A1. The FDA review of literature published from January 1997 through May 2010 identified 34 unique cases of ALCL in women with breast implants worldwide. In addition, the FDA has received information from other international regulatory agencies, scientific experts and breast implant manufacturers. Altogether, the agency is aware of approximately 60 cases of ALCL in women with breast implants.
Based on all evidence available to us at this time, the FDA believes that women with breast implants may have a very low but increased risk of developing ALCL.
A full summary of FDA’s findings have been posted on FDA’s Web site in a document titled Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: Preliminary FDA Findings and Analyses.
Q2. What is anaplastic large cell lymphoma (ALCL)?
A2. ALCL is not breast cancer. According the National Cancer Institute, ALCL is a rare malignant tumor (non-Hodgkin lymphoma) that may appear in several parts of the body including the lymph nodes, skin, bones, soft tissue, lungs or liver. According to the National Cancer Institute, an estimated 1 in 500,000 women per year in the U.S. is diagnosed with ALCL. ALCL in the breast is even rarer. Approximately 3 in 100 million women per year in the U.S. are diagnosed with ALCL in the breast.
Q3. Is ALCL breast cancer?
A3. No. Even though ALCL has been found in the breasts of some women with breast implants, it is not breast cancer. ALCL is a type of 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 ALCL in women with breast implants?
A4. The main symptoms of ALCL in women with breast implants were persistent swelling or pain in the vicinity of the breast implant. These symptoms were noted to occur well after the surgical incision had 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 ALCL been found in women with breast implants?
A5. In the case studies reported in the literature, the ALCL was 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 ALCL?
A6. Some scientists have suggested that a textured surface may be a risk factor for ALCL, but this has not been evaluated in a large, well-designed, epidemiologic study. Most of the ALCL cases reported in breast implant patients failed to include information about the texture of the shell. Therefore the FDA cannot determine whether ALCL may be found more or less frequently in women with textured breast implants compared to women with smooth breast implants.
Q7. Does the fill of the breast implant – silicone versus saline – increase a woman’s risk of developing ALCL?
A7. Some scientists have suggested that the type of implant fill may be a risk factor for 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. ALCL is a very 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 is recommending that health care professionals:
- Report all confirmed cases of 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 Medical Device Safety Communication for additional recommendations.
FDA is recommending that women:
- Continue their routine medical care and follow-up. ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants.
- 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.
- Women who are considering breast implant surgery should discuss the risks and benefits of the procedure with their doctors.
Q9. How can health care professionals report cases of ALCL in their patients?
A9. Report all confirmed cases of 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.
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:
- FDA Breast Implant Information
- FDA Medical Device Safety Communication: Reports of Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants
- Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings & Analyses