Medical Devices

Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Q1. What does the FDA know about BIA-ALCL?
A1. The FDA has updated its Web content about BIA-ALCL based on several advances in the description of the disease and treatment recommendations. The World Health Organization describes BIA-ALCL as a T-cell lymphoma that can develop following breast implants. At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces, and half of the reported cases were diagnosed within 7-8 years.

The FDA first identified a possible association between breast implants and the development of ALCL in 2011. At that time, the FDA knew of so few cases of this disease that it was not possible to determine what factors increased the risk. In a report summarizing the Agency's findings, we emphasized the need to gather additional information to better characterize ALCL in individuals with breast implants.

Q2. What is BIA-ALCL? Is BIA-ALCL breast cancer?
A2. According to the World Health Organizationdisclaimer icon, BIA-ALCL is a T-cell lymphoma that can develop following breast implants. Anaplastic Large Cell Lymphoma is a type of non-Hodgkin's lymphoma, a cancer of the cells of the immune system. It can occur in many different parts of the body, including the lymph nodes and skin. Even though BIA-ALCL is found in the breasts of some individuals (cis- and trans-gender women and men) with breast implants, it is not breast cancer.

Q3. What are the symptoms of BIA-ALCL?
A3. The main symptoms of BIA-ALCL are persistent swelling or pain in the vicinity of the breast implant. These symptoms may occur well after the surgical incision has healed, often years after implant placement.

Upon evaluation by a health care provider, evidence of fluid collection around the breast implant (seroma) is often observed. Some patient reports indicated that a lump under the skin or capsular contracture (thick and noticeable scar capsule around the implant) were present.

Q4. Where in the breast has BIA-ALCL been found?
A4. In the case studies reported in the literature, BIA-ALCL is usually found near the breast implant, contained within the fibrous scar capsule, and not in the breast tissue itself. The illustration below shows the location of the ALCL in these reports. In most cases, the ALCL cells were found in the fluid surrounding the implant (seroma) or contained within the fibrous scar capsule. [Modified from Thompson et al, 2010]

This illustration shows the breast implant placed under the skin and breast tissue. The implant is separated from the breast tissue by a fibrous scar capsule. ALCL lymphoma cells are shown in the effusion fluid between the breast implant and the capsule and attached to the capsule itself.

Q5. Does the surface texture of the breast implant shell–smooth versus textured–increase a woman's risk of developing BIA-ALCL?
A5. At this point, the data suggest that BIA-ALCL occurs more frequently in individuals with textured breast implants, though more work needs to be done to understand the risk factors for the disease.

Q6. Does the fill of the breast implant–silicone versus saline–increase an individual's risk of developing BIA-ALCL?
A6. The type of implant fill does not appear to be a risk factor for BIA-ALCL, but this has not been evaluated in a large, well-designed, epidemiologic study. To date, there has not been sufficient data to determine whether ALCL may be found more or less frequently in individuals with silicone-filled breast implants compared to individuals with saline-filled breast implants.

Q7. What should health care providers and patients do?
A7. The FDA is recommending that health care providers continue to provide their patients routine care and support. When BIA-ALCL occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma. Because it has generally only been identified in patients with symptoms such as pain, lumps, swelling, or asymmetry that occur after the surgical incision has fully healed, breast implant removal in patients without symptoms or other abnormality is not recommended.

See FDA's BIA-ALCL webpage for FDA’s recommendations for patients and health care professionals.

Q8. How can health care professionals report cases of BIA-ALCL in their patients?
A8. Health care professionals should:

  • Report all confirmed cases of ALCL in individuals with breast implants to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. In some cases, the FDA may contact you for additional information. The FDA will keep the identities of the reporter and the patient confidential.
  • Submit case reports of BIA-ALCL to the PROFILE Registry disclaimer icon to contribute to a better understanding of the causes and treatments of BIA-ALCL.

Q9. If an individual is considering breast implants, what should they do?
A9. If an individual is considering breast implant surgery, they should educate themselves about breast implants and discuss the risks and benefits of the procedure with their doctor. FDA also has some helpful information on its website for consumers (www.fda.gov/breastimplants).

Q10. Where can we find more information?
A10. The documents discussed above and other information can be found on FDA’s breast implant webpages:

Page Last Updated: 03/21/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English