebrum at sarah@surgery.org or 562-799-2356.

This information represents data known as of September 26, 2018. Updates to this document will be provided as warranted and as more information becomes known.