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 FDA concurs with the World Health Organization that BIA-ALCL is a rare 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.
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 women with breast implants.
Q2. What is BIA-ALCL?
A2. BIA-ALCL is not breast cancer. According to the World Health Organization, BIA-ALCL is a rare T-cell lymphoma that can develop following breast implants.
Q3. Is BIA-ALCL breast cancer?
A3. No. Even though BIA-ALCL is found in the breasts of some women with breast implants, it is not breast cancer. 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.
Q4. What are the symptoms of BIA-ALCL in women?
A4. 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, evidence of fluid collection around the breast implant (seroma) was observed. Some patient reports indicated that a palpable mass or capsular contracture (thick and noticeable scar capsule around the implant) were present.
Q5. Where in the breast has BIA-ALCL been found?
A5. 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 effusion fluid (seroma) surrounding the implant or contained within the fibrous scar capsule. [Modified from Thompson et al, 2010]
Q6. Does the surface texture of the breast implant shell – smooth versus textured – increase a woman's risk of developing BIA-ALCL?
A6. At this point, the data suggest that BIA-ALCL occurs more frequently following textured than smooth breast implants, though more work needs to be done to understand the risk factors for the disease.
Q7. Does the fill of the breast implant – silicone versus saline – increase a woman's risk of developing BIA-ALCL?
A7. 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 women with silicone-filled breast implants compared to women with saline-filled breast implants.
Q8. What should health care providers and patients do?
A8. The FDA is recommending that health care providers continue to provide their patients routine care and support. BIA-ALCL is a rare condition; when it 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, prophylactic breast implant removal in patients without symptoms or other abnormality is not recommended.
At this time, the FDA recommends that health care professionals:
- Be aware that most confirmed cases of BIA-ALCL have occurred in women with textured breast implants. Provide the manufacturers' labeling as well as any other educational materials to your patients before surgery and discuss with them the benefits and risks of the different types of implants.
- Report all confirmed cases of BIA-ALCL in women with breast implants to Medwatch, FDA's safety information and adverse event reporting program. Report online at http://www.fda.gov/Safety/MedWatch/default.htm or by calling 1-800-332-1088.
- Consider the possibility of ALCL when they have a patient with late onset, persistent fluid around the implant (peri-implant seroma). When testing for ALCL, collect fresh seroma fluid and representative portions of the capsule and send for pathology tests.
- See FDA's BIA-ALCL Web page for additional recommendations.
FDA is recommending that women:
- Educate themselves about breast implants and discuss the risks and benefits of the types of implants with their doctors before agreeing to surgery.
- Continue their routine medical care and follow-up. BIA-ALCL is rare.
- Monitor their breast implants and contact their doctors promptly if they notice pain, swelling or any changes in or around their breast implants. There is no reason to contact their doctors if they have no symptoms.
Q9. How can health care professionals report cases of BIA-ALCL in their patients?
A9. Health care professionals should
- Report all confirmed cases of ALCL in women with breast implants to the FDA. 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 to contribute to a better understanding of the causes and treatments of BIA-ALCL.
Q10. If a woman is considering breast implants, what should she do?
A10. If a woman is considering breast implant surgery, she should discuss the risks and benefits of the procedure with her doctor. FDA also has some helpful information on its Web site for consumers (www.fda.gov/breastimplants).
Q11. Where can we find more information?
A11. The documents discussed above and other information can be found on the FDA website: