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 of the immune system. To date, BIA-ALCL has only been found in patients with breast implants that have a rough surface, 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: As of January 2020, the Food and Drug Administration (FDA) received 733 reports of BIA-ALCL. These included 36 deaths. However, this number may include duplicate and unverified cases. The ASPS/FDA PROFILE Registry contains 364 unique cases in the US as of June 30, 2021. 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.
Importantly, BIA-ALCL has been identified in patients with all types of 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 1:355 to 1:30,000 in women with textured implants. Risk may change based on implant manufacturer. For example, the risk appears to be higher with implants that have a rougher surface compared to those whose surface is less rough.
Q: What does the FDA say about BIA-ALCL?
A: The FDA states that BIA-ALCL is uncommon and can be cured if caught early. 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 diagnosed with BIA-ALCL will need surgery to treat their disease. All cases of BIA-ALCL cases should be reported to the PROFILE registry for detailed tracking. (ThePSF.org/PROFILE)
If women with breast implants have no symptoms or signs of BIA-ALCL, 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. As of June 30, 2021, the PROFILE registry* has recorded 364 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, over 1,000 cases have been reported. Among these, 28 patients have died.
The ASPS and ASAPS offer free online tools to help inform patients about the disease. The risk of BIA-ALCL is low, but patient safety is the primary focus of the plastic surgery community. Educating and informing our members and the public about BIA-ALCL symptoms and risks is of the utmost importance.
Q: Can you explain the differences in implant texture and what role it plays in research?
A: BIA-ALCL seems to occur in only women who have or have had textured breast implants. The reasons why some women develop BIA-ALCL is not fully understood. Scientists are studying different factors that may contribute to development of the disease. These factors include irritation from textured implant particles on the surface of an implant, the body's immune reaction to a foreign body and/or the body's reaction to bacteria that may be present on a breast implant.
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. 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.
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 of any type. 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.
Q: How is BIA-ALCL treated and what happens during the disease?
A: BIA-ALCL is diagnosed and treated based on the National Comprehensive Cancer (NCCN) guidelines. These guidelines are written by experts in the field and outline steps that should be taken in the diagnosis and treatment of different cancers. (The NCCN guidelines for BIA-ALCL available on the ASPS and ASAPS websites.) The current treatment for BIA-ALCL is removing the breast implant entirely, removing the scar tissue (capsule) around a breast implant and removing any related lumps or masses. For some patients, both breasts are affected. Surgeons may therefore remove implants and capsules from both breasts.
Surgery will offer a cure for most patients with BIA-ALCL. Most patients in the early stages of BIA-ACL do not need further treatment. Patients may 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 breast implants in women without symptoms. These women also do not need extra testing to look for BIA-ALCL.
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 may include swelling of the breast or a lump in the breast or in the underarm.
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 approved 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.
One specific brand of textured breast implants, called Allergan Biocell, was recalled in July 2019 and is no longer available in the United States for implantation.
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 recommend using breast imaging to see if there is any fluid around an implant or if there is the presence of a lump or mass next to the device.
If The fluid should be removed using a needle. As much fluid as available (at least 50 mL) should be sent for
- CD30 immune staining
- 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 surgery.org/professionals.
Q: After diagnosis, what tests are performed before surgery?
A: After BIA-ALCL is diagnosed, positron emission tomography (PET) and/or computer tomography (CT) scanning can help doctors know if the cancer has spread to other parts of the body. Doctors can use these scans to the stage of the disease. Patients with BIA-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) or ultrasound (US) after five years and then every two to three years for the life of the implant. This helps detect implant ruptures. Implant patients should undergo regular check-ups. These may include tests for complications such as capsular contracture.
Q: Where can I find more information on BIA-ALCL?
A: Further information, downloadable manuscripts and resources on BIA-ALCL are available online. Go to: ThePSF.org/PROFILE and at PlasticSurgery.org/ALCL. Further resources are found in the Medical Professionals section of Surgery.org, and by searching "ALCL" on RADAR.
Reporters seeking information or plastic surgeons contacted by a member of the media are encouraged to forward inquiries to:
- ASPS Media Relations Office at email@example.com or (847) 228-3333.
- Sarah Lebrum at firstname.lastname@example.org or (562) 799-2356.
This information represents data known as of June 30, 2021. Updates to this document will be provided as warranted and as more information becomes known.
- Indolent: An indolent cancer is one that progresses slowly.
- CD30: CD30 is a substance that normally occurs on activated T-cell lymphocytes. It also is found rarely in some lymphomas. Testing for CD30 through a process called immunohistochemistry can indicate BIA-ALCL. This test should be performed on all fluid that collects more than one year after implantation. If CD30 is not detected in the fluid, BIA-ALCL can be excluded. If CD30 is detected, this may indicate BIA-ALCL. Before a doctor can make a final diagnosis, two other tests should be done: cell block cytology and flow cytometry.
- Lymphoma: Lymph cells are part of the body's immune system. They help protect the body and rid it of anything that might harm it. A lymphoma is cancer of the lymph system. Lymph nodes are glands. They are part of the lymph system. They are present in many places in the body.
- PROFILE Registry: The ASPS, The PSF and the FDA created the PROFILE Registry in 2012. It prospectively tracks confirmed BIA-ALCL patients in the US. PROFILE data are regularly updated and are available on the internet at ThePSF.org/PROFILE.
- National Comprehensive Cancer Network (NCCN): An alliance of 27 US cancer centers. It establishes a consensus diagnosis and treatment recommendations for most known cancers. In 2016, NCCN established guidelines for BIA-ALCL that are based on research data.
- Capsular Contracture: A reaction by the immune system when there are foreign material(s) in the body.
- Textured Implant Particles: Small pieces of the rough surface of an implant.
- Cell Block Cytology: A technique in which doctors examine cells by taking out small bits of tissue in fluid removed through a fine needle, making them into a concentrated solution and then checking them.
- Flow Cytometry: A technology to analyze the physical and chemical characteristics of particles in a fluid as they pass through a laser.
- Inflammation: Occurs when a part of the body becomes red, swollen, hot and often painful, especially because of an injury or infection.
- Anaplastic Cell: Large abnormal cells.
- Clonal Expansion: A cancer cell that replicates itself.